CORNERSTONE THERAPEUTICS, INC. et al v. SANDOZ INC.
Filing
309
MARKMAN OPINION. Signed by Judge Noel L. Hillman on 2/18/2016. (drw)
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
CHIESI USA, INC., et al.,
Civil No. 13-5723 (NLH/AMD)
Plaintiffs,
MARKMAN OPINION
v.
SANDOZ INC., et al.,
Defendants.
APPEARANCES:
Michael R. Griffinger
Robert C. Brady
Charles H. Chevalier
GIBBONS P.C.
One Gateway Center
Newark, New Jersey 07102-5310
Edgar H. Haug
Angus Chen
Nicholas F. Giove
Leann M. Clymer
Michael W. Harkness
FROMMER LAWRENCE & HAUG LLP
745 Fifth Avenue
New York, New York 10151
On behalf of Plaintiffs Chiesi USA, Inc., Cornerstone BioPharma,
Inc., and EKR Therapeutics, LLC
Eric I. Abraham
Christina L. Saveriano
HILL WALLACK LLP
21 Roszel Road
Princeton, New Jersey 08540
David C. Doyle
MORRISON & FOERSTER LLP
12531 High Bluff Drive, Suite 100
San Diego, California 92130-2040
Matthew M. D’Amore
Sarah L. Prutzman
David J. Austin
MORRISON & FOERSTER LLP
250 West 55th Street
New York, NY 10019-9601
On behalf of Defendants and Counterclaim-Plaintiffs Sandoz Inc.,
Sandoz AG and ACS Dobfar Info SA
HILLMAN, District Judge
I.
Introduction
Presently before the Court in this Hatch-Waxman Act 1 action
is the dispute over the construction of claims in four patents
relating to Cardene® I.V. Premixed Injection, which is a premixed ready-to-use nicardipine hydrochloride drug product that
is used for the treatment of cardiovascular and cerebrovascular
disorders.
Plaintiffs Chiesi USA, Inc., Cornerstone BioPharma,
Inc., and EKR Therapeutics, LLC (“Chiesi”) are the holders of
1
The Third Circuit Court of Appeals recently explained,
With the Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. No. 98–417, 98 Stat. 1585, commonly
known as the Hatch–Waxman Act, Congress attempted to
balance the goal of “mak[ing] available more low cost
generic drugs,” H.R. Rep. No. 98–857, pt. 1, at 14–15
(1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647–48, with
the value of patent monopolies in incentivizing beneficial
pharmaceutical advancement, see H.R.Rep. No. 98–857, pt. 2,
at 30 (1984), reprinted in 1984 U.S.C.C.A.N. 2686, 2714.
The Act seeks to accomplish this purpose, in part, by
encouraging “manufacturers of generic drugs . . . to
challenge weak or invalid patents on brand name drugs so
consumers can enjoy lower drug prices.” S. Rep. No. 107–
167, at 4 (2002).
King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., 791
F.3d 388, 394 (3d Cir. 2015).
2
U.S. Patent Nos. 7,612,102 (“the ’102 patent”), 7,659,290 (“the
’290 patent”), 7,659,291 (“the ’291 patent”), and 8,455,524
(“the ’524 patent”), and they have filed a patent infringement
suit against defendants Sandoz Inc., Sandoz AG, and ACS Dobfar
Info SA (“Sandoz”) arising from Sandoz’s filing of an
Abbreviated New Drug Application (“ANDA”) seeking FDA approval
to market generic versions of Chiesi’s Cardene® I.V. Premixed
Injection. 2
A two-day claim construction hearing was held on May 12 and
13, 2015, at which the Court heard testimony from two experts on
behalf of Chiesi - Alexander M. Klibanov, Ph.D. and Benny D.
Freeman, Ph.D., P.E. – and one expert on behalf of Sandoz –
Michael B. Maurin, R.Ph., Ph.D. - in addition to presentations
by the parties’ attorneys.
Following the conclusion of the parties’ arguments and the
testimony and cross-examination of the expert witnesses, the
Court provided preliminary findings with regard to the
construction of the patent claims at issue.
The Court permitted
the parties to submit supplemental briefing, and on June 30,
2015, the Court, having considered the entire record and
additional briefing and argument by counsel, issued an oral
2
This Court has jurisdiction over the subject matter of this
action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, 2202 and 35
U.S.C. § 271.
3
Opinion on the Court’s final construction of the patent claims.
This Opinion formally memorializes the Court’s findings as to
its construction of the patent claims at issue pursuant to
Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
II.
Legal Standard for Claim Construction
The ultimate question of the proper construction of a claim
in a patent is a question of law for the court to determine.
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831,
837 (2015) (citing Markman v. Westview Instruments, Inc., 517
U.S. 370, 388-91 (1996)) (further explaining, “While we held in
Markman that the ultimate issue of the proper construction of a
claim should be treated as a question of law, we also recognized
that in patent construction, subsidiary factfinding is sometimes
necessary.”).
A patent claim is that “‘portion of the patent
document that defines the scope of the patentee's rights.’”
Id.
(quoting Markman, 517 U.S. at 372).
The Federal Circuit has set forth a “familiar approach to
claim construction.”
In re Papst Licensing Digital Camera
Patent Litigation, 778 F.3d 1255, 1261 (Fed. Cir. 2015).
In
construing a patent claim, which should be considered in the
mindset of a person having ordinary skill in the art (“POSA”):
(1) a court should give words of a claim their
ordinary meaning in the context of the claim and the whole
4
patent document;
(2) the specification particularly, but also the
prosecution history, informs the determination of claim
meaning in context, including by resolving ambiguities;
(3) even if the meaning is plain on the face of the
claim language, the patentee can, by acting with sufficient
clarity, disclaim such a plain meaning or prescribe a
special definition; and
(4) the court should apply the principle that “[t]he
construction that stays true to the claim language and most
naturally aligns with the patent's description of the
invention will be, in the end, the correct construction.”
In re Papst, 778 F.3d at 1261 (citing Phillips v. AWH Corp., 415
F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc)) (explaining that
claim terms should be given their ordinary and customary meaning
to a person having ordinary skill in the art at the time of the
effective date of the patent application).
Although intrinsic
evidence is important in claim construction, district courts may
also rely upon extrinsic evidence, which “‘consists of all
evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and
learned treatises.’”
Phillips, 415 F.3d at 1317 (quoting
Markman, 52 F.3d at 980).
5
III. Discussion
Although there are four patents-in-suit, the ‘102 patent
contains the majority of disputed claim terms, most of which are
also contained in the other three patents.
The ‘102 patent
provides, in relevant part,
What is claimed is:
1. A pharmaceutical composition for parenteral
administration comprising a pre-mixed aqueous solution with
a pH from about 3.6 to about 4.7 comprising:
from about 0.1 to 0.4 mg/mL nicardipine hydrochloride;
a tonicity agent selected from (i) about 4.5% to about 5%
dextrose or (ii) about 0.8% to about 0.9% sodium chloride;
a buffer in an amount to maintain pH from about 3.6 to
about 4.7;
the aqueous solution contained in a pharmaceutically
acceptable container such that the solution does not come
into contact with polar polymers;
the aqueous solution when stored in the container for
at least one year at room temperature exhibiting (i) less
than a 10% decrease in the concentration of nicardipine
hydrochloride and (ii) a total impurity formation of less
than about 3%.
(Docket No. 1-1 at 22.)
The disputed claim terms 3 at issue in this case are:
1. “pre-mixed aqueous solution” (in the ‘102, ‘290, ‘291, ‘524
patents)
3
The parties also dispute the term “a total impurity formation”
(in ‘102, ‘290, ‘291, ‘524 patents). The parties agree that the
term means the percent weight-by-weight (% w/w) formation of
nicardipine-related impurities, where the numerator is the
weight of nicardipine-related impurities formed. The parties
disagree as to the proper calculation of the denominator. The
parties have agreed, however, that the weight to be used in the
denominator can be addressed during the liability phase, and,
therefore, the Court does not have to construe this claim term
at this time.
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2. “pre-mixed composition” (in the ‘290 patent)
3. “a pharmaceutically acceptable container” (in the ‘102,
‘290, ‘291, ‘524 patents)
4. “container” (in the ‘102, ‘290, ‘291, ‘524 patents)
5. “does not come into contact with polar polymers” (in the
‘102, ‘290, ‘291 patents)
6. “is in contact with non-polar polymers” (in the ‘524
patent)
7. “one year at room temperature” (in the ‘102, ‘290, ‘291,
‘524 patents)
8. “three months at room temperature” (in the ‘102, ‘291, ‘524
patents)
The Court will address each disputed claim term in turn, first
presenting Chiesi’s and Sandoz’s claim construction, and then
providing the Court’s construction of the claim term.
In
addition to the concise explanation of the Court’s construction
of the disputed claim terms contained in this written Opinion,
the Court’s findings are further detailed during the three inperson hearings.
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1.
“pre-mixed aqueous solution”/ “pre-mixed composition”
Claim Term
pre-mixed
aqueous
solution
pre-mixed
composition
Chiesi’s
Proposed Construction
Sandoz’s
Proposed Construction
a ready-to-use pharmaceutical
composition that is an aqueous solution
already mixed from the point of
manufacture and is stable, allows
medical personnel to use prepared
containers containing an injectable
formulation off the shelf without
additional preparation, avoids potential
contamination problems, and
eliminates dosage errors
an aqueous solution that is mixed and
ready to use prior to its point-of-care
administration
a composition that is mixed and ready
to use prior to its point-of-care
administration
The Court finds that these claim terms mean:
“a ready-to-use pharmaceutical composition that is an
aqueous solution already mixed from the point of manufacture and
is stable, allows medical personnel to use prepared containers
containing an injectable formulation off the shelf without
additional preparation”
Sandoz has accepted the first part of the construction of
these terms: “ready-to-use pharmaceutical composition that is an
aqueous solution already mixed from the point of manufacture.”
The remainder of the Court’s construction is supported by the
teachings of the patent and the plain meaning of the patent
terms.
The stability of the solution is the hallmark of the
specific formulation and the appropriate container.
The
stability of the solution also informs the inclusion of the
8
phrase “allows medical personnel to use prepared containers
containing an injectable formulation off the shelf without
additional preparation” because it must be read in tandem with
the claim term “parental administration,” which requires the
pre-mixed solution to be appropriate for off-the-shelf injection
into patients.
The Court rejects “avoids potential contamination problems,
and eliminates dosage errors” as advocated by Chiesi.
There is
nothing in the claim itself that speaks of contamination or
dosage errors, and this additional language is merely the
intended benefit that may have inspired the patentee.
2.
“a pharmaceutically acceptable container”/“container”
Claim Term
a pharmaceutically
acceptable container
Chiesi’s
Proposed Construction
a container for drug storage
and direct administration to
patients
container
Sandoz’s
Proposed Construction
a container acceptable for
pharmaceutical use
This term does not require construction
and should be accorded its plain and
ordinary meaning in the art.
Should the court require a construction,
the term “container” means an object
suitable for containing a liquid.
The Court finds that these claim terms mean:
“a container for drug storage and administration to
patients without additional preparation of the stored solution”
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The Court rejects that these terms are limited to their
plain meaning, or that a “container” is simply an object
suitable for containing liquid.
The container must be
“pharmaceutically acceptable” because it is specifically
described as such in the patents’ claims, and because this term
encompasses the whole purpose of the patents.
The Court also
rejects the addition of the term “direct” to the “administration
to patients” phrase because the patents did not intend for the
container to be literally attached to a patient’s body.
The Court’s addition of the phrase “without additional
preparation of the stored solution” encapsulates the claim’s
essence of a pre-mixed solution ready to be used off-the-shelf.
Even though the container, such as an IV bag, is not directly
attached to a patient’s arm and requires the use of tubing,
ports, and other accessories, to administer the drug, the
container itself must be one that does not require additional
efforts to ready the solution inside of it.
This phrase
accounts for the claim’s requirement that the solution is for
“parenteral administration,” and it distinguishes it from, for
example, an ampule, which is also a pharmaceutically acceptable
container, but which in this case is used to hold a concentrated
version of the drug which must be diluted or mixed before it can
be administered to a patient.
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3.
“does not come into contact with polar polymers”/ “is
in contact with non-polar polymers”
Chiesi’s
Proposed Construction
Claim Term
Sandoz’s
Proposed Construction
does not come
into contact
with polar
polymers
does not contact polar polymers
sufficiently to cause significant
drug adsorption
has no contact with any
polar polymers
is in contact with
non-polar
polymers
is in contact with non-polar
polymers to minimize drug
adsorption
has contact with non-polar
polymers
The Court finds that these claim terms mean:
“does not come into contact with polar polymers” and “is in
contact with non-polar polymers”
The Court does not agree that these phrases would be read
by a person of ordinary skill in the art to include “to minimize
drug adsorption.”
These terms mean what they say – that the
solution inside a pharmaceutically acceptable container does not
contact polar polymers at all, and that the solution inside a
pharmaceutically acceptable container is in contact with only
non-polar polymers.
The plain meaning of these phrases, in
addition to the teachings in the patent, do not support the
notion that the solution inside a pharmaceutically acceptable
container “can contact polar polymers a little bit as long as
there is insignificant adsorption.” 4
4
While the patent includes
This finding also rejects the argument that “contact” means
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embodiments in which some contact with polar polymers is
described, the patent when read as whole informs this Court that
the resulting and significant drug adsorption in those
embodiments compels a limitation of the claim to one in which no
contact with polar polymers would occur.
This construction of these terms also does not support the
notion that the pharmaceutically acceptable container itself
must not be comprised of poly polymers in every instance.
The
patent means what it says – the invention is a ready-to-use
pharmaceutical composition that is an aqueous solution already
mixed from the point of manufacture, is stable, allows medical
personnel to use prepared containers containing an injectable
formulation off the shelf without additional preparation, and
that the solution does not come into contact with polar
polymers, but does come in contact with non-polar polymers, when
contained in a pharmaceutically acceptable container.
Whether
the bag or other container has polar polymers in it, is of no
moment, so long as there is no contact between the polar
polymers and the solution prior to administration.
“interact with,” as the latter term suggests the amount of drug
adsorption, which is beyond the ordinary meaning of “contact.”
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4.
“one year at room temperature”/ “three months at room
temperature”
Claim Term
one year [three
months] at
room
temperature
Chiesi’s
Proposed Construction
one year [three months]
full-term at room
temperature
Sandoz’s
Proposed Construction
The terms “one year [three months] at
room temperature” and the clause within
which [each] appears is merely functional
language that recites the benefit achieved
when practicing the claim.
These terms do not require construction
and should be accorded its plain and
ordinary meaning in the art, in the
context of the entire clause within
which it appears.
The Court finds that these claim terms mean:
“one year full-term at room temperature” and “three months
full-term at room temperature”
A person of ordinary skill in the art would understand that
a pre-mixed solution formulated for off-the-shelf use maintains
its ready-to-use characteristic for its stated storage duration.
The ‘102 patent claims that the solution exhibits a certain
decrease in concentration and total impurity formation when
“stored in the container for at least one year at room
temperature.”
The POSA would understand that the stated
decrease in concentration and total impurity formation is the
same on day one and on day 365.
Thus, the addition of “full-
term” to the phrase “one year at room temperature” captures the
meaning and purpose of the claim, and is more than functional
13
language that recites the benefit achieved when practicing the
claim.
IV.
This is also true for the three-month term. 5
CONCLUSION
In summary, the disputed claim terms in U.S. Patent Nos.
7,612,102 (“the ’102 patent”), 7,659,290 (“the ’290 patent”),
7,659,291 (“the ’291 patent”), and 8,455,524 (“the ’524 patent”)
are:
1. “pre-mixed aqueous solution” (in ‘102, ‘290, ‘291, ‘524
patents) / “pre-mixed composition” (in ‘290 patent)
The Court’s construction:
“a ready-to-use pharmaceutical composition that is an
aqueous solution already mixed from the point of manufacture and
is stable, allows medical personnel to use prepared containers
containing an injectable formulation off the shelf without
additional preparation”
2. “a pharmaceutically acceptable container” (in ‘102, ‘290,
‘291, ‘524 patents) / “container” (in ‘102, ‘290, ‘291, ‘524
patents)
The Court’s construction:
“a container for drug storage and administration to
5
The issue argued at the hearings concerning accelerated data –
i.e., whether the inventors determined that the solution would
be self-stable for at least one year through the observation of
the solution over the course of one year or through
extrapolation from a shorter duration of observation – is not
relevant to the Court’s construction of this claim, and it is
more appropriately considered in the context of Chiesi’s
infringement claims and Sandoz’s invalidity defenses.
14
patients without additional preparation of the stored solution”
3. “does not come into contact with polar polymers” (in ‘102,
‘290, ‘291 patents) / “is in contact with non-polar polymers”
(in ‘524 patent)
The Court’s construction:
“does not come into contact with polar polymers” and “is in
contact with non-polar polymers”
4. “one year at room temperature” (in ‘102, ‘290, ‘291, ‘524
patents) / “three months at room temperature” (in ‘102, ‘291,
‘524 patents)
The Court’s construction:
“one year full-term at room temperature” and “three months
full-term at room temperature”
An appropriate Order will be issued.
Date: February 18, 2016
At Camden, New Jersey
s/ Noel L. Hillman
NOEL L. HILLMAN, U.S.D.J.
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