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Par Pharmaceutical, Inc. v. Hospira, Inc.

United States District Court, D. Delaware

April 30, 2019

PAR PHARACEUTICAL, INC., PAR STERILE PRODUCTS, LLC, and ENDO PAR INNOVATION COMPANY, LLC, Plaintiffs,
v.
HOSPIRA, INC., Defendant.

         UNSEALED 5/7/2019

          REPORT AND RCOMMENDATION

          SHERRY R. FALLON, UNITED STATES MAGISTRATE JUDGE.

         I. INTRODUCTION

         In this patent infingement action fled by plaintiffs Par Pharmaceutical, Inc., Pa Sterile Products, LLC, and Endo Par Innovation Company, LLC ("Par") against defendant Hospira, Inc. ('-Hospira"), Par alleges infingement of United States Patent Nos. 9, 119, 876 ("the '876 patent") and 9, 295, 657 ("the '657 patent") (together, the "patents-in-suit"). (D.I. 1) Presently before the court is the matter of claim construction.[1] This decision sets forth the court's recommendations of constructions fr the disputed claim terms discussed in the briefing and at the Markman hearing held on March 27, 2019.

         II. BACKGROUND

         The patents-in-suit, entitled "Epinephrine Formulations," claim priority to U.S. Patent Application No. 14/657, 990 ("the '990 application") and have an efective fling date of March 13, 2015. The '657 patent is a continuation of the '876 patent, and it shares the same inventors and specification. (D.I. 151, Exs. 1 & 2) The patents-in-suit are directed to a specific epinephrine formulation with improved stability, as evidenced by the limited amounts of certain impurities after eighteen months of storage. In pharmaceutical compositions, epinephrine acts to improve breathing, stimulate the heart, raise dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat. ('876 patent, col. 1:15-19) Epinephrine is used as an emergency treatment for Type 1 allergic reactions, among other conditions. (Id., col. 1:20-29)

         On July 13, 2017, Par filed suit against Hospira, alleging that Hospira's ANDA product infringes the patents-in-suit, as embodied by Par's Adrenalin® product. (D.I. 1) In 2012, the Food and Drug Administration ("FDA") approved the Adrenalin® epinephrine injection formulation of Par's predecessor, JHP Pharmaceuticals ("JHP"). However, the FDA asked JHP to investigate improvements to the formulation and process to reduce the levels of impurities in the Adrenalin® product. Subsequent testing revealed the presence of Impurity A, Impurity B, and Unknown C. The inventors developed a procedure using gradient Hydrophobic Interaction Liquid Chromatography ("HILIC")[2] to isolate Impurity A, Impurity B, and Unknown C. ('876 patent, col. 16:38-20:61, Figs. 1-4)

         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. . .").

         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), aff'd, 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 ...


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