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VIIV Healthcare Co. v. Lupin Limited

United States District Court, D. Delaware

September 26, 2019

VIIV HEALTHCARE COMPANY, SHIONOGI & CO., LTD, and VIIV HEALTHCARE UK (NO. 3) LIMITED, Plaintiffs,
v.
LUPIN LIMITED et al., Defendants.

          MEMORANDUM OPINION

          Goldberg, J.

         This patent litigation dispute involves seven consolidated patent infringement and invalidity lawsuits, all arising under the Hatch-Waxman Act. Plaintiffs-the owner, assignee, and licensee of U.S. Patent No. 9, 246, 986 (“the ’986 Patent”)-filed each of these actions for patent infringement alleging violation of 35 U.S.C. § 271, based upon Defendants’ submissions of Abbreviated New Drug Applications (“ANDAs”) with the Federal Drug Administration (“FDA”).[1]Those ANDAs seek FDA approval of generic versions of one or both of two brand-name drugs, “TIVICAY®” and “TRIUMEQ®.” Defendants responded with counterclaims for non-infringement and invalidity. Currently before me is the claim construction of two terms contained in the ’986 Patent.

         I. FACTUAL AND PROCEDURAL BACKGROUND[2]

         Plaintiff ViiV Healthcare Company sells and distributes TIVICAY® and TRIUMEQ®, both of which are tablets taken orally to treat HIV. TIVICAY® contains the active ingredient dolutegravir sodium. TRIUMEQ® contains three active ingredients including dolutegravir sodium.

         The ’986 Patent, entitled “synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates, ” issued on January 26, 2016. Plaintiff Shionogi & Co., Ltd. is the assignee of the ’986 Patent, and Plaintiff ViiV Healthcare UK (No. 3) Limited is the exclusive licensee of the ’986 Patent. Pursuant to 21 U.S.C. § 255, the ’986 Patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection with TIVICAY® and TRIUMEQ®.

         Each of the Defendants in these cases filed ANDAs with the FDA, seeking approval to sell generic versions of TIVICAY® or TRIUMEQ® before the expiration of the ’986 Patent.[3]Thereafter, Plaintiffs filed these lawsuits for patent infringement. Plaintiffs and Defendants dispute the appropriate construction of two claim terms: (1) “A crystal form of a sodium salt of a compound of formula AA, ” contained in Claims 1 through 6 of the ’986 Patent; and (2) “A crystal form of a hydrate of a sodium salt of a compound of formula AA, ” contained in Claims 7 through 12 of the ’986 Patent.

         II. LEGAL PRINCIPLES GOVERNING CLAIM CONSTRUCTION

         Claim construction is the first step in the infringement analysis. At claim construction, the court defines the meaning and scope of the disputed claim terms. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996). Claim construction is an issue of law for the court to decide. Id. Following claim construction, the court’s interpretations are used by the factfinder to determine whether there has been infringement, by comparing the asserted claims with the accused device or prior art. Id.

         “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 banc) (internal quotation marks omitted). Thus, the focus of a court’s analysis must therefore begin and remain on the language of the claims, “for it is that language that the patentee chose to use to ‘particularly point[] out and distinctly claim[] the subject matter which the patentee regards as his invention.’” Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (quoting 35 U.S.C. § 112, & 2). There is a “heavy presumption” that the terms of a claim mean what they say and have their ordinary and customary meaning. Texas Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002). That ordinary meaning “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 1313.

         Generally, a person of ordinary skill in the art would not understand the ordinary and customary meaning of a claim term in isolation. As such, the ordinary meaning may be derived from a variety of sources including intrinsic evidence, such as the claim language, the written description, drawings, and the prosecution history; as well as extrinsic evidence, such as dictionaries, treatises, or expert testimony. Dow Chem. Co. v. Sumitomo Chem. Co., Ltd., 257 F.3d 1364, 1373 (Fed. Cir. 2001).

         The “most significant source” of authority is “the intrinsic evidence of record, i.e., the patent itself, including the claims, the patent specification[4] and, if in evidence, the prosecution history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); see also Phillips, 415 F.3d at 1313 (holding that a person of ordinary skill in the art is deemed to read the claim terms in the context of the entire patent, including the specification). The specification “is the single best guide to the meaning of a disputed term” and is usually dispositive as to the meaning of words. Vitronics, 90 F.3d at 1582. Although it is improper to import limitations from the specification into the claims, “one may look to the written description to define a term already in a claim limitation, for a claim must be read in view of the specification of which it is a part.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). On occasion, “the specification may reveal a special definition given to a claim term . . . that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. The specification may also reveal an intentional disclaimer, or disavowal, of claim scope by the inventor . . . [, which] is regarded as dispositive.” Id. “The 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, 158 F.3d at 1250.

         The court “should also consider the patent’s prosecution history, if it is in evidence.” Markman, 52 F.3d at 980. This consists of “the complete record of proceedings before the Patent Office and includes the prior art cited during examination.” Phillips, 415 F.3d at 1317. “Like the specification, the prosecution history provides evidence of how the [Patent and Trademark Office (‘PTO’)] and the inventor understood the patent.” Id. at 1317. Nonetheless, it is the least probative form of intrinsic evidence because it “represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation.” Id.

         If ambiguity still exists after considering all the intrinsic evidence, the court may rely on extrinsic evidence, which is “all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980. “[D]ictionaries, and especially technical dictionaries, . . . have been properly recognized as among the many tools that can assist the court in determining the meaning of particular terminology.” Phillips, 415 F.3d at 1318. Additionally, expert testimony can provide background on the technology at issue, explain how it works, speak to what a person of ordinary skill in the art would understand, and establish that a particular term has a particular meaning in the pertinent field. Id. Notably, however, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quoting Vanderlande Indus. Nederland BV v. Int’l Trade Comm’n, 366 F.3d 1311, 1318 (Fed. Cir. 2004)).

         Ultimately, during claim construction, “[t]he sequence of steps used by the judge in consulting various sources is not important; what matters is for the court to attach the appropriate weight to be assigned to those sources in light of the statutes and policies that inform patent law.” Phillips, 415 F.3d at 303.

         III. DISCUSSION

         Plaintiffs and Defendants dispute the appropriate construction of two claim terms, focusing specifically on the following italicized language: (1) “A crystal form of a sodium salt of a compound of formula AA” (contained in Claims 1 through 6 of the ’986 Patent); and (2) “A crystal form of a hydrate of a sodium salt of a compound of formula AA, ” (contained in Claims 7 through 12 of the ’986 Patent). Plaintiffs maintian that both of these terms need no further construction and should be read in light of their plain and ordinary meaning. Defendants contend that the terms should be construed as, respectively, “an anhydrate crystalline form of dolutegravir sodium” and “a monohydrate crystalline form of dolutegravir sodium in which one molecule of water is in the crystal lattice for every one molecule of dolutegravir sodium.” (Joint Claim Construction Chart). Understanding these positions requires some background regarding the chemistry of crystalline compounds like those covered by the ’986 Patent.

         A. Scientific Background

         A chemical compound can take either an “amorphous” form or a “crystalline” form. When a compound is in a crystalline form, its molecules appear in regular arrangements that are repeated in three dimensions (forming a “lattice” structure). By contrast, and as the name suggests, an “amorphous” compound does not have molecules that are arranged in a regular order. The ’986 Patent covers certain crystalline forms of the compound dolutegravir sodium. (See Pl.’s Br. 4; Defs.’ Br. 4.)

         A crystalline compound can sometimes crystallize in different arrangements or forms. These different crystal forms are called “polymorphs.” Distinguishing between different polymorphs is important, because different polymorphs of the same compound can exhibit different chemical and physical properties, such as different melting points or dissolution rates. Thus, different polymorphs can have different clinical effects. (See Pl.’s Br. 4.)

         A crystalline compound becomes a “solvate” when it incorporates a solvent into its crystalline structure. When that solvent is water, the solvate is a known as a “hydrate.” But when the crystalline compound does not incorporate any solvent into its structure, it is referred to as an “anhydrate.” (See Pl.’s Br. 5; Defs.’ Br. 4.)

         Solvates and hydrates can be either “stoichiometric, ” meaning the ratio of compound to solvent remains constant, or “non-stoichiometric, ” meaning that the ratio does not stay constant but, rather, changes depending on certain conditions like humidity. The different ratios of compound to water are referred to as “hydration states.” A few examples of hydration states are “monohydrate” (a 1:1 ratio of compound molecules to water molecules) and “dihydrate” (a 1:2 ratio of compound molecules to water molecules). (See Pl.’s Br. 5–6; Defs.’ Br. 4–5.)

         The extent to which a crystalline compound’s hydration state impacts its structure is somewhat disputed by the parties. Plaintiffs maintain that while structure may be impacted by hydration state, that is not always the case. (See Pl.’s Br. 6; Tr. of Oral Argument 14:22–15:7.) Specifically, Plaintiffs’ expert posits that non-stoichiometric solvates can go through changes in hydration state without changing structure. (Pl.’s Br. 6 (citing Myerson Decl. ¶¶ 34, 36).) Defendants have not addressed this point directly, but did note at oral argument their disagreement with the general proposition that “hydration or solvation doesn’t identify a crystal form.” (Tr. of Oral Argument 16:6–9.)

         Importantly, the parties do agree that a compound’s crystalline structure can be identified using a number of different measurement techniques, including “X-ray powder diffraction (“XRPD”), infrared absorption spectroscopy (“IR”), and solid-state NMR spectroscopy (“ssNMR”). Thus, the data yielded by using one or more of these techniques provide a unique ...


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