Novartis Pharmaceuticals Corporation et al v. Par Pharmaceutical Inc.
Filing
97
MEMORANDUM OPINION providing claim construction for disputed term in U.S. Patent Nos. 7,297,703 and 7,741,338. Within five days the parties shall submit a proposed order consistent with this Memorandum Opinion. Signed by Judge Richard G. Andrews on 11/23/2015. Associated Cases: 1:14-cv-01494-RGA, 1:14-cv-01508-RGA, 1:15-cv-00078-RGA, 1:15-cv-00128-RGA(nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
NOVARTIS PHARMACEUTICALS
CORPORATION and NOVARTIS AG,
Plaintiffs,
Civil Action No. 14-1494-RGA
v.
Civil Action No. 15-78-RGA
PAR PHARMACEUTICAL, INC.,
· Defendant.
NOVARTIS PHARMACEUTICALS
CORPORATION and NOVARTIS AG,·
Plaintiffs,
Civil Action No. 14-1508-RGA
v.
Civil Action No. 15-128-RGA
ROXANE LABORATORIES, INC.,
Defendant.
MEMORANDUM OPINION
Daniel M. Silver, Esq., McCARTER & ENGLISH, LLP, Wilmington, DE; Nicholas N. Kallas,
Esq., Christopher E. Loh, Esq. (argued), Charlotte Jacobsen, Esq., Christina Schwarz, Esq.,
Laura K. Fishwick, Esq., FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY,
attorneys for Plaintiffs.
Steven J. Fineman, Esq., Katharine C. Lester, Esq., RICHARDS LAYTON & FINGER, P.A.,
Wilmington, DE; Daniel G. Brown, Esq. (argued), LATHAM & WATKINS LLP, New York,
NY; Roger J. Chin, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Marc N. Zubick,
Esq., Brenda L. Danek, E.sq., LATHAM & WATKINS LLP, Chicago, IL; Parker M. Tresemer,
Esq., LATHAM & WATKINS LLP, Los Angeles, CA, attorneys for Defendant Par
Pharmaceutical, Inc.
David E. Moore, Esq., Richard L. Horwitz, Esq., Bindu A. Palapura, Esq., POTTER
ANDERSON & CORROON LLP, Wilmmgton, DE; Marta E. Gross, Esq., Keith A. Zullow,
Esq., Michael B. Cottler, Esq., Steven J. Bernstein, Esq., GOODWIN PROCTER LLP, New
York, NY, attorneys for Defendant Roxane Laboratories, Inc.
Novemberd3 , 2015
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~U~~GE:
Presently before the Court is a supplemental claim construction of a term in U.S. Patent
Nos. 7,297,703 ("the '703 patent") and 7,741,33°8 ("the '338 patent"). Plaintiffs Novartis
Pharmaceuticals Corporation and Novartis AG assert claims of the '703 patent, the '338 patent,
and U.S. Patent No. 5,665,772 against Defendants Par Pharmaceutical, Inc. and Roxane
Laboratories, Inc. in the above-captioned cases. 1 The Court previously construed another
disputed term submitted by the parties. (D.I. 80, 84).2 In the present matter, the Court has
considered the parties' Joint Claim Construction Brief. (D.I. 89). The Court heard oral
argument on November 13, 2015 (D.I. 95 [hereinafter, "Tr."]).
I. LEGAL STANDARD
"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) (en bane) (internal quotation marks omitted). '" [T]here is no magic formula or
catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
SoftViewLLCv. Apple Inc., 2013 WL4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
sources, "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." Phillips, 415 F.3d
at 1315 (internal quotation marks and citations omitted).
1
2
The claim terms of U.S. Patent No. 5,665,772 are not at issue in this proceeding.
Citations to "D.I. "are citations to the docket in C.A. No. 14-1494.
3
"[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."
Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
understood by a person of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely accepted
meaning ofcommonly understood words." Id. at 1'314 (internal citations omitted).
When a court relies solely upon the intrinsic evidence----the patent claims, the
specification, and the prosecution history-the court's construction is a determination oflaw.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
make factual findings based upon consideration of 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 1317-19 (internal quotation marks and
,citations omitted). Extrinsic evidence may assist the court in understanding the underlying
technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
and its prosecution history. Id. "A claim construction is persuasive, not because it follows a
certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v.
Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
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II. CONSTRUCTION OF DISPUTED TERM
Claim 1 of the '703 patent and claim 1 of the '338 patent are each directed to the disputed
term "solid mixture." ('703 patent, col. 8, ll. 37-41; '338 patent, col. 10, 11. 12-13). The '703
and '338 patents share the same specification.
1.
"solid mixture"
a.
Plaintiffs' proposed construction: mixture in solid form of two or more
substances, which mixture is not a pharmaceutical composition
b.
Defendants' proposed construction: a solid combination of two or more solid
substances that are mixed, but not chemically combined
c.
Court's construction: a solid combination of two or more solid substances that
are mixed, but not chemically combined
The parties agree that the claimed "solid mixture" is a combination of two or more solid
substances that are not chemically corribined. (D.I. 89 at 6, 12). The dispute concerns whether
the solid mixture can be a pharmaceutical composition. (Id.).
Plaintiffs argue that the claimed "solid mixture" cannot be a pharmaceutical composition
because claims 1 and 6 of the '703 patent and claims 1 and 3 of the '338 patent draw.an "express
distinction between (i) a solid mixture of a macrolide and an antioxidant, and (ii) a
pharmaceutical composition that incorporates a solid mixture of a macrolide and an antioxidant."
(Id. at 7). Claims 1 and 6 of the '703 patent read:
1.
A solid mixture comprising a poly-ene macrolide and an antioxidant wherein
the poly-ene macrolide is selected from the group consisting of rapamycin, a
16-0-substituted rapamycin, and a40-0-substituted rapamycin and wherein
the antioxidant is present in a catalytic amount.
6.
A pharmaceutical composition comprising as active ingredient, a mixture
according to claim 1 or 2, admixed with one or more pharmaceutically
acceptable carriers or diluents.
('703 patent, col. 8, 11. 37-41, 55-58).
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Claims 1 and 3 of the '338 patent read:
1.
A solid mixture comprising 40-0-(2-hydroxy)ethyl-rapamycin and 2,6-ditert-butyl-methylphenol (BHT).
3. A pharmaceutical composition comprising the solid mixture of claim 1
together with one or more pharmaceutically acceptable diluent or carrier.
('338 patent, col. 10, 11. 12-13, 16-18). Plaintiffs contend that ifthe claimed solid mixture were
a pharmaceutical composition, "then claim 6 of the '703 patent and claim 3 of the '338 patent
would cover a pharmaceutical composition comprising, as an active ingredient or element
thereof, a pharmaceutical composition." (D.I. 89 at 7). Plaintiffs argue that Defendants'
construction is improper because it renders claim 6 of the '703 patent and claim 3 of the '338
patent nonsensical. (Id.). Plaintiffs further contend that, like the claims, the specification .
expressly distinguishes a solid mixture of a macrolide and an antioxidant from a pharmaceutical
composition that incorporates a solid mixture of a macrolide and an antioxidant. (Id. at 9-10).
Defendants respond that a claim directed to a pharmaceutical composition comprising, as
an active ingredient or element thereof, a pharmaceutical composition is not nonsensical. (Id. at
14). "A pharmaceutical composition comprising a ph~aceutical composition" makes sense
because a pharmaceutical composition can be one element of another pharmaceutical
composition. (Tr. at 26). Defendants contend, for example, that replacing the term "mixture" in
claim 6 of the '703 patent with the term "pharmaceutical composition" would not render the
resulting claim nonsensical because claim 6 "would simply require admixing 'one or more
pharmaceutically acceptable carriers or diluents' in addition to whatever is already in the mixture
of claim 1." (D .I. 89 at 15). With respect to Plaintiffs' argument that the intrinsic evidence
repeatedly distinguishes solid mixtures from pharmaceutical compositions, Defendants' view is
that the fact that the claims and specification refer to "mixtures" in some instances and
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. "pharmaceutical compositions" in other instances suggests that "mixture" and "pharmaceutical
composition" do not have identical scope, but does not preclude their having overlapping scope.
(Id. at 15, 17). Defendants argue that their proposed construction simply gives the term "solid
mixture" "the full scope of its plain meaning, which would not exclude 'pharmaceutical
compositions."' (Id. at 15). I agree that Defendants' proposed construction does not render the
dependent claims facially nonsensical and is consistent with the patents' distinguishing
"mixture" from "pharmaceutical composition:"
Defendants argue that Plaintiffs' proposed negative limitation violates the principle that
dependent claims must fall within the scope of the independent claims from which they depend.
(Id. at 23 (citing Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)).
The parties agree that claim 6 of the '703 patent depends from claim 1 of the '703 patent and
claim 3 of the '338 patent depends from claim 1 of the '338 patent. (Id. at 23-24; Tr. at 6).
Defendants argue that under Plaintiffs' proposed construction claim 1 of the '703 patent cannot
include claim 6 of the '703 patent within its scope and claim 1 of the '338 patent cannot include
claim 3 of the '338 patent within its scope. (D.I. 89 at 23).
Relying on Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305 (Fed. Cir.
2001), Plaintiffs respond that claim 6 ofthe '703 patent and claim 3 of the '338 patent properly
depend on the first claims of their respective patents. (Tr. at 15-17). In Forest Laboratories, the
court h.eld that a claim to a "pharmaceutical composition ... comprising ... [the] surface active
material ... in claim 1" properly depended on claim 1, which recited a "surface active material
comprising [certain material]." Forest Labs., Inc., 239 F.3d at 1310, 1311 n.3. In reaching that
conclusion, the court recounted the test for proper dependency in the Manual of Patent
Examining Procedure, which provides: "The test [of proper dependency] is not whether the
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claims differ in scope. A proper dependent claim shall not conceivably be infringed by anything
which would not also infringe the basic claim." Id. at 1311 n.3. Relying on that test, the court
. concluded that the claims to a pharmaceutical composition properly depended on the claims to
surface active material because "[a]ny pharmaceutical composition that would infringe the
dependent claims must necessarily contain a surface active material that would also infringe the
independent claims." Id.
Forest Laboratories does not support Plaintiffs' construction that "solid mixture"
excludes pharmaceutical compositions. In Forest Laboratories, the court did not adopt a
construction of "surface active material" that excluded from it "pharmaceutical compositions."
To the contrary, the court held that "[w]hen the surface active material is combined with a
pharmaceutically acceptable carrier, it does not necessarily cease to be the claimed surface active
material." Id. at 1310. Applying the Forest Laboratories reasoning to the claims at issue in this
case, the conclusion would be that when the solid mixture is combined with one or more
pharmaceutically acceptable carriers or diluents, it would not necessarily cease to be the claimed
solid mixture. That solid mixture, combined with one or more pharmaceutically acceptable
carriers or diluents, would be the pharmaceutical composition claimed in the dependent claims.
Thus, Forest Laboratories does not support Plaintiffs' construction.
More generally, it is simply not possible for both (1) "solid mixture" to exclude
pharmaceutical compositions and (2) the dependent claims to properly depend on their respective
independent claims. By the terms of the claims themselves, a substance that would infringe
claim 6 of the '703 patent or claim 3 of the '338 patent would be a "pharmaceutical
composition." ('703 patent, col. 8, 11. 55-58; '338 patent, col. 10, 11. 16-18). For that substance
to also infringe claim 1 of either patent, according to the claims themselves, it would have to be a
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"solid mixture." ('703 patent, col. 8, 11. 37-41; '338 patent, col. 10, 11. 12-13). Thus, the
pharmaceutical composition would have to be a solid mixture. Alternatively, if one accepted that
"solid mixture" excludes pharmaceutical compositions, then claim 6 of the '703 patent and claim
3 of the '3 3 8 patent would not properly depend on their respective independent claims because
the pharmaceutical composition that would infringe claim 6 of the '703 patent or claim 3 of the
'338 patent could not infringe the independent claims.
Defendants also argue that Plaintiffs' "proposed construction does not meet the Federal
Circuit's high bar for adopting a negative limitation." (D.I. 89 at 13). Negative limitations will
generally not be added to claim terms without "express disclaimer or independent lexicography
in the intrinsic record that justifies including the negative limitation." Vehicle IP, LLC v. AT & T
Mobility, LLC, 594 F. App'x 636, 642 (Fed. Cir. 2014). Although the claims and specification
distinguish "solid mixture" from "pharmaceutical composition," Plaintiffs do not dispute that
patentees did not expressly disavow or disclaim "pharmaceutical compositions" from the scope
of the term "solid mixture" in the specification or during prosecution. (D.I. 89 at 14, 18-19).
Patentees did not act as their own lexicographers by clearly setting forth a definition of "solid
mixture" that excluded "pharmaceutical compositions" from its scope. In fact, the specification
does not use the term "solid mixture."
Plaintiffs maintain that express disavowal and lexicography are not the sole means by
which claim terms can be limited. (Id. at 19). As Plaintiffs point out, claim terms are sometimes
limited in view of intrinsic evidence even absent express disavowal and lexicography. (Id. at
19); see, e.g., Cephalon, Inc. v. Barr Labs., Inc., 389 F. Supp. 2d 602, 606 (D. Del. 2005). Still,
the intrinsic evidence Plaintiffs cite here is insufficient to support their proposed negative
limitation in light of the lack of express disavowal and lexicography.
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Further, Defendants argue that the prosecution history of the '338 patent supports their
construction. (D.I. 89 at 24--25). In rejecting patentees' amendment to add as claim 3 "[a]
pharmaceutical composition comprising the solid mixture of claim 1," the examiner stated that
"[n]ew claim 3 is a duplicate of claim 1. Insertion of the language ... which reads 'together with
one or more pharmaceutically acceptable diluent or carrier' would overcome the objection."3
(D.I. 90-1 at 54, 57). Patentees acquiesced to the examiner's rejection and made the suggested
amendment. (Id. at 59). Plaintiffs argue that their proposed construction is consistent with
patentees' acquiescence to the examiner's rejection because the need to add a limitation in claim
3 requiring the presence of pharmaceutically acceptable diluents or carriers demonstrates that the
solid mixture in claim 1 does not contain such pharmaceutically acceptable diluents or carriers
and thus is not a pharmaceutical composition. (Tr. at 19-20). That a mixture meeting the
limitations of claim 1 may not contain pharmaceutically acceptable carriers or diluents does not
mean that it must not. Consequently, Patentees' acquiescence to the examiner's objection that a
pharmaceutical composition comprising the solid mixture of claim 1 is a duplicate of claim 3
defeats Plaintiffs' proposed construction.
For the reasons stated above, although "solid mixture" does not mean "pharmaceutical
composition," it is possible for a pharmaceutical composition to be a solid mixture. I therefore
adopt Defendants' proposed construction.
Ill.
CONCLUSION
Within five days the parties shall submit a proposed order consistent with this
Memorandum Opinion.
3
The patent examiner evidently understood the term "solid mixture" as including pharmaceutical compositions.
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