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Supernus Pharmaceuticals, Inc. v. TWI Pharmaceuticals, Inc.

United States District Court, D. New Jersey

September 21, 2017

SUPERNUS PHARMACEUTICALS, INC., Plaintiff,
v.
TWI PHARMACEUTICALS, INC. and TWI INTERNATIONAL LLC d/b/a TWI PHARMACEUTICALS USA, Defendants. Claim Term Supernus's Proposed Construction TWi's Proposed Construction

          Charles Michael Lizza, Esq. William C. Baton, Esq. Sarah Ann Sullivan, Esq. Saul Ewing, LLP, Edgar H. Haug, Esq. Nicholas F. Giove, Esq. Andrew S. Roper, Esq. Erika Vanessa Selli, Esq. Kevin J. Georgek, Esq. Rachel P. McClure, Esq. Stephanie M. Roberts, Esq. Jonathan A. Herstoff, Esq. Laura A. Chubb, Esq. Haug Partners LLP, Attorneys for Plaintiff Supernus Pharmaceuticals, Inc.

          Karen A. Confoy, Esq. Allison Linda Hollows, Esq. Fox Rothschild LLP, Don J. Mizerk, Esq., John A. Sholar, Esq., Marc R. Wezowski, Esq., Dustin L. Taylor, Esq. Husch Blackwell LLP 120 S. Riverside Plaza, Suite 2200 Chicago, IL 60606 Attorneys for Defendants TWi Pharmaceuticals, Inc. and TWi International LLC d/b/a TWi Pharmaceuticals USA

          OPINION FOR PUBLIC VIEWING

          RENÉE MARIE BUMB, UNITED STATES DISTRICT JUDGE

         TABLE OF CONTENTS

         I. INTRODUCTION ......................................... 4

         II. BACKGROUND .......................................... 7

         A. The Drug Approval Process ........................... 7

         B. The Patents-in-Suit ................................. 8

         i. The '898 Patent ................................... 9

          ii. The '131 Patent ................................... 9

         iii. The '930 Patent .................................. 10

         C. Oxtellar XR® ....................................... 11

         D. TWi's ANDA ......................................... 11

         III. LEGAL ANALYSIS ..................................... 12

         A. Claim Construction ................................. 13

         i. Homogeneous Matrix ............................... 15

         ii. Agent that Enhances the Solubility of Oxcarbazepine 16

         B. Infringement ....................................... 19

         i. The Patents-in-Suit .............................. 19

         ii. The TWi ANDA Product ............................. 21

         C. Invalidity ......................................... 71

         i. Written Description .............................. 73

         ii. Indefiniteness ................................... 82

         IV. CONCLUSION ......................................... 87

         I. INTRODUCTION

         This is an action for patent infringement brought by Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus” or the “Plaintiff”) against Defendants TWi International LLC and TWi Pharmaceuticals, Inc. (together, “TWi” or the “Defendants”), pursuant to 35 U.S.C. § 271(e)(2)(A) and 35 U.S.C. §§ 271(a), (b), and (c).

         This case involves Supernus's Oxtellar XR® product, a once-a-day extended release oxcarbazepine tablet for the treatment of partial epilepsy seizures in adults and children above the age of six. Supernus seeks to prevent TWi from selling a generic version of Oxtellar XR®, in connection with TWi's submission of Abbreviated New Drug Application (“ANDA”) No. 206576, seeking the approval of the United States Food & Drug Administration (“FDA”) to market its generic version of Oxtellar XR® (the “ANDA Product” or the “TWi Tablets”) prior to the expiration of certain patents held by Supernus. Specifically, Supernus alleges that, in selling its ANDA Product, TWi will infringe U.S. Patent Nos. 7, 722, 898 (the “'898 Patent”), 7, 910, 131 (the “'131 Patent”), and 8, 821, 930 (the “'930 Patent”) (collectively, the “Supernus Patents” or the “Patents-in-Suit”).[1] Supernus asserts Claims 1 and 11 of the '898 Patent, Claims 1, 11, and 21 of the '131 Patent, and Claims 1 and 19 of the '930 Patent. The asserted claims all require a homogeneous matrix comprising the active pharmaceutical ingredient (“API”), oxcarbazepine, a matrix-forming polymer, a solubility-enhancing agent, and a release-promoting agent.

         Claim 1 of the '898 Patent provides:[2]

1. A pharmaceutical formulation for once-a-day administration of oxcarbazepine comprising a homogeneous matrix comprising:
(a) oxcarbazepine;
(b) a matrix-forming polymer selected from the group consisting of cellulosic polymers, alginates, gums, cross-linked polyacrylic acid, carrageenan, polyvinyl pyrrolidone, polyethylene oxides, and polyvinyl alcohol;
(c) at least one agent that enhances the solubility of oxcarbazepine selected from the group consisting of surface active agents, complexing agents, cyclodextrins, pH modifying agents, and hydration promoting agents; and
(d) at least one release promoting agent comprising a polymer having pH-dependent solubility selected from the group consisting of cellulose acetate phthalate, cellulose acetate succinate, methylcellulose phthalate, ethylhydroxycellulose phthalate, polyvinylacetate phthalate, polyvinylbutyrate acetate, vinyl acetate-maleic anhydride copolymer, styrene-maleic mono-ester copolymer, and Eudragit L 100-55 (Methacrylic Acid-Ethyl Acrylate Copolymer (1:1)), and methyl acrylate-methacrylic acid copolymers.

         The dependent claims of the Patents-in-Suit include additional limitations, generally specifying the types of excipients for the matrix-forming polymer, solubility enhancing agent, and release promoting agent, and/or the nature of the dosage form.

         The Court conducted a four-day bench trial from April 3, 2017 through April 6, 2017. It then permitted the parties to submit post-trial briefing.[3]

         After considering all the evidence, as well as the parties' submissions, and for the reasons set forth herein, the Court finds that: (1) TWi's ANDA Product will infringe each of the Patents-in-Suit; and (2) each of the Patents-in-Suit is valid. Accordingly, the Court enters judgment against TWi and in favor of Supernus as to the '898 Patent, the '131 Patent, and the '930 Patent. This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).

         II. BACKGROUND[4]

         A. The Drug Approval Process

         Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the FDA must approve all new drugs before they may be distributed in interstate commerce. 21 U.S.C. § 355(a). To secure approval for a new drug, an applicant may file a New Drug Application (“NDA”) that includes, inter alia, the number and expiration date of any patents which claim the drug or a method of using the drug if a claim of patent infringement could reasonably be asserted. Id. § 355(b)(2). “The FDA publishes the names of approved drugs and their associated patent information in the Approved Drug Products with Therapeutic Equivalence Evaluations list, commonly referred to as the ‘Orange Book.'” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1045 (Fed. Cir. 2010). An applicant seeking approval to market a generic version of a drug that has already been approved by the FDA may file an ANDA, which “allows an applicant to rely on the safety and efficacy information for the listed drug if the applicant can show that the generic drug is ‘bioequivalent' to the listed drug.” Id. (citing 21 U.S.C. §§ 355(b)(2), 355(j)).

         “[F]or each patent listed in the Orange Book that claims either the listed drug or a use of the listed drug for which the applicant is requesting approval, an ANDA must include either one of four certifications or a ‘section viii statement.'” AstraZeneca LP, 633 F.3d at 1046. If an applicant submits a certification, the applicant must certify “(I) that . . . patent information has not been filed, (II) that such patent has expired, (III) . . . the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug.” 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). The last of these is known as a “paragraph IV certification.” If an ANDA applicant submits a paragraph IV certification and a patent infringement suit is commenced within 45 days, then the FDA may not approve the ANDA until the expiration of a 30-month statutory period. Id.

         § 355(c)(3)(C).

         B. The Patents-in-Suit

         The Patents-in-Suit describe and claim a specific type of oxcarbazepine formulation for the treatment of seizures with a “homogeneous matrix” containing the active ingredient, oxcarbazepine, and certain categories of excipients. The “homogeneous matrix” is central to the claimed invention.

         i. The '898 Patent

         On May 25, 2010, the United States Patent and Trademark Office (the “PTO”) issued the '898 Patent, entitled “Modified-Release Preparations Containing Oxcarbazepine and Derivatives Thereof.” PTX 1(A). The named inventors are Dr. Padmanabh P. Bhatt, Dr. Argaw Kidane, and Dr. Kevin Edwards. The '898 Patent was filed on April 13, 2007 as Application No. 11/734, 874 and is related to Provisional Application No. 60/794, 837, filed on April 26, 2006. The '898 Patent expires on April 13, 2027. PTX 1(A); Joint Final Pretrial Order, Stipulated Facts (“SF”) ¶ 12. The '898 Patent covers an oxcarbazepine formulation administered once-daily for the treatment of seizures. PTX 1(A).

         ii. The '131 Patent

         The '131 Patent, entitled “Method of Treating Seizures Using Modified Release Formulations of Oxcarbazepine, ” was filed on August 27, 2008 as Application No. 12/230, 276, which was a continuation of Application No. 11/734, 874, filed on April 13, 2007. PTX 2(A). The '131 Patent is also related to Provisional Application No. 60/794, 837, filed on April 26, 2006. The '131 Patent was issued by the PTO on March 22, 2011 and expires on April 13, 2027. PTX 2(A); SF ¶ 13. The '131 Patent covers a method of treating seizures by administrating an oxcarbazepine pharmaceutical formulation. PTX 2(A).

         iii. The '930 Patent

         The '930 Patent, entitled “Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof, ” was filed on December 11, 2013 as Application No. 14/103, 103, which was a continuation of Application No. 13/476, 337, filed on May 21, 2012, which is, in turn, a continuation of Application No. 13/137, 382, filed on August 10, 2011, which is a division of Application No. 12/230, 275, filed on August 27, 2008, which is a continuation of Application No. 11/734, 874, filed on April 13, 2007. It is also related to Provisional Application No. 60/794, 837, filed on April 26, 2006. PTX 4(A); SF ¶ 14. The '930 Patent issued on September 2, 2014 and expires on April 13, 2027. The '930 Patent covers an oxcarbazepine formulation for the treatment of seizures. Its terms are largely similar to those of the '898 Patent, but also include, in relevant part, certain percentages by weight of the formulation limitations.

         TWi disputes Supernus's claims relating to each of the Patents-in-Suits on the grounds of non-infringement and invalidity.

         C. Oxtellar XR®

         In October 2012, the FDA approved NDA No. 202810 for an oxcarbazepine extended-release oral tablet, which Supernus markets under the name Oxtellar XR®. Its sole active ingredient is oxcarbazepine. Oxtellar XR® is indicated for use as a once-daily adjunctive therapy in the treatment of partial seizures in adults and children 6 to 17 years of age. SF ¶¶ 1, 6.

         D. TWi's ANDA

         On December 30, 2013, TWi filed ANDA No. 206576 with the FDA seeking regulatory approval to market extended-release oxcarbazepine oral tablets in 150 mg, 300 mg, and 600 mg dosages. SF ¶ 27. TWi's ANDA identifies the listed drug product that is the basis for the submission as Oxtellar XR®. PTX 88.5. TWi's ANDA included a paragraph IV certification asserting that the '898, '131, and '930 Patents are invalid, unenforceable, or will not be infringed by the manufacture or sale of its generic extended-release oxcarbazepine tablets. SF ¶ 27. On January 18, 2017, TWi submitted an ANDA amendment to the FDA, which included changes to the formulation of TWi's 150 mg and 300 mg tablets only. SF ¶ 28. Xxxxx

         III. LEGAL ANALYSIS

         To prove infringement, the patentee must show that it is more likely than not that the proposed ANDA product would, if commercially marketed, meet all of the claim limitations of the Patents-in-Suit. See Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d 1283, 1287 (Fed. Cir. 2010) (en banc); Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002) (infringement analysis turns on whether accused product satisfies every limitation of the claim in question). In other words, the patentee “has the burden of proving infringement by a preponderance of the evidence.” Kegel Co., Inc. v. AMF Bowling, Inc., 127 F.3d 1420, 1425 (Fed. Cir. 1997); SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988). Determining whether an accused product infringes the patent involves a two-step analysis. Kegel, 127 F.3d at 1425. The Court must first construe the scope and meaning of the asserted claims and then compare the accused product to the properly construed claims. Id.

         Before beginning this two-step analysis, the Court observes that, although the parties do not agree on the exact definition of a person of ordinary skill in the art, sometimes referred to as a POSA, their respective definitions are fairly similar and they have made no arguments as to which definition the Court should adopt.[5] More importantly, the parties have not identified how the Court's analysis would differ depending on the definition adopted. Nonetheless, the Court sees no material difference between the definitions put forth by the parties and finds that its claim construction, infringement, and validity analyses would be the same under either definition.

         A. Claim Construction

         As for the first step, on August 31, 2015, the parties filed their Joint Claim Construction and Prehearing Statement, pursuant to Local Patent Rule 4.3 and the Court's July 17, 2015 Scheduling Order [Docket No. 64]. On October 7, 2015, the Court conducted a Markman hearing [Docket No. 81]. The Court construed several terms, of which the only disputed claim term that remains contested at this juncture is “agent that enhances the solubility of oxcarbazepine.” The parties stipulated to the Court's construction of the term “homogeneous matrix” in a related action, Supernus Pharm., Inc. v. Actavis, Inc., Civil Action Nos. 13-4740, 14-1981 (the “Actavis Matter”). Joint Claim Construction Br. at 5 [Docket No. 64].[6]

         Claim construction is a question of law. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 391 (1996). The Court determines the meaning of disputed claim terms as understood by one of ordinary skill in the art at the time of invention. See Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). Claim terms generally should be given their ordinary and customary meaning to a person of skill in the art at the time of the invention. See id. To determine the ordinary meaning, the Court first looks to the intrinsic evidence, which includes the claims, the specification, and the prosecution history. Id. at 1312-17 (“Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.”).

         The starting point for claim interpretation is the claim language itself, which can “provide substantial guidance as to the meaning of particular claim terms.” Id. at 1314. Thus, the language of the claims is paramount. Pass & Seymour, Inc. v. Int'l Trade Comm'n, 617 F.3d 1319, 1324 (Fed. Cir. 2010); see Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (“in accord with our settled practice we construe the claim as written, not as the patentees wish they had written it”). The claims, however, “must be read in view of the specification, of which they are a part.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed Cir.), aff'd, 517 U.S. 370 (1996). Extrinsic evidence, such as dictionaries, may be consulted to assist in understanding disputed terms. Phillips, 415 F.3d at 1318. Extrinsic evidence, however, must be “considered in the context of the intrinsic evidence.” Id. at 1317-19.

         i. Homogeneous Matrix

         The parties agreed to adopt the Court's construction of the term “homogeneous matrix” in the Actavis Matter. Joint Claim Construction Br. at 5. In the Actavis Matter, the Court construed the term "homogeneous matrix" as "a matrix in which the ingredients or constituents are uniformly dispersed." Markman Order, Civ. Action No. 13-4740 [Docket No. 244]. The Court incorporates its reasoning for this claim construction as set forth in its February 5, 2016 Opinion in the Actavis Matter. Supernus Pharm. Inc. v. Actavis Inc., 2016 WL 527838, at *6-8 (D.N.J. Feb. 5, 2016), aff'd, 665 F.App'x 901 (Fed. Cir. 2016).

         ii. Agent that Enhances the Solubility of Oxcarbazepine

         The Court construed the term "an agent that enhances the solubility of oxcarbazepine" as "an agent, other than oxcarbazepine, that enhances the solubility of oxcarbazepine, which agent cannot also serve as the sole matrix-forming polymer in 1(b) or the sole release promoting agent in 1(d) in claim 1." Markman Order ¶ 2 [Docket No. 84]. The parties had proposed the following constructions:

Claim Term
Supernus's Proposed Construction
TWi's Proposed Construction
"agent that enhances the solubility of oxcarbazepine"
Requires no construction -plain and ordinary meaning ("an agent that functions to increase the aqueous solubility of the oxcarbazepine")
"an agent that functions to increase the aqueous solubility of oxcarbazepine to a point where it impacts the availability of the drug for systemic absorption in patients, which is not: (a) oxcarbazepine, (b) a matrix-forming polymer, or (c) a release promoting agent"

         Joint Claim Construction Br., Ex. A.

         The parties did not genuinely dispute that the plain and ordinary meaning of the term “agent that enhances the solubility of oxcarbazepine” was an “agent that functions to increase the aqueous solubility of oxcarbazepine.” That is evident from their respective proposed constructions. TWi, however, wished to further limit the term in two ways. First, TWi sought the addition of essentially a materiality provision, requiring that the increase in aqueous solubility of oxcarbazepine be “to a point where it impacts the availability of the drug for systemic absorption in patients.” At the Markman hearing, however, the parties agreed that the solubility enhancing agent must result in an increase in the solubility of oxcarbazepine that was more than de minimis. Markman Tr. 66:22-68:1 [Docket No. 85]. In light of the parties' agreement on this issue, the Court declined to expressly supplement the claim language in this respect.

         Second, TWi argued that the solubility enhancing agent cannot be oxcarbazepine, a matrix-forming polymer, or a release promoting agent. TWi expressed concerns regarding a construction that permitted a single excipient that serves several different functions to satisfy multiple claim elements. The Court agreed that such “double duty” was not envisioned by the inventors or in the specifications or claim language of the Patents-in-Suit. For example, the specifications state that a “combination of solubility and release promoters is contemplated in this invention.” '898 Patent, col. 4, ll. 14-16 (emphasis added). In this Court's view, it is clear that a person skilled in the art would understand the claim language to require that a single excipient cannot serve, for example, as both the only solubility enhancing agent and the only release promoting agent in the formulation. TWi's proposed construction, however, is unnecessarily restrictive. Nothing in the claim language, the specifications, or the prosecution history suggests that an excipient cannot function as an agent that enhances the solubility of oxcarbazepine just because it also can function as a matrix-forming polymer or a release promoting agent, so long as the formulation also contains a distinct matrix-forming polymer and release promoting agent. Accordingly, the Court adopted a variation of TWi's proposed construction that eliminated the possibility of improper “double duty, ” while recognizing that excipients may serve several functions at once.

         At trial, however, the parties conveyed to the Court that its construction of the term “agent that enhances the solubility of oxcarbazepine” was no longer relevant to the infringement theories or defenses advanced by the parties. Tr. 28:8-30:13.

         B. Infringement

         i. The ...


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