Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 1 of 10 PageID #: 1812
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`Plaintiffs,
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`Civil Action No. 14-1494-RGA
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`Civil Action No. 15-78-RGA
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`v.
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`PAR PHARMACEUTICAL, INC.,
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`· Defendant.
`
`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOV ARTIS AG,·
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`Plaintiffs,
`
`Civil Action No. 14-1508-RGA
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`v.
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`ROXANE LABORATORIES, INC.,
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`Defendant.
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`Civil Action No. 15-128-RGA
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`MEMORANDUM OPINION
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`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.
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`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.
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`

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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 2 of 10 PageID #: 1813
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`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.
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`Novemberd3 , 2015
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`2
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`

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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 3 of 10 PageID #: 1814
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`~U~~GE:
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`Presently before the Court is a supplemental claim construction of a term in U.S. Patent
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`Nos. 7,297,703 ("the '703 patent") and 7,741,33°8 ("the '338 patent"). Plaintiffs Novartis
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`Pharmaceuticals Corporation and Novartis AG assert claims of the '703 patent, the '338 patent,
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`and U.S. Patent No. 5,665,772 against Defendants Par Pharmaceutical, Inc. and Roxane
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`Laboratories, Inc. in the above-captioned cases. 1 The Court previously construed another
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`disputed term submitted by the parties. (D.I. 80, 84).2 In the present matter, the Court has
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`considered the parties' Joint Claim Construction Brief. (D.I. 89). The Court heard oral
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`argument on November 13, 2015 (D.I. 95 [hereinafter, "Tr."]).
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`I. LEGAL STANDARD
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`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '" [T]here is no magic formula or
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`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
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`weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
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`SoftViewLLCv. Apple Inc., 2013 WL4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324). When construing patent claims, a court considers the literal language of the
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`claim, the patent specification, and the prosecution history. Markman v. Westview Instruments,
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`Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these
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`sources, "the specification is always highly relevant to the claim construction analysis. Usually,
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`it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d
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`at 1315 (internal quotation marks and citations omitted).
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`1 The claim terms of U.S. Patent No. 5,665,772 are not at issue in this proceeding.
`2 Citations to "D.I.
`"are citations to the docket in C.A. No. 14-1494.
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`3
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 4 of 10 PageID #: 1815
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`"[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."
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`Id. at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary meaning of a
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`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
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`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
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`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
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`construction in such cases involves little more than the application of the widely accepted
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`meaning ofcommonly understood words." Id. at 1'314 (internal citations omitted).
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`When a court relies solely upon the intrinsic evidence----the patent claims, the
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`specification, and the prosecution history-the court's construction is a determination oflaw.
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`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which "consists of all
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
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`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks and
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`,citations omitted). Extrinsic evidence may assist the court in understanding the underlying
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`technology, the meaning of terms to one skilled in the art, and how the invention works. Id.
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`Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent
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`and its prosecution history. Id. "A claim construction is persuasive, not because it follows a
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`certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v.
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`Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 5 of 10 PageID #: 1816
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`II. CONSTRUCTION OF DISPUTED TERM
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`Claim 1 of the '703 patent and claim 1 of the '338 patent are each directed to the disputed
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`term "solid mixture." ('703 patent, col. 8, ll. 37-41; '338 patent, col. 10, 11. 12-13). The '703
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`and '338 patents share the same specification.
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`1.
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`"solid mixture"
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`a.
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`b.
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`c.
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`Plaintiffs' proposed construction: mixture in solid form of two or more
`substances, which mixture is not a pharmaceutical composition
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`Defendants' proposed construction: a solid combination of two or more solid
`substances that are mixed, but not chemically combined
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`Court's construction: a solid combination of two or more solid substances that
`are mixed, but not chemically combined
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`The parties agree that the claimed "solid mixture" is a combination of two or more solid
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`substances that are not chemically corribined. (D.I. 89 at 6, 12). The dispute concerns whether
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`the solid mixture can be a pharmaceutical composition. (Id.).
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`Plaintiffs argue that the claimed "solid mixture" cannot be a pharmaceutical composition
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`because claims 1 and 6 of the '703 patent and claims 1 and 3 of the '338 patent draw.an "express
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`distinction between (i) a solid mixture of a macrolide and an antioxidant, and (ii) a
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`pharmaceutical composition that incorporates a solid mixture of a macrolide and an antioxidant."
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`(Id. at 7). Claims 1 and 6 of the '703 patent read:
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`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.
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`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.
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`('703 patent, col. 8, 11. 37-41, 55-58).
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 6 of 10 PageID #: 1817
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`Claims 1 and 3 of the '338 patent read:
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`1. A solid mixture comprising 40-0-(2-hydroxy)ethyl-rapamycin and 2,6-di(cid:173)
`tert-butyl-methylphenol (BHT).
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`3. A pharmaceutical composition comprising the solid mixture of claim 1
`together with one or more pharmaceutically acceptable diluent or carrier.
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`('338 patent, col. 10, 11. 12-13, 16-18). Plaintiffs contend that ifthe claimed solid mixture were
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`a pharmaceutical composition, "then claim 6 of the '703 patent and claim 3 of the '338 patent
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`would cover a pharmaceutical composition comprising, as an active ingredient or element
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`thereof, a pharmaceutical composition." (D.I. 89 at 7). Plaintiffs argue that Defendants'
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`construction is improper because it renders claim 6 of the '703 patent and claim 3 of the '338
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`patent nonsensical. (Id.). Plaintiffs further contend that, like the claims, the specification .
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`expressly distinguishes a solid mixture of a macrolide and an antioxidant from a pharmaceutical
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`composition that incorporates a solid mixture of a macrolide and an antioxidant. (Id. at 9-10).
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`Defendants respond that a claim directed to a pharmaceutical composition comprising, as
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`an active ingredient or element thereof, a pharmaceutical composition is not nonsensical. (Id. at
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`14). "A pharmaceutical composition comprising a ph~aceutical composition" makes sense
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`because a pharmaceutical composition can be one element of another pharmaceutical
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`composition. (Tr. at 26). Defendants contend, for example, that replacing the term "mixture" in
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`claim 6 of the '703 patent with the term "pharmaceutical composition" would not render the
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`resulting claim nonsensical because claim 6 "would simply require admixing 'one or more
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`pharmaceutically acceptable carriers or diluents' in addition to whatever is already in the mixture
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`of claim 1." (D .I. 8 9 at 15). With respect to Plaintiffs' argument that the intrinsic evidence
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`repeatedly distinguishes solid mixtures from pharmaceutical compositions, Defendants' view is
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`that the fact that the claims and specification refer to "mixtures" in some instances and
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`6
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 7 of 10 PageID #: 1818
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`. "pharmaceutical compositions" in other instances suggests that "mixture" and "pharmaceutical
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`composition" do not have identical scope, but does not preclude their having overlapping scope.
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`(Id. at 15, 17). Defendants argue that their proposed construction simply gives the term "solid
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`mixture" "the full scope of its plain meaning, which would not exclude 'pharmaceutical
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`compositions."' (Id. at 15). I agree that Defendants' proposed construction does not render the
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`dependent claims facially nonsensical and is consistent with the patents' distinguishing
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`"mixture" from "pharmaceutical composition:"
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`Defendants argue that Plaintiffs' proposed negative limitation violates the principle that
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`dependent claims must fall within the scope of the independent claims from which they depend.
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`(Id. at 23 (citing Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)).
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`The parties agree that claim 6 of the '703 patent depends from claim 1 of the '703 patent and
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`claim 3 of the '338 patent depends from claim 1 of the '338 patent. (Id. at 23-24; Tr. at 6).
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`Defendants argue that under Plaintiffs' proposed construction claim 1 of the '703 patent cannot
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`include claim 6 of the '703 patent within its scope and claim 1 of the '338 patent cannot include
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`claim 3 of the '338 patent within its scope. (D.I. 89 at 23).
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`Relying on Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305 (Fed. Cir.
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`2001), Plaintiffs respond that claim 6 ofthe '703 patent and claim 3 of the '338 patent properly
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`depend on the first claims of their respective patents. (Tr. at 15-17). In Forest Laboratories, the
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`court h.eld that a claim to a "pharmaceutical composition ... comprising ... [the] surface active
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`material ... in claim 1" properly depended on claim 1, which recited a "surface active material
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`comprising [certain material]." Forest Labs., Inc., 239 F.3d at 1310, 1311 n.3. In reaching that
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`conclusion, the court recounted the test for proper dependency in the Manual of Patent
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`Examining Procedure, which provides: "The test [of proper dependency] is not whether the
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 8 of 10 PageID #: 1819
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`claims differ in scope. A proper dependent claim shall not conceivably be infringed by anything
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`which would not also infringe the basic claim." Id. at 1311 n.3. Relying on that test, the court
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`. concluded that the claims to a pharmaceutical composition properly depended on the claims to
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`surface active material because "[a]ny pharmaceutical composition that would infringe the
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`dependent claims must necessarily contain a surface active material that would also infringe the
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`independent claims." Id.
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`Forest Laboratories does not support Plaintiffs' construction that "solid mixture"
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`excludes pharmaceutical compositions. In Forest Laboratories, the court did not adopt a
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`construction of "surface active material" that excluded from it "pharmaceutical compositions."
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`To the contrary, the court held that "[w]hen the surface active material is combined with a
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`pharmaceutically acceptable carrier, it does not necessarily cease to be the claimed surface active
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`material." Id. at 1310. Applying the Forest Laboratories reasoning to the claims at issue in this
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`case, the conclusion would be that when the solid mixture is combined with one or more
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`pharmaceutically acceptable carriers or diluents, it would not necessarily cease to be the claimed
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`solid mixture. That solid mixture, combined with one or more pharmaceutically acceptable
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`carriers or diluents, would be the pharmaceutical composition claimed in the dependent claims.
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`Thus, Forest Laboratories does not support Plaintiffs' construction.
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`More generally, it is simply not possible for both (1) "solid mixture" to exclude
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`pharmaceutical compositions and (2) the dependent claims to properly depend on their respective
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`independent claims. By the terms of the claims themselves, a substance that would infringe
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`claim 6 of the '703 patent or claim 3 of the '338 patent would be a "pharmaceutical
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`composition." ('703 patent, col. 8, 11. 55-58; '338 patent, col. 10, 11. 16-18). For that substance
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`to also infringe claim 1 of either patent, according to the claims themselves, it would have to be a
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 9 of 10 PageID #: 1820
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`"solid mixture." ('703 patent, col. 8, 11. 37-41; '338 patent, col. 10, 11. 12-13). Thus, the
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`pharmaceutical composition would have to be a solid mixture. Alternatively, if one accepted that
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`"solid mixture" excludes pharmaceutical compositions, then claim 6 of the '703 patent and claim
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`3 of the '3 3 8 patent would not properly depend on their respective independent claims because
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`the pharmaceutical composition that would infringe claim 6 of the '703 patent or claim 3 of the
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`'338 patent could not infringe the independent claims.
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`Defendants also argue that Plaintiffs' "proposed construction does not meet the Federal
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`Circuit's high bar for adopting a negative limitation." (D.I. 89 at 13). Negative limitations will
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`generally not be added to claim terms without "express disclaimer or independent lexicography
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`in the intrinsic record that justifies including the negative limitation." Vehicle IP, LLC v. AT & T
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`Mobility, LLC, 594 F. App'x 636, 642 (Fed. Cir. 2014). Although the claims and specification
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`distinguish "solid mixture" from "pharmaceutical composition," Plaintiffs do not dispute that
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`patentees did not expressly disavow or disclaim "pharmaceutical compositions" from the scope
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`of the term "solid mixture" in the specification or during prosecution. (D.I. 89 at 14, 18-19).
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`Patentees did not act as their own lexicographers by clearly setting forth a definition of "solid
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`mixture" that excluded "pharmaceutical compositions" from its scope. In fact, the specification
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`does not use the term "solid mixture."
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`Plaintiffs maintain that express disavowal and lexicography are not the sole means by
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`which claim terms can be limited. (Id. at 19). As Plaintiffs point out, claim terms are sometimes
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`limited in view of intrinsic evidence even absent express disavowal and lexicography. (Id. at
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`19); see, e.g., Cephalon, Inc. v. Barr Labs., Inc., 389 F. Supp. 2d 602, 606 (D. Del. 2005). Still,
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`the intrinsic evidence Plaintiffs cite here is insufficient to support their proposed negative
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`limitation in light of the lack of express disavowal and lexicography.
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`Case 1:15-cv-00128-RGA Document 106 Filed 11/24/15 Page 10 of 10 PageID #: 1821
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`Further, Defendants argue that the prosecution history of the '338 patent supports their
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`construction. (D.I. 89 at 24--25). In rejecting patentees' amendment to add as claim 3 "[a]
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`pharmaceutical composition comprising the solid mixture of claim 1," the examiner stated that
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`"[n]ew claim 3 is a duplicate of claim 1. Insertion of the language ... which reads 'together with
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`one or more pharmaceutically acceptable diluent or carrier' would overcome the objection."3
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`(D.I. 90-1 at 54, 57). Patentees acquiesced to the examiner's rejection and made the suggested
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`amendment. (Id. at 59). Plaintiffs argue that their proposed construction is consistent with
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`patentees' acquiescence to the examiner's rejection because the need to add a limitation in claim
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`3 requiring the presence of pharmaceutically acceptable diluents or carriers demonstrates that the
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`solid mixture in claim 1 does not contain such pharmaceutically acceptable diluents or carriers
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`and thus is not a pharmaceutical composition. (Tr. at 19-20). That a mixture meeting the
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`limitations of claim 1 may not contain pharmaceutically acceptable carriers or diluents does not
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`mean that it must not. Consequently, Patentees' acquiescence to the examiner's objection that a
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`pharmaceutical composition comprising the solid mixture of claim 1 is a duplicate of claim 3
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`defeats Plaintiffs' proposed construction.
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`For the reasons stated above, although "solid mixture" does not mean "pharmaceutical
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`composition," it is possible for a pharmaceutical composition to be a solid mixture. I therefore
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`adopt Defendants' proposed construction.
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`Ill. CONCLUSION
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`Within five days the parties shall submit a proposed order consistent with this
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`Memorandum Opinion.
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`3 The patent examiner evidently understood the term "solid mixture" as including pharmaceutical compositions.
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`10