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IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

August 16, 2019


          Jack B. Blumenfeld and Brian P. Egan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Jeffrey J. Oelke (argued), Ryan P. Johnson (argued), Laura T. Moran, and Eric M. Majchrzak, FENWICK & WEST LLP, New York, NY; Erica R. Sutter, FENWICK & WEST LLP, Mountain View, CA. Attorneys for Plaintiffs.

          John W. Shaw, Karen E. Keller, and Nathan R. Hoeschen, SHAW KELLER LLP, Wilmington, DE; J.C. Rozendaal (argued), Kristina Caggiano Kelly (argued), Michael Joffre, and Deirdre M. Wells, STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C, Washington, DC. Attorneys for Defendant.



         Presently before me is the issue of claim construction of multiple terms in U.S. Patent No. 7, 723, 390 ('"390 Patent"). (D.I. 70). I have considered the Parties' Joint Claim Construction Brief and supplemental submissions. (Id; D.I. 97, 98). I heard oral argument on June 27, 2019. (D.I. 94 ("Tr.")).


         A. Claim Construction

         "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) (citation omitted). '"[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law.'" SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Of these sources, "the 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." Phillips, 415 F.3d at 1315.

         "[T]he words of a claim are generally given their ordinary and customary meaning. . . . [This 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." Id. at 1312-13. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321. "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

         When a court relies solely on the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based on consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

         "A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." 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) (citation omitted).

         B. Indefiniteness

         "[A] patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see also 35 U.S.C. § 112 ("The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor ... regards as the invention.")- A patent claim is sufficiently definite if it is "precise enough to afford clear notice of what is claimed, thereby apprising the public of what is still open to them." Nautilus, 572 U.S. at 909 (cleaned up).

         "Indefiniteness is a question of law" to which the general principles of claim construction apply. Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1370 (Fed. Cir. 2017). A claim term "is indefinite if its language 'might mean several different things and no informed and confident choice is available among the contending definitions.'" Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed Cir. 2015) (quoting Nautilus, 572 U.S. at 911 n.8).


         The patent-in-suit relates generally to pharmaceutical compositions for thyroid hormones. ('390 Patent at 1:6-7). The patent descends from an Italian priority application. (See D.I. 71-1, Exh. O (Italian application); see also D.I. 71-1, Exh. P (February 11, 2019 translation of Italian application)).

         The specification discusses only the T3 and T4 thyroid hormones. (See '390 Patent at 1:11-16). The body also produces Tl and T2 thyroid hormones. (Tr. at 13:15-20). The numbers (one through four) refer to the number of iodine atoms attached to the base molecule, thyronine. (Id.).

         The Parties dispute the proper construction of terms in claims 1, 7, and 8:

1. A pharmaceutical composition comprising thyroid hormones or their sodium salts in the form of either:
a) a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said inner phase, dissolved in gelatin and/or glycerol, and optionally ethanol, said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers, or
b) a swallowable uniform soft-gel matrix comprising glycerol and said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said matrix.
7. The pharmaceutical composition according to claim 1, having an outer coating which simplifies ingestion.
8. The pharmaceutical composition according to claim 1, wherein the material of the capsule contents or the swallowable uniform soft-gel matrix includes a plasticizer to control its hardness.

('390 Patent, claims 1, 7, 8 (disputed terms italicized)).


         1."thyroid hormones or their [sodium] salts"

         a. Plaintiffs' proposed construction:

Plain and ordinary meaning: "one or more thyroid hormones or their [sodium] salts"

         b. Defendant's proposed construction:

Plain and ordinary meaning: multiple thyroid hormones or sodium salts of multiple thyroid hormones

         c. Court's construction:

"one or more thyroid hormones or their [sodium] salts"

         The Parties agree that this claim covers compositions that contain more than one type of thyroid hormone.[1] (See D.I. 70 at 3-20). They disagree, however, whether the claim covers ...

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