Supernus Pharms. Inc. v. Actavis Inc.
| Decision Date | 05 February 2016 |
| Docket Number | Civil No. 13-4740 (RMB/JS),Civil No. 14-1981 (RMB/JS) |
| Parties | SUPERNUS PHARMACEUTICALS INC., Plaintiff, v. ACTAVIS INC. et al., Defendants. |
| Court | U.S. District Court — District of New Jersey |
(PUBLICLY FILED)
Appearances:
Charles M. Lizza
William C. Baton
Sarah A. Sullivan
Saul Ewing, LLP
One Riverfront Plaza
Newark, NJ 07102-5490
Edgar H. Haug
Sandra Kuzmich
Jason A. Lief
Nicholas F. Giove
Andrew S. Roper
Laura A. Chubb
Jonathan Herstoff
Rachel P. McClure
Kevin J. Georgek
Frommer Lawrence & Haug
745 Fifth Avenue, Floor 10
New York, NY 10051
Charles A. Weiss
Howard S. Suh
Michael B. Eisenberg
Eric H. Yecies
Leisa Smith Lundy
Christopher M. Scott
Nicholas P. Chiara
Holland & Knight
31 West 52nd Street
New York, NY 10019
Liza M. Walsh
Jennifer Critchley
Eleonore Ofosu-Antwi
Christopher J. Borchert
Connell Foley LLP
One Newark Center
1085 Raymond Blvd, 19th Floor
Newark, NJ 07102
TABLE OF CONTENTS
I. INTRODUCTION ............................................ 4
II. BACKGROUND .............................................. 7
III. LEGAL ANALYSIS ......................................... 13
IV. CONCLUSION ............................................ 135
I. INTRODUCTION
This is an action for patent infringement brought by Plaintiff Supernus Pharmaceuticals, Inc. ("Supernus" or "Plaintiff") against Defendants Actavis Inc., Watson Laboratories, Inc. - Florida n/k/a Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Watson Laboratories, Inc., and ANDA, Inc. (collectively, "Actavis" or "Defendants") pursuant to 35 U.S.C. § 271(e)(2)(A) and §§ 271(a), (b), and (c).
This case involves Supernus's Oxtellar XR® product, a once-daily extended release oxcarbazepine tablet used to treat partial epilepsy seizures in adults and children above the age of six. Supernus seeks to prevent the Defendants from selling a generic version of Oxtellar XR®, in connection with Actavis's submission of Abbreviated New Drug Application ("ANDA") number 205444 seeking the approval of the U.S. Food & Drug Administration ("FDA") to market its generic ANDA product (the "Actavis Tablets") prior to the expiration of certain patents held by Supernus. Specifically, Supernus alleges that in selling its generic version of Oxtellar XR®, the Defendants will infringe U.S. Patent Nos. 7,722,898 (the "'898 Patent"), 7,910,131 (the "'131 Patent"), and 8,617,600 (the "'600 Patent") (collectively, the "Supernus Patents" or the "Patents-in-Suit").
Supernus is asserting claims 1, 6 to 8, 11, 18, and 19 of the '898 Patent, claims 6 to 8, 11, 18, 19, and 21 of the '131Patent, and claims 1, 7 to 9, 12, 18, and 19 of the '600 Patent. The asserted claims all require a homogeneous matrix comprising the active pharmaceutical ingredient oxcarbazepine, a matrix forming polymer, a solubility enhancing agent, and a release promoting agent. Claim 1 of the '898 Patent provides:1
The dependent claims of the '898, '131, and '600 patents generally specify the types of excipients for the matrix forming polymer, solubility enhancing agent, and release promoting agent. They also specify the ranges of fluctuation in pharmacokinetic parameters.
The Court conducted a seven-day bench trial from November 18, 2015 through December 4, 2015. It then permitted the parties to file post-trial briefing.2
After considering all the evidence, and for the reasons set forth below, the Court finds that: (1) the Defendants will infringe the '898 Patent and the '131 Patent; (2) the Defendants will not infringe the '600 Patent; and (3) all the Patents-in-Suit are valid. Accordingly, the Court enters judgment against Actavis and in favor of Supernus as to the '898 and '131 Patents and against Supernus and in favor of Actavis as to the '600 Patent. This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Rule 52(a).3
II. BACKGROUND4
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 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 application until the expiration of a 30-month statutory period. Id. § 355(c)(3)(C).
Epilepsy is a serious and chronic neurological disorder characterized by seizures. It cannot be cured, but it can be managed by anti-epileptic drugs ("AEDs"). Trial Transcript ("Tr.") 1195:20-1196:7 (Wheless Direct). Seizure control, through medication, is crucial and often challenging to achieve. Likewise, patients' compliance with their medication regimen is paramount given the potentially devastating consequences of apatient not taking the medication properly. Id. at 1201:4-1202:15. Once a physician has established an effective AED regimen for a given patient, the physician will likely be reluctant to change the regimen for fear of breakthrough seizures or changes in the patient's tolerability for the medication. See, e.g., Tr. 1517:19-1519:1 (Rausser Direct); Tr. 1257:4-5 (Lado Direct).
Prior to the commercial release of Oxtellar XR®, there were over twenty different types of AEDs available on the market worldwide. Tr. 1242:24-1243:2 (Lado Direct). These included oxcarbazepine formulations, as well as medications with different active ingredients, such as carbamazepine. Some AEDs had already been reformulated for extended release. Id. at 1242:24-1243:6, 1244:24-1245:12. Oxcarbazepine, however, had not. Additionally, the available AEDs at the time utilized varying mechanisms or modes of action. Id. at 1243:8-15; DTX 471 at ACT-OXXR002757935. Twice daily oxcarbazepine first entered the market as branded Trileptal® in 2000. Several generic versions followed. Id. at 1241:17-1242:1.
The Patents-in-Suit describe and claim a specific type of oxcarbazepine formulation for the treatment of seizures with a"homogenous matrix" containing the active ingredient, oxcarbazepine, and excipients. The "homogeneous matrix" is...
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