Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 1 of 9 PageID #: 1262
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NOV ARTIS PHARMACEUTICALS
`. CORPORATION and NOV ARTIS 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.
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`NOV ARTIS PHARMACEUTICALS
`CORPORATION and NOV ARTIS AG,
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`Plaintiffs,
`
`Civil Action No. 14-1508-RGA
`
`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,,
`LauraK. 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., LATHAM & WATKINS LLP, New York, NY; Roger
`J. Chin, Esq., LATHAM & WATKINS LLP, San Francisco, CA; Marc N. Zubick, Esq., Brenda
`L. Danek, Esq., 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 81 Filed 10/16/15 Page 2 of 9 PageID #: 1263
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`Richard L. Horwitz, Esq., David E. Moore, Esq., Bindu A. Palapura, Esq., POTTER
`ANDERSON & CORROON LLP, Wilmington, DE; Marta E. Gross, Esq., Keith A. Zullow,
`Esq., Michael B. Cottier, Esq. (argued), Steven J. Bernstein, Esq., GOODWIN PROCTER LLP,
`New York, NY, attorneys for Defendant Roxane Laboratories, Inc.
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`October J./;l., 2015
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 3 of 9 PageID #: 1264
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`Presently before the Court is the issue of claim construction of a term in U.S. Patent Nos.
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`7,297,703 ("the '703 patent") and 7,741,338 ("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.' The Court has considered the parties' Joint
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`Claim Construction Brief. (D.I. 72).2 The Court heard oral argument on October 14, 2015.
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`I. LEGAL ST AND ARD
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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. A WH 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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`Soft View LLC v. Apple Inc., 2013 WL 4758195, 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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`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`1 The claim terms ofU.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 81 Filed 10/16/15 Page 4 of 9 PageID #: 1265
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`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 of commonly understood words." Id. at 1314 (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 of law.
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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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`II. CONSTRUCTION OF DISPUTED TERM
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`The disputed claim term "catalytic amount" appears in claim 1 of the '703 patent and
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`claim 2 of the '338 patent. (D.I. 72 at 8). The '338 patent is a continuation of the '703 patent
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`and the '703 and '338 patents share the same specification. (D.I. 73-1 at 13; D.I. 72 at 8). The
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 5 of 9 PageID #: 1266
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`parties agree that the term should be construed to have the same meaning in the claims of the
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`'703 and '338 patents. (D.I. 72 at 8).
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`1.
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`"catalytic amount"
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`a.
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`b.
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`c.
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`Plaintiffs' proposed construction: small amount as compared to the amount of the
`poly-ene macrolide
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`Defendants' proposed construction: an amount up to 1 % based on the weight of the
`poly-ene macrolide
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`Court's construction: small amount as compared to the amount of the poly-ene
`macrolide
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`The parties agree that the term "catalytic amount" refers to an amount of antioxidant that
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`is relative to the amount of the claimed poly-ene macrolide. (D.I. 72 at 9-10, 26). The dispute
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`concerns how much antioxidant is a "catalytic amount" as that term is used in the asserted
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`claims.
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`Plaintiffs argue that their construction is proper under principles of claim differentiation,
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`relying on claims 1 and 2 of the '703 patent. (Id. at 12). Claims 1 and 2 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 a 40-0-substituted rapamycin and wherein
`the antioxidant is present in a catalytic amount.
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`2. A mixture according to claim 1, wherein the antioxidant is present in an
`amount of up to 1 % based on the poly-ene macrolide weight.
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`('703 patent, col. 8, 11. 37-44). Plaintiffs contend that "catalytic amount" in claim 1 of the '703
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`patent should be construed to encompass amounts greater than the amount disclosed in
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`dependent claim 2 of that patent, "up to 1 % based on the poly-ene macrolide weight," because
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`the scope of an independent claim is presumed to be different from and broader than the scope of
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`a claim that depends from the independent claim. (D.I. 72 at 12-14). Plaintiffs further contend
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`that a claim terin expressed in general descriptive terms typically should "not be limited to a
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 6 of 9 PageID #: 1267
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`numerical range that may appear in the written description as referring to a preferred
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`embodiment or in other, narrower claims." (Id. at 14 (quoting RF Del., Inc. v. Pac. Keystone
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`Techs., Inc., 326 F.3d 1255, 1263 (Fed. Cir. 2003) (internal quotation marks omitted))).
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`Plaintiffs maintain that their construction can be applied to the'338 patent consistent with the
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`doctrine of claim differentiation. (Id. at 15). Claims 1 and 2 of the '338 patent read:
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`1. A solid mixture comprising 40-0-(2-hydroxy)ethyl:.rapamycin and 2,6-di-tert(cid:173)
`butyl-methylphenol (BHT).
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`2. A mixture according to claim 1, wherein said 2,6-di-tert-butyl-4-methylphenol
`(BHT) is present in a catalytic amount.
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`('338 patent, col. 10, 11. 12-15). Plaintiffs argue th_at the scope of independent claim 1 of the
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`'338 patent remains broader than the scope of dependent claim 2 under its proposed construction
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`of "catalytic amount" because the amount of BHT in claim 1 is not limited, while the amount of
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`BHT in claim 2 is limited to a catalytic amount. (D.I. 72 at 15).
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`Defendants argue that the specification defines the disputed term and that that definition
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`must govern construction of the claim term in spite of Plaintiffs' claim differentiation arguments.
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`(Id. at 28, 30). Defendants maintain that the term "catalytic amount" is defined in the
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`specification language that follows:
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`According to the invention, there is provided
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`1. A process for stabilizing a poly-ene macrolide comprising adding an
`antioxidant to the purified macrolide, preferably at the commencement of its
`isolation step. This process is particularly useful for the production of a
`stabilized poly-ene macrolide in bulk. The amount of antioxidant may
`conveniently be up to 1%, more preferably from 0.01 to 0.5% (based on the
`weight of the macrolide). Such a small amount is referred to hereinafter as a
`catalytic amount.
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`('703 and '338 patents, col. 1, 11. 27-36 (emphasis added); D.I. 72 at 28). Relying on
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`Sinorgchem Co., Shandongv. International Trade Commission, 511F.3d1132, 1136 (Fed. Cir.
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 7 of 9 PageID #: 1268
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`2007), Defendants argue that the presence of the words "is referred to" indicates that the
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`patentees acted as their own lexicographers and that the term "catalytic amount" is defined in the
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`specification as an amount up to 1 % based on weight of the macrolide. (D.I. 72 at 28).
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`Plaintiffs respond that the specification does not limit the claim term "catalytic amount"
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`to the specific numeric ranges disclosed because the specification makes clear that the numeric
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`ranges are merely "convenient" and "preferable" examples of catalytic amounts. (Id. at 17-18).
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`Plaintiffs also respond that, to control construction of a claim term, a definition in the
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`specification must be set forth with "reasonable clarity, deliberateness, and precision." (D.I. 72
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`at 41 (quoting Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1354 (Fed. Cir. 2003)).
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`Plaintiffs argue that the specification does not clearly express an intent to define the term
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`"catalytic amount" because the specification does not state that "catalytic amount" "is" or "refers
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`to" a certain amount and the claim term is not set off in quotation marks. (Id. at 41-42).
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`Regarding extrinsic evidence, Plaintiffs argue that the term "catalytic amount" is used by
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`persons having ordinary skill in the art to encompass small anlounts relative to the weight of
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`reactants, which is a broader meaning than "up to 1 %"of the weight ofreactants. (Id. at 21-25).
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`Defendants argue that Plaintiffs' reliance on extrinsic evidence is unavailing because: (1)
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`extrinsic evidence is irrelevant when an analysis of intrinsic evidence alone resolves the
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`ambiguity in a claim term; (2) the prior art on which Plaintiffs rely is inapposite; and (3)
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`Plaintiffs' expert's declaration improperly argues legal issues. (Id. at 33-35).
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`Defendants also contend that Plaintiffs' proposed construction frustrates the purpose of
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`claim construction because it does not clarify the meaning of the claim term and itself requires
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`construction. (Id. at 36). Plaintiffs respond that a proper construction can be provided in
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`descriptive terms and need not set forth an exact numeric bound. (Id. at 49-50). Plaintiffs
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 8 of 9 PageID #: 1269
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`maintain that their construction does not introduce additional vagueness into the claim term. (Id.
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`at 49).
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`Here, the patentee did not "clearly set forth a definition of the disputed claim term[] and
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`clearly express an intent to define the term." GE Lighting Solutions, LLC v. AgiLight, Inc., 750
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`F.3d 1304, 1309 (Fed. Cir. 2014) (internal quotation marks omitted). The language identified by
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`Defendants does not express an intent to define "catalytic amount" as an amount of antioxidant
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`"up to 1 %"for several reasons. First, the numerical percentage recited in the specification is
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`preceded by the non-limiting phrase "may conveniently be," which weighs against adopting a
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`claim construction that is limited to what follows the phrase. See Glaxo Group LTD v. Teva
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`Pharm. USA, Inc., 2009 WL 1220544, at *3 (D. Del. Apr. 30, 2009). Second, although the
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`presence of the phrase "is referred to" is one factor that may indicate that the patentee acted as
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`his own lexicographer, see In re Imes, 778 F.3d 1250, 1252-53 (Fed. Cir. 2015), Linear Tech.
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`Corp. v. Int'! Trade Comm 'n, 566 F.3d 1049, 1054 (Fed. Cir. 2009), here the phrase does not
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`connect the term and its alleged definition. Rather, it connects the term with an intervening
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`phrase, "[s]uch a small amount," which, in tum, refers to the previous sentence containing
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`Defendants' proposed construction. Third, there are no quotation marks around "catalytic
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`amount." Although the absence of quotation marks around a supposedly defined term does not
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`. necessarily mean that the patentee did not act as his own lexicographer, it is one factor tending to
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`show that the description is not definitional. See France Telecom, S.A. v. Marvell
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`Semiconductor, Inc., 2014 WL 1007449, at *4 (N.D. Cal. Mar. 12, 2014).
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`Analysis of Plaintiffs' extrinsic evidence is unnecessary because the intrinsic evidence
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`resolves the dispute. See Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1583 (Fed. Cir.
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`1996). Because I conclude that the specification does not define the term "catalytic amount,'' I
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`Case 1:15-cv-00128-RGA Document 81 Filed 10/16/15 Page 9 of 9 PageID #: 1270
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`construe the term as Plaintiffs propose, in accordance with the doctrine of claim differentiation.
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`This construction does not introduce additional vagueness by failing to import a numerical
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`limitation.
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`III. 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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