CIPHER PHARMACEUTICALS, INC. et al v. WATSON LABORATORIES, INC.-FLORIDA et al

Filing 109

OPINION. Signed by Judge Joseph E. Irenas on 4/20/2015. (tf, )

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

CIPHER PHARMACEUTICALS INC.,
et al.,

:
:
:
Plaintiffs,
:
:
v.
:
:
ACTAVIS LABORATORIES FL, INC.,:
et al.,
:
:
Defendants.
:

Civil No. 13-6502 (JEI/AMD)

OPINION

APPEARANCES:

EPSTEIN, BECKER & GREEN, P.C.
By: Theodora McCormick, Esq.
One Gateway Center
Newark, New Jersey 07102
and
KIRKLAND & ELLIS LLP
By: Leora Ben-Ami, Esq.
Jeanna M. Wacker, Esq.
Laura A. Keay, Esq.
601 Lexington Avenue
New York, New York 10022
Counsel for Plaintiffs
CONNELL FOLEY LLP
By: Liza M. Walsh, Esq.
Tricia B. O’Reilly, Esq.
Eleonore Ofosu-Antwi, Esq.
85 Livingston Avenue
Roseland, New Jersey 07068
and
ROTHWELL, FIGG, ERNST & MANBECK
By: E. Anthony Figg, Esq.
C. Nichole Gifford, Esq.
Lisa N. Phillips, Esq.
1

Brett A. Postal, Esq.
607 14th Street, NW, Suite 800
Washington, DC 20005
Counsel for Defendants

IRENAS, Senior United States District Judge:
This is a patent infringement suit.

The Court conducted a

Markman hearing on April 2, 2015, which included extensive
testimony from the parties’ expert witnesses.

This opinion

construes the five remaining disputed terms 1 of the two related
patents, the ‘427 patent 2 and the ‘102 patent 3, both of which
disclose a “pharmaceutical semi-solid composition of
isotretinoin,” commercially known as the prescription drug
Absorica.

I.
According to Plaintiffs, Absorica is an improvement on the
well-known acne drug, Accutane, which is another formulation of
isotretinoin. 4

1

The parties’ Joint Claim Construction and Prehearing
Statement, see Local Patent Rule 4.3, identified nine terms to
be construed. By the time of the Markman hearing, the parties
had narrowed that number to five.
2

U.S. Patent No. 7,435,427, issued October 14, 2008.

3

U.S. Patent No. 8,367,102, issued February 5, 2013.

4

Outside the United States, Accutane is marketed as Roaccutane.
The patents-in-suit refer to Roaccutane.
2

Isotretinoin, a retinoid (related to Vitamin A), is a
difficult drug with which to work for three reasons.
degrades when exposed to light and air.
poorly water soluble.

First, it

Second, it is very

Third, it has a narrow therapeutic

window, meaning that there is a small range between the dose at
which the drug is effective and the dose at which it is toxic. 5
Accutane purportedly sought to address at least some of
these problems by dissolving isotretinoin in a gelatin capsule
(to be taken orally) largely composed of oily, fatty ingredients
such as beeswax and vegetable oil.

However, when patients

ingested Accutane, it did not mix well in the aqueous (watery)
environment of the human body, leading to poor bioavailability
of the isotretinoin active ingredient.

Thus, to boost

absorption, patients were instructed to take Accutane with food.
However, this approach, according to Plaintiff, was not
ideal.

The “food effect” was strong, resulting in radical

spikes in absorption and an increased risk of overshooting the
therapeutic window.

Decreased absorption associated with low

food intake was also a problem; it could lead to “re-treatment”
which itself carries a risk of toxic exposure simply due to

5

Toxic effects include severe birth defects, liver toxicity,
vomiting, headaches, skin anemia, severe mucosal irritation, and
appendicitis.
3

taking the drug for a longer period of time. 6

The absorption

problem was magnified by the reality that typical isotretinoin
patients are teenagers, who, as a group, are known to be
“notoriously non-compliant.” (Plaintiffs’ tutorial, p. 2)
Absorica allegedly solves the “food effect” absorption
problem by creating a novel semi-solid formulation of
isotretinoin.

Absorica, like Accutane, has an oily vehicle

(i.e., oily excipient); but, unlike Accutane, Absorica also has
a water-soluble component (i.e., hydrophilic excipient).

This

new formulation allegedly obviates the need to take the drug
with food.

Absorica is the only isotretinoin product currently

on the market with the dosage instruction that the capsules
should be taken “without regard to meals.”
The terms to be construed are:
Term 1: “semi-solid suspension”
Term 2: “hydrophobic lipidic balance (HLB) value”
Term 3: “having an HLB value equal to or greater than
10” / “has an HLB value of at least [12, 13]”
Term 4: “the isotretinoin is partially in suspension
and/or partially in solution”
Term 5: “an amount of about 1 to 10% of at least one
additional surfactant” / “about 1 – 10% of an
additional surfactant”

6

A typical course of treatment with isotretinoin lasts 15-20
weeks.
4

II.
Claim construction is a matter of law for the Court to
decide.

Markman v. Westview Instruments, Inc., 517 U.S. 370,

391 (1996).

“It is a ‘bedrock principle’ of patent law that

‘the claims of a patent define the invention to which the
patentee is entitled the right to exclude.’”

Phillips v. AWH

Corp., 415 F.3d 1303, 1319 (Fed. Cir. 2005) (en banc) (quoting
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,
381 F.3d 1111, 1115 (Fed. Cir. 2004)).
The Court begins a claim construction analysis by examining
the intrinsic evidence, which includes the claims, the
specification, and the prosecution history.

Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

“A

claim construction analysis must begin and remain centered on
the claim language itself.”

Innova, 381 F.3d at 1116.

There is

a heavy presumption that a claim term conveys its ordinary and
customary meaning, which “is the meaning that the term would
have to a person of ordinary skill in the art in question at the
time of the invention.”

Phillips, 415 F.3d at 1313.

But a

patentee may overcome this presumption and choose “to be his or
her own lexicographer by clearly setting forth an explicit
definition for a claim term.”

Johnson Worldwide Assocs., Inc.

v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999); see also
5

Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir.
2000); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979–
80 (Fed. Cir. 1995), aff’d 517 U.S. 370 (1996).
The claims themselves and the context in which a term is
used within the claims can “provide substantial guidance as to
the meaning of particular claim terms.”
1314.

Phillips, 415 F.3d at

In addition, other claims of the patent may be useful in

construing a claim term, as “claim terms are normally used
consistently throughout the patent.”

Id.

Similarly, claims

that differ from each other may provide insight into how a term
should be read.

Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533,

1538 (Fed. Cir. 1991).
After examining the claims, “it is always necessary to
review the specification to determine whether the inventor has
used any terms in a manner inconsistent with their ordinary
meaning.”

Vitronics, 90 F.3d at 1582.

“For claim construction

purposes, the description may act as a sort of dictionary, which
explains the invention and may define terms used in the claims.”
Markman, 52 F.3d at 979.

For this reason, “the specification is

always highly relevant to the claim construction analysis.
Usually, it is dispositive; it is the single best guide to the
meaning of a disputed term.”

Vitronics, 90 F.3d at 1582.

Finally, the Court should also examine the prosecution
history, if it is in evidence.

Phillips, 415 F.3d at 1317.
6

“The prosecution history can often inform the meaning of the
claim language by demonstrating how the inventor understood the
invention and whether the inventor limited the invention in the
course of prosecution, making the claim scope narrower than it
would otherwise be.”

Id.

“[I]deally there should be no ‘ambiguity’ in claim language
to one of ordinary skill in the art that would require resort to
evidence outside the specification and prosecution history.”
Markman, 52 F.3d at 986.

But if the term remains unclear or

ambiguous after examining the intrinsic evidence, the Court may
turn to extrinsic evidence.

Pall Corp. v. Micron Separations,

Inc., 66 F.3d 1211, 1216 (Fed. Cir. 1995).

“Extrinsic evidence

consists of all evidence external to the patent and prosecution
history, including expert and inventor testimony, dictionaries,
and learned treatises.”

Markman, 52 F.3d at 980.

Although

extrinsic evidence is useful in determining how a person of
ordinary skill in the art would understand the term, it is less
reliable for the purposes of claim construction than the patent
and its prosecution history.

Phillips, 415 F.3d at 1318-19.

Therefore, extrinsic evidence must be viewed within the context
of intrinsic evidence.

Id. at 1319.

III.
7

The Court addresses one initial issue before turning to the
disputed terms.

A.
Defendants assert that four out of the five disputed claim
terms are indefinite.

Defendants urge the Court to decide that

issue now, at the claim construction phase of this suit.
Plaintiffs argue that neither the parties, nor the
governing scheduling order, contemplated addressing
indefiniteness at the Markman hearing.

Plaintiffs urge the

Court to address indefiniteness later, upon an appropriate
motion for summary judgment.
There is no dispute that the issues of indefiniteness and
claim construction are-- or at least, often will be-intertwined.

See generally Manzo, Patent Claim Construction in

the Federal Circuit (2012 ed.) § 4:1 (“The determination of
indefiniteness arises out of the court’s performance of its duty
to construe claims”; “[Indefiniteness] is intimately related to
claim construction.”).
Indeed, the Supreme Court’s recent Nautilus decision
appears to draw indefiniteness and claim construction even
closer together.

See Nautilus, Inc. v. Boisig Instruments,

Inc., 134 S.Ct. 2120 (June 2, 2014).

The indefiniteness inquiry

no longer asks whether claim terms are insolubly ambiguous.
8

Rather, the Nautilus Court held, “a patent is invalid for
indefiniteness if its claims, read in light of the specification
delineating the patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art
about the scope of the invention.”

134 S.Ct. at 2124.

Thus,

the question of whether the Court should decide indefiniteness
at claim construction is, in this respect, relatively new. 7
In this Court’s view, taking a claim-by-claim approach to
Defendants’ indefiniteness arguments is necessary because the
asserted reasons for the disputed terms’ indefiniteness are
different. 8

Those reasons are sometimes very closely intertwined

with the actual meaning or construction of the words 9, but other

7

Even before Nautilus however, courts were deciding
indefiniteness at, or even before, the claim construction phase.
See, e.g., Teva Pharmaceuticals USA, Inc., et al. v. Sandoz,
Inc., et al., 810 F.Supp.2d 578, 581 (S.D.N.Y. 2011). There
seems to be little reasonable dispute that the Court can decide
indefiniteness now. The issue presented here is, should the
Court-- in the context of this particular case, and the parties’
disputes as they currently stand-- decide indefiniteness now?

8

See generally, Manzo, Patent Claim Construction in the Federal
Circuit (2012 ed.) § 4:1 (cataloging eight “types” of
indefiniteness assertions).

9

See, e.g., Manzo § 4:1 (“A sixth type [of indefiniteness
assertion] is when the claim language is not intentionally
imprecise but the meaning cannot reasonably be discerned.”).
9

times the reasons may not be so intertwined. 10

Two of this

case’s disputed terms provide contrasting examples.
First, Defendants argue that hydrophobic lipidic balance
(term 2) is indefinite because there is no such term of art; the
term has no meaning to one skilled in the art and therefore is
indefinite.

Plaintiffs on the other hand, agree there is no

such term of art, they simply urge the Court to draw a different
conclusion-- namely, that the term is a typographical error.
This type of indefiniteness dispute is, for lack of a
better term, “ripe,” for decision at the Markman stage.

If the

Court accepts Defendants’ conclusion, the term undisputedly
would be indefinite because even Plaintiffs concede, hydrophobic
lipidic balance does not exist.

But, if the Court concludes

that there was a typographical mistake, even Defendants concede
that hydrophilic lipidic balance is a term of art, and they
agree with Plaintiffs on what that term of art means.

Either

way, construing the term, or concluding that it cannot be
construed, simultaneously resolves the indefiniteness issue.
Not so, however, with respect to term 5 (“about 1 - 10%”).
As to that term, Defendants’ indefiniteness argument does not

10

See, e.g., Manzo § 4:1 (“The first type [of indefiniteness
assertion is] imprecision by design. This occurs when claim
drafters include words to indicate affirmatively that precision
is not required. Examples of such words are ‘substantially,’
‘about,’ and the like. Such words have routinely been used in
patent drafting.”).
10

directly implicate the construction of the word “about” because
Defendants argue that even if the Court, consistent with
governing caselaw, see infra, construes “about” to mean
“approximately,” the indefiniteness problem persists.
Here, Defendants argue that the scope of the claim is
unreasonably uncertain not because a person skilled in the art
would not understand the term, but rather, that person would not
know where to draw the line between several readily
understandable alternatives: does “about 1%” include 0.9%?
0.85%? 0.5%? etc.

Thus, this dispute, unlike the dispute over

term 2, ventures far beyond the inherent meaning of the words,
and therefore is not appropriately decided at the Markman stage.
Construing the term in this instance does not resolve the
indefiniteness issue.
Thus, whether to decide indefiniteness during claim
construction depends on why the alleged infringer asserts that
the claim is indefinite.

When a claim is asserted to be

indefinite because it has no meaning to a person skilled in the
art, an indefiniteness decision at the claim construction stage
may be practically unavoidable.

But in other situations, the

issues may not be as closely dependent on each other, and
therefore an indefiniteness decision will be better left for
decision at summary judgment, on a more developed record.

11

With these principles in mind, at this time the Court will
rule upon Defendants’ indefiniteness arguments as to disputed
terms 2 and 4, but not 3 and 5.

B.
(1)

“semi-solid suspension”
Plaintiffs argue that “suspension” is a term of art and

should not be replaced with any other words.

They assert

that “suspension” has a plain meaning to a person of
ordinary skill in the art and that the patent and the
prosecution history support this plain meaning.
Defendants, on the other hand, would like the Court to
“provide an explanation of the claim language as it would have
been understood by a person of ordinary skill,” (Opening brief,
p. 17), therefore, they propose a construction that attempts to
define “suspension” without using the word “suspension.”
Defendants’ proposed construction is: “a semi-solid composition
in which isotretinoin is predominantly undissolved and is
dispersed in the at least two lipidic excipients.”
The issue is whether “suspension” should be limited to
suspensions in which isotretinoin is “predominantly
undissolved,” i.e., where more than 50% of the isotretinoin
particles are in suspension, as opposed to being in solution.
(See Hr. Tr. 117:10-15) (“THE COURT:
12

Basically, you’ve just

really added the word ‘predominantly.’
down to.

[Mumper]:

That’s what it comes

That is correct.”); (See also Hr. Tr.

174:2-12).
Plaintiffs are correct that limiting “suspension” in this
way would be inconsistent with the patents’ specifications:
•

“For suspensions, it was possible to
dissolve a high fraction of isotretinoin
in the mix of excipients and even the whole
quantity of the active ingredient if the
manufacturing conditions . . . and the
formulations
were
optimized.”
(‘102
Patent, column 5, lines 20-25; ‘427 Patent,
column 5 lines 16-21)

•

“the isotretinoin may be solubilized in the
mix
of
excipients
or
partially
solubilized” (‘102 Patent, column 3, lines
4-5; ‘427 Patent, column 2, lines 61-62)

•

the invention contains excipients that
“totally or partially (depending on the
ratio
between
excipients)
dissolve
isotretinoin.”
(‘102 Patent, column 5,
lines 16-19; ‘427 Patent, column 5, lines
12-15)

There simply is no support in the patents’ claims or
specifications for Defendants’ proposed qualifier of
“predominantly.”
Defendants mischaracterize Plaintiff’s position by arguing
that Plaintiffs equate solution and suspension.

According to

Defendants, Plaintiffs argue for a construction wherein all of
the isotretinoin could be dissolved in suspension.

This is not

Plaintiffs’ position insofar as they urge the Court to construe
13

“suspension” as “suspension,” and suspension does not mean
“solution.”

(See Davies Testimony, Hr. Tr. 38:18-20; 60:24-

61:1) (“Q: And if all of the [drug] particles are dissolved,
would you consider that to be a suspension?

A: No.

That would

be a solution.”; “if that formulation was one where the drug was
completely dissolved, it would not be considered a
suspension.”). 11

The parties do not dispute that a “suspension”

wherein all of the API is dissolved simply is not a suspension,
it is a solution.
The Court holds that “semi-solid suspension” means “a
semi-solid composition wherein the isotretinoin is not 100%
in solution.”

(2)

“hydrophobic lipidic balance (HLB) value”
The issue is whether “hydrophobic lipidic” is an obvious

typographical error which the Court may correct to say
“hydrophilic lipophilic.”

Plaintiffs assert that it is.

Defendants assert that “this term is not amenable to
construction,” and is indefinite.

11

(See also Plaintiffs’ closing argument, Hr. Tr. 200:1-5) (“in
defendants’ rebuttal Markman brief, they made statements that
plaintiffs are arguing that a suspension means that all of the
particles can be dissolved, and that is not what we’re
arguing.”).
14

“‘A district court can correct a patent only if (1) the
correction is not subject to reasonable debate based on
consideration of the claim language and the specification and
(2) the prosecution history does not suggest a different
interpretation of the claims.”

CBT Flint Partners, LLC v.

Return Path, Inc., 654 F.3d 1353, 1358 (Fed. Cir. 2011).
Plaintiffs’ position has ample support in: (a) the claim in
which the term appears (claim 1); (b) the specification; and (c)
the prosecution history.

Plaintiffs’ position is also supported

by (d) the claims and specification of the ‘427 patent.
First, claim 1 of the ‘102 patent discloses:
A method of treating a skin disorder, which
comprises . . . a semi-solid preparation containing
two lipidic excipients, at least one of them being
hydrophilic having a Hydrophobic Lipidic Balance
(HLB) value equal to or greater than 10, the other
being an oily vehicle, whereby the at least one
hydrophilic lipidic excipients(s) with an HLB value
of at least 10 is selected . . .

(emphasis added).
The facial inconsistency of the claim is immediately
obvious: a hydrophilic excipient logically cannot have a
hydrophobic lipidic balance.

It makes no sense; the two terms

are diametrically opposed, as Defendants’ own expert recognized
in his testimony at the Markman hearing.

(Mumper Testimony, Hr.

Tr. 111:20-25) (See also Mumper Decl. ¶ 20) (“a person of
ordinary skill in the art would have considered [hydrophobic and
15

hydrophilic] to be opposites.”)

The parties agree, hydrophilic

literally means “water loving,” whereas hydrophobic means “water
fearing.”
Second, the very first sentence of the specification reads:
“[t]he present invention relates to an oral pharmaceutical
composition of isotretinoin containing at least two excipients,
one of them being hydrophilic (i.e., having an HLB value
superior or equal to 10), the other being an oily vehicle.”
(emphasis added)
In four other places, the specification clearly refers to a
“hydrophilic/lipophilic balance value (HLB)” (column 3, line 1617), or a hydrophilic excipient having an HLB value of at least
10 (see column 4, line 10-11; column 4, line 16-17; column 5,
line 15-16). 12
Third, the prosecution history shows that the Patent
Examiner himself understood “hydrophobic” to be a mistake.

In

the Notice of Allowability, the examiner stated that the

12

Defendants’ expert all but conceded this point during the
Markman hearing: “THE COURT: Isn’t there other things in the
specifications that tell you what [hydrophobic lipidic balance]
really means, that it really means hydrophilic? Mumper: There
are, in the specifications, uses the term hydrophilic lipophilic
balance.” (Hr. Tr. 135:24-136:3)
The Court finds Mumper’s testimony as to this particular
claim evasive and disingenuous, and therefore discredits
Mumper’s ultimate conclusion that a person skilled in the art
would conclude that hydrophobic lipidic balance is indefinite,
rather than a typographical mistake.
16

predecessor to claim 1 “should be amended by replacing the term
hydrophobic in line 4 with the term hydrophilic.”

(Davies Decl.

Ex. 22, ‘102 Patent prosecution history, RANB00000320)
Unfortunately, as Plaintiff observes, hydrophobic appeared
twice-- “one of them being hydrophobic having a Hydrophobic
Lipidic Balance (HLB) value equal to or greater than 10” (Id. at
RANB00000296)-- yet only the first instance was corrected.
Considering the claim, the specification and the
prosecution history together, hydrophobic lipidic balance
appears only a single time.

While Defendants argue that this

fact supports the inference that the departure was intentional,
the Court concludes precisely the opposite.

Hydrophobic lipidic

balance sticks out like a sore thumb when considered in the
context of all of the intrinsic evidence.
Fourth, in eight different places in the ‘427 patent, the H
in HLB clearly stands for hydrophilic.

(column 1, line 6-7;

column 3, line 5-6; column 4, line 6-7; column 4, line 12-13;
column 4, line 16-17; column 5, line 11-12; column 11, line 50;
column 14, line 2-3)

Nowhere does the ‘427 patent speak of

hydrophobic lipidic balance.
Moreover, and perhaps most tellingly, Defendants provide no
definition or explanation for what hydrophobic lipidic balance
could mean.

Both experts testified at the Markman hearing that

there is no such term of art. (Davies Testimony, Hr. Tr. 63:517

12) (“THE COURT: is there such a thing as hydrophobic lipidic
balance?

A: No.

THE COURT: It doesn’t exist, does it?

THE COURT: In science, I mean.
scientists know.

A:

No.

A: No.

It’s not something

Scientists know hydrophilic lipidic

balance.”); (Mumper Testimony, Hr. Tr. 135:16-22).
While Defendants use this fact to support their argument
that “hydrophobic lipidic balance” must be indefinite, the Court
disagrees because all of the evidence before the Court clearly
establishes that HLB is a standard term used in the industry
that means hydrophilic lipidic balance.

(See Davies Testimony,

Hr. Tr. 62:5-11; Mumper Testimony, Hr. Tr. 161:5-9); (See also
Davies Decl. ¶¶ 40, 44).

Where, as here, the claim term is an

obvious mistake, and importantly, the evidence unequivocally
shows what the replacement term should be (see Davies Testimony,
Hr. Tr. 99:11-15) (“hydrophilic lipidic balance is what
everybody knows.

The hydrophobic lipophilic balance isn’t

something that’s in the art.”); (Mumper Testimony, Hr. Tr. 113114:24-1) (“a person of skill in the art would recognize the
term hydrophilic lipophilic balance.

Would not recognize the

term hydrophobic lipidic balance.”), the disputed term is not
indefinite.

Rather, it is a mistake that the Court will

correct.
Lastly, Defendants’ distinction between lipidic and
lipophilic is a red herring.

Plaintiffs have presented
18

persuasive evidence that the L in HLB can stand for either
lipidic, lipophilic, or lipophile.
Rebuttal Decl. ¶¶ 15-17)

(Davies Decl. ¶ 44; Davies

Most notably, both parties’ experts

agree that a 1998 article published in International Journal of
Pharmaceutics defined HLB as “hydrophilic-lipidic balance.”
(Davies Rebuttal Decl. ¶ 17; Mumper Dep. 261:7-9, 265:17-20)
In conclusion, what makes Absorica unique, and an
improvement on Accutane, is the fact that it contains a
hydrophilic excipient which increases bioavailability.

A

hydrophobic excipient could not achieve the same result.

A

person of ordinary skill in the art would understand hydrophobic
lipidic balance to be a typographical error.
The Court holds that “hydrophobic lipidic balance (HLB)
value” means “hydrophilic lipophilic balance (HLB) value.”

(3)

“having an HLB value equal to or greater than 10” / “has an
HLB value of at least [12, 13]”

Defendants argue that “HLB value” is indefinite because
various methods exist for determining HLB values, with different
formulas producing different values, yet the patents-in-suit do
not specify which method to use.
Plaintiffs argue that the terms should be given their plain
meaning, i.e., they mean exactly what they say.

19

As discussed supra, this indefiniteness issue goes beyond
the meaning of the disputed term.

HLB value is a term of art,

and Defendants do not dispute its meaning.
Accordingly, the Court holds that “having an HLB value
equal to or greater than 10” / “has an HLB value of at least
[12, 13]” needs no construction.

(4)

“the isotretinoin is partially in suspension and/or
partially in solution”

Defendants argue the use of “and/or” renders this term
indefinite.

Specifically, Defendants take no issue with the

“and” part.

They concede that if the term used only “and,” the

term would “make sense.”

(Responsive Markman Brief p. 15) (See

also Defendants’ closing argument, Hr. Tr. 222:22-223:4)

But

Defendants argue, partially in suspension or partially solution
makes no sense because “or” indicates “two mutually exclusive
states,” meaning that the isotretinoin would have to be “in some
third, undefined state,” (Id.)-- a crystalline lump (Defendants’
closing argument, Hr. Tr. 226-229)-- which the parties agree is
not pharmacologically acceptable.
Plaintiffs assert that this term covers products where the
isotretinoin is (1) partially in suspension; (2) partially in
solution; and (3) partially in suspension and partially in
solution.

Conversely, Plaintiffs assert that isotretinoin that
20

is neither partially in suspension nor partially in solution is
not covered by the term.
Plaintiffs’ construction comports with the plain meaning of
the term “and/or,” which the Merriam-Webster Dictionary defines
as “a function word to indicate that two words or expressions
are to be taken together or individually.” 13

According to

Plaintiffs, “partially in suspension and/or partially in
solution” can be taken together: option (3) above; or it can be
taken individually: options (1) and (2) above.
Nothing in the patent or the prosecution history indicates
the inventors’ intention to use “or” in the mutually exclusive
sense of the word.

Stated in formal logic terms, “or” can be

used to form two types of compound sentences: inclusive
disjunctions and exclusive disjunctions.

An inclusive

disjunction is “a complex sentence in logic that is true when
either or both of its constituent propositions are true.”
Merriam-Webster Dictionary (emphasis added).

An exclusive

disjunction is “a compound proposition in logic that is true
when one and only one of its constituent statements is true.”
Id. (emphasis added)

13

See also Oxford English Dictionary, “and/or” (“either or both
of two possibilities”); Cambridge Dictionary of American
English, “and/or” (“used to refer to both things or either one
of the two mentioned”).
21

Defendants propose a construction consistent with an
exclusive disjunction but such a construction would render the
“and” in “and/or” completely superfluous.

In this Court’s view,

the use of “and/or” clearly indicates an inclusive disjunction
(See Hr. Tr. 127-128; 216-217; 220), and therefore the claim is
not indefinite.
The Court holds that “the isotretinoin is partially in
suspension and/or partially in solution” means “the isotretinoin
is either partially in suspension, partially in solution, or
both.”

(5)

“an amount of about 1 to 10% of at least one additional
surfactant” / “about 1 – 10% of an additional surfactant”

Plaintiffs propose that “about” should be construed as
“approximately.”

Defendants argue that “Plaintiffs’ proposed

substitution . . . does nothing to advance the ball,”
(Responsive Markman Brief, p. 18), and that using either “about”
or “approximately” renders the term indefinite.
The Court will adopt Plaintiffs’ proposed construction.

As

the Federal Circuit has stated time and again, there is a heavy
presumption that a claim term conveys its ordinary and customary
meaning.

Starhome GmbH v. AT&T Mobility LLC, 743 F.3d 849, 857

(Fed. Cir. 2014)(internal citation omitted).

“About” has an

ordinary and customary meaning of “approximately.”
22

See Ferring

B.V. v. Watson Labs, Inc., 764 F.3d 1382, 1389 (Fed. Cir. 2014)
(in an ANDA case, holding, “[w]e affirm the district court’s
construction of ‘about’ to mean ‘approximately,’ as well as its
refusal to construe ‘about’ to represent a particular numerical
error rate.”); see also Merck & Co., Inc. v. Teva Pharms. USA,
Inc., 395 F.3d 1364, 1369-70 (Fed. Cir. 2005) (“the term ‘about’
should be given its ordinary and accepted meaning of
‘approximately’ unless the patentee clearly redefines ‘about’ in
the specification”).
As stated above, whether “approximately 1 - 10%” is
indefinite will not be decided now.
Likewise, the Court will not address whether “additional
surfactant” is indefinite.
The Court holds that “about 1 - 10%” / “about 1 to 10%”
means “approximately 1 - 10%” / “approximately 1 to 10%.”

IV.
For the foregoing reasons, the disputed terms are construed
as set forth above.

An appropriate order accompanies this

opinion.

Dated:

April 20, 2015

s/ Joseph E. Irenas
Joseph E. Irenas, S.U.S.D.J.

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