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Silvergate Pharmaceuticals Inc. v. Bionpharma Inc.

United States District Court, D. Delaware

April 3, 2018

SILVERGATE PHARMACEUTICALS INC., Plaintiff,
v.
BIONPHARMA INC., Defendant.

          MEMORANDUM OPINION

          Goldberg, J.

         Before me are two consolidated patent infringement and invalidity cases arising under the Hatch-Waxman Act.[1] Plaintiff Silvergate Pharmaceuticals Inc., the owner of U.S. Patent No. 8, 568, 747 (“the '747 Patent”) and U.S. Patent No. 8, 778, 366 (“the '366 Patent”), has filed two one-count complaints for patent infringement against Defendant Bionpharma Inc. alleging violation of 25 U.S.C. § 271(e)(2)(A) based upon Defendant's submission of an Abbreviated New Drug Application (“ANDA”) with the Federal Drug Administration (“FDA”) seeking approval of a generic version of Plaintiff Silvergate's liquid formulation of EPANED® (hereinafter “EPANED® product”). Defendant responded with counterclaims for non- infringement and invalidity. Presently before me are the parties' briefs on claim construction of seven terms contained in the '747 Patent and the '366 Patent's claims.[2]

         I. Factual and Procedural Background

         Plaintiff's EPANED® product treats hypertension in children and is also indicated to treat hypertension in adults, heart failure, and asymptomatic left ventricular dysfunction. EPANED® is a pharmaceutical powder that is reconstituted into an oral liquid formulation.

         The '747 Patent issued on October 29, 2013 and covers the approved formulation of the EPANED® product. Pursuant to 21 U.S.C. § 255, the '747 Patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection with EPANED®.

         Plaintiff is the assignee and exclusive licensee of the '747 Patent. Claims 1, 2, 4, and 5 are at issue in this case and state:

Claim 1: A pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of:
(a) About 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof,
(b) About 85% (w/w) mannitol, and
(c) About 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25±5° C. and 55±10% relative humidity.
Claim 2: The pharmaceutical powder of claim 1, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.
Claim 4: The pharmaceutical powder of claim 1, wherein the powder is reconstituted in syrup for the oral liquid.
Claim 5: The pharmaceutical powder of claim 1, wherein the powder is stable for at least six months at ambient, accelerated or refrigerated conditions.

         On August 19, 2016, Defendant notified Plaintiff that it had submitted ANDA No. 209375 to the FDA under Section 505(j)(2)(B) of the Federal Food, Drug and Cosmetic Act, seeking to engage in the commercial manufacture, use, and sale of a generic version of the EPANED® product before the expiration of the '747 Patent.

         The '366 Patent was issued to the same inventors on July 15, 2014. The claims of the '366 Patent cover one of the approved indications of the EPANED® product. The '366 Patent is also listed in the Orange Book in connection with EPANED®. On November 23, 2016, Defendant notified Plaintiff that it had submitted ANDA No. 209375 to the FDA seeking to engage in the commercial manufacture, use, and sale of a generic version of the EPANED® product before the expiration of the '366 Patent.

         Of the fifteen claims in the '366 Patent, only Claims 14 and 15 are at issue in this case.

         They are:

Claim 14: A method of treating heart failure in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25±5° C. and 60±10% relative humidity.
Claim 15: A method of treating left ventricular dysfunction in a subject in need comprising administering to that subject a therapeutically effective amount of a pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25±5° C. and relative humidity.

         The parties have fully briefed proposed claim constructions of the seven terms at issue, which are: “about”; “about 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof”; “about 85% (w/w) mannitol”; “about 1% (w/w) colloidal silicon dioxide”; “consisting of”; “mannitol”; and “stable.” On February 15, 2018, I held a hearing on the parties' proposed claim constructions.[3]

         II. Claim Construction of the '747 Patent and the '366 Patent

         Claim construction is a two-step process. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). First, the court must define the meaning and scope of the disputed claim terms, which is an issue of law. Id. Second, those interpretations are used by the fact finder in 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). “‘[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., No. 10-389, 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman, Inc., 52 F.3d at 977-80. 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 (internal quotation marks and citations omitted).

         “[T]he words of a claim 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.” Id. at 1312-13 (internal quotation marks and citations omitted). “[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent.” Id. at 1321 (internal quotation marks omitted). “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 (internal citations omitted).

         A court may consider extrinsic evidence, which “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises, ” in order to understand the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. at 1317-19 (internal quotation marks and citations omitted). 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) (internal quotation marks and citation omitted).

         A. Claim Terms Using the Word “About”

         The first term requiring construction is the word “about” as it is used in Claim 1 of the '747 Patent and Claims 14 and 15 of the '366 Patent.[4] “About” appears in the following claim terms: “about 14% enalapril or pharmaceutically acceptable salt thereof”; “about 85% w/w mannitol”; and “about 1% w/w colloidal silicon dioxide.” Because the construction of “about” will bear on construction of these terms, I discuss all four terms in this section.

         Plaintiff proposes I construe “about” to mean “approximately.” Thus it contends I construe the three terms as “approximately 14% (w/w) enalapril or a pharmaceutically acceptable salt thereof, wherein enalapril refers to enalapril base, its salt, or solvate or derivative or isomer or polymorph thereof”; “approximately 85% w/w mannitol”; and “approximately 1% w/w colloidal silicon dioxide.” Plaintiff submits that this construction is applied by courts as the plain and ordinary meaning of “about” where a patentee has not acted as its own lexicographer by redefining the term in the common specification.

         Defendant asserts that I construe “about” to mean “to indicate that a value includes the standard level of error for the evidence or method being used.” Regarding the three “about” terms, Defendant proposes the following constructions: “13.86% to 14.14% (w/w) enalapril or a pharmaceutically acceptable salt thereof as determined by HPLC analysis, or any other scientifically acceptable method of equal or greater precision”; “82.45% to 87.55% (w/w) mannitol as determined by HPLC analysis, or any other scientifically acceptable method of equal or greater precision”; and “0.95% to 1.05% (w/w) colloidal silicon dioxide as determined by gravimetric analysis, or any other scientifically acceptable method of equal or greater precision.” According to Defendant, language in the common specification demonstrates that the patentee acted as its own lexicographer, defining the term. In support, Defendant points to the following language in Column 19 of the '747 Patent's common specification:[5] “The term ‘about' is used to indicate that a value includes the standard level of error for the device or method being employed to determine the value.” From this language, Defendant argues that a person of ordinary skill in the art (“a POSA”) would ...


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