SANOFI-AVENTIS U.S. LLC et al v. MYLAN N.V. et al

Filing 582

OPINION. Signed by Judge Stanley R. Chesler on 3/9/2020. (sm)

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
____________________________________
:
:
:
Plaintiffs,
:
:
v.
:
:
MYLAN GMBH et al.,
:
:
Defendants.
:
____________________________________:
SANOFI-AVENTIS U.S. LLC et al.,

Civil Action No. 17-9105 (SRC)

OPINION

CHESLER, U.S.D.J.
INTRODUCTION
Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi- Aventis Deutschland GmbH, and Sanofi
Winthrop Industrie (collectively, “Sanofi”) bring this action for patent infringement against
Defendants Mylan GmbH, Biocon Ltd., Biocon Research Ltd., Biocon Sdn. Bhd., and Biocon
S.A. (collectively, “Mylan.”) Plaintiffs own U.S. Patent No. 9,526,844 (“the ’844 patent”),
which is listed in the Orange Book as protecting Plaintiffs’ Lantus® SoloSTAR® insulin pen
product. Mylan GmbH has filed New Drug Application (“NDA”) No. 210605 seeking approval
to market an insulin pen product. Plaintiffs complain that, by filing this NDA with the United
States Food and Drug Administration, Defendants have infringed claims 21, 22, 25, and 30 of the
’844 patent. Mylan contends that the asserted patent claims are invalid, pursuant to 35 U.S.C. §
112 ¶ 1 and 35 U.S.C. § 103. A bench trial on patent infringement and patent validity was held
for 5 days, beginning on December 2, 2019, and ending on December 6, 2019. Upon hearing
1

the evidence presented at trial, this Court finds that Sanofi has failed to prove that claims 21, 22,
25, and 30 are infringed by Mylan’s NDA product, and Mylan has proven that the asserted
claims are invalid for failure to satisfy the written description requirement stated in 35 U.S.C. §
112 ¶ 1.

STIPULATED FACTS
The parties stipulated to the following facts in the Final Pretrial Order (“FPO”):
72.

The following documents are prior art to the Device Patents under 35 U.S.C. §
102:
a. U.S. Patent No. 4,865,591 (“Sams”)
b. U.S. Patent No. 6,235,004 (“Steenfeldt-Jensen”)
c. U.S. Patent No. 5,674,204 (“Chanoch”)
d. U.S. Patent No. 6,221,046 (“Burroughs”)
e. U.S. Patent No. 7,241,278 (“Møller”)
f. U.S. Patent No. 6,248,095 (“Giambattista ’095”)
g. U.S. Patent No. 6,582,404
h. U.S. Patent App. Pub. No. 2002/0052578
i. EU Patent Specification EP 0 608 343
j. Erdman Arthur G & Sandor, George N., Mechanism Design: Analysis and
Synthesis, 110-20 (Prentice Hall 1984)
k. Sclater, Neil & Chironis, Nicholas P., Mechanisms & Mechanical Devices
Sourcebook, 191-95 (McGraw Hill, 3d ed. 2001)
l. European Standard EN ISO 11608-1 (Dec. 2000)
2

THE ISSUES FOR TRIAL
1.

Have Plaintiffs proven, by a preponderance of the evidence, that Defendants’ NDA
product infringes claims 21, 22, 25, or 30 of the ’844 patent?

2.

Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
30 of the ’844 patent are invalid as obvious, pursuant to 35 U.S.C. § 103?

3.

Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
30 of the ’844 patent are invalid for lack of adequate written description, pursuant to 35
U.S.C. § 112 ¶ 1?

4.

Have Defendants proven, by clear and convincing evidence, that claims 21, 22, 25, and
30 of the ’844 patent are invalid for lack of enablement, pursuant to 35 U.S.C. § 112 ¶ 1?

THE EVIDENCE AT TRIAL
What follows are selected summaries of the testimony of the witnesses appearing in
Court at trial:
A.

Testimony of Robert Veasey

What follows is a summary of the witness’s testimony. Mr. Veasey is a co-inventor,
with Robert Perkins and David Plumptre, on the ’844 patent.

(Tr. 33:25-34:2.) The

SoloSTAR® pen injector is a commercial product that came from this project. (Tr. 36:19-21.)
The project to develop SoloSTAR® was named “Alpha.” (Tr. 38:8-10.) When he began work
on the Alpha project, three disposable injector pens were available to consumers, Opti Set,
Humalog, and Novo’s FlexPen, which was considered better than the others. (Tr. 38:11-22.)
The Alpha team studied the FlexPen and measured aspects of it, including the coefficient of
3

friction. (Tr. 39:2-8.) The coefficient of friction is a measure of the resistance to sliding of two
components in contact with each other. (Tr. 40:10-13.) The team derived a coefficient of
friction of .15 for the FlexPen, based on the measured value of the most critical friction interface
in the device, which was between the dial, the dose dial and the body. (Tr. 40:15-20.) Mr.
Veasey told Dr. Slocum that .1 was the lowest realistic value that one could achieve for the
coefficient of friction in a high-volume product like SoloSTAR® or FlexPen, if one used
tribological grades of polymers, which have additives in them that make them slip particularly
well. (Tr. 41:1-10.)
The team studied the FlexPen and found shortcomings, and designed the SoloSTAR® to
improve on them. (Tr. 42:4-20.) In the real world, the coefficient of friction affects the amount
of force a user must use to depress the pen button. (Tr. 44:4-16.) One goal for the design
project was a pen with low injection force, because the elderly diabetes population has lower
hand strength. (Tr. 46:15-47:15.) Another goal was a pen that had a maximum insulin dose of
80 units or more. (48:10-16.) SoloSTAR® is about 40 percent lower injection force than
FlexPen. (Tr. 50:20-21.) The ’844 patent embodies the team’s design concept 12. (Tr. 56:2557:1.) A patent application for the SoloSTAR® design was filed in Great Britain in March of
2003, and it has essentially the same specification as the ’844 patent has. (Tr. 57:9-23.)
The OptiClik was a reusable pen injector from Sanofi with a very different mechanism
from SoloSTAR®. (Tr. 58:7-13.) To date, about 3 billion SoloSTAR® pens have been sold.
(Tr. 61:4-5.) The SoloSTAR® has been awarded a number of industry awards. (Tr. 61:6-23.)
On cross-examination, Mr. Veasey said that he held an actual FlexPen at the end of 2001.
(Tr. 64:1-11.)
4

B.

Testimony of Charles Reinholtz

What follows is a summary of the witness’s testimony. Dr. Reinholtz was qualified as
an expert in mechanical engineering mechanisms as it relates to the issues of infringement in this
case. (Tr. 89:15-20.) Dr. Reinholtz identified exhibit PTX-894 as the assembled Semglee1
pen. (Tr. 92:12-14.) Becton Dickinson is the company that designed the Semglee pen. (Tr.
93:16-20.) As to ’844 claim 21, the parties have agreed that only three elements are disputed as
to infringement; the first is 21e. (Tr. 97:4-25.)
Limitation 21e states: “A sleeve that is disposed between the dose indicator and the
driving member and releasably connected to the dose indicator.” (Tr. 97:25-98:2.) The parties’
dispute over 21e concerns the “releasably connected” limitation. (Tr. 98:3-6.) Defendants
have taken the position that this means connected when the device is in a resting state, but Dr.
Reinholtz disagreed with this. (Tr. 98:7-13.) He disagreed because the claim limitation does
not require it to be connected in any particular state. (Tr. 98:15-16.)
The language of limitation 21e does not require that the sleeve is connected to the dose
indicator during dose setting or injection. (Tr. 98:17-23.)

The sleeve in the patent claims is

called the setback in the Semglee, and the dose indicator is called the dose set knob in the
Semglee. (Tr. 99:4-16.)
the dose set knob.

In the Semglee, the setback is releasably connected, in rotation, to

(Tr. 99:17-23.)

The NDA for the Semglee says that, when the user dials

up a dose, there is no pressure on the button to lock the DSK and setback together so that the
DSK can rotate freely whilst the setback remains rotationally static. (Tr. 100:17-24.)

1

Then, to

“Semglee” is one of the names used to refer to Mylan’s accused pen, which is also called
“Vystra.” “Vystra” is the name that this Opinion will generally use for Mylan’s accused device.
5

deliver a dose, the user pushes a button and this locks those two components together so they’re
connected and they rotate together. (Tr. 100:25-101:2.)
rotatable connection is released. (Tr. 101:7-10.)

When the user releases the button, the

The Semglee pen practices limitation 21e.

(Tr. 102:8-10.)
As to limitation 21f, the parties dispute whether the piston rod must be solid or may be
hollow. (Tr. 102:22-25.)

The Semglee has a hollow piston rod. (Tr. 103:1-2.) A hollow rod

is still a rod. (Tr. 103:5-6.) Nothing in the ’844 patent requires the piston rod to be solid, nor
precludes it from being hollow. (Tr. 103:7-12.) Limitation 21f says the rod can have an
internal thread, which requires a portion that is hollow. (Tr. 103:13-18.) Limitation 21f refers
to a third thread, which is on the driving member in claim 21, or the lead screw in the Semglee.
(Tr. 104:2-9.) The plunger rod in the Semglee has either an internal or an external fourth thread
that is engaged with the third thread of the lead screw. (Tr. 104:10-18.)
the Semglee pen advances the piston. (Tr. 105:8-10.)

The plunger rod in

The Semglee pen practices limitation

21f. (Tr. 106:8-11.)
As to limitation 21g, the piston rod holder of claim 21 is the component in the Semglee
called the tower core. (Tr. 106:22-25.)

Defendants dispute that the tower core is the claimed

piston rod holder, and also whether it is configured to prevent the piston rod from rotating during
dose setting. (Tr. 107:1-7.) Defendants dispute whether the tower core holds the piston rod in
the Semglee, and also that the tower core is configured to prevent rotation during dose
dispensing. (Tr. 107:10-21.) “Hold” means to constrain, so as to remove degrees of freedom
from one part relative to another. (Tr. 108:1-3.) There is a slot in the tower core that engages
with a tab in the piston rod, and the engagement is like a keyed connection that only allows the
6

piston rod to slide axially relative to the tower core; it does not allow it to rotate relative to the
tower core or move side to side relative to the tower core. (Tr. 108:7-16.) The tower core
holds the plunger rod against rotation, and prevents it from moving side to side, so it is therefore
a piston rod holder. (Tr. 109:7-14.) In the Semglee, the tower core is configured to prevent the
plunger rod from rotating during dose setting because it’s configured to prevent it from rotating
at all times when the pen is assembled. (Tr. 109:18-21.)

The Semglee NDA states that the

tower core is keyed to the plunger rod and prevents it from rotating when the lead screw rotates
during dose delivery, which confirms this. (Tr. 110:1-11.)

If the keyed connection were not

present, the plunger rod could rotate during dose setting. (Tr. 110:22-25.)
an experiment that confirmed this. (Tr. 111:16-114:15.)

Dr. Reinholtz did

The tower core is a piston rod holder

that is configured to prevent the piston rod from rotating during dose setting. (Tr. 115:6-9.)
Limitation 21g also requires that the piston rod holder is rotatably fixed relative to the
housing. (Tr. 115:13-16.) In the Semglee, it is labeled the upper body housing, and the tower
core is rotatably fixed relative to it. (Tr. 115:17-24.) The tower core snaps into the brake
tower, and the brake tower stays fixed with respect to the housing. (Tr. 115:25-116:2.) Once
assembled, these three pieces are locked together. (Tr. 116:3-4.) The Semglee NDA confirms
that the housing retains the brake tower, which retains the tower core; the three components
cannot move relative to one another. (Tr. 116:8-22.)
Limitation 21g also requires that the piston rod holder be configured to permit the piston
rod to traverse axially toward the distal end during dose dispensing, and it isn’t disputed that the
Semglee practices this. (Tr. 117:6-12.) The Semglee NDA confirms that the plunger rod
traverses axially toward the distal end during dose dispensing. (Tr. 117:17-118:1.)
7

The

Semglee tower core is a piston rod holder configured to permit the piston rod to traverse axially
toward the distal end during dose dispensing. (Tr. 118:4-7.) The Semglee practices the
limitation in 21g and claim 21 is infringed by the accused device. (Tr. 118:10-21.)
Dependent claim 22 requires the device of claim 21 where the piston rod has a circular
cross-section, and the Semglee plunger rod does, as the picture shows. (Tr. 119:14-20.) It is a
cylinder along its length. (Tr. 119:24.) A wide feature at its distal end is a pressure foot, and it
is an integral, molded part of the plunger rod. (Tr. 120:3-13.) Claim 22 is infringed by the
Semglee. (Tr. 120:18.)
Claim 23 recites the device of claim 21 further comprising a clutch, which is the setback
in the Semglee. (Tr. 120:24-121:8.) When the user presses the button, the dose set knob and
the setback are locked in rotation; the setback is both the sleeve of claim 21 and the clutch of
claim 23. (Tr. 121:13-21.)
Claim 24 recites the device of claim 23 where the clutch provides audible and tactile
feedback indicative of unit doses of medicament; the setback has teeth, and those teeth interact
with a pair of arms that have teeth on them, part of the double clicker. (Tr. 122:6-123:6.) The
relative rotation of these components causes a clicking sound and tactile feedback. (Tr. 123:79.) Each click corresponds to one unit dose of medication, so each is indicative of unit doses of
medicament. (Tr. 123:13-17.)
Claim 25 recites the device of claim 24 where the clutch provides audible clicks during
dose canceling, where each click is equal to a unit dose of medicament, and the setback does that
during dose cancelling. (Tr. 124:14-21.) Claim 25 is infringed by the Semglee. (Tr. 125:8.)
Claim 30 recites the device of claim 21 further comprising a nut that tracks each set dose
8

of medicament delivered; in the Semglee, this nut is called the dose stop. (Tr. 125:13-19.) The
parties dispute whether the dose stop is a nut in part because it has external threads. (Tr.
125:21-24.) Defendants contend that the nut must have internal threads, but some nuts have
external threads -- flare nuts, as well as lug nuts in automobiles have only external threads. (Tr.
125:25-126:7.)

Defendants also question whether the dose stop is a nut because it does not

wrap around in a full circle. (Tr. 126:15-18.) A nut that wraps around in a full circle is a full
nut, while a nut that wraps around halfway would be a half nut or partial nut. (Tr. 126:19-24.)
The ’844 patent specification states that the nut 40 in figure 5 is a half-nut. (Tr. 127:3-10.) The
Semglee dose stop is a nut, even though it is not a full nut. (Tr. 127:16-18.)
Claim 30 also requires that the nut tracks each set dose of medicament delivered, and the
dose stop does this. (Tr. 127:19-23.)

The nut threads along the axis of the pen as the user

dials a dose and ultimately prevents the user from dialing a dose that exceeds what is available.
(Tr. 128:4-11.) The nut moves along the pen to track each set dose of medicament delivered.
(Tr. 128:16-20.)

Exhibit PTX-394 confirms that the dose stop rides along with the dose set

knob to track doses. (Tr. 129:1-8.) Claim 30 is infringed by Semglee. (Tr. 129:11-15.)
On cross-examination, Dr. Reinholtz stated that he had not published any paper that
talked about injector pens, nor had he ever done research (prior to this case) on them, nor
designed any. (Tr. 130:11-131:1.)

When the Semglee is at rest, the sleeve and dose set knob,

or dose indicator, are not connected. (Tr. 132:5-11.) In the ’844 patent figures showing the
embodiment, the sleeve and dose indicator are coupled when the device is at rest; when the user
depresses the button, those two components become uncoupled. (Tr. 133:14-24.) Thus, in the
’844 embodiment, at rest, the sleeve is connected to the dose indicator; in the Semglee, the
9

setback and dose set knob become coupled only upon pressing the button. (Tr. 133:25-134:12.)
As to the hollow rod, the Semglee has a hollow piston rod, which could be called a tube,
a cylinder, or a sleeve. (Tr. 137:12-21.) The ’844 patent does not disclose an embodiment with
a hollow tube as a rod. (Tr. 137:22-25.)
The term “holder” does not appear in the ’844 patent except in the claim. (Tr. 138:21139:2.)

When Dr. Reinholtz did his experiment on the tower core, he used a knife to cut off the

part of the tower core that is the slotted portion that resides inside the piston rod tube. (Tr.
139:9-24.) After he did the cut, he reassembled the pen without the dose stop nut. (Tr. 141:57.) The Semglee’s setback serves the functions of both the sleeve and the clutch in the patent.
(Tr. 150:1-20.)
Most of the nuts we’re familiar with day to day are internally threaded. (Tr. 152:10-13.)
The nut shown in the ’844 patent is internally threaded. (Tr. 153:9-11.) A pipe nipple,
depending on how it’s used, could be considered a nut, but Dr. Reinholtz would not generally
describe it as a nut. (Tr. 154:7-21.)
On redirect examination, Dr. Reinholtz said that limitation 21f allows for a hollow piston
rod. (Tr. 155:17-22.)
C.

Testimony of Robin Goland

What follows is a summary of the witness’s testimony. Dr. Goland was admitted as an
expert in endocrinology and treatment of patients with diabetes. (Tr. 159:25-160:4.)

Taking

injections is hard for everybody, and the need to use your hands and complicated self-care
techniques makes it harder, so it is important to have an easy-to-use pen to administer insulin.
(Tr. 162:10-18.) Prior to the launch of the SoloSTAR® pen, Lantus was administered to
10

patients with the OptiClik pen, and Levemir with the FlexPen. (Tr. 163:5-17.) These pens
were not easy to use. (Tr. 163:18-19.) The OptiClik was not easy to use because it was big,
not disposable, people struggled to replace the cartridge and see the numbers, and they had
trouble pressing the button. (Tr. 163:23-164:5.) The FlexPen was not easy to use because the
dose stop didn’t work properly, and it was a lot harder to push. (Tr. 164:8-16.) Because of the
problems with OptiClik and FlexPen, there was a need for an easy-to-use pen with a low
injection force in 2007, and SoloSTAR® met that need. (Tr. 164:23-165:3.) The improvement
from the OptiClik to the SoloSTAR® was dramatic. (Tr. 165:4-6.) Prior to the launch of the
SoloSTAR®, patients would look at the vial and syringe and say it was too scary. (Tr. 165:1418.) The SoloSTAR® is discreet, can be carried in the pocket, is disposable, very easy to push,
the numbers are easy to read, and you can hear the dose as you dial it up. (Tr. 166:5-14.) The
low injection force of the SoloSTAR® helped patients with limited dexterity, and Dr. Goland
switched patients to SoloSTAR® because of its low injection force and ease of use. (Tr. 167:712.) The SoloSTAR® can administer up to 80 units in an injection, whereas previous pens had
a maximum of 60 units. (Tr. 167:13-20.) Dr. Goland never encountered a patient who had
difficulty using the SoloSTAR®. (Tr. 168:5-8.) None of her patients switched to SoloSTAR®
based on her handing out marketing samples. (Tr. 170:5-8.)
On cross-examination, Dr. Goland said that the OptiClik had many issues, was actually
defective, a very bad pen, did not deliver accurately, was big, and the numbers were hard to read.
(Tr. 171:7-21.) The SoloSTAR® satisfied a long-felt need. (Tr. 172:7-10.) Dr. Goland did
not review the ’844 patent and does not know what it says. (Tr. 172:17-173:10.) When insulin
glargine was launched, it met a long-felt and unmet need. (Tr. 173:11-18.) Sanofi also sells
11

Apidra, a short-acting insulin, in the SoloSTAR® pen. (Tr. 174:5-10.) The only available
Lantus pen product is the SoloSTAR®. (Tr. 176:3-6.) Patients all notice the injection force of
the SoloSTAR®, and they’re very happy that it’s so much easier than expected. (Tr. 177:2-6.)
On redirect examination, Dr. Goland agreed that, were Apidra offered in the OptiClik
pen, the SoloSTAR® pen with Apidra would be an improvement over it. (Tr. 178:14-16.)
D.

Testimony of Henry Grabowski

What follows is a summary of the witness’s testimony. Dr. Grabowski was admitted as
an expert in the field of economics, including pharmaceutical and health economics. (Tr. 189:813.) Dr. Grabowski said that his assignment in this case was to determine using economic data
whether SoloSTAR® was a commercial success and also whether there was a nexus to the patent
at issue, and he concluded that SoloSTAR® is a commercial success and there is a nexus to the
patent at issue. (Tr. 189:18-25.)
When Lantus SoloSTAR® was introduced in 2007, it immediately became the market
leader and, by its second full year on the market, it had more than 60% market share among
long-acting pens. (Tr. 191:3-10.) The FlexPen flatlined at about 30% share after SoloSTAR®
was introduced. (Tr. 191:11-15.) After SoloSTAR® was introduced, the number of
prescriptions written rapidly grew much faster than the other long-acting pens in the market, and
it is the most-prescribed long-acting insulin pen product since 2008. (Tr. 191:23-192:7.) By
2013, it became the market leader among all insulin injectable products. (Tr. 192:18-19.) Over
all the years, it has had gross sales of more than $40 billion. (Tr. 194:21.) Lantus SoloSTAR®
has been successful not only in terms of insulin injectable products, but it has been one of the
most successful introductions in the last 15 years. (Tr. 193:22-194:2.)
12

As to the nexus between the commercial success of SoloSTAR® and the three claims of
the ’844 patent, Dr. Grabowski compared Lantus SoloSTAR® to Lantus OptiClik, and the
SoloSTAR® practices the ’844 patent while the OptiClik does not. (Tr. 195:1-21.) While the
two products have the same insulin, SoloSTAR® dramatically outperformed OptiClik, which
was eventually discontinued in 2012. (Tr. 196:8-15.) Dr. Grabwski also compared Apidra in
OptiClik with Apidra in SoloSTAR®, and SoloSTAR® was prescribed several multiples more
than the OptiClik version. (Tr. 196:23-197:8.) This confirms the view that the features enabled
by the ’844 patent were a driving factor in the performance of SoloSTAR®. (Tr. 197:12-15.)
These comparisons show that the performance of SoloSTAR® was not due to the insulin it
delivered. (Tr. 197:16-24.) Dr. Grabowski did not, however, attempt to apportion the
commercial success among the various factors that have contributed to it. (Tr. 199:8-11.) A
study by Clarke and Spollett showed that the injection force of SoloSTAR® was 30% lower than
that of FlexPen. (Tr. 201:13-18.) Two award press releases mention low injection force.
(202:23-204:3.)
Dr. Grabowski disagrees with Dr. McDuff’s positions about blocking patents because the
blocking patents cover insulin glargine, not pens. (Tr. 205:2-5.) And the blocking patents
expired in 2014-2015, so they have not been in effect for the past several years. (Tr. 205:2023.) Dr. Grabowski also disagreed with Dr. McDuff about the role of marketing efforts and
conversion strategy: there’s no evidence that Sanofi did excessive marketing for this product.
(Tr. 205:24-206:11.)
On cross-examination, Dr. Grabowski agreed that, by 2004, Lantus could be considered a
blockbuster drug. (Tr. 207:14-19.) The DCA press release does not constitute industry praise.
13

(Tr. 211:16-19.) The article Dr. Grabowski cited about superior injection force was authored by
Sanofi. (Tr. 214:11-14.) In 2007, there were 30 pages of winners of the Good Design Award,
with 16 other recipients in the medical category. (Tr. 217:14-23.)
E.

Testimony of Michael Quinn

What follows is a summary of the witness’s testimony. Mr. Quinn is a mechanical
engineer who designed the BD Vystra2 pen, which is Mylan’s proposed product. (Tr. 222:1225.) Mr. Quinn was admitted as an expert in the field of mechanical engineering, mechanisms,
and mechanical systems, including medical devices, medical injector pen, and medical device
design, development, and manufacturing. (Tr. 226:1-6.)
In the ’844 pen, the clutch and dial sleeve are connected to each other, and during dialing
the clutch and drive sleeve rotate. (Tr. 228:20-22.) In Mylan’s pen, the dose set knob and the
setback are not connected, and as a user would dial or dial back, the setback and lead screw don't
rotate relative to the rest of the pen. (Tr. 228:23-229:1.) The opposite are the case during dose
administration. (Tr. 229:2-10.)
As to the “releasably connected” limitation in claim 21, the word “connected” implies
that the components in a nominal state are joined to each other; the word is not “connectable,”
but “connected.” (Tr. 235:20-236:2.) The ’844 patent specification discloses that the clutch
and the dial sleeve are spring-loaded to be connected in a nominal state as well as dialing and
dial back. (Tr. 236:6-9.) The Vystra pen does not meet the “releasably connected” limitation
in claim 1. (Tr. 238:7-11.)

2

It appears that “Semglee” and “Vystra” are different names for the same thing, Mylan’s
accused pen product. (See Tr. 249:3-9.)
14

As to the limitation in claim 21 that requires a piston rod holder configured to prevent
rotation during dose setting, the Vystra pen does not have this element. (Tr. 238:16-20.) Dr.
Reinholtz testified that the brake tower was the piston rod element, but his report said that it was
the tower core alone or in conjunction with the brake tower. (Tr. 238:21-239:5.) Mr. Quinn
disagreed with Dr. Reinholtz, because the plunger rod has no torque applied to it from the pen
during dose dialing, so nothing is needed to prevent its rotation. (Tr. 239:6-11.) The plunger
rod doesn’t receive any torque because the setback absorbs it all and prevents any further motion
during dialing. (Tr. 239:13-15.) Because the setback isn't rotating during dose setting, nothing
inside of it is rotating during dose setting, including the lead screw and including the plunger rod.
(Tr. 240:5-7.) The tower core in Vystra is not configured to prevent rotation, but instead has
two main functions. (Tr. 240:8-10.) The first is to hold the lead screw and keep it from
popping out the back of the pen. (Tr. 240:11-13.) The second is to prevent the plunger rod
from rotating during dose injection because it’s during dose injection that the lead screw is
turning, and that’s when torque is applied to the plunger rod. (Tr. 240:17-20.) The components
in the Vystra are not configured as the claim language requires. (Tr. 241:4-14.)
Dr. Reinholtz’ experiment on the Vystra did not accurately represent the pen. (Tr.
241:20-24.) In addition to removing the tower core, Dr. Reinholtz also removed the dose stop,
and he also pre-advanced the stopper in the cartridge. (Tr. 242:1-3.) He loosened up the
setback, which allows the lead screw to have more play, and he removed the tower core, which
supports the shaft of the lead screw, allowing the lead screw more freedom to move around.
(Tr. 242:6-11.) Most importantly, he pre-advanced the stopper away from the pressure foot of
the plunger rod; all these changes made a very loose system of parts. (Tr. 242:12-14.) The
15

experiment does not prove that the tower core is configured to prevent rotation during dialing.
(Tr. 242:19-20.) Dr. Reinholtz removed constraints in the pen with the effect of allowing more
vibration. (Tr. 242:22-23.) He eliminated a key constraint on the plunger rod, its contact with
the rubber stopper in the cartridge holder. (Tr. 242:23-25.) By aiming the pen upward and
using dialing to create vibration, he got the plunger rod to rotate itself back down on the lead
screw. (Tr. 243:1-5.) He also admitted that, if he points the needle end down and the pressure
foot of the plunger rod touches the stopper, if dialed, the plunger rod does not rotate. (Tr.
243:5-8.) The experiment is not something a person of ordinary skill in the art (hereinafter,
“POSA”) would consider in evaluating a pen injector. (Tr. 243:12-17.) Vystra does not meet
the limitations of claim 21. (Tr. 243:21-22.)
Vystra does not meet the limitations of claim 25 because claim 25 depends on claim 23,
which requires a clutch, which Vystra does not have. (Tr. 244:4-9.) According to Dr.
Reinholtz, the sleeve of claim 21 is the setback of the Vystra, so there’s no component left to be
the clutch. (Tr. 244:12-245:2.) If one allows one component to have two functions, the setback
could have a clutch function: a series of four nubs interact with the dose set knob on
injection, and those are the clutch elements. (Tr. 245:16-21.) The setback has a lot of
functions besides the clutching function; there are internally facing click teeth, but these have
nothing to do with clutching. (Tr. 245:24-246:5.) The audible clicks do not come from the
clutching aspect of the setback. (Tr. 246:8-9.) Vystra does not meet the limitations of claim
25. (Tr. 246:10-13.)
As to the nut limitation in claim 30, a POSA would understand a nut as a mechanical
component containing internal threads and some form of features on the outside for fixation or
16

connection using tools. (Tr. 246:21-25.) The ’844 specification, at col.4 ll.26-35, describes the
nut as having internal threads and external teeth, which interact with the housing to prevent
rotation. (Tr. 247:1-7.) Dr. Reinholtz contends that the Vystra dose stop is a nut; it has
external threads and a smooth inside surface. (Tr. 247:13-20.) A pipe nipple is not a nut. (Tr.
248:2-7.) The Vystra does not meet the limitations of claim 30. (Tr. 248:8-11.)
On cross-examination, Mr. Quinn said that, while the claim did not use language
requiring a releasable connection in the resting state, that is implied by the ordinary meaning of
“connected.” (Tr. 251:23-252:3.) In the Vystra, the tower core holds the piston rod and
prevents rotation during injection. (Tr. 252:13-17.) Mr. Quinn stated that he had a patent
application related to Vystra, and the tower core and the piston rod in that application correspond
to what is in the Vystra. (Tr. 253:5-25.) This application states: “The brake tower core 220
functions to prevent rotation of the piston rod 206 relative to the brake tower 205 and thus the
pen upper body 201.” (Tr. 254:2-7.) The keyed engagement between the tower core and the
piston rod functions to prevent rotation between them. (Tr. 254:13-19.) The keyed connection
always exists. (Tr. 254:20-24.)
The Vystra setback is both a sleeve and a clutch. (Tr. 258:11-12.) In the patent
application related to the Vystra, the dose stop member is described as a half nut-like element.
(Tr. 259:21-260:13.) Mr. Quinn agreed that he is a named inventor on U.S. Patent No.
9,757,525. (Tr. 261:3-6.) Figure 16a in that patent shows a threaded piston rod with a circular
cross-section. (Tr. 261:18-25.)
On redirect examination, Mr. Quinn said that the Vystra tower core prevented rotation on
dose administration, but Vystra is not configured to prevent rotation during dose setting. (Tr.
17

263:3-11.) As to DDX-209, the image shows two different sets of teeth; the teeth with a red and
yellow outline are the teeth that result in the clicking, and these are different from the setback
clutch teeth which are shown in blue. (Tr. 263:12-264:1.) The phrase “half nut-like” is not
equivalent to “half nut;” what is “half nut-like” is not a “half nut.” (Tr. 264:8-17.)
F.

Testimony of Karl Leinsing

What follows is a summary of the witness’s testimony. Mr. Leinsing was admitted as an
expert in mechanical engineering, mechanisms for medical systems, full life cycle product
development of medical devices from conception to manufacturing, drug and delivery medical
devices such as auto injectors, pen injectors, and pumps. (Tr. 277:10-17.) Mr. Leinsing said
that, for his analysis in this case, he used March 3, 2003, the date of filing of a foreign priority
application, as the priority date. (Tr. 279:12-22.)
Mr. Leinsing said that the claims at issue lack written description and enablement. (Tr.
280:16-19.) The claims of the ’844 patent refer to an internally threaded piston rod, but the
specification does not describe or show one. (Tr. 283:24-284:4.) Figure 1 of the ’844 patent
teaches only a piston rod with two opposing threads on the outside of the piston rod; there is no
mechanism with threads on the inside. (Tr. 284:20-285:7.) Claim 21 discloses a piston rod
comprising either an internal or an external fourth thread that is engaged with the third thread,
but nothing in the specification mentions anything about internal threads on the piston rod. (Tr.
285:11-22.) Given this, it would have been very difficult for a POSA at the time to design and
implement an internally threaded piston rod; it would have required a lot of changes. (Tr.
285:23-286:2.) There’s no prior art that shows a pen injector with threads on the inside of a
piston rod, and a POSA would not have understood. (Tr. 286:2-8.) As to the sketch that Dr.
18

Slocum made at his deposition, the sketch shows that a lot of detail is required, and it creates
structural problems and manufacturing problems. (Tr. 286:17-287:5.) Also, the ’844 patent
has discussions of the drive sleeve needing to be between the dose setting sleeve and the piston
rod, and that’s not possible with this configuration. (Tr. 287:7-11.) Dr. Slocum’s sketch shows
a tiny threaded rod that goes inside the piston rod, which he calls a stinger, but it would have to
be extremely small and would likely buckle, forcing the whole device to be made much bigger.
(Tr. 287:22-288:4.) Mr. Leinsing did not know of anything that would fit inside the hole in the
piston rod, and it’s not something that’s been ever been done in a pen injector. (Tr. 289:1-9)
Dr. Slocum’s proposed design also requires an additional part and a bond, plus the small
threaded rod would have to be aligned with an outer sleeve, which would add complexity and
require time and experimentation to figure out; it would not be easy. (Tr. 289:15-25.) Mr.
Leinsing did not believe that the inventors possessed an internally threaded piston rod. (Tr.
290:4-7.)
The claim speaks of a “drive member,” and, when you look at the specification, the only
thing that could be is a sleeve, and the specification says that the drive sleeve is located between
the dose dial sleeve and the piston rod. (Tr. 290:12-17.) So Dr. Slocum’s proposal conflicts
with the specification, because that would mean the drive member would not be between the
piston rod and the dose dial sleeve; instead, the piston rod would be between a drive rod and a
dose setting sleeve. (Tr. 290:17-23.) Dr. Slocum’s proposal would be a different device
altogether, and it would take at least a year of experimentation to make it all work. (Tr. 291:37.) Dr. Slocum’s proposal would require making the entire device bigger, which is problematic,
because we want these devices to be small enough to hold in one’s hand. (Tr. 291:23-292:4.)
19

Claim 21 requires a piston rod holder that is rotatably fixed relative to the housing, so it’s
fixed to the outer housing of the pen injector, and configured to prevent the piston rod from
rotating during dose setting, and to permit the piston rod to traverse axially toward the distal end
during dispensing. (Tr. 293:7-12.) The word “holder” does not appear in the specification, and
the closest thing Mr. Leinsing could find was insert 16, which is like a washer with threads on
the inside. (Tr. 293:16-24.) In other places in the specification, it says that the threads on the
inside of this insert work with the opposing threads of the piston rod to prevent rotation, so the
insert 16 does not prevent rotation all on its own. (Tr. 293:25-294:4.) The insert 16 is not a
holder and not labeled as a holder. (Tr. 294:11-13.) A POSA would not have thought that the
inventors had possession of the claimed piston rod holder as of the priority date. (Tr. 294:1417.)
Four elements in claim 21 are at issue in this trial: 1) a driving member comprising a
third thread; 2) a piston rod comprising either an internal or an external fourth thread that is
engaged with a third thread; 3) the driving member is configured to rotate relative to the piston
rod; and 4) the piston rod and the driving member are configured to rotate relative to one another
during dose dispensing, and the piston rod is configured to traverse axially towards the dose
dispensing and during dose dispensing [sic]. (Tr. 295:22-296:12.) These four elements are all
related to the concept of having a driver with threads within it and a nut member that would have
a through slot or a guide. (Tr. 296:13-17.) The Steenfeldt-Jensen patent (hereinafter, “SJP”)
has five embodiments, and the fifth embodiment, in figures 15 through 17, is of particular
interest. (Tr. 297:2-8.) SJP has certain teachings about the way in which the driver, the piston
rod, and the nut member work together. (Tr. 299:4-10.) Inside the driver, there is a slotted
20

guide. (Tr. 300:4-6.) SJP teaches that you can exchange the threads in the nut member and the
slot in the driver: you can put the threads in the driver and the slot into the nut. (Tr. 300:15-19.)
SJP teaches that these are alternative design choices: you can put the threads on the
nut member or you can put the threads on the driver and put the slotted guide on the nut member
or on the driver. (Tr. 301:7-11.) It doesn’t matter which alternative you pick; you get the same
action on the piston rod. (Tr. 301:11-13.) SJP encourages switching the slot and the threads.
(Tr. 302:18-22.) Swapping the threads and the slot can eliminate the need for a thrust washer,
and eliminating a component helps reduce cost. (Tr. 305:4-13.) Claims 1 and 6 in the ’844
patent show the same idea, swapping the threads and the slot. (Tr. 305:20-306:5.) This swap is
very simple and has been done in other pieces of prior art, Giambattista and Chanoch. (Tr.
306:22-25.)
Mr. Leinsing did not agree with Dr. Slocum that such a change would increase the
injection force by about 50%. (Tr. 307:14-20.) The change would result in the piston rod no
longer turning, which would reduce the friction, and Dr. Slocum did not account for that. (Tr.
308:8-19.) Mr. Leinsing did not agree with the value of the coefficient of friction Dr. Slocum
used in his calculations, .15; using lubricants can bring the value down to .05, and Dr. Slocum
said that some plastics could produce a value of .08, which would reduce the 51% figure he
computed. (Tr. 309:3-7.) Dr. Slocum should have used .05. (Tr. 309:8-11.) Dr. Slocum also
didn’t take into account the pressure foot, as well as changes that you can make with the thrust
bearing. (Tr. 309:23-25.) Had he chosen a smaller size for the thrust bearing, that would have
reduced the friction. (Tr. 310:1-3.)
Mr. Leinsing said that the Chanoch patent confirmed the interchangeability of slots and
21

threads. (Tr. 310:6-13.) A POSA swapping slots and threads in SJP embodiment 5 would have
a reasonable expectation of success. (Tr. 311:16-20.)
Claim 22 requires a piston rod with a circular cross-section. (Tr. 312:9-11.) The
specification refers to a piston rod that is generally circular in cross-section. (Tr. 312:12-20.)
When you look at the actual piston rod, it has threads and flats on it, as well as other parts that
don’t make it circular, so it is described as generally circular. (Tr. 312:22-25.) The original
British patent application shows a piston rod with threads on both ends; a cross-section of either
threaded section is not circular. (Tr. 313:1-25.) It also has little holes in it that prevent it from
being perfectly circular, and that’s why it is described as generally circular. (Tr. 314:1-3.) A
threaded rod does not have a perfectly circular cross-section. (Tr. 314:13-16.) It’s not
appropriate to ignore the threads when considering the shape of the cross-section. (Tr. 314:1720.) SJP discloses a piston rod with a circular cross-section. (Tr. 314:21-24.) Mr. Leinsing
did not agree with Dr. Slocum that claim 22 requires a circular section along the entire length of
the piston rod. (Tr. 315:10-17.) Claim 22 does not specify the entire length of the piston rod.
(Tr. 315:19-21.) Claim 22 is obvious over SJP in view of Chanoch because those references
disclose piston rods with circular cross-sections. (Tr. 316:5-10.)
As to claim 30, disclosing a nut that tracks each set dose of medicament delivered, prior
art would teach a POSA that dose tracking is important. (316:13-18.) ISO standard 11608-1,
from the year 2000, sets requirements for pen injectors, including, “does not allow a larger dose
to be preset than is left in the cartridge.” (Tr. 316:22-317:9.) A POSA would understand from
this that they need to track the amount of medication that’s in the cartridge, which was
commonly done in 2003 with a nut member that tracked over threads. (Tr. 317:14-22.) A
22

DCA document on the FlexPen shows a small nut member that rides over threads which
correspond to the amount of medication that’s in the vial. (Tr. 318:3-16.) The nut moves to
track the amount remaining and, when it gets to the very end, the medication remaining is zero,
and the device cannot rotate anymore. (Tr. 318:17-21.) Figure 3 of the Klitgaard reference
shows the same thing, and a POSA would have known how to use a nut to track the amount of
remaining medication in an injector pen. (Tr. 319:2-22.) Claim 30 would be obvious over SJP
in view of Chanoch. (Tr. 320:1-4.)
SJP and the FlexPen are very similar, but FlexPen also has a nut member to track the
medication left in the vial. (Tr. 320:10-17.) DDX-331 shows that SJP and FlexPen have all the
same components, with small changes, and the addition of this limiting nut. (Tr. 320:18-25.)
Because SJP and FlexPen have the same components, the analysis is the same. (Tr. 321:1-3.)
Mr. Leinsing had held a FlexPen in his hands before 2003, in 2002. (Tr. 323:3-19.) Claim 21
is obvious over the FlexPen. (Tr. 323:24-324:1.) Claim 22 has the same analysis for FlexPen
as for SJP; FlexPen has areas of circular cross-sections. (Tr. 324:5-8.)
The Giambattista Patent (hereinafter, “GiaP”), from June of 2001, teaches a piston rod
holder meeting the limitations of claim 21. (Tr. 325:4-11.) In figure 4, there’s an element with
a guided slot and with teeth; when assembled, those teeth line up with other teeth to prevent
rotation, and it is the piston rod holder. (Tr. 325:16-24.) Figure 9 shows a piston rod with a
generally circular cross-section, so it would meet the limitations of claim 22. (Tr. 326:5-14.)
On cross-examination, Mr. Leinsing said that, with a few changes, the FlexPen is
essentially the fifth embodiment of SJP (“SJP5.”) (Tr. 328:7-18.) The key element that is not
in SJP is the dose limiting nut. (Tr. 328:21-329:1.) Both FlexPen and SJP5 have a piston rod,
23

a driver tube, and a nut, and the piston rod’s threads mate with the nut’s threads; we can swap the
driver tube slot with the threads on the nut. (Tr. 336:5-337:1.) FlexPen had a high injection
force relative to some other pens. (Tr. 338:8-14.) In designing the Next Generation FlexPen,
Novo reduced the injection force of the FlexPen. (Tr. 338:14-340:14.) At his deposition, Mr.
Leising had opined that the swap of slot and threads would be “essentially a wash” as to injection
force, but his expert report had no force calculations. (Tr. 341:8-24.) Based on the calculations
he performed but did not report, he stated at his deposition that the swap would produce a 25 to
30% increase in injection force, but that did not include the correction of the thrust washer. (Tr.
341:23-342:19.) Claims 1 and 6 of SJP require a piston rod having a not circular cross-section.
(Tr. 343:3-16.) SJP repeatedly describes the piston rod as having a noncircular cross-section,
but the figures plainly show other sections of the piston rod that are circular, even though SJP
never refers to the piston rod as having a circular cross-section. (Tr. 343:18-344:16.) Mr.
Leinsing believes that the SJP piston rod has a circular cross-section because portions at either
end have such. (Tr. 344:17-23.) On one end is an interface to the bearing, on the other end is a
circular flange, and in the middle is the threaded part of the rod; there is a part with a circular
cross-section and a part with a noncircular cross-section. (Tr. 345:14-25.)
As to GiaP, Mr. Leinsing opined that retract nut 4 is the claimed piston rod holder. (Tr.
346:1-6.) The retract nut is designed so that it can be rotated with respect to the housing when
you disassemble the pen, but not in normal operation. (Tr. 346:11-19.) The insert 16 in the
’844 patent cannot be rotated out of the housing, but it’s still a piston rod holder. (Tr. 347:113.)
Mr. Leinsing agreed that he opined that use of an internally threaded piston rod would
24

require enlarging the entire device but did no calculations to support that. (Tr. 353:5-17.)
On redirect examination, Mr. Leinsing stated that the GiaP pen is reusable, and the holder
that is rotatably fixed during injection permits rotation during cartridge reloading. (Tr. 359:111.)
G.

Testimony of William Biggs

What follows is a summary of the witness’s testimony. Dr. Biggs was admitted as an
expert in endocrinology and in the treatment of patients with diabetes. (Tr. 369:18-22.) He
began prescribing Lantus® insulin in vials in 2001 and it was far superior to existing long-acting
insulins. (Tr. 372:1-7.) Existing injector pens were easy to use. (Tr. 373:15-16.) Lantus®
insulin was available in the OptiClik pen prior to SoloSTAR®, but the OptiClik was defective
and unreliable in giving the correct dose. (Tr. 374:2-4.) Dr. Biggs has never had any problems
or complaints from patients about injection force. (Tr. 375:18-21.) A patient can use less force
in injection and it just makes the insulin go in a little slower. (Tr. 376:16-20.) Injection force
has never prevented any of Dr. Bigg’s patients from using an injection pen. (Tr. 376:23-24.) If
a patient can’t use one brand of pen, it would be foolish and hazardous to try to use another,
because they are not that significantly different. (Tr. 377:13-15.) Multiple pens prior to
SoloSTAR®, including OptiClik, had a capacity of 80 units. (Tr. 378:3-7.) The advantages
that Dr. Goland stated were unique to SoloSTAR® are shared among other pens and were
available in other pens before SoloSTAR®. (Tr. 379:7-12.) SoloSTAR® is a fine pen, but it’s
not special. (Tr. 380:1-4.) The FlexPen worked fine and Dr. Biggs never had a reason to
change a patient from FlexPen. (Tr. 381:2-9.) Lantus SoloSTAR® did not satisfy any long-felt
unmet need. (Tr. 382:7-9.)
25

On cross-examination, Dr. Biggs stated that he had patients with hand dexterity problems
and other difficulties with the use of their hands. (Tr. 386:19-387:11.)
H.

Testimony of Robert McDuff

What follows is a summary of the witness’s testimony. Dr. McDuff was admitted as an
expert in the area of economics, including health and pharmaceutical economics. (Tr. 404:1719.) Dr. McDuff, in summary, concluded that Dr Grabowski’s economic analysis was flawed,
that there was no nexus to the ’844 patent, and that the effect of blocking patents makes
commercial success irrelevant. (Tr. 405:23-406:3.) Sanofi’s own analysis showed that the
increment that came from SoloSTAR® was small relative to overall Lantus® use, and
SoloSTAR® had a relatively modest impact on the overall performance of the group of products.
(Tr. 410:1-14.)
The available data shows that, contrary to what Dr. Grabowski stated, Lantus®
prescriptions did not accelerate after the introduction of SoloSTAR®; there is no observable
change. (Tr. 410:21-411:7.) To the contrary, after the introduction of SoloSTAR®, the
prescription growth rate diminished. (Tr. 411:10-16.)
Dr. McDuff said that there was a very weak connection between the ’844 patent and any
commercial success. (Tr. 412:5-7.) The Lantus® products were covered by 22 patents listed
by Sanofi in the Orange Book. (Tr. 412:19-22.) If one does not consider all of the relevant
patents, you might misattribute sales to one patent because you haven’t looked at the others.
(Tr. 413:2-6.)
Exhibit DTX-2634 is Sanofi document related to a third-party analysis conducted by
Compass which identifies the most important attributes for SoloSTAR®, and the most important
26

attributes are properties of the insulin, not the pen. (Tr. 414:17-415:7.) A 2011 analysis of
SoloSTAR® injection force shows the same thing, that the pen is of secondary importance
relative to the insulin. (Tr. 416:3-12.) A Sanofi document ranked pen attributes, and injection
force was the eighth most important attribute out of 13. (Tr. 416:13-417:2.) The sales of
SoloSTAR® were driven by the properties of the insulin, not the pen. (Tr. 417:9-14.) Lantus
SoloSTAR® sales declined with the launch of the Basaglar KwikPen, which also uses insulin
glargine like Lantus®. (Tr. 418:1-7.) And, while it is true that SoloSTAR® won some awards,
those awards are for the pen and do not focus on the benefits of the ’844 patent. (Tr. 419:1419.)
Dr. McDuff used the wrong time period in his blocking analysis, pointing to the
expiration of patents in 2014. (Tr. 420:6-13.) The relevant time period is that leading up to the
priority date in 2003. (Tr. 420:15-17.)
Analysis of market share of the various Lantus® and SoloSTAR® products shows that
the primary commercial opportunity was the opportunity to sell insulin glargine, which was
protected by the blocking insulin glargine patents. (Tr. 423:23-424:11.) “The big difference
between the insulin glargine SoloSTAR® products and the other insulins shows that it’s the
insulin not the SoloSTAR® that's driving sales.” (Tr. 424:13-15.) The blocking patents
provided strong disincentives to develop products sooner, so there is no inference to be made
about the obviousness of the ’844 patent. (Tr. 424:18-21.)
On cross-examination, Dr. McDuff agreed that the Design Business Association press
release about the award it gave SoloSTAR® in 2009 mentioned low injection force. (Tr.
430:10-17.) Dr. McDuff agreed that, comparing the prescriptions for OptiClik and SoloSTAR®
27

in the first four years of each, shows that SoloSTAR® achieved quadruple the amount that
OptiClik did. (Tr. 431:17-432:1.)
I.

Testimony of Alexander Slocum

What follows is a summary of the witness’s testimony. Dr. Slocum was admitted as an
expert in the field of mechanical engineering, mechanisms and mechanical systems, including
medical devices. (Tr. 444:16-20.) Dr. Slocum stated that the FlexPen corresponds to the fifth
embodiment of SJP (“SJP5”), and there is no meaningful difference for the purpose of the
analysis of claim 21. (Tr. 451:17-20.)

Mr. Leinsing had characterized the modifications to

SJP5, which result in the device of claim 21, as a simple substitution, but it is not. (Tr. 455:24456:2.) These modifications change the physics of operation, or the force loop, and actually
increase the injection force needed. (Tr. 456:3-10.) These modifications introduce a rotating
element after the nut thread that produces a lot of drag. (Tr. 459:11-14.) The result is that the
device becomes less efficient, and you have a higher injection force, which would increase
significantly. (Tr. 460:21-461:3.) The POSA would not be motivated to make this
modification because one goal of the patent was to lower injection force. (Tr. 461:4-9.) The
proposed modification of the FlexPen would increase injection force by about 50%. (Tr. 462:26.)
Dr. Slocum stated that his analysis of injection force used as inputs measurements of the
FlexPen done by Mr. Veasey, as well as Mr. Veasey’s measurement of the coefficient of friction
between the plastic elements. (Tr. 462:7-13.) Mr. Veasey gave Dr. Slocum a value of .1 for
the coefficient of friction, which is what Dr. Slocum used. (Tr. 462:24-463:2.) Mr. Veasey’s
actual measurement of the coefficient of friction in the FlexPen was .15, but Dr. Slocum knew
28

from his own experience that .1 was a very good value. (Tr. 463:5-10.) Dr. Slocum did not
agree with Mr. Leinsing that one could use a value of .05. (Tr. 463:11-14.) But using a lower
coefficient of friction would still result in an increase in injection force of about 30%; the
increase will not go to zero. (Tr. 465:17-19.)
Dr. Slocum described an article he reviewed about the modifications to the FlexPen
which produced the Next Generation FlexPen; the article reported a 30% reduction in injection
force. (Tr. 472:5-473:4.)
Dr. Slocum did not agree that the specification of SJP suggests swapping the driver tube
and the threads in SJP5. (Tr. 473:22-474:4.) The first and fifth embodiments in SJP are very
different. (Tr. 475:5-7.)
Dr. Slocum did not agree that the pressure foot, which Mr. Leinsing called a “thrust
washer,” could be eliminated. (Tr. 483:19-484:2.) As to Chanoch, which uses a threaded
driver tube, using a threaded driver tube with SJP5 would increase the injection force required.
(Tr. 484:13-24.)
GiaP lacks a piston rod holder rotatably fixed to the housing. (Tr. 485:10-13.) Dr.
Slocum disagreed with Mr. Leinsing that the GiaP retract nut 4 is a piston rod holder rotatably
fixed to the housing. (Tr. 485:21-486:2.) GiaP discloses a reusable pen injector; when one
exchanges the vial, the retract nut disengages and freely rotates, so it is not fixed to the housing.
(Tr. 486:2-19.)
As to the requirement in claim 22 of a piston rod with a circular cross-section, SJP5 does
not have one, nor does FlexPen, nor does GiaP. (Tr. 487:1-12.) The piston rod in figure 17 of
SJP has a rather rectangular cross-section. (Tr. 487:14-25.) The abstract of SJP refers to a
29

piston rod with a non-circular cross-section. (Tr. 488:2-9.) Because of the non-circular crosssection, the driver tube and piston rod in SJP always rotate together. (Tr. 488:20-23.) The
piston rod of the FlexPen is very similar to SJP, a cross-section like a rectangle with rounded
ends. (Tr. 489:10-17.) GiaP also has a piston rod with flat sides. (Tr. 490:3-6.) Dr. Slocum
did not agree with Mr. Leinsing that the SJP piston rod has a circular cross-section based on the
ends, because the ends of a lead screw are not doing the screwing; they are called end journals.
(Tr. 490:20-491:5.) The end journals of lead screws can have many different shapes; it is the
threaded part of the lead screw that does the work of providing the axial force, so that’s where
you look at the cross-section. (Tr. 491:6-13.) Dr. Slocum also did not agree that the piston rod
in the ’844 patent has a non-circular cross-section because it has threads; a POSA would ignore
the thread in assessing the cross-section of the rod. (Tr. 491:19-492:9.)
As to the issue surrounding the piston rod comprising an internal third thread, Dr. Slocum
stated that he believed that these limitations had written description support and are enabled.
(Tr. 492:21-493:8.) External and internal thread are alternative terms for male and female
thread, respectively. (Tr. 493:9-12.) In Figure 1 of the ’844 patent, the piston rod has external
threads and the drive sleeve has internal threads. (Tr. 493:17-494:1.) There are two possible
arrangements for the threading of a piston rod threaded to a driver: internal/external and
external/internal. (Tr. 495:13-17.) The specification, in columns 1 and 2, does not yet choose
one arrangement of the two. (Tr. 494:6-495:12.) The Great Britain application gives an
example of a leadscrew drive system, a concept that is centuries old. (Tr. 496:5-497:4.) Dr.
Slocum said that he wrote a textbook in 1995 that taught the principles of a leadscrew drive
system with a leadscrew and nut, which produce relative rotation between leadscrew and nut.
30

(Tr. 497:8-498:4.) A POSA would understand that a piston rod threaded to a driver is a
leadscrew system. (Tr. 498:5-7.) In 2003, it was known in the art that a piston rod can have
internal threads, engaged with a driver having external threads. (Tr. 498:22-25.) The ’872
patent, from 1987, discloses an insulin pump with an internally threaded piston member, which
advances the piston. (Tr. 499:4-24.) The ’824 patent, from 1988, discloses an injection device
with an internally threaded piston rod which receives a drive screw. (Tr. 500:2-18.)
Dr. Slocum drew a diagram at his IPR deposition to depict the two possible threading
arrangements. (Tr. 501:4-14.) The drawing shows the arrangement of the dose dial sleeve, the
tubular clutch, the drive sleeve, and the piston rod. (Tr. 502:1-21.) At one end of the piston
rod are the labels, “first thread” and “external.” (Tr. 502:21-23.) At the other end, it just says,
“thread?” and the drawing depicts internal threading there. (Tr. 502:23-503:3.) The drive sleeve
is a relatively long, thin threaded piece labeled a “stinger.” (Tr. 503:4-25.) This diagram relies
only on the patent and the background knowledge of a POSA. (Tr. 504:1-4.) A POSA who
read the ’844 patent and had the knowledge of the art about leadscrew drive systems could
envision arrangements in which a piston rod with an internal thread is engaged with a driver
having an external thread. (Tr. 504:5-11.) Dr. Slocum did not agree with Mr. Leinsing that this
arrangement requires that the entire device be bigger, nor that there would be manufacturing
problems with bonding inside the drive sleeve, nor that the size of the driver would result in
buckling. (Tr. 504:12-506:21.) The patent disclosure enables the POSA to practice the pen
injector having a piston rod with either internal or external threads, without undue
experimentation. (Tr. 506:24-507:8.) It might take a POSA a month to make. (Tr. 507:9-12.)
This modification differs from the question of switching the slot and the threads in SJP, which
31

fundamentally changes the physics of operation of the device. (Tr. 509:21-511:18.)
As to the piston rod holder, the ’844 specification depicts insert 16. (Tr. 512:2-10.)
The insert 16 is secured against rotation and has a threaded opening through which the piston rod
extends, and the opposing thread directions prevent piston rod rotation. (Tr. 512:17-24.)
Removal of the insert allows the piston rod to rotate. (Tr. 514:21-515:7.) The insert is also
configured to permit the piston rod to traverse axially toward the dose dispensing end, because if
one rotates the drive sleeve, it moves relative to the insert and the piston rod rotates with the
threads engaged and it advances. (Tr. 515:17-22.) There is written description support for the
piston rod holder limitation, and the patent teaches a POSA to make and use the piston rod
holder without undue experimentation. (Tr. 515:23-516:4.)
SoloSTAR® practices claims 21, 25, and 30 of the ’844 patent. (Tr. 516:11-13.) Two
pieces of the SoloSTAR®, snapped together, form the housing. (Tr. 517:9-20.) The claimed
invention provides benefits of high efficiency, requiring less thumb force for injection, and a
lower component count. (Tr. 518:1-25.)
On cross-examination, Dr. Slocum said that, as of March, 2003, he had no personal
experience designing injector pens. (Tr. 519:17-19.) The first declaration he filed when
retained by Sanofi for the IPR contained an error. (Tr. 520:8-24.) Dr. Slocum agreed that he
had relied on information about injection pens provided by Mr. Veasey. (Tr. 522:5-524:18.)
Dr. Slocum disagreed with Mr. Leinsing that a POSA would have swapped the slot and the
threads. (Tr. 525:3-13.) Dr. Slocum thought that the passage in SJP that talks about the swap
would be ignored by a POSA who would think that it is a stupid idea and would ignore it. (Tr.
525:14-529:12.) Nonetheless, Dr. Slocum agreed that that particular passage in SJP does
32

envision swapping the slot and the thread. (Tr. 530:2-10.) As to the first embodiment in SJP, a
POSA could accomplish that swap. (Tr. 530:12-15.) While embodiments one and five in SJP
are very different, they are very similar in terms of dispensing and the force chain for dispensing.
(Tr. 531:2-22.)
The piston rod in SJP claim 6 corresponds to the piston rod threading limitation in ’844
patent claim 21. (Tr. 536:8-24.) The piston rod drive in SJP claim 6 meets the claim 21
limitation of a driving member comprising a third thread. (Tr. 538:13-23.) SJP claim 6 also
meets the claim 21 limitation of a driving member configured to rotate relative to the piston.
(Tr. 539:20-540:15.) SJP claim 6 also meets the claim 21 limitation about the configuration of
the piston rod and the driving member during dose dispensing. (Tr. 540:19-541:11.) Dr.
Slocum agreed that SJP claim 6 meets all four of the claim 21 limitations that the parties did not
stipulate to. (Tr. 542:13-24.)
Dr. Slocum did his injection force analysis on an Excel spreadsheet. (Tr. 544:3-5.)
Many of the inputs were values that Mr. Veasey gave Dr. Slocum. (Tr. 546:11-17.) The
coefficient of friction value of .1 came from Mr. Veasey. (Tr. 553:24-25.) Lubricious plastics
can get down to values of .08 or lower in some instruments. (Tr. 554:14-18.) While Mr.
Veasey measured a value of .15, he recommended a value of .1, which Dr. Slocum used. (Tr.
555:2-7.) The 51% value is the ratio of the force outputs for the devices compared. (Tr. 557:16.) Dr. Slocum had written in a book that sliding contact bearings have a coefficient of friction
on the order of .05 to .1. (Tr. 558:8-559:2.) The exact value depends on what plastic you use.
(Tr. 559:8-13.) A change in the outside and inside diameter values used would change the 51%
value. (Tr. 559:24-560:5.) The spreadsheet does not account for certain lost friction force.
33

(Tr. 562:20-24.)
As to GiaP, when the pen is operational, the retract nut is rotatably fixed relative to the
housing. (Tr. 565:3-11.)
SJP figure 8 shows a piston rod with an end journal with a circular cross-section. (Tr.
575:18-576:3.) One can change the spreadsheet analysis to reflect a stinger design and it shows
that the stinger will not buckle. (Tr. 580:6-585:4.) The Camen patent and the Spinello
reference do not deal with injector pens, and both designs have motors. (Tr. 586:8-587:1.) The
claims of the ’844 patent do not require low injection force, or shorter dial extension and
increased maximum dose. (Tr. 593:11-22.)
On redirect examination, Dr. Slocum said that SJP claim 6 does not have a housing with a
thread, nor a dose indicator with a second thread that engages the housing thread, nor a
releasably connected sleeve. (Tr. 597:6-598:3.) In order to find every element of claim 21 in
SJP, one must mix and match between SJP embodiments and make changes to SJP5. (Tr.
598:10-14.) Even if Dr. Slocum had used a value for the coefficient of friction of .05 in his
spreadsheet, the required injection force, comparing SJP5 with modified SJP5, would still
increase. (Tr. 598:20-25.) Dr. Slocum used a value of .1, even though Mr. Veasey had
measured a value of .15, because Mr. Veasey said the use of lubricious plastics maybe could
result in a value of .1. (Tr. 599:8-13.)
DISCUSSION
Sanofi contends that the Vystra would infringe claims 21, 22, 25, and 30 of the ’844
patent. These claims, together with intervening dependent claims, are as follows:
21. A drug delivery device comprising: a housing comprising a dose dispensing
end and a first thread; a dose indicator comprising a second thread that engages
34

with the first thread; a driving member comprising a third thread; a sleeve that is
(i) disposed between the dose indicator and the driving member and (ii) releasably
connected to the dose indicator; a piston rod comprising either an internal or an
external fourth thread that is engaged with the third thread; a piston rod holder
that is rotatably fixed relative to the housing and configured to (i) prevent the
piston rod from rotating during dose setting and (ii) permit the piston rod to
traverse axially towards the distal end during dose dispensing; wherein: the
housing is disposed at an outermost position of the drug delivery device; the dose
indicator is disposed between the housing and the sleeve and is configured to (i)
rotate and traverse axially away from the dose dispensing end during dose setting
and (ii) rotate and traverse axially towards the dose dispensing end during dose
dispensing; the driving member is configured to rotate relative to the piston rod;
the sleeve is rotatably fixed relative to the driving member and configured to
traverse axially with the dose indicator; and the piston rod and the driving
member are configured to rotate relative to one another during dose dispensing;
and the piston rod is configured to traverse axially towards the dose dispensing
end during dose dispensing.
22. The drug delivery device of claim 21 where the piston rod has a circular crosssection.
23. The drug delivery device of claim 21 further comprising a clutch.
24. The drug delivery device of claim 23 where the clutch provides audible and
tactile feedback indicative of unit doses of medicament.
25. The drug delivery device of claim 24 where the clutch provides audible clicks
during dose cancelling, where each click is equal to a unit dose of medicament.
30. The drug delivery device of claim 21 further comprises a nut that tracks each
set dose of medicament delivered.
A. Infringement
The parties entered into a key stipulation on November 29, 2019, regarding claim
elements contained in the Vystra and in certain prior art references (hereinafter, the “Element
Stipulation”), signed and filed by the Court on December 2, 2019. In the Element Stipulation,
the parties agreed that the Vystra meets every limitation of claim 21, with the exception of the
following:
35

and (ii) releasably connected to the dose indicator; a piston rod comprising either
an internal or an external fourth thread that is engaged with the third thread; a
piston rod holder that is rotatably fixed relative to the housing and configured to
(i) prevent the piston rod from rotating during dose setting and (ii) permit the
piston rod to traverse axially towards the distal end during dose dispensing;
(Element Stipulation at 2-3.) This streamlines the claim 21 infringement inquiry at trial and
limits it to three principal elements: 1) a sleeve releasably connected to the dose indicator; 2) the
piston rod, with its internal or external thread; and 3) the piston rod holder, with its configuration
relative to the piston rod. In its post-trial brief (“PTB”), Sanofi asserts that Vystra meets these
three limitation elements. In its PTB, Mylan disputes that Vystra contains a releasably
connected sleeve or the piston rod holder. Thus, Mylan does not dispute Sanofi’s contention
that Vystra meets the piston rod limitation (“a piston rod comprising . . . third thread”).
1. Infringement of claim 21: “releasably connected”
Claim 21 contains these limitations:
a sleeve that is (i) disposed between the dose indicator and the driving member
and (ii) releasably connected to the dose indicator;
The dispute over this part of claim 21 turns on the application of the “releasably connected”
limitation to the Vystra. The parties do not dispute that the Vystra contains a setback
component, which meets the sleeve limitation, a dose set knob, which meets the dose indicator
limitation, and a lead screw, which meets the driving member limitation. Nor do they dispute
that the sleeve is disposed between the dose indicator and the driving member. The sole point
of disagreement is whether the setback is “releasably connected” to the dose set knob.
The parties also agree on certain key underlying facts. In the Vystra’s “resting state” –
that is, the state it would be in when the user has removed it from the packaging, but not yet
started to set the dose or inject the insulin –, the setback and the dose set knob are disconnected.
36

It is only during injection, after the user presses the button, that the setback and the dose set knob
are connected. Because that connection is released after injection (when the user releases the
finger pressure on the button), the setback and dose set knob are connected only during injection.
These facts are undisputed.
Sanofi’s brief does not contain any persuasive argument to explain how, given these
undisputed facts, the Vystra infringes the “releasably connected” limitation. Sanofi argues:
“Defendants’ interpretation fails because it is not the plain and ordinary meaning of ‘connected,’
and instead derives solely from improperly reading an extraneous limitation into the claim.”
(PPTB at 4.) Neither point succeeds. First, as to the ordinary meaning of connected, Sanofi
contends: “The plain and ordinary meaning of ‘connected’ does not restrict when two
components are connected.” (Id.) That is a mix of true, false, and irrelevant. The ordinary
meaning of “connected” may not set limits on when things may connect, but the ordinary
meaning of “connected” is limited to those things that are connected. And that is the problem
for Sanofi here. There is no evidence of record that the pen that will be sold and delivered to a
purchaser at a pharmacy will contain within it a setback that is connected to a dose set knob.
The evidence of record supports the finding that, in the product that Mylan will deliver to
patients, the setback and the dose set knob will not be connected.3
There is no dispute here about the ordinary meaning of “connected.” Neither side
defined it, and there did not appear to be any confusion, uncertainty, or even discussion about
3

Sanofi appears to confuse “connected” with “connectable.” The evidence of record shows that
the product that Mylan will deliver to patients contains a setback that is likely, at some future
point, to become connected to the dose set knob, while the patient depresses the button to inject.
The setback and dose set knob in the product as it is delivered to the patient at the pharmacy are
properly described as “connectable,” not “connected.”
37

what the ordinary meaning of “connected” is. Sanofi’s brief did not propose any definition of
“connected,” ordinary or otherwise. Using the ordinary meaning of “connected,” the setback
and the dose set knob in the Vystra are connected only during injection, and not at other times.
The ordinary meaning of “connected” is not at issue.
The plain meaning of “releasably connected” requires that the objects are connected by
default, and that the connection can be released. This construction of “releasably connected” is
supported by the patent’s specification, which describes an embodiment in which “the drive
sleeve [is] releasably connected to the dose dial sleeve” and “clutch means are provided which
upon depression of the button permit rotation between the dose dial sleeve and the drive sleeve.”
‘844 patent, col.2 ll.1-4, 7-9. In the specification, then, “releasably connected” is used to
describe an embodiment in which, in the resting state, the drive sleeve is connected to the dose
dial sleeve, and that connection is released upon depression of the button, which permits relative
rotation between the previously connected components. The evidence shows that the situation
in the Vystra is the reverse of this.
This interpretation of “releasably connected” is not, as Sanofi contends, an attempt to
import an extraneous claim limitation, but merely construes the claim according to its plain
meaning and the intrinsic evidence. Sanofi contends that this is an improper attempt to
incorporate embodiments into a claim, which is unexplained, unsupported, and thus purely
rhetorical. Defendants are not implying a limitation of the device to its resting state.
To the contrary, Defendants are reading the claim as it is written, and applying it to the
product they will sell. The claim says, “releasably connected,” and there is no evidence that the
pen that will be delivered to customers will contain the required releasable connection. No
38

embodiments and no limitations are being imported.
The Vystra product that will be delivered to customers at the pharmacy, in its packaging,
will not infringe this limitation.
2. Infringement of claim 21: the piston rod holder
Claim 21 contains this language regarding the element of the piston rod holder:
a piston rod holder that is rotatably fixed relative to the housing and configured to
(i) prevent the piston rod from rotating during dose setting and (ii) permit the
piston rod to traverse axially towards the distal end during dose dispensing;
In the PTB, Sanofi begins by stating, correctly, that, at trial, Mylan disputed only whether
the Vystra piston rod holder was configured to prevent the piston rod from rotating during dose
setting. Indeed, Mylan contends that the Vystra tower core is configured to prevent the piston
rod from rotating during injection, not during dose setting. Sanofi argues that the Vystra tower
core is configured to prevent the piston rod from rotating at all times.
The parties do not dispute the fundamental facts of the Vystra design: the tower core has
a longitudinal slot that engages with a tab on the plunger rod and provides a keyed connection
that has the capacity to prevent the plunger rod from rotating. Sanofi does not appear to dispute
Mylan’s contention that no drive mechanism applies rotational force to the plunger rod during
dose setting. Instead, Sanofi contends that, absent this functionality in the tower core, the
plunger rod might rotate due to other forces: “Without the Tower Core’s keyed connection, the
Plunger Rod would at times rotate during dose setting due to gravity and vibrational forces.”
(PPTB at 8.) This is speculation and has no basis in evidence. All that Sanofi offers in support
is this testimony from Dr. Reinholtz:
Q. And can you explain to us why the plunger rod could rotate if the keyed
connection between the tower core and the plunger rod were not present?
39

A. Sure. Once that keyed connection is removed, then the plunger rod is free to
rotate off of the lead screw and any forces that act on it, including gravity or
vibrations due to dialing the pen, for example, cause the plunger rod to rotate
relative to the tower core.
Q. Have you done an experiment to confirm that gravity or vibrations of the pen
could cause the plunger rod to rotate during dose setting if this keyed connection
of the tower core weren't present?
A. Yes, I have.
(Tr. 111:1-14.) This is not evidence demonstrating the functioning of the tower core in the
accused product; it is evidence about what happens when the pen is cut apart by an expert. Note
the key qualification to Dr. Reinholtz’ statement about gravity and vibration: “Once that keyed
connection is removed.” No one contends that the keyed connection gets removed during
normal operation of the pen. This testimony, and the experiment that followed, say nothing
about the normal operation of the pen. This Court is not persuaded that the operation of a
dissassembled Vystra after an expert has cut it apart has any relevance to questions about its
operation when intact. Sanofi has failed to point to any credible evidence that, were it not for
the tower core’s keyed connection, the plunger rod would rotate during dose setting due to the
forces of gravity and vibration. There is simply no credible evidence that, during dose setting,
the plunger rod is subject to any rotational force. If the plunger rod is not subject to any
rotational force during dose setting, the tower core cannot be said to prevent its rotation in that
phase of operation.
Mylan points to evidence that shows that, yes, certain components in the Vystra pen are
designed to prevent the rotation of the plunger rod during dose setting, but by the functioning of
the setback, not the tower core. As Mylan’s expert, Mr. Quinn, who designed the Vystra pen,
40

explained:
The other job of the tower core is to prevent the plunger rod from rotating during
dose injection because it’s during dose injection that the lead screw is turning, and
that’s when torque is applied to the plunger rod.
(Tr. 240:17-20.) Mylan also points to exhibit PTX-350, which Dr. Reinholtz identified as a
“Becton Dickinson document describing the mechanical design of the pen.” (Tr. 122:14-15.)
Sanofi and Dr. Reinholtz relied on this document during the direct examination of Dr Reinholtz
about the components of the Vystra and their functioning. On page 2 are diagrams of the pen,
under the heading, “Device Operation: Dose Setting.” (PTX-350 at PTX-0350.0002.) The text
on page 2 reads:
1a. User dials DSK counter-clockwise, causing DSK to move out of the upper
housing along a helical path
1b. Setback moves axially with the DSK, but without rotation due to a 1-way
rachet engagement with the brake tower
(Id.) On page 4, under the heading, “Device Operation: Dose Administration,” the text reads:
2a. User presses Button causing DSK and Setback to be coupled together (via
clutch teeth) and rotate helically clockwise into the Body.
2b. Rotation of the Setback causes rotation of the Lead Screw due to keyed
engagement between the leadscrew and setback.
2c. Rotation of the Lead screw causes axially [sic] displacement of the Plunger
rod via internal threads on the Plunger rod.
(PTX-350 at PTX-0350.0004.) This is an exceptionally clear summary of the operation of the
Vystra. On page 2, it makes clear that, during dose setting, the user rotates the dose set knob
(DSK), but that rotation is not transferred to the drive train. Instead, the setback moves only
axially, “without rotation,” because of the one-way rachet engagement with the brake tower.
(Id.) This states clearly that, during dose setting, the transmission of rotation from the DSK
41

beyond the setback, to the drive train, is prevented by the one-way rachet engagement of the
setback.
The one-way ratchet engagement is an element of the setback, as shown in PTX-394.
This document is an excerpt from the Vystra NDA, and was identified and relied on by Dr.
Reinholtz during his direct examination. (Tr. 99:24-100:5.) A subsection within PTX-394
provides a narrative description of the design of the device, and counsel quoted from this
subsection in the direct examination of Dr. Reinholtz. (Tr. 100:6-11, referencing PTX-394 at
PTX-0394.0017.) On that same page of the Vystra NDA, it states:
A one-way ratchet on the set back engages with splines (ridges) on the outside of
the brake tower.
...
When the user dials up a dose, there is no pressure on the button to lock the DSK
and set back together, so that the DSK can rotate freely whilst the set back
remains rotationally static but moves axially with the DSK. The ratchets on the set
back slide up the splines on the brake tower. . . To deliver the dose, the user
pushes on the button. This locks the set back and DSK, so that they rotate and
translate together. The rotation of the set back is transmitted to the lead screw, and
the rotation of the lead screw drives the plunger rod forward to push the cartridge
plunger stopper and deliver the dose.
(PTX-394 at PTX-0394.0017.) This confirms two key points: 1) the one-way ratchet is part of
the setback; and 2) during dose setting, the dose set knob rotates freely while the setback remains
rotationally static. It is not until the button is pressed that the dose set knob becomes locked to
the setback, transmitting rotation to the lead screw. This evidence confirms that the part that
prevents the transmission of rotational motion during dose setting is the setback.
Sanofi also argues that Mr. Quinn “confirmed that the Tower Core’s keyed connection
prevents the Plunger Rod from rotating, and that this keyed connection exists at all times, which
would include dose setting.” (PPTB at 8.) This statement is half true. There is no dispute
42

that, in an assembled and intact pen, the keyed connection between tower core and plunger rod
exists at all times; there is no dispute that the piston rod holder, the tower core in the Vystra,
holds the plunger rod at all times. This is not the issue. At issue is the claim language that
specifies that the piston rod holder must be “configured to (i) prevent the piston rod from rotating
during dose setting.” The evidence shows that the one-way rachet on the setback is the
component configured to prevent the piston rod from rotating during dose setting. The evidence
does not support the assertion that the tower core is configured to prevent the piston rod from
rotating during dose setting. The fact that the tower core/plunger rod keyed connection exists at
all times is not sufficient to show infringement of the piston rod holder limitation in claim 21.
The evidence presented at trial supports the factual determination that, in the Vystra, it is
the setback, not the tower core, that prevents the transmission of rotational movement during
dose setting. The Vystra tower core does not prevent the piston rod from rotating during dose
setting. Plaintiffs have not proven that the Vystra infringes the piston rod holder limitation in
claim 21. The Vystra does not infringe the piston rod holder limitation in claim 21.
Mylan’s PTB did not contest infringement of claim 22. Because claim 22 depends on
claim 21, and this Court has determined that the Vystra does not infringe claim 21, claim 22 is
not infringed.
3. Infringement of claim 25
Claim 25 depends on claim 24, which depends on claim 23, which depends on claim 21.
Sanofi contends that the Vystra meets the limitations of these four claims. Mylan has already
disputed claim 21 and additionally disputes that the Vystra meets the limitations stated in claims
23 and 25.
43

Claim 23 states: “The drug delivery device of claim 21 further comprising a clutch.”
Sanofi contends that the Vystra setback functions as both the sleeve of claim 21 and the clutch of
claim 23. Mylan does not dispute that the setback can be understood to meet the sleeve
limitation, and also to meet the clutch limitation, but contends that it is improper to have one
physical component satisfy both limitations. Mylan argues: “Sanofi failed to identify a separate
component as the claimed ‘clutch’ in claim 23.”
Mylan argues that claim 23 states, “ further comprising a clutch,” and that the use of the
word “further” requires a physically separate component. Mylan relies on two arguments.
First, Mylan says that the inventors deliberately chose the word “further,” and that choice must
be honored. There is no dispute over that here: this Court will not disregard the word “further.”
The question is what it means.
Second, Mylan relies on the principle of claim differentiation to argue that “further” must
require an additional and physically separate component.4 After post-trial briefs were
submitted, the parties filed a set of letters in which Sanofi argued that this claim differentiation
argument was new and should be struck. This Court need not reach that dispute because the
claim differentiation argument is unpersuasive, whether it is new or old. Mylan first states the
principle of claim differentiation: a dependent claim must narrow the scope of the claim from
which it depends. So far, so good. It is the next step in the argument that has the problem:
“But Sanofi failed to identify a limitation in claim 23 that narrows claim 21 in any way.”

4

The appearance of the word “further” in a dependent claim is neither unusual nor surprising.
The statute says: “a claim in dependent form shall contain a reference to a claim previously set
forth and then specify a further limitation of the subject matter claimed.” 35 U.S.C. § 112(d)
(italics added.)
44

(DPTB at 9.) This makes no sense: the limitation in claim 23 that narrows claim 21 is the
requirement of a clutch. The requirement of claim differentiation is satisfied because claim 21
does not require a clutch and claim 23 does. The scope of claim 23 is narrower than that of
claim 21 because of the clutch limitation.
As to Mylan’s argument that Sanofi has failed to identify a separate component as the
clutch, if there is Federal Circuit authority for the proposition that one physical component
cannot have different features that meet different claim limitations, Mylan has not cited it.
Mylan next argues that the part of the Vystra setback that does the clutching is different
from the part of the setback that does the clicking, and that therefore the Vystra clutch does not
provide audible clicks during dose cancelling, as required by claim 25. There is no dispute
about the underlying facts. Sanofi cites a Becton Dickinson document that states: “Clicking
during dose correction is caused by the double [ratchet] as it interacts with teeth inside the
setback.” (PTX-0350.0003.) Mr. Quinn testified that the teeth that do the clicking are different
from the teeth that do the clutching. (Tr. 263:15-264:7.) Sanofi has not disputed this. The
document just cited, PTX-350, shows that clicking during dose correction is caused by the
interaction of teeth inside the setback with the double ratchet. That same document also states:
2a. User presses Button causing DSK and Setback to be coupled together (via
clutch teeth) and rotate helically clockwise into the Body.
(PTX-0350.0004.) The Mylan NDA states:
The set back is located inside the DSK. Axial teeth on the lower surface of the
top flange of the set back engage with corresponding teeth in the DSK to lock the
two together under axial loading.
(PTX-0394.0017.) This documentary evidence confirms Mr. Quinn’s testimony: the clutch
teeth are on the lower surface of the top flange of the setback, while the clicker teeth are on the
45

inside of the setback.
The dispute, then, is not about the facts, but whether these facts give rise to a finding of
infringement. Sanofi argues that the setback is a clutch that provides audible clicks during dose
canceling. Mylan argues that the clutching and clicking functions are provided by different
parts of the setback. In opposition to Mylan’s position, Sanofi says only: “This view is
inconsistent with Court’s construction for clutch, which defines the clutch as a component, not a
set of features.” (PPTB at 12.) In opposition to Sanofi’s position, Mylan says only: “Sanofi
did not establish why teeth unrelated to, and therefore having no role in, the clutching function
should be considered part of the claimed ‘clutch.’” (DPTB at 10.) Sanofi’s argument is
unpersuasive. During the Markman process, neither party raised the issue of whether the clutch
was a component or a set of features, or whether it could be a part of a physically separate
component.5 The Court construed “clutch” as: “a component that can operate to reversibly lock
two components in rotation.” (Markman Opinion at 13.) Sanofi has offered no reason why
“component” should imply “physically unique component that meets no other claim limitation”
or “physically separate component” – particularly since this Court stated clearly in the Markman
Opinion that it had not been presented with this issue.
Moreover, Mylan is correct: Sanofi has not established why teeth unrelated to clutching
should be considered part of the clutch. Sanofi, as patentee, bears the burden of proof of
infringement by a preponderance of the evidence, and this Court concludes that, as to claim 25, it

5

Coincidentally, this Court made a note of this fact in the Markman Opinion, distinguishing the
Lilly court’s construction of “clutch” on the ground that the Lilly court had been presented with
the issue of separateness of components, whereas the parties in the instant case had not raised
that issue. (Markman Opinion at 11.)
46

has not met this burden. The Vystra clutch does not provide audible clicks during dose
canceling. The Vystra does not contain a clutch that provides audible clicks during dose
canceling, and does not infringe claim 25.
4. Infringement of claim 30
The parties agree that the question of whether Vystra infringes claim 30 turns on the
question of whether the ordinary meaning of nut allows for external threads instead of internal
threads: “The only contested issue is whether the Dose Stop is a nut because it has external
threads.” (PPTB at 13.) Sanofi points to the testimony of its expert, Dr. Reinholtz, who merely
said: “some nuts have external threads.” (Tr. 126:4.) The Court considers this testimony to be
too vague to even be called conclusory. Neither party contends that, in the context of claim 30,
“nut” has anything but its ordinary meaning to a POSA at the Priority Date. Dr. Reinholtz’
testimony does not inform the Court about the ordinary meaning of “nut” to a POSA at the
Priority Date. Sanofi also points to this exchange with Mr. Quinn:
Q. Are things with external threads introduced as nuts, as far as you know?
A. They are typically not.
(Tr. 247:23-25.) The Court does not find any admission about external threads in that exchange.
Mylan’s post-trial brief is not more persuasive, also relying on vague comments by the
experts. The Court finds that none of the experts had anything informative to say at trial about
the ordinary meaning of “nut” to a POSA as of the Priority Date. Nor has either party pointed to
any evidence in the intrinsic record that sheds light on this.6 Given the absence of any intrinsic

6

Mylan notes that the single embodiment in the ’844 specification has an internally threaded
nut. Absent some justification, this Court will not import a claim limitation from the sole
embodiment.
47

evidence, or helpful expert testimony, this Court turns to general purpose dictionaries for
guidance in ascertaining the ordinary meaning of “nut” to a POSA as of the Priority Date. In
Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010), the Federal Circuit held:
The patent specification does not assign or suggest a particular definition to the
term “case.” Therefore, in determining the ordinary and customary meaning of the
claim term as viewed by a person of ordinary skill in the art, it is appropriate to
consult a general dictionary definition of the word for guidance.
The same is true in the instant case: the patent specification does not assign or suggest a
particular definition to the term “nut.” It is therefore appropriate to consult a general dictionary
definition of the word for guidance. Moreover, in Phillips, the Federal Circuit held:
[W]e do not intend to preclude the appropriate use of dictionaries. Dictionaries
or comparable sources are often useful to assist in understanding the commonly
understood meaning of words and have been used both by our court and the
Supreme Court in claim interpretation. A dictionary definition has the value of
being an unbiased source “accessible to the public in advance of litigation.”
Vitronics, 90 F.3d at 1585. As we said in Vitronics, judges are free to consult
dictionaries and technical treatises
at any time in order to better understand the underlying technology
and may also rely on dictionary definitions when construing claim
terms, so long as the dictionary definition does not contradict any
definition found in or ascertained by a reading of the patent
documents.
Id. at 1584 n.6.
Phillips v. AWH Corp., 415 F.3d 1303, 1322-23 (Fed. Cir. 2005) (citations omitted). In the
instant case, the parties have not pointed to any definition of “nut” to be found in the patent
documents.
The Court consulted three online dictionaries to find the ordinary meaning of nut, as it
relates to the mechanical component, and found these definitions:
1. “A small flat piece of metal or other material, typically square or hexagonal,
48

with a threaded hole through it for screwing on to a bolt as a fastener.”7
2. “a perforated block usually of metal that has an internal screw thread and is
used on a bolt or screw for tightening or holding something”8
3. “a block, usually of metal and generally square or hexagonal, perforated with
a threaded hole so that it can be screwed down on a bolt to hold together
objects through which the bolt passes.”9
These online general dictionaries agree about the question of internal threads: a nut has a
threaded hole, and thus an internal thread. The ordinary meaning of “nut” to a POSA, as of the
Priority Date, is limited to an object with an internal thread. This is consistent with the
embodiment disclosed in the specification, in which “[t]he nut 40 has an internal thread.” ‘844
patent, col.4 ll.29-30.
The Vystra dose stop does not have an internal thread. The Vystra does not contain a
nut within the meaning of claim 30. The Vystra does not infringe claim 30.
B. Invalidity
1. Invalidity pursuant to 35 U.S.C. § 112
Defendants contend that the ’844 patent is invalid pursuant to 35 U.S.C. § 112 for lacking
written description and failing to enable the full scope of the claims, on two grounds: 1) the ’844
patent does not describe or enable embodiments having an internally threaded piston rod; and 2)
to the extent the embodiment in the patent has a “piston rod holder,” the patent does not describe
or enable the configuration of that holder to prevent rotation during dose setting.

7

https://www.lexico.com/en/definition/nut (last retrieved 2/25/2020.)
https://www.merriam-webster.com/dictionary/nut (last retrieved 2/25/2020.)
9
https://www.dictionary.com/browse/nut (last retrieved 2/25/2020.)
8

49

a. Written description
Mylan contends that certain elements within claim 21 are not described or enabled in the
specification. Claim 21 recites “a piston rod comprising either an internal or an external fourth
thread,” as well as a “driving member comprising a third thread,” where the
third thread engages with the fourth thread of the piston rod. Mylan contends that the ’844
patent does not describe either an internally threaded piston rod or an externally threaded driving
member.10 In support, Mylan cites the testimony of Mr. Leinsing, who stated that the ’844
patent specification nowhere describes or shows an internally threaded piston rod. (Tr. 283:22284:4; 285:19-22.) Mr. Leinsing also stated that there were no examples in the prior art of an
injection pen with an internally threaded piston rod. (Tr. 286:3-5.) Mr. Leinsing also
expressed the opinion that, based on the evidence in the ’844 patent, he did not believe that the
inventors had possession of an internally threaded piston rod. (Tr. 290:4-7.) He opined that it
would have been very difficult, as of the Priority Date, for a POSA to design and implement an
internally threaded piston rod (Tr. 285:23-286:1), and it would have required considerable
experimentation (Tr. 290:18-22.)
Sanofi contends that, as to the elements of claim 21 in question, the written description
and enablement requirements are met. At the outset, it is essential to note that Sanofi bears no
burden of proof of the validity of the patent. The patent is presumed valid, and Mylan bears the
burden of proof of invalidity by clear and convincing evidence. Sanofi-Aventis U.S., LLC v.
Dr. Reddy's Labs., Inc., 933 F.3d 1367, 1375 (Fed. Cir. 2019) (“A patent is presumed valid, and

10

There is no dispute that the specification adequately describes and enables an externally
threaded piston rod.
50

overcoming that presumption at the district court requires clear and convincing evidence.”)
Nonetheless, the Federal Circuit has given this guidance:
The party challenging the validity of a patent always has the burden of persuading
the trial court of invalidity. However, once a challenger has presented a prima
facie case of invalidity, the patentee has the burden of going forward with rebuttal
evidence. But, all that means is that even though a patentee never must submit
evidence to support a conclusion by a judge or jury that a patent remains valid,
once a challenger introduces evidence that might lead to a conclusion of
invalidity—what we call a prima facie case—the patentee would be well advised
to introduce evidence sufficient to rebut that of the challenger.
Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1101-02 (Fed. Cir. 2015) (citations
omitted.) In the instant case, Mylan has introduced evidence that might lead to a conclusion of
invalidity, and the Court now considers Sanofi’s rebuttal evidence.
The rebuttal case in Sanofi’s brief tracks Dr. Slocum’s testimony:
A POSA knows that there are only two variations regarding the threading between
a piston rod and a driver: internal/external and external/internal. Thus, when the
’844 Patent broadly discloses a pen injector having a piston rod with a threaded
portion connected to a threaded drive sleeve, a POSA would understand that the
piston rod’s threaded portion could be internal or external.
(PPTB at 34.) Sanofi then points to Dr. Slocum’s testimony that leadscrew mechanical devices
were centuries old and, next, to the fact that Dr. Slocum cited two patents for medical devices
(although these devices were motor-driven pumps, not injector pens.) Dr. Slocum testified that
he had written a 1995 textbook with a section about leadscrew devices. (Tr. 497:8-498:7.)
Sanofi then makes a number of challenges to Mylan’s invalidity case.
Even before considering Dr. Slocum’s testimony, the Court notes that Sanofi’s rebuttal
argument is quite limited: Sanofi contends, in short, that leadscrew devices were well-known in
the art, that a POSA reading the patent’s opening summary of the device would already be
envisioning the two simple options (internally and externally threaded piston rod) that are
51

available for connecting the piston rod to the drive sleeve, and two prior art medical device
patents disclose an internally threaded piston rod driven by an externally threaded driver.
Before examining the evidence, the Court considers these arguments in light of the
relevant legal standard. The Federal Circuit has set forth these fundamental principles for the
inquiry into whether a patent is invalid for failure to meet the written description requirement:
Since its inception, this court has consistently held that § 112, first paragraph,
contains a written description requirement separate from enablement, and we have
articulated a fairly uniform standard, which we now affirm. Specifically, the
description must clearly allow persons of ordinary skill in the art to recognize that
[the inventor] invented what is claimed. In other words, the test for sufficiency
is whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed subject
matter as of the filing date.
The term “possession,” however, has never been very enlightening. It implies that
as long as one can produce records documenting a written description of a
claimed invention, one can show possession. But the hallmark of written
description is disclosure. Thus, “possession as shown in the disclosure” is a more
complete formulation. Yet whatever the specific articulation, the test requires an
objective inquiry into the four corners of the specification from the perspective of
a person of ordinary skill in the art. Based on that inquiry, the specification must
describe an invention understandable to that skilled artisan and show that the
inventor actually invented the invention claimed.
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citations omitted.)
The last sentence is key here, because it sets forth a two-pronged test: the specification must both
describe an invention understandable to the POSA, and the specification must show that the
inventor actually invented the invention claimed.
Sanofi’s arguments are directed to the first prong, but not the second. Sanofi contends
no more here than that the specification describes an invention easily understandable to the
POSA. Sanofi has made no argument that the specification shows that the inventor actually
invented the invention claimed. Sanofi’s brief does not address this part of the standard. Of
52

course, it has no obligation to do so.
With that in mind, the Court considers Sanofi’s evidence in support, which is principally
the testimony of Dr. Slocum. Dr. Slocum was persuasive on two points: 1) lead screw systems
were well-known in the prior art; and 2) medical devices with internally threaded piston rods
were known in the prior art. These points were persuasive because Dr. Slocum’s testimony was
backed up with documentary evidence: his textbook and the prior art patents. As to the points
which were not backed up with supporting evidence, the Court found Dr. Slocum’s testimony to
be glib, unpersuasive, and worthy of little weight. As already discussed, Dr. Slocum testified
that, in essence, a POSA reading the patent’s opening summary of the device would already be
envisioning the two simple options (internally and externally threaded piston rod) that are
available for connecting the piston rod to the drive sleeve. As to these points, Sanofi offers only
Dr. Slocum’s testimony, without any supporting evidence. Mylan has argued that there are no
examples of prior art injection pens with an internally threaded piston rod and, while Sanofi has
no obligation to disprove this, it offered no evidence that rebutted it.
Dr. Slocum’s testimony on these points appeared simplistic. For example, both in the
brief and while examining Dr. Slocum, Sanofi cited to the ’844 specification, column 1 line 47 to
column 2 line 9, which is, indeed, a general statement about the device and many of its
components. At trial, Dr. Slocum was asked about this section of the specification, and he went
through it, line by line. When he got to the part about the piston rod threads, he said, first
reading the line aloud:
‘Preferably the piston rod has a first threaded portion at first end and a second
threaded portion at a second end.’ It just says “threaded.” There’s only two
things it can be. So in the POSA’s mind it’s -- in your brain you see
external/internal.
53

(Tr. 494:22-495:1.) Here, Dr. Slocum glosses over the word that starts the sentence:
“preferably.” That might not otherwise mean too much, except that Dr. Slocum relies on this
sentence as the basis for his assertion that “there’s only two things it can be,” and he has
disregarded the key word alerting the reader to the fact that the scope of the invention is broader
than the remainder of the sentence indicates. This is a tip-off that Dr Slocum may be
oversimplifying. Moreover, even if there are just two options for each thread, shouldn’t that
make four options for a rod with two threaded ends, not two?
What followed at trial was an examination of Dr. Slocum about a diagram he had drawn
at his deposition, in which he sketched an internally threaded piston rod with a driver that he
called a “stinger.” He stated:
Q. Now, what knowledge did you use to make this drawing?
A. Well, it's just all the material in the patent and then what the POSA also has in
their head, what I put in the spreadsheet. That's it.
Q. Is it your opinion that a POSA reading the ’844 specification and having the
knowledge in the art about leadscrew drive systems, for example, would be able
to envision arrangements where the piston rod has an internal thread that is
engaged with a driver having an external thread?
A. Yes. They would just do what I did here.
(Tr. 504:1-11.) The implication here is that this business of changing the externally threaded
piston rod – and there is no dispute that an externally threaded piston rod is adequately described
in the specification – to an internally threaded one, connecting to an externally threaded drive
sleeve, is simple and basic for the POSA, just using the information in the patent and ordinary
background knowledge that a POSA would have. Neither Dr. Slocum nor Sanofi have provided
other evidence which supports this.
54

Rather, perhaps inadvertently, Dr. Slocum provided evidence that this was much
oversimplified. On cross-examination, Dr. Slocum was questioned about the deposition
diagram and an Excel spreadsheet he had made in regard to the question of whether the stinger
would buckle when used. Dr. Slocum appeared to agree that he could use the spreadsheet to
determine whether the stinger would buckle. (Tr. 580:6-9.) Dr. Slocum, on the stand, began
altering values in the spreadsheet to answer this question, narrating as he went.11 He mentioned
the following design choices: 1) the root diameter of the piston rod thread (Tr. 580:13-24); 2)
stinger length (582:1-3); 3) choice of plastic (Vectra) and its modulus elasticity (Tr. 582:5-25);
4) choice of different plastic (Delrin) for another part (Tr. 583:8-10); and 5) a question of
whether to weld the two parts or have a snap fit (583:4-13). At this point, the attorneys started
worrying about time, and Dr. Slocum gave this rapid monologue as he worked on the
spreadsheet:
So go down. Hold on. Do you see where it says 1.1 shaft with flats and then shaft
without flats. I need the 1.6. Click on that. Do you see thin max over thin TB?
And now go to the buckle. Then click on the buckle where it says "no."
Hold on. So what happens here is it's taking the with and without, and the
buckling formula depends upon the modulus. It's linear with the modulus. It's
going to be linear in that other length but also will depend upon the end
conditions.
In the stinger you will have what is called -- it will be fixed on one end and
simply supported on the other. And the leadscrew that's in these pen injectors, it's
a simple-simple connection. There's a coefficient, it's called C, when you do the
buckling equation. The difference between the simple-simple and fixed simple is
how you support it. It's about almost a factor 3. So the leadscrew buckling
calculation that was done here was for the piston rod which you could model as
simple-simple. It's just two simple supports. If you want to do the buckling
calculation for the stinger, it's clamped simple. It's about three times higher. But
even if we keep the same simple-simple, you see it's not going to buckle.
11

Sanofi, in its brief, called this “a live simulation at trial.” (PPTB at 37.)
55

(Tr. 584:4-585:2.) Dr. Slocum’s live simulation testimony is credible evidence that the design
choices needed to answer only the single question of whether the stinger would buckle were
numerous and complicated. It seems safe to infer that the design choices that would be required
to produce a fully functional injection pen, with an internally threaded piston rod, would be more
numerous and more complicated, than what Dr. Slocum demonstrated in this simulation.
This inference is supported by the deposition testimony of Robert Perkins, one of the
named inventors on the ’844 patent, who stated:
Q. And how about if you took the threads that are on the outside of the button end
of the piston rod 20, put those on the inside instead of the outside and reassemble
the pen, would that work?
A. Again, you can't look at one feature on its own. It’s part of a complex system.
So a cause and effect. If you change one thing, you have to look at the bigger
picture and make other amendments to correct for that change.
Q. So if you put the threads of the piston rod on the inside of the piston rod, you
would then have to go and make modifications to other components in the pen
before you would have a functional design again?
A. A theoretically functional design, yeah.
Q. Why did you say theoretically?
A. Because there is other constraints that need to be considered as well.
(DTX-2921 at 114:17-115:12.) The most important point here is that an inventor of the ʼ844
pen characterized it as a complex system to modify: you cannot look at one feature on its own,
but must consider modifying multiple parts of that complex system. Although Mr. Perkins did
not assess the degree of complexity, his testimony supports Mylan’s position that this would be
complicated, and is evidence against Sanofi’s contention that it would be a matter of a simple
choice between two well-understood options.
56

Turning back to the bigger picture, Sanofi contends that it would have been a fairly
simple matter for a POSA to use background knowledge with the teachings of the ’844 patent to
make and use an injection pen with an internally threaded piston rod. Mylan contends that it
would have been very complicated. The evidence at trial is: 1) Dr. Slocum suggests that it is so
simple that an MIT professor can draw it in a few minutes; and 2) Dr. Slocum demonstrates that
the design choices for the stinger alone are extremely complicated. The Court finds Dr.
Slocum’s spreadsheet demonstration to be credible and his testimony to the contrary to be
undermined by the spreadsheet demonstration. As stated, the Court concludes that Dr. Slocum’s
testimony about the simplicity of modifying the embodiment disclosed in the ’844 patent to work
as an injection pen with an internally threaded piston rod is not credible and not deserving of any
weight. Nor does this Court find that Dr. Slocum’s deposition diagram deserves any weight as
evidence of the simplicity of making a modified design: it is similarly undermined by the
spreadsheet demonstration. The Court further determines, as a factual matter, that a POSA who
wanted to modify the embodiment disclosed in the ’844 patent to work as an injection pen with
an internally threaded piston rod would face a complicated design task with many choices. The
evidence presented at trial does not support Sanofi’s contention that a POSA could easily modify
the design of the injection pen disclosed in the ’844 patent specification to create a functional
pen with an internally threaded piston rod.
With this foundation, the Court returns to the two-pronged Ariad test: does the
specification describe an invention understandable to the POSA, and does the specification show
that the inventor actually invented the invention claimed? There is no dispute that the
specification does not disclose an internally threaded piston rod. Sanofi argues that Federal
57

Circuit law does not require the inventor to “spell out every detail.” This is true, but let us
consider what the Federal Circuit has said about that:
A claim will not be invalidated on section 112 grounds simply because the
embodiments of the specification do not contain examples explicitly covering the
full scope of the claim language. That is because the patent specification is
written for a person of skill in the art, and such a person comes to the patent with
the knowledge of what has come before. Placed in that context, it is unnecessary
to spell out every detail of the invention in the specification; only enough must be
included to convince a person of skill in the art that the inventor possessed the
invention and to enable such a person to make and use the invention without
undue experimentation.
LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (citations
omitted). As LizardTech explains, while it is unnecessary to spell out every detail of the
invention in the specification, there must be enough included to convince a POSA that the
inventor possessed the invention. Although Sanofi’s brief acknowledges that this is the
standard, its sole argument that the standard has been met is: “Dr. Slocum testified that the broad
embodiment described at column 1, line 47 to column 2, line 9 of the ’844 Patent conveyed to a
POSA possession of an internally threaded piston rod.” (PPTB at 36.) The citation to the
transcript that follows this assertion references Mr. Leinsing’s testimony, not Dr. Slocum’s.
Sanofi’s assertion about Dr. Slocum’s testimony is not supported by the evidence.
During the examination of Dr. Slocum about the contents of columns 1 and 2 of the
specification, Dr. Slocum did not testify that the specification conveyed to a POSA that the
inventors had possession of an injection pen with an internally threaded piston rod, nor anything
close to that. For one thing, Dr. Slocum was not an expert in the design of injection pens, and
he admitted that, as of the Priority Date, he had no personal experience with injector pens. (Tr.
521:8-10.) Dr. Slocum was not admitted as an expert in the design of injection pens. The
58

bottom line is that Sanofi has pointed to no evidence that the specification conveyed to a POSA
that the inventors had possession of an injection pen with an internally threaded piston rod. To
the extent that Dr. Slocum’s testimony about the simplicity of envisioning such a design could be
viewed as supporting an inference that the inventors had such possession, this Court has rejected
that testimony as not credible and as contradicted by Dr. Slocum’s spreadsheet demonstration,
which showed persuasively the complexity of modifying the design depicted in the ’844
specification.
Mylan offered the testimony of its design expert, Mr. Leinsing, who stated that the
specification does not offer evidence that the inventors had possession of an injector pen with an
internally threaded piston rod. With this Court’s rejection of Dr. Slocum’s testimony about the
ease with which a POSA would envision such a design, Mylan’s evidence is unrebutted. As
already stated, in Ariad, the Federal Circuit set forth this standard for the written description
requirement of § 112: “the test for sufficiency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. The Court concludes
that Mylan has proven, by clear and convincing evidence, that the disclosure of the ’844 patent
does not reasonably convey to a POSA that the inventor had possession of all of the subject
matter of claim 21 as of the Priority Date. Claim 21 of the ’844 patent is invalid for failure to
meet the written description requirement.
Mylan also contends that claim 21 fails to meet the written description requirement with
regard to these limitations: “a piston rod holder that is rotatably fixed relative to the housing and
configured to (i) prevent the piston rod from rotating during dose setting.” In opposition, Sanofi
59

points to Dr. Slocum’s detailed testimony that, in the embodiment disclosed in the ‘844
specification, insert 16 meets those limitations. (Tr. 512:2-513:9.) Later in Mylan’s PTB,
Mylan concedes that the specification does teach one way to make and use a piston rod holder to
prevent rotation, using oppositely disposed threads. (See FOF ¶¶ 207-208.) This concession
undermines Mylan’s argument that the specification fails to convey that the inventors possessed
an injection pen with the specified piston rod holder. The Court finds that Dr. Slocum’s
testimony is supported by Mylan’s concession and credits both. Mylan has failed to show, by
clear and convincing evidence, that claim 21 is invalid for lack of written description of the
“piston rod holder.”
b. Enablement
Mylan also argues that claim 21 is invalid for lack of enablement, pursuant to § 112.
“To be enabling, the specification of a patent must teach those skilled in the art how to make and
use the full scope of the claimed invention without undue experimentation.”
Trs. of Bos. Univ. v. Everlight Elecs. Co., 896 F.3d 1357, 1362 (Fed. Cir. 2018). As to claim
21, Mylan’s post-trial brief makes its § 112 enablement argument in a single paragraph, in which
it points to two pieces of evidence: 1) Mr. Perkins’ testimony that redesigning the ’844
embodiment to have internal threading would require making additional changes to other
components to have “a theoretically functional design” because “it’s part of a complex system;”
and 2) Mr. Leinsing’s testimony that such a redesign would have been difficult and required
many changes. While this evidence supports Mylan’s position, Mylan has not come close to
proving invalidity by clear and convincing evidence. Sanofi argues that the opinions from Mr.
Leinsing that Mylan relies on are conclusory, or supported by irrelevant considerations such as
60

manufacturing.
There is no dispute that the ’844 patent nowhere teaches how to make and use an injector
pen with an internally threaded piston rod. Mr. Leinsing testified:
Q. Now, in the specification did you find anything that taught about making those
threads on the piston rod internal?
A. There's nothing in the specification or the figures that mentions anything about
internal threads on the piston rod.
Q. So given this, how difficult would it have been at the time for a POSA to
design and implement an internally threaded piston rod?
A. It would have been very difficult. There -- would have required a lot of
changes. And keeping in mind both myself and Sanofi, experts on both sides,
there's not a single piece of prior art of a pen injector with threads on the inside of
a piston rod. It just doesn't exist. So it's not something that's inherent that a person
of skill in the art would have understood in 2003, so it's not -- not only is it not
inherently known, it was not taught in the patent in any way.
Q. Now, Dr. Slocum at one of his depositions said essentially a person of ordinary
skill in the art would be able to come up with an internally threaded piston rod
and sketched out a document. Did you see that?
A. Yes, I did.
Q. Did you consider that in connection with your opinions in this case?
A. Yes, I did.
MR. CARSTEN: Let's take a look at DTX-2846 if we might.
BY MR. CARSTEN:
Q. What is that, Mr. Leinsing?
A. This is the sketch that Dr. Slocum made during one of his depositions.
Q. Do you agree that a person of ordinary skill in the art would be able to call to
mind this structure based upon the disclosures of the '844 patent in the
background of a person of skill in the art that the person brings with her?
A. No. As you can see, even in his sketch that he's trying to create, there's a lot of
detail that's required. It creates a lot of structural problems. It creates a lot of
61

manufacturing problems.
(Tr. 285:19-287:5.) This testimony is followed by several pages of examination and testimony
on the issues of possible buckling of the piston rod and whether to weld certain parts together.
(Tr. 287-290.)
Mr. Leinsing’s testimony supports Mylan’s contention that the POSA would have had
difficulty with making and using an injection pen with an internally threaded piston rod. The
problem for Mylan, though, is that it has not focused on the requirements of Federal Circuit law.
Mr. Leinsing’s testimony supports Mylan’s contention that the POSA would have had difficulty
with making and using an injection pen with an internally threaded piston rod. The problem for
Mylan, though, is that it has overlooked a key element of the Federal Circuit enablement
standard: the specification must teach a POSA how to make and use an invention without undue
experimentation. Mylan’s post-trial brief does not even address this element, much less
persuade the Court that the evidence clearly and convincingly shows that a POSA would be
unable to make and use the claimed invention without undue experimentation.
The Federal Circuit’s decision in Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330,
1338 (Fed. Cir. 2013), is instructive. The district court had found the claim at issue invalid for
want of enablement, and Watson, the challenger, had relied heavily on expert testimony that
practice of the invention, based on the patent disclosure, would be “difficult” and “complicated.”
Id. The Federal Circuit found that the expert’s conclusions in this regard were “largely
unsupported” and should therefore carry little weight. Id. The district court also weighed in
Watson’s favor testimony from the opposing expert that some routine experimentation would be
required. Id.
62

The Federal Circuit held that the district court had erred, particularly in its understanding
of the experimentation requirement. Id. The Federal Circuit explained:
The question of undue experimentation is a matter of degree, and what is required
is that the amount of experimentation not be unduly extensive. For example, the
fact that a clinician's involvement may be necessary to determine effective
amounts of the single compound effervescent agent and its corresponding soluble
acid source does not itself constitute undue experimentation. In addition,
extensive experimentation does not necessarily render the experiments unduly
extensive where the experiments involve repetition of known or commonly used
techniques. Thus, the focus is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely routine, or if the
specification in question provides a reasonable amount of guidance.
Permissible experimentation is, nevertheless, not without bounds.
Id. at 1338-39 (citations omitted). The Federal Circuit stated: “Watson had the burden to show
by way of testimony or documentary evidence the amount of experimentation needed to” make
and use the claimed invention. Id. at 1339. It found that Watson had not shown that the
experimentation needed would have been excessive, such as by taking “an unreasonable length
of time.” Id. The Federal Circuit concluded:
Unsubstantiated statements indicating that experimentation would be “difficult”
and “complicated” are not sufficient. In light of the lack of evidence on the
record of undue experimentation, the district court erred as a matter of law in
holding that Watson proved its case on enablement by clear and convincing
evidence.
Id.
In the instant case, similarly, Mylan has not shown that the experimentation needed
would be excessive. Rather, like Watson, it has pointed to unsubstantiated expert testimony that
the experimentation would be difficult and complicated. As Cephalon makes clear, this is
insufficient to prove invalidity for want of enablement by clear and convincing evidence.
Mylan did not develop evidence showing the quantum of experimentation that would be needed
63

to make and use the invention at issue. From the evidence presented at trial, Mylan showed that
a substantial amount of experimentation would be needed. This, however, is not sufficient
under the law. In 1982, the predecessor court to the Federal Circuit stated:
The test is not merely quantitative, since a considerable amount of
experimentation is permissible, if it is merely routine, or if the specification in
question provides a reasonable amount of guidance with respect to the direction in
which the experimentation should proceed to enable the determination of how to
practice a desired embodiment of the invention claimed.
Ex parte Mariana Jackson et al., 217 U.S.P.Q. (BNA) 804, 806 (Bd. Pat. App. & Interferences
November 12, 1982). This continues to be the law. Mylan made no showing of whether the
experimentation required would or would not be routine. As to the internally threaded piston
rod, Mylan has failed to prove, by clear and convincing evidence, that claim 21 is invalid for
want of enablement.
Mylan also contends that claim 21 is invalid for want of enablement of the “piston rod
holder” limitation. Mylan’s position has two principal defects. First, Mylan’s PTB concedes
that the specification does teach one way to make and use a piston rod holder to prevent rotation,
using oppositely disposed threads. (See FOF ¶¶ 207-208.) Second, despite this concession, the
PTB then makes the conclusory assertion that “the POSA could not make and use the full scope
of the claims without undue experimentation;” no evidence in support is cited. (DPTB at 17.)
As to the piston rod holder limitation, Mylan has failed to prove, by clear and convincing
evidence, that claim 21 is invalid for want of enablement.
There is no contradiction in finding claim 21 invalid for failure to meet the written
description requirement, but also finding that Mylan has failed to show claim 21 invalid for lack
of enablement. Although both the written description and enablement requirements derive from
64

paragraph 1 of 35 U.S.C. § 112, the substance of the requirements and the applicable legal
standards differ significantly. As the Federal Circuit has explained, “the fact that an invention
may be enabled does not mean it is adequately described, and vice versa.” Nuvo Pharm. (Ir.)
Designated Activity Co. v. Dr. Reddy's Labs. Inc., 923 F.3d 1368, 1382 (Fed. Cir. 2019). The
Federal Circuit carefully analyzed the relationship between the two requirements in Ariad, in
which it stated:
Perhaps there is little difference in some fields between describing an invention
and enabling one to make and use it, but that is not always true of certain
inventions, including chemical and chemical-like inventions. Thus, although
written description and enablement often rise and fall together, requiring a written
description of the invention plays a vital role in curtailing claims that do not
require undue experimentation to make and use, and thus satisfy enablement, but
that have not been invented, and thus cannot be described.
598 F.3d at 1352. As to claim 21 in the instant case, written description and enablement did not
rise and fall together at trial. Although it is clear that the ´844 specification neither discloses an
injection pen with an internally threaded piston rod, nor shows how to make and use one, the
reason for the difference in this Court’s validity determinations may be as simple as this: Mylan
assembled a much more convincing case on the written description problem than it did on
enablement. Even though the disclosure in the specification never changed, while Mylan
convincingly demonstrated that the specification failed to reasonably convey that the inventor
had possession of the claimed subject matter, it neglected to develop evidence about the
experimentation that would be needed to make and use it, and therefore failed to convincingly
demonstrate lack of enablement.
2. Invalidity pursuant to 35 U.S.C. § 103
Mylan contends that the claims at issue are invalid as obvious, pursuant to 35 U.S.C. §
65

103. During closing arguments, Sanofi cited the stipulation entered into by the parties dated
June 14, 2019, which was Ordered and filed by the Court on June 17, 2019 (hereinafter, the “IPR
Stipulation.”) In the IPR Stipulation, the parties agreed that, in this case, Defendants would not
pursue the grounds upon which certain IPRs had been instituted by the PTAB, in reference to a
number of patents, including the patent at issue in this trial, the ’844 patent. As to the ’844
patent, the IPR Stipulation described those grounds as follows:





Obviousness over Giambattista ‘794 in combination with Steenfeldt-Jensen ‘004
(claims 24-29)
Obviousness over Giambattista ‘794 in combination with U.S. Patent No.
6,582,404 (“Klitgaard ‘404”) (claim 30)
Obviousness over Steenfeldt-Jensen ‘004 alone (claims 21-29)
Obviousness over Steenfeldt-Jensen in combination with Klitgaard ‘404 (claim
30)

(IPR Stipulation at 2.) During its closing argument, Mylan responded:
Now, there’s been suggestion that we’re creating a brand-new argument. That's
absolutely not true. We stand by every word in that stipulation from back in June,
Your Honor. We relied heavily upon Chanoch in order to demonstrate that the
change of the threads, the swap of the threads in the slot, would be reasonably
expected to succeed by a person of ordinary skill in the art. That’s our argument.
That’s what we stick to.
(Tr. 650:20-651:2.) Despite having stipulated that it would not assert an obviousness argument
over SJP alone (claims 21-29), and despite using the subheading, “Steenfeldt-Jensen In View Of
Chanoch Render The Asserted Claims Obvious (DPTB at 18), Mylan’s post-trial brief makes
many assertions about SJP alone. This Court honors and enforces the IPR Stipulation, and this
Court will not consider, for claims 21 through 29, obviousness arguments based on SJP alone,
which have been waived.
As to obviousness over SJP in view of Chanoch, Mylan makes a somewhat complicated

66

argument which can be summarized simply: Mylan argues that all of the elements of claim 21
can be found somewhere in SJP, but definitely in the combination of SJP and Chanoch. And,
with that, Mylan goes no further. This is a fragment of an obviousness argument. As already
stated, this Court will not consider the argument that claim 21 is invalid for obviousness based
on SJP alone, pursuant to the IPR Stipulation. Mylan is left with an argument of obviousness
based on SJP in view of Chanoch, in line with the subheading. Even if, for the sake of
discussion, this Court agreed that every element of claim 21 is found somewhere in those two
references – and the Court need not reach that question – , where is the rest of the theory?
The Federal Circuit has summarized the fundamental principles of the law of obviousness
as follows:
Under § 103, a patent may not issue “if the differences between the subject matter
sought to be patented and the prior art are such that the subject matter as a whole
would have been obvious at the time the invention was made to a person having
ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103
(2006). Obviousness is a question of law based on underlying factual
determinations, including: (1) the scope and content of prior art; (2) differences
between prior art and claims; (3) the level of ordinary skill in the art; and (4)
objective indicia of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 1718, 86 S. Ct. 684, 15 L. Ed. 2d 545 (1966). A party asserting that a patent is
obvious must demonstrate by clear and convincing evidence that a skilled artisan
would have had reason to combine the teaching of the prior art references to
achieve the claimed invention, and that the skilled artisan would have had a
reasonable expectation of success from doing so.
Par Pharm., Inc. v. TWi Pharm., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014). The final sentence
from this quote states a standard that Mylan has not come close to meeting. Mylan does not
even attempt to show that the POSA would have had a reason to combine the teachings of SJP
and Chanoch to achieve the invention of claim 21, or that the POSA would have had a
reasonable expectation of success from doing so. Mylan’s first obviousness argument fails.
67

Mylan’s next subheading reads: “Claim 22: Steenfeldt-Jensen And Chanoch Render
Obvious A Piston Rod That Has ‘A Circular Cross-Section.’” (DPTB at 23.) The Court makes
the exact same analysis here: even if, for the sake of discussion, this Court agreed that every
element of claim 22 is found somewhere in those two references – and the Court need not reach
that question – , where is the rest of the theory? Where are the arguments about motivation to
combine and reasonable expectation of success? Mylan’s second obviousness argument fails.
The next subheading states: “Claim 30: A ‘Nut That Tracks Each Set Dose of
Medicament’ Is Obvious Over Steenfeldt-Jensen And The Prior Art.” (DPTB at 25.) In this
single paragraph, Mylan argues that a dose tracking nut was known and used by others in the art,
pointing to FlexPen and Klitgaard. In the IPR stipulation, Mylan waived the argument that
claim 30 is obvious over SJP and Klitgaard, and this Court will not consider it. This leaves the
combination of SJP and FlexPen.12
It is at this point that Mylan addresses the motivation to combine for the first time,
contending: “Sanofi did not dispute that the POSA would be motivated to add and could and
would add a dose tracking nut.” (DFOF ¶ 121.) Mylan cites two sections of testimony. In the
first, Mr. Leinsing testified that: 1) as of the Priority Date, an ISO standard required injector pens
to have dose tracking (Tr. 317:1-18); 2) FlexPen has a dose tracking nut (Tr. 318:10-21); and 3)
a POSA would have known how to use a nut for dose tracking (Tr. 319:13-22). The second
12

Sanofi contends that Mylan failed to prove by clear and convincing evidence that FlexPen was
available in the United States before the Priority Date. As Mylan observes, Sanofi is in a tricky
position with this one: having made Dr. Slocum’s analysis of the FlexPen a key point in its
invalidity rebuttal case, Sanofi cannot have it both ways. If FlexPen is not prior art, Sanofi’s
expert’s analysis of it is irrelevant. That may be why Sanofi does not object too strenuously to
FlexPen as prior art. In any case, Sanofi asserts that, even if the Court found that FlexPen is
valid prior art, all of Mylan’s obviousness arguments would still fail.
68

section that Mylan cites is the first 48 pages of Dr. Slocum’s testimony. The Court will not
guess what Mylan was hoping the Court would find there, but the Court will comment that it did
not find any testimony about a dose tracking nut.
Having looked at the underlying evidence, the Court considers Mylan’s assertion: “Sanofi
did not dispute that the POSA would be motivated to add and could and would add a dose
tracking nut.” (DFOF ¶ 121.) This assertion goes far beyond the cited evidence. The cited
testimony from Mr. Leinsing supports only these relevant inferences: 1) a POSA would have
been motivated to make a pen injector with dose tracking because of the requirement of the ISO
standard; and 2) the FlexPen used a dose tracking nut to track dosing. There is a sizable gap
between these inferences and clear and convincing evidence that claim 30 is obvious in view of
SJP and FlexPen. For starters, Mr. Leinsing did not testify that a POSA would have found it
obvious to combine SJP and FlexPen to create the device of claim 30, nor that the POSA would
have had a reasonable expectation of success in doing so. At trial, Mylan does not appear to
have asked its expert for an opinion on those questions, and he did not give any. Mylan’s third
obviousness argument fails.
Mylan next argues that FlexPen renders obvious all the claims, but offers very little in
support. This assertion is both cryptic and incomplete.
Lastly, Mylan argues that GiaP renders both claims 21 and 22 obvious. As to claim 21,
Mylan first points to the fact that Sanofi stipulated that GiaP contained every limitation in claim
21 except for one: “a piston rod holder that is rotatably fixed relative to the housing and
configured to (i) prevent the piston rod from rotating during dose setting and (ii) permit the
piston rod to traverse axially towards the distal end during dose dispensing.” Mylan contends
69

that GiaP does in fact meet this limitation, notwithstanding the undisputed fact that the device
does not meet this claim limitation during one phase of operation, cartridge replacement. The
argument that the GiaP device meets this limitation during two out of three phases of operation is
not persuasive. As to claim 22, because claim 22 depends on claim 21, having failed to
persuade that claim 21 is obvious over GiaP, Mylan cannot succeed with claim 22.
In light of this Court’s conclusion that Mylan has failed to demonstrate any motivation to
combine the teachings of the prior art references, and failed to meet its burden of proof of
invalidity based on obviousness by clear and convincing evidence, there is no need for a detailed
discussion of secondary considerations of non-obviousness to uphold the patent. But see Geo
M. Martin Co. v. All. Mach. Sys. Int’l LLC, 618 F.3d 1294, 1304 (Fed. Cir. 2010) (“Secondary
considerations of non-obviousness must be considered when present.”) The Court notes,
however, that Mylan has made a substantial showing that the nexus between the commercial
success and the ‘844 patent is tenuous at best, given the overwhelming success of the medicine
injected, insulin glargine. Furthermore, the Orange Book currently states that the Lantus®
SoloSTAR® pen is protected by eighteen patents, and Sanofi’s evidence did not support any
conclusion about which of these eighteen, if any, might account for any success. Mylan has also
made a substantial demonstration that industry praise, under the circumstances of this case, is of
minimal importance, given the fact that it primarily consisted of industry awards for which
Sanofi nominated itself, or for which there were numerous award recipients in the same category.
The Court concludes that Sanofi has failed to prove that the Vystra infringes claims 21,
22, 25, or 30. Mylan has proven, by clear and convincing evidence, that claim 21 is invalid for
failure to meet the written description requirement in 35 U.S.C. § 112 ¶ 1, and therefore Mylan
70

has proven that claims 22, 25, and 30, which depend on claim 21, are invalid as well. Mylan
has failed to prove, by clear and convincing evidence, that claims 21, 22, 25, and 30 are invalid
under their theories based on § 103 obviousness or the enablement requirement in 35 U.S.C. §
112 ¶ 1. This Court determines that claims 21, 22, 25, and 30 are not infringed by the Vystra.
This Court determines that claims 21, 22, 25, and 30 are invalid for lack of adequate written
description. Judgment will be entered in favor of Mylan on Sanofi’s infringement claims and on
Mylan’s affirmative defense of invalidity for failure to meet the written description requirement
in 35 U.S.C. § 112 ¶ 1.
Pursuant to FED. R. CIV. P. 52(a), the Court presents its findings of fact and conclusions
of law.
FINDINGS OF FACT
I.

This Opinion incorporates by reference all stipulated facts set forth in the Final Pretrial
Order.

II.

Based on the evidence presented at trial, this Court now makes the following findings of
fact:
1.

The ’844 patent descends from application No. 10/790,225, and claims priority to
foreign application GB 0304822.0, filed on March 3, 2003 (the “Priority Date.”)

2.

When not in use by a patient (either for dose setting or injection), the Vystra is in
a resting state in which the setback and the dose set knob are disconnected. The
setback and dose set knob are connected only during injection. The connection
between setback and dose set knob is disconnected, or released, at the end of the
injection process, when the user releases finger pressure on the button.

3.

The Vystra tower core has a longitudinal slot that engages with a tab on the
plunger rod and provides a keyed connection that has the capacity to prevent the
plunger rod from rotating.

4.

During the dose setting phase of operation of the Vystra, no drive mechanism
71

applies rotational force to the plunger rod.
5.

Dr. Reinholtz’ experiment, in which he cut apart the Vystra, proved nothing about
the characteristics of the Vystra as it will be sold.

6.

Sanofi offered no credible evidence that, during dose setting, either gravity or
vibration cause the Vystra plunger rod to rotate.

7.

During dose setting in the Vystra, the rotation of the dose set knob is not
transferred to the drive train of the pen. Transfer of rotational movement to the
drive train during dose setting is prevented by the operation of the setback’s oneway engagement with the brake tower. It is the one-way rachet on the setback
that prevents transfer of rotational movement. No other mechanism subjects the
plunger rod to rotational force during dose setting.

8.

The Vystra setback contains one area that provides clutching functionality, and a
different area that provides clicking functionality during dose cancelling. The
clutch area of the setback does not provide audible clicks, and the clicker area of
the setback does not operate as a clutch.

9.

The Vystra contains a dose stop element, which has an external thread and no
internal thread.

10.

The ‘844 specification discloses only a nut with an internal thread.

11.

Three general purpose dictionaries state that the word “nut” is limited to an object
which has an internal thread.

12.

The specification of the ’844 patent does not describe or depict either an
internally threaded piston rod or an externally threaded driving member.

13.

No prior art reference discloses an injection pen with an internally threaded piston
rod. The prior art did not know how to make an injection pen with an internally
threaded piston rod.

14.

Modification of the embodiment depicted in the ’844 specification to incorporate
an internally threaded piston rod would present the POSA with a complicated
design task with many choices.

15.

A POSA, as of the Priority Date, could not have easily modified the embodiment
depicted in the ’844 specification to incorporate an internally threaded piston rod.

16.

A POSA, as of the Priority Date, would not have been convinced that the
inventors of the ’844 patent had, at that time, invented an injection pen with an
72

internally threaded piston rod.
17.

Mr. Leinsing’s expert testimony about the difficulty a POSA would have
encountered in making and using an injection pen with an internally threaded
piston rod was conclusory and unsupported by evidence.

18.

Mylan presented no evidence regarding the amount of experimentation that would
be required for a POSA, relying only on the disclosure of the ’844 patent and the
knowledge in the art as of the Priority Date, to make and use an injection pen with
an internally threaded piston rod.

19.

Mylan presented no evidence that a POSA would have had a reason to combine
the teachings of SJP and Chanoch to achieve the invention of claim 21.

20.

Mylan presented no evidence that a POSA, seeking to achieve the invention of
claim 21 by combining the teachings of SJP and Chanoch, would have had a
reasonable expectation of success in doing so.

21.

Mylan presented no evidence that a POSA, seeking to achieve the invention of
claim 22 by combining the teachings of SJP and Chanoch, would have had a
reasonable expectation of success in doing so.

22.

Mylan presented no evidence that a POSA, seeking to achieve the invention of
claim 30 by combining the teachings of SJP and FlexPen, would have had a
reasonable expectation of success in doing so.

23.

Mylan presented no evidence that a POSA, seeking to achieve the invention of
any of claims 21, 22, 25, or 30 by modifying the teachings of FlexPen, would
have had a reasonable expectation of success in doing so.

24.

The device disclosed in the GiaP reference contains a piston rod holder that is
rotatably fixed to the housing during the dose setting phase, and the injection
phase, but the piston rod holder is not rotatably fixed to the housing during the
cartridge replacement phase of operation.
CONCLUSIONS OF LAW

1.

This Court has jurisdiction over this case pursuant to 28 U.S.C. § 1331.

2.

The parties accept this Court’s personal jurisdiction.

3.

Venue is proper in this district pursuant to 28 U.S.C. § 1391(b).

4.

“A patent shall be presumed valid. Each claim of a patent (whether in
73

independent, dependent, or multiple dependent form) shall be presumed valid
independently of the validity of other claims; dependent or multiple dependent
claims shall be presumed valid even though dependent upon an invalid claim. The
burden of establishing invalidity of a patent or any claim thereof shall rest on the
party asserting such invalidity.” 35 U.S.C. § 282.
5.

The claim term, “releasably connected,” in claim 21, has its ordinary meaning.

6.

The setback and the dose set knob in the Vystra, as it will be distributed, are
neither connected nor releasably connected, within the ordinary meaning of
“releasably connected” in claim 21. The Vystra does not meet the “releasably
connected” limitation contained in claim 21.

7.

Claim 21 requires a piston rod holder configured to prevent the piston rod from
rotating during dose setting. During dose setting, the flow of rotational force
from the dose set knob is interrupted by the operation of the setback’s one-way
rachet engagement with the brake tower. Because of this, the piston rod holder
does not prevent the piston rod from rotating during dose setting. The Vystra
piston rod holder, during dose setting, is not configured to prevent the piston rod
from rotating during dose setting. The Vystra does not meet the requirement in
claim 21 of a piston rod holder configured to prevent the piston rod from rotating
during dose setting.

8.

The Vystra does not meet two limitations in claim 21. It does not contain a
releasably connected sleeve, and it does not contain a piston rod holder
configured to prevent the piston rod from rotating during dose setting.

9.

Sanofi has failed to prove, by a preponderance of the evidence, that the Vystra
contains every limitation in claim 21. The Vystra does not infringe claim 21.

10.

Because claims 22, 25, and 30 depend on claim 21, and the Vystra does not
infringe claim 21, the Vystra cannot infringe claims 22, 25, and 30.

11.

In claim 23, the claim term, “further,” has its ordinary meaning. The ordinary
meaning of “further” does not imply any requirements in terms of physical
separateness or uniqueness.

12.

Sanofi has failed to prove, by a preponderance of the evidence, that the Vystra
contains a clutch that provides audible clicks during dose cancelling.

13.

Sanofi has failed to prove, by a preponderance of the evidence, that the Vystra
infringes claim 25.

14.

In claim 30, the claim term, “nut,” has its ordinary meaning, which is limited to
74

an object with an internal thread.
15.

Sanofi has failed to prove, by a preponderance of the evidence, that the dose stop
in the Vystra is a nut, within the ordinary meaning of the term in claim 30.

16.

Sanofi has failed to prove, by a preponderance of the evidence, that the Vystra
infringes claim 30.

17.

The Vystra does not infringe any claim asserted by Sanofi in the ’844 patent.

18.

As to an injection pen with an internally threaded piston rod, the ’844
patent specification does not describe such an invention so as to be
understandable to a POSA, nor does it show that the inventor possessed
that invention.

19.

As of the Priority Date, a POSA reading the ’844 patent specification
would not be convinced that the inventors possessed an injection pen with
an internally threaded piston rod.

20.

The disclosure of the ’844 patent does not reasonably convey to those
skilled in the art that the inventors had possession of an injection pen with
an internally threaded piston rod, as of the Priority Date.

21.

Mylan has proven, by clear and convincing evidence, that claim 21 is invalid for
failure to meet the written description requirement, pursuant to 35 U.S.C. § 112 ¶
1.

22.

Claim 21 is invalid for failure to meet the written description requirement,
pursuant to 35 U.S.C. § 112 ¶ 1.

23.

Because claims 22, 25, and 30 depend on claim 21, which Mylan has proven is
invalid for failure to meet the written description requirement, pursuant to 35
U.S.C. § 112 ¶ 1, claims 22, 25, and 30 must necessarily also be invalid for failure
to meet the written description requirement.

24.

As to the “piston rod holder” limitation in claim 21, Mylan has failed to prove, by
clear and convincing evidence, that claim 21 is invalid for failure to meet the
written description requirement, pursuant to 35 U.S.C. § 112 ¶ 1.

25.

Mylan has failed to prove, by clear and convincing evidence, that claim 21 is
invalid for failure to meet the enablement requirement, pursuant to 35 U.S.C. §
112 ¶ 1.

26.

Claim 21 is not invalid for failure to meet the enablement requirement, pursuant
75

to 35 U.S.C. § 112 ¶ 1.
27.

Claims 22, 25, and 30 are not invalid for failure to meet the enablement
requirement, pursuant to 35 U.S.C. § 112 ¶ 1.

28.

This Court honors and enforces the IPR Stipulation entered into by the parties, in
which Mylan waived these obviousness arguments: 1) obviousness of claims 21
through 29 over SJP alone; and 2) obviousness of claim 30 over SJP in
combination with Klitgaard. Although Mylan relied on such arguments in its
post-trial briefing, the Court has not considered them.

29.

Mylan has failed to prove, by clear and convincing evidence, that claim 21 is
invalid as obvious over SJP in view of Chanoch.

30.

Mylan has failed to prove, by clear and convincing evidence, that claim 22 is
invalid as obvious over SJP in view of Chanoch.

31.

Mylan has failed to prove, by clear and convincing evidence, that claim 30 is
invalid as obvious over SJP and FlexPen.

32.

Mylan has failed to prove, by clear and convincing evidence, that any asserted
claim is invalid as obvious over FlexPen.

33.

The GiaP reference does not disclose a piston rod holder that is rotatably fixed to
the housing during all phases of operation of the device.

34.

Mylan has failed to prove, by clear and convincing evidence, that claims 21 or 22
are invalid as obvious over GiaP.

35.

Claims 21, 22, 25, and 30 are not invalid as obvious, pursuant to 35 U.S.C. § 103.

36.

Claims 21, 22, 25, and 30 of U.S. Patent No. 9,526,844 are invalid for failure to
meet the written description requirement stated in 35 U.S.C. § 112 ¶ 1.

37.

Defendants’ proposed NDA product, the Vystra pen, does not infringe claims 21,
22, 25, or 30 of the ’844 patent.

An appropriate Order follows.
s/ Stanley R. Chesler
Stanley R. Chesler, U.S.D.J.
Dated: March 9, 2020
76