Cadence Pharmaceuticals Inc. et al v. Agila Specialties Private Limited Inc. et al

Filing 147

MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 8/29/16. (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
CADENCE PHARMACEUTICALS,
INC. , SCR PHARMATOP, and
MALLINCKRODT IP,
C.A. No. 14-1499-LPS

Plaintiffs,
v.
AGILA SPECIALTIES INC. and
MYLAN LABORATORIES LIMITED,
Defendants.

Thomas C. Grimm and Jeremy A. Tigan, MORRIS , NICHOLS, ARSHT & TUNNELL LLP,
Wilmington, DE
Kenneth G. Schuler, Marc N. Zubick, Emily C. Melvin, Matthew C. Darch, and Sarah W . Wang,
LATHAM & WATKINS LLP, Chicago, IL
Darryl H. Steensma, LATHAM & WATKINS LLP, San Diego, CA
Melissa A. Brand, LATHAM & WATKINS LLP, Boston, MA
Attorneys for Plaintiffs.

Dominick T. Gattuso, PHILLIPS GOLDMAN MCLAUGHLIN & HALL, P.A. , Wilmington, DE
Deepro R. Mukerjee and Lance Soderstrom, ALSTON & BIRD LLP, New York, NY
James C. Grant and Jonathan D. Parente, ALSTON & BIRD LLP, Atlanta, GA
Attorneys for Defendants.

MEMORANDUM OPINION

August 29, 2016
Wilmington, Delaware

ST

U.S. Distric

On December 19, 2014, Plaintiffs Cadence Pharmaceuticals, Inc. , SCR Pharmatop, and
Mallinckrodt IP ("Plaintiffs") filed suit against Defendants Agila Specialties Limited and Mylan
Laboratories Limited ("Defendants") alleging infringement of U.S. Patent Nos. 6,028,222 (the
'" 222 patent") and 6,992,218 (the "'218 patent"). The patents claim aqueous acetaminophen
formulations and methods of manufacturing them.
The parties submitted technology tutorials (D.I. 65 and 66) and claim construction briefs
(D.I. 68, 69, 74 and 76). The Court held a claim construction hearing on June 27, 2016. (See
D.I. 130 ("Tr.")) The parties submitted additional, unsolicited letters after the hearing, which the
Court has considered. (D.I. 131 and 134)
I.

LEGAL STAND ARDS

The ultimate question of the proper construction of a patent is a question oflaw. See Teva
Pharm. USA, Inc. v. Sandoz, Inc. , 135 S. Ct. 831 , 837 (2015) (citing Markman v. Westview
Instruments, Inc., 517 U.S . 370, 388-91 (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 , 1312 (Fed. Cir. 2005) (internal quotation marks omitted).

"[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324.
Instead, the court is free to attach the appropriate weight to appropriate sources " in light of the
statutes and policies that inform patent law." Id.
"[T]he words of a claim are generally given their 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, i.e., as of the effective filing date of the patent application."
1

Id. at 1312-13 (internal citations and quotation marks omitted). " [T]he ordinary meaning of a
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). The patent 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 Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
While "the claims themselves provide substantial guidance as to the meaning of particular
claim terms," the context of the surrounding words of the claim also must be considered.

Phillips, 415 F.3d at 1314. Furthermore, " [o]ther claims of the patent in question, both asserted
and unasserted, can also be valuable sources of enlightenment ... [b ]ecause claim terms are
normally used consistently throughout the patent .... " Id. (internal citation omitted).
It is likewise true that " [d]ifferences among claims can also be a useful guide . ... For
example, the presence of a dependent claim that adds a particular limitation gives rise to a
presumption that the limitation in question is not present in the independent claim." Id. at 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co. , Ltd. v. SRAM Corp. , 336 F.3d 1298, 1303 (Fed. Cir. 2003).
It is also possible that "the specification may reveal a special definition given to a claim
term by the patentee that differs from the meaning it would otherwise possess. In such cases, the
inventor' s lexicography governs ." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven
when the specification describes only a single embodiment, the claims of the patent will not be
read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope

2

using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker

Corp. , 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
F.3d 898, 906 (Fed. Cir. 2004)) (internal quotation marks omitted).
In addition to the specification, a court "should also consider the patent' s prosecution
history, if it is in evidence." Markman v. Westview Instruments, Inc. , 52 F.3d 967, 980 (Fed. Cir.
1995), ajf'd, 517 U.S . 370 (1996). The prosecution history, which is " intrinsic evidence,"
"consists of the complete record of the proceedings before the PTO [Patent and Trademark
Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d
at 1317. " [T]he 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.
In some cases, "the district court will need to look beyond the patent' s intrinsic evidence
and to consult extrinsic evidence in order to understand, for example, the background science or
the meaning of a term in the relevant art during the relevant time period." Teva, 135 S. Ct. at
841. 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. For instance, technical dictionaries can assist the court in determining the meaning of a
term to those of skill in the relevant art because such dictionaries "endeavor to collect the
accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d
at 1318. In addition, expert testimony can be useful "to ensure that the court' s understanding of
the technical aspects of the patent is consistent with that of a person of skill in the art, or to

3

establish that a particular term in the patent or the prior art has a particular meaning in the
pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and
testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from
bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be
useful" to the court, it is "less reliable" than intrinsic evidence, and its consideration "is unlikely
to result in a reliable interpretation of patent claim scope unless considered in the context of the
intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the
scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney

Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90
F.3d at 1583).
Finally, "[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."

Renishaw PLC v. Marposs Societa ' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows
that "a claim interpretation that would exclude the inventor' s device is rarely the correct
interpretation." Osram GmbH v. Int '/ Trade Comm 'n, 505 F.3d 1351 , 1358 (Fed. Cir. 2007)
(quoting Modine Mfg. Co. v. US. Int'/ Trade Comm 'n, 75 F.3d 1545, 1550 (Fed. Cir. 1996)).

4

II.

CONSTRUCTION OF DISPUTED TERM 1
A.

"liquid formulation for intravenous administration consisting essentially of
acetaminophen dispersed in an aqueous medium" 2

Plaintiffs
a solution of acetaminophen dissolved in a medium containing water or aqueous mixtures of
water and a polyhydric compound and/or a water soluble alcohol for intravenous
administration
Defendants
a solution of acetaminophen dissolved in a medium containing water or aqueous mixtures of
water and a polyhydric compound and/or water soluble alcohol for intravenous solution, that is
not reconstituted
Court
a solution of acetaminophen dissolved in a medium containing water or aqueous mixtures of
water and a polyhydric compound and/or a water soluble alcohol for intravenous
administration
This claim term includes amendments made during a recent ex parte reexamination of the
' 222 patent. (D.I. 67-1 at 17) Prior to reexamination, claim 1 was directed to a "liquid
formulation consisting essentially of acetaminophen dispersed in an aqueous medium." The
Court previously construed that version of the claim term as "a solution of acetaminophen
dispersed in a medium containing water or aqueous mixtures of water and a polyhydric
compound and/or a water soluble alcohol." Cadence Pharm. , Inc. v. Paddock Labs. Inc., 886 F.
Supp. 2d 445, 455 (D. Del. 2012), affd sub nom. Cadence Pharm. Inc. v. Exela PharmSci Inc.,
780 F.3d 1364 (Fed. Cir. 2015).

1

The parties previously disputed, and submitted claim construction briefs regarding, the
term "[a]n injectable aqueous solution containing, as an active ingredient, a principle of phenolic
nature susceptible to oxidation, preserved by the method of claim 1,'' which appears in claim 19
of the ' 218 patent. The Court understands that the parties have now stipulated that no
construction of this term is necessary. (See Tr. at 4-5)
2

This term appears in claims 1, 37, and 44 of the ' 222 patent.

5

During the reexamination, the patentee added language specifying that the claims are
directed to a liquid formulation ''for intravenous administration." Defendants argue that the
patentee added this term to the claims "in order to exclude reconstituted products from their
claims." (D.I. 68 at 6) Plaintiffs disagree.
The portions of the prosecution history bearing directly upon the reasons for the
"intravenous administration" amendment show that it was for purposes other than excluding
reconstituted products from the scope of the claims. After receiving an initial rejection in view
of prior art references directed to "iajectable" formulations of acetaminophen, the patentee added
"intravenous administration" in order to distinguish its invention from "injectable" (i.e. , into
muscle) formulations . (D.I. 62-1 at 105) The patentee explained that its amendment differed
from the prior art because the prior art references were directed to formulations for
administration into muscle or fatty tissue. (D.I. 62-1 at 148-149) In contrast, the claimed
formulations were designed for administration into veins. (Id.) Hence, the amendment had
nothing to do with the issue Defendants now press: whether the claim excludes reconstituted
products.
Defendants nevertheless argue that the patentee' s description of its products during
prosecution shows that the patentee' s amendment also ruled out the possibility of a reconstituted
product. As evidence of such a disclaimer, they point to portions of the prosecution history in
which the patentee notes that the claimed formulations are distinct from prior art formulations
that needed to be reconstituted immediately prior to use. (D.I. 68 at 9-12)
Careful examination of the prosecution history shows, however, that the patentee
distinguished the patented formulations based on their stability, not based on whether they were

6

"reconstituted." During reexamination, the examiner found that the patent owner had
"established that there was a persistent need for a stable, aqueous" form of acetaminophen. (D.I.
67 Ex.Kat 59) The examiner noted that, at the time of the patentees' invention, the most similar
commercial product was unstable as a liquid. (Id.) As a result, it could not be mixed at the
manufacturing site and shipped as a liquid, but instead needed to be "sold as a powder that had to
be reconstituted" at the treatment site shortly before use. (Id.) This was inconvenient because
the need to reconstitute the formulation precluded healthcare providers from using the drug in
"time sensitive, emergency situations." (Id.; see also D.I. 62-2 ilil 40, 50 (explaining that need to
take time to reconstitute prior art intravenous products "immediately before" administration was
problematic because acetaminophen is often needed urgently))
This discussion indicates that the patentee' s invention differed from the prior art because
of its stability in liquid form. It also establishes that this stability could be beneficial because,
unlike unstable prior art products, stable products do not require reconstitution immediately
prior to use. But it does not suggest that the claims do not cover solutions made by

reconstituting a solid. Rather, the claims potentially include within their scope any products that
are stable - be they reconstituted or not. Indeed, Defendants conceded at the claim construction
hearing that the claims do cover preferred embodiments that consist of solutions prepared by
dissolving solid excipients. 3 (See Tr. 27-31 ; see also id. at 8-9)
The patentee' s emphasis on stability, as opposed to a lack of reconstitution, is evident in
other portions of the prosecution history. For example, the file history includes a rejection based

3

Defendants did not explain how a solution whose excipients were at some point solids
could be characterized as "not reconstituted." (Tr. at 29-30)
7

on the examiner' s finding that the claims were not commensurate in scope with the long-felt
need for a shelf-stable liquid formulation of acetaminophen. The examiner explained that these
claims were too broad because they covered formulations that were not shelf-stable. (D.I. 67 Ex.
K at 59) In response, the patentee amended the claims to add a claim limitation on the
concentration of acetaminophen. (D.I. 62-1 at 12) The patentee explained that this limitation
would address the stability requirement, ensuring that any formulation covered by the claims
could if needed be made "ready for direct patient administration without mixing, reconstitution,
or further processing." (D.I. 62-1 at 120, 146-47)4
Thus, having found that the patentee did not disavow reconstituted solutions, the Court
adopts Plaintiffs' proposed construction.
B.

"while preserving for a prolonged period" 5

Plaintiffs

the aqueous solution does not decompose substantially such that the formulation has a
prolonged phannaceutically acceptable shelflife
Defendants

Indefinite
Court
The Court will not construe this term at this time.

4

At most, this history suggests that, in determining whether a formulation meets the
claims' stability requirement, one might consider how far in advance the formulation could be
reconstituted. If a formulation were stable for only minutes at a time, such that healthcare
providers could not avoid the difficulties associated with reconstituting the product at
inopportune moments, then one might be able to argue that the formulation would fail to meet
the long-felt need for a "stable" formulation. That dispute is not before the Court today.
5

This term appears in claim 1 of the '2 18 patent.
8

The Court understands that the parties do not want the Court to construe this term at this
time, and have only identified the term as disputed in order to preserve their rights to raise a
dispute about its construction in the future. For this reason, the Court has not construed this
term.

III.

CONCLUSION
The Court construes the disputed term as explained above. An appropriate Order follows.

9