In re Depomed Patent Litig.

• Decision Date: 30 September 2016
• Docket Number: Civil Action No.: 13-4507 (CCC-MF)
• Parties: IN RE DEPOMED PATENT LITIGATION
• Court: U.S. District Court — District of New Jersey

IN RE DEPOMED PATENT LITIGATION

Civil Action No.: 13-4507 (CCC-MF)

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

September 30, 2016

OPINION

CECCHI, District Judge.

I. INTRODUCTION

This is a consolidated¹ Hatch-Waxman patent infringement action brought by Plaintiffs Depomed, Inc. ("Depomed") and Grünenthal GmbH ("Grünenthal") (collectively, "Plaintiffs"). The Defendants in the consolidated action are Actavis Elizabeth LLC, Actavis UT, Actavis LLC, Actavis, Inc. (collectively, "Actavis"), Roxane Laboratories, Inc. ("Roxane"), and Alkem Laboratories Ltd. ("Alkem").

Plaintiffs have asserted three patents against Defendants: U.S. Patent No. RE39,593 (the "'593 patent"), U.S. Patent No. 7,994,364 (the "'364 patent"), and U.S. Patent No. 8,536,130 (the "'130 patent") (collectively, the "patents-in-suit"), which are directed to compositions and methods relating to Plaintiffs' NUCYNTA® tapentadol hydrochloride products, including NUCYNTA® IR, NUCYNTA® ER, and NUCYNTA® Oral Solution.² Defendants have sought approval from the United States Food and Drug Administration ("FDA") to market generic versions of tapentadol hydrochloride. Plaintiffs allege that Defendants will infringe the patents-in-suit by marketing their generic products.

The Court conducted a bench trial in this matter beginning March 9, 2016 through March 23, 2016. The parties submitted post-trial briefing and proposed findings of fact and conclusions of law on April 18, 2016. Closing arguments were held on April 27, 2016.³

This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). The findings of fact are based on the Court's observations and credibility determinations of the witnesses who testified and a thorough review of all the evidence admitted at trial. For the reasons stated herein, the Court finds as follows:

As to the '593 patent, Defendants have not met their burden of proving by clear and convincing evidence that the '593 patent is invalid. As Defendants stipulated to infringement of the '593 patent, judgment of infringement will be entered in favor of Plaintiffs on the '593 patent.

As to the '364 patent, Defendants have not met their burden of proving by clear and convincing evidence that the '364 patent is invalid. As Defendants stipulated to infringement of the '364 patent, judgment of infringement will be entered in favor of Plaintiffs on the '364 patent.

As to the '130 patent, Plaintiffs have met their burden of proving induced infringement of the '130 patent by a preponderance of the evidence as to Alkem. Plaintiffs have not met their burden of proving induced infringement of the '130 patent by a preponderance of the evidence as to Actavis or Roxane. Plaintiffs have not met their burden of proving contributory infringement by a preponderance of the evidence against any of the Defendants. Defendants have not met their burden of proving by clear and convincing evidence that the '130 patent is invalid. Accordingly, judgment of infringement will be entered in favor of Plaintiffs against Alkem on the '130 patent. Judgment of noninfringement will be entered in favor of Actavis and Roxane on the '130 patent.

II. BACKGROUND

A. THE PARTIES

i. Plaintiff Grünenthal

Plaintiff Grünenthal is a corporation organized and existing under the laws of Germany. [Plaintiffs' Proposed Findings of Fact ("PFOF") ¶ 1; Pre-Trial Order ("PTO") ¶ 17.] Grünenthal owns all right, title, and interest in the patents-in-suit. [PFOF ¶ 2; PTO ¶¶ 18.]

ii. Plaintiff Depomed

Plaintiff Depomed is a California corporation. [PFOF ¶ 4; PTO ¶ 10.] Depomed is an exclusive licensee of the patents-in-suit, which it acquired from former plaintiff Janssen Pharmaceuticals, Inc. ("Janssen"). [PFOF ¶ 5; PTX-1563 at DM_0000020.] Depomed holds FDA-approved New Drug Applications ("NDA") for three formulations of NUCYNTA®—an immediate release formulation, an extended release formulation, and an oral solution—and it manufactures and markets NUCYNTA® branded products in the United States. [PFOF ¶ 8; PTO ¶¶ 11-16.]

iii. Defendant Actavis

Defendant Actavis submitted Abbreviated New Drug Application ("ANDA") Nos. 204791, 204972, and 206657 to the FDA, seeking approval to engage in the commercial manufacture, use, importation, offer for sale, and sale of generic tapentadol hydrochloride immediate release tablets, tapentadol hydrochloride extended release tablets, and 20 mg/mL tapentadol hydrochloride oral solution, respectively. [PFOF ¶ 10; PTO ¶¶ 55, 60.] All three of Actavis's ANDAs have received tentative approval from the FDA, subject to this Court's resolution of the patent issues related to the patents-in-suit. [See PFOF ¶¶ 13-14.]

iv. Defendant Roxane

Defendant Roxane submitted ANDA Nos. 205057 and 206418 to the FDA, seeking approval to engage in the commercial manufacture, use, importation, offer for sale, and sale of generic tapentadol hydrochloride immediate release tablets and tapentadol hydrochloride extended release tablets, respectively. [PFOF ¶ 20; PTO ¶¶ 91, 96.] Roxane's ANDA No. 205057 for the immediate release formulation of tapentadol hydrochloride has received tentative approval from the FDA, subject to this Court's resolution of the patent issues related to the patents-in-suit. [PFOF ¶ 22.]

v. Defendant Alkem

Defendant Alkem submitted ANDA Nos. 205015 and 205016 to the FDA, seeking approval to engage in the commercial manufacture, use, importation, offer for sale, and sale of generic tapentadol hydrochloride immediate release tablets and tapentadol hydrochloride extended release tablets, respectively. [PFOF ¶ 16; PTO ¶¶ 75, 80, 81.] Alkem's ANDA No. 205015 has received tentative approval from the FDA, subject to this Court's resolution of the patent issues related to the patents-in-suit. [PFOF ¶ 18.]

B. THE PATENTS-IN-SUIT

i. The '593 patent

The '593 patent, entitled "1-PHENYL-3-DIMETHYLAMINOPROPANE COMPOUNDS WITH A PHARMACOLOGICAL EFFECTS", was issued by the United States Patent and Trademark Office ("USPTO") on April 24, 2007. [PFOF ¶ 25; PTO ¶ 23.] The '593 patent relates generally to a class of compounds and methods of using those compounds. [PTX-312.]

The '593 patent is a reissue of U.S. Patent No. 6,248,737 (the "'737 patent"), which was filed on June 6, 1995 and issued on June 19, 2001. [PFOF ¶ 28; PTO ¶ 26.] The '737 patent claims priority to German Patent Application No. 44 26 245.0, which was filed on July 23, 1994. [PFOF ¶ 29; PTO ¶ 27.]

The inventors listed on the '593 patent are Helmut Buschmann, Wolfgang Strassburger, and Elmar Friedrichs. [PTX-312.] The '593 patent was assigned to Grünenthal on July 17, 1995 and the assignment was recorded with the USPTO on August 1, 1995. [PFOF ¶ 27; PTO ¶ 25.]

ii. The '364 patent

The '364 patent, entitled "CRYSTALLINE FORMS OF (-)-(1R,2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)-PHENOL HCL," was issued by the USPTO on August 9, 2011. [PFOF ¶ 31; PTO ¶ 34.] The '364 patent relates generally to a crystalline form of tapentadol hydrochloride. [PTX-1458.]

The '364 patent issued from U.S. Patent App. No. 12/634,777, which was filed on December 10, 2009. [PFOF ¶ 33; PTO ¶ 37.] The '364 patent claims priority to European App. No. 04015091, which was filed on June 28, 2004. [PFOF ¶ 34; PTO ¶ 38.]

The inventors listed on the '364 patent are Andreas Fischer, Helmut Buschmann, Michael Gruss, and Dagmar Lischke. [PTX-1458.] The '364 patent was assigned to Grünenthal by the various inventors on April 13, 16, and 26, 2007 and the assignment was recorded with the USPTO on May 23, 2007. [PFOF ¶ 32; PTO ¶ 36.]

iii. The '130 patent

The '130 patent, entitled "USE OF 1 PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR TREATING NEUROPATHIC PAIN," was issued by the USPTO on September 17, 2013. [PFOF ¶ 36; PTO ¶ 44.] The '130 patent relates generally to methods of using tapentadol hydrochloride to treat polyneuropathic pain. [PTX-485.]

The '130 patent issued from U.S. Patent App. No. 12/850,208, which was filed on August 4, 2010. [PFOF ¶ 38 PTO ¶ 47.] The '130 patent claims priority to German Patent App. No. 10 2007 012 165.4, which was filed on March 12, 2007. [PFOF ¶ 39; PTO ¶ 48.]

The inventors listed on the '130 patent are Thomas Christoph, Elmar Friedrichs, Babette-Yvonne Koegel, and Murielle Meen. [PTX-485.] The '130 patent was assigned to Grünenthal by the various inventors on September 16, 19, and 27, 2009 and the assignment was recorded with the USPTO on October 1, 2009. [PFOF ¶ 37; PTO ¶ 46.]

C. ISSUES TO BE DECIDED

Plaintiffs have asserted the following claims against Defendants:

'593 patent: Claims 8, 61, 117, and 147 [PFOF ¶ 30]

'364 patent: Claims 1, 2, 3, and 25 [PFOF ¶ 35]

'130 patent: Claims 1 and 2 (against all Defendants)

Claims 3 and 6 (against Alkem only) [PFOF ¶ 40]

Defendants have stipulated to infringement of the '593 and '364 patents. [ECF No. 400.] Defendants contend that the '593 patent is invalid, that the '364 patent is invalid and unenforceable, and that the '130 patent is not infringed and invalid.

The following issues must be decided by the Court.

i. '593 Patent - Invalidity

1. Obviousness: Defendants allege the asserted claims of the '593 patent would have been obvious to a Person of Ordinary Skill in the Art ("POSA") under 35 U.S.C. § 103.

2. Utility: Defendants allege that the asserted claims of the '593 patent lack utility under 35 U.S.C. § 101.

3. Written Description: Defendants allege that asserted claims 61, 117, and 147 of the '593 patent do not meet the written description requirement of 35 U.S.C. § 112. 4. Original Patent: Defendants allege that asserted claims 61, 117, and 147 of the '593 patent do not satisfy the original patent rule of 35 U.S.C. § 251.

5. Enablement: Defendants allege that asserted claim 8 of the '593 patent does not meet the enablement requirement of 35 U.S.C. § 112.

ii. '364 Patent - Invalidity

1. Inherent Anticipation: Defendants allege that the asserted claims of the '364 patent are inherently anticipated under 35 U.S.C. §

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