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LEO Pharma A/S v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

December 28, 2017





         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, 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"), 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 Perrigo, 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) 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 September 15, 2017.


         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)[1]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 Patents-In-Suit

         1. The Aylward Patents

         The Aylward patents[2] are a group of related patents sharing a common specification and having one named inventor, James Harrison Aylward. The Aylward patents are directed to methods of treating various cancerous conditions using certain ingenane compounds, including ingenol mebutate. ('656 patent,, Abstract; col. 34:23-24) Dr. Aylward isolated compounds from certain species of Euphorbia, a genus of flowering plants used for traditional medicinal remedies, and discovered that angeloyl-substituted ingenanes could selectively kill cancer cells. (Id. at 4:62-5:1; 6:8-38) The claims of the '161 and '013 patents are directed to treating cancerous conditions with specific compounds obtained from the sap of Euphorbia species. ('161 patent, col. 31:22-32:35; '013 patent, col. 32:8-60) The claims of the '656 patent are more generally directed to isolated compounds. ('656 patent, col. 34:13-34)

         2. 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 Brown patents claim pharmaceutically acceptable formulations of ingenol-3-angelate combined with pharmaceutical solvents and excipients to achieve a stable form. ('292 patent, col. 1:60-67)


         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), affd, 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. AWHCorp., 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), affd, 481 F.3d 1371 (Fed. Cir. 2007). The specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004).

         In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman, 52 F.3d at 980. The prosecution history, which is also "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.

         A court also may rely on "extrinsic evidence, " which "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 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. ("[C]onclusory, unsupported assertions by experts as to the definition of a claim term are not useful to a court."). 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." Mat 1318-19.

         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'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007).


         A. Disputed Terms in the Aylward Patents

         1. "[an] isolated compound" ('656 patent, claim 1)


"a compound separate from other components, except that a small amount of residual other components may remain"

"a compound purified from a plant"

"a compound purified from a plant"

         I recommend that the court adopt defendants' construction, which is supported by the intrinsic evidence. The parties do not dispute the degree of isolation or purity of the compound.[5](9/15/17 Tr. at 44:17-45:2; 54:1-10) Instead, the dispute focuses on whether the compound is isolated from a plant, as opposed to isolation from either a plant or a reaction mixture, or, more broadly, from "no specific source." (D.I. 68 at 17-18)

         The written description repeatedly identifies plants as the source of "[an] isolated compound." The Abstract of the '656 patent states that "[t]his invention relates to a compound or group of compounds present in an active principle derived from plants of species Euphorbia peplus, Euphorbia hirta and Euphorbia drummondiir ('656 Patent, Abstract) The Cross-Reference to Related Applications section also states that "[t]his invention relates to a compound [] present in an active principle derived from the family EuphorbiaceaeT (Id., col. 1:15-17) The Summary of the Invention section reiterates that "the invention provides a compound or compounds present in plants of the genus Euphorbia." (Id., col. 6:25-28) Consistent with defendants' proposed construction, all the disclosed embodiments of the compound in the specification are derived from a plant. Examples 1 to 3 of the specification teach the preparation of "crude sap." (Id., col. 10:39-63; col. 12:64-13:2; col. 15:11) Examples 4 and 6 to 9 teach various purifications from the crude sap. (Id., col. 16:40-17:26; col. 18:6-24:6)

         Other statements made in the specification also lend support to defendants' proposed construction. First, the Background of the Invention section distinguishes the prior art uses of plant sap on the basis of newly discovered uses. After noting that "there has been no reliable or reproducible report of the use of any extract from Euphorbia species" for the treatment of certain skin cancers, (Id., col. 5:40-42), the specification discloses that "[t]he inventor has now surprisingly found that sap of plants from three different Euphorbia species [] specifically inhibits growth of three different human tumour cell lines, " (Id., col. 6:9-13), and that "[these anti-skin cancer] results were particularly striking, " (Id., col. 6:19-22). The specification thus confirms that the subject matter of the '656 patent covers new methods for using extracted plant sap, as opposed to methods for synthesizing any plant-sap ingredients. See Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (finding that the statements in the specification, which distinguished the prior art as inferior and touted the advantages of a conical shaped cup for use in an artificial hip device, "make clear that the '589 patent discloses only conical shaped cups and nothing further.").

         Moreover, the prosecution history distinguishes claim 1 over prior art methods of obtaining sap extracts on the basis of purification to separate-not reactions to synthesize any angeloyl-substituted ingenane. (D.I. 98, Ex. 11 at 6) The examiner initially rejected claim 1 as anticipated by the Tamas reference, which "describes Euphorbia Hirta plants and their extracts as being used to prepare medicaments for tumor therapy." (D.I. 98, Ex. 11 at 4 and 8) To overcome this rejection, the patentees stressed that "Tamas does not teach, disclose an isolated angeloyl-substituted ingenane, as recited in the claim, " and that "even if an angeloyl-substituted ingenane were present in the extracts, the ingenane would be part of an extract, and not separate therefrom." (D.I. 98, Ex. 11 at 2, 4 and 6) These statements describe and enable only the compounds "from a plant."

         The specification explicitly addresses any residual uncertainty as to the scope of "various modifications and alterations to the embodiments and methods described herein." ('656 patent, col. 32:39-41) The Summary of the Invention section provides that, "while the invention is described in detail with reference to compounds detected in sap or sap extracts, these compounds, when present in or extracted from whole plants or parts thereof, are still within the scope of the invention." ('656 patent, col. 6:49-53) The '656 patent does not contemplate synthetic or semi-synthetic compounds. See Wang Labs., Inc. v. America Online, Inc., 197 F.3d 1377 1382 (Fed. Cir. 1999) (holding that the "only system that is described and enabled" in the patent specification "uses a character-based protocol, " and that references to bit-mapped protocols did "not describe them as included in the applicant's invention, and that the specification would not be so understood by a person skilled in the field of the invention."). Therefore, the entire specification and prosecution history define "[an] isolated compound" as from a specific source-a plant from the Euphorbia species.

         LEO relies on a single sentence in the specification that "[t]he Promega mRNA isolation kit was used to isolate mRNA." ('656 patent, col. 27:15-16) However, this portion of the specification found in Example 13 describes the isolation of mRNA, and not the isolation of the claimed compound. (Id., col. 27:3-5) In other words, while the usage of the term "isolated" in Claim 1 refers to a new preparation method of the claimed compound, the usage of the term "isolating" in Example 13 refers to a routine characterization method for determining the anticancer functions of the claimed compound. A person of ordinary skill in the art would not ...

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