Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Leo Pharma v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

June 5, 2018

LEO PHARMA A/S, LEO LABORATORIES LIMITED, AND LEO PHARMA, INC., Plaintiffs,
v.
ACTAVIS LABORATORIES UT, INC., AND ACTAVIS, INC., Defendants. LEO PHARMA A/S, LEO LABORATORIES LIMITED, AND LEO PHARMA, INC., Plaintiffs,
v.
PERRIGO UK FINCO LIMITED PARTNERSHIP AND PERRIGO COMPANY, Defendants.

          REPORT AND RECOMMENDATION

          SHERRY R. FALLON, UNITED STATES MAGISTRATE JUDGE

         I. INTRODUCTION

         In these patent infringement actions filed under the Hatch-Waxman Act by plaintiffs LEO Pharma A/S ("LEO Pharma"), LEO Laboratories Limited ("LEO Labs"), and LEO Pharma, Inc. ("LEO, Inc.") (collectively, "LEO") against defendants Actavis Laboratories UT, Inc. and Actavis, Inc. (together, "Actavis"), and Perrigo UK Finco Limited Partnership and Perrigo Company (together, "Perrigo"), LEO alleges infringement of numerous patents directed to LEO's Picato® drug. Against Actavis in Civil Action No. 16-333-JFB-SRF, LEO filed a second amended complaint alleging infringement of United States Patent Nos. 7, 410, 656 ("the '656 patent"), 8, 278, 292 ("the '292 patent"), [1] 8, 372, 827 ("the '827 patent"), 8, 372, 828 ("the '828 patent"), 8, 377, 919 ("the '919 patent"), 8, 536, 163 ("the '163 patent"), 8, 716, 271 ("the '271 patent"), 8, 735, 375 ("the '375 patent"), 9, 676, 698 ("the '698 patent"), and 9, 416, 084 ("the '084 patent"). (C.A. No. 16-333-JFB-SRF, D.I. 73) Against Actavis in Civil Action No. 18-402-JFB-SRF, LEO filed a complaint alleging infringement of the '292 patent and United States Patent Nos. 9, 820, 959 ("the '959 patent"), 9, 933, 428 ("the '428 patent"), and 9, 833, 429 ("the '429 patent"). (C.A. No. 18-402-JFB-SRF, D.I. 2) Against Perrigo in Civil Action No. 16-430-JFB-SRF, LEO filed a first amended complaint alleging infringement of United States Patent Nos. 6, 787, 161 ("the '161 patent") and 6, 844, 013 ("the '013 patent), as well as the '656 patent, the '292 patent, the '827 patent, the '828 patent, the '919 patent, the '163 patent, the '271 patent, the '375 patent, the '698 patent, and the '084 patent. (C.A. No. 16-430-JFB-SRF, D.I. 99) Against Perrigo in Civil Action No. 18-401-JFB-SRF, LEO filed a complaint alleging infringement of the '292 patent, the '959 patent, the '428 patent, and the '429 patent. (C.A. No. 18-401-JFB-SRF, D.I. 2)

         Presently before the court is the matter of claim construction. This decision sets forth the court's recommendations of constructions for the disputed claim terms discussed in the briefing and at the Markman hearing held on May 2, 2018.

         II. BACKGROUND

         A. Parties

         LEO is the holder of New Drug Application ("NDA") No. 202833 for ingenol mebutate gel, 0.015% and 0.05%, which was approved by the FDA on January 23, 2012. (D.I. 73 at ¶ 13)[2]LEO markets the drug under the trade name Picato®. (Id.) The active pharmaceutical ingredient ("API") in Picato® is ingenol mebutate, or ingenol-3-angelate. (Id. at ¶ 14)

         Actavis manufactures and sells generic copies of branded pharmaceutical products throughout the United States. (Id. at ¶ 6) Actavis has submitted two Abbreviated New Drug Applications ("AND A") to the FDA for approval of a generic version of Picato®: ANDA No. 208807 and ANDA No. 209086. (Id. at ¶¶ 32-33)

         Perrigo manufactures and sells generic copies of branded pharmaceutical products. Perrigo has submitted two AND As to the FDA for approval of a generic version of Picato®: ANDA No. 209018 and ANDA No. 209019. (Id. at ¶¶ 45-46)

         B. Technology of the Brown Patents

         The Brown Patents[3] share a common specification and name as inventors Marc Barry Brown, Michael Edwards Crothers, and Tahir Nazir. The Brown Patents are directed to topical skin cancer treatments. Specifically, the '292 patent, entitled "Therapeutic Compositions," claims pharmaceutically acceptable formulations of ingenol-3-angelate combined with pharmaceutical solvents and excipients to achieve a stable form. ('292 patent, col. 1:60-67)

         On December 6, 2017, LEO filed complaints in Civil Action Nos. 17-1752-JFB-SRF and 17-1753-JFB-SRF, alleging infringement of the '959 patent, the '428 patent, and the '429 patent (collectively, the "New Brown Patents"). The New Brown Patents are members of the Brown Patent family that had not yet been issued at the time the original complaints in the 2016 actions were filed. Like the Brown Patents, the New Brown Patents disclose pharmaceutical formulations of ingenol-3-angelate.

         On March 14, 2018, LEO filed complaints in Civil Action Nos. 18-401-JFB-SRF and 18-402-JFB-SRF, alleging infringement of the '292 patent, the '959 patent, the '428 patent, and the '429 patent. In April 2018, the court entered stipulations dismissing Civil Action Nos. 17-1752-JFB-SRF and 17-1753-JFB-SRF without prejudice and consolidating Civil ActionNos. 18-401-JFB-SRF and 18-402-JFB-SRF with Civil Action Nos. 16-333-JFB-SRF and 16-430-JFB-SRF. (C.A. No. 16-333-JFB-SRF, D.I. 289; C.A. No. 16-430-JFB-SRF, D.I. 252)

         III. LEGAL STANDARD

         Construing the claims of a patent presents a question of law, although subsidiary fact finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015) (citing Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 388-90 (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 may attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.

         The words of the claims "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." Phillips, 415 F.3d 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); see also Eon Corp. IP Holdings v. Silver Spring Networks, Inc., 815 F.3d 1314, 1320 (Fed. Cir. 2016). Claim terms are typically used consistently throughout the patent, and "usage of a term in one claim can often illuminate the meaning of the same term in other claims." Phillips, 415 F.3d at 1314 (observing that "[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... .").

         It is likewise true that "[differences 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 1314-15 (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) (citing Ecolab Inc. v. Paraclipse, Inc., 285 F.3d 1362, 1375 (Fed. Cir. 2002).

         Other intrinsic evidence, including 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). "[T]he 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 (citing CCS Fitness, Inc. v. Brunswick Corp.,288 F.3d 1359, 1366 (Fed. Cir. 2002)). 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 using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim Co. v. Medrad, Inc.,358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted), ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.