Purdue Pharm. Prods. L.P. v. Actavis Elizabeth LLC

• Decision Date: 27 March 2015
• Docket Number: Civil Action No. 12-5311 (JLL) (JAD)
• Court: U.S. District Court — District of New Jersey
• Parties: PURDUE PHARMACEUTICAL PRODUCTS L.P. et al., Plaintiffs, v. ACTAVIS ELIZABETH LLC, et al., Defendants.

PURDUE PHARMACEUTICAL PRODUCTS L.P. et al., Plaintiffs, v. ACTAVIS ELIZABETH LLC, et al., Defendants.

Civil Action No. 12-5311 (JLL) (JAD)

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

March 27, 2015

NOT FOR PUBLICATION

OPINION

LINARES, District Judge.

This case involves the issues of infringement and validity of three patents covering Plaintiffs' product Intermezzo®. Intermezzo® is a drug manufactured for the treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep. After careful consideration of the evidence presented at a bench trial held December 1 -15, 2014, the Court finds as follows: As to the '131 patent, Defendants have met their burden of proving this patent is invalid as obvious, but failed to prove that the claim element "without residual sedative effects" is invalid as indefinite. Plaintiffs have proved by a preponderance of the evidence that the asserted claims of the '131 patent are infringed by all Defendants. As to the '628 patent, Plaintiffs have failed to meet their burden of proving infringement as to Defendants, DRL and Actavis. Plaintiffs, however, have met their burden of proving that Novel infringes the '628 patent. While Defendants have failed to prove this patent is invalid as anticipated, the '628 patent is invalid as obvious. As to the '809 patent, Plaintiffs have met their burden of proving infringement as toDefendants, DRL and Novel. Defendants, on the other hand, have proved by clear and convincing evidence that the '809 patent is obvious and therefore invalid. This Opinion articulates the basis for each of these conclusions.

INTRODUCTION

This is an infringement action brought by Plaintiffs relating to the patents covering Intermezzo®. This action was commenced as a result of Defendants each filing an Abbreviated New Drug Application ("ANDA") pursuant to the Hatch-Waxman Act, seeking FDA approval to sell a generic version of Intermezzo® prior to the expiration of the relevant patents. This Court has subject matter jurisdiction over this action under 28 U.S.C. §§ 1331 and 1338(a). No party contests personal jurisdiction or venue for the purposes of this civil action.

BACKGROUND¹

I. The Parties

Plaintiffs, Purdue Pharma L.P., and Purdue Pharmaceutical Products L.P., are the current holders of New Drug Application No. 022328, for sublingual tablets containing 1.75 mg and 3.5 mg of zolpidem tartrate. These Plaintiffs market the approved drug under the tradename Intermezzo®. Plaintiff, Transcept Pharmaceuticals, Inc., ("Transcept"), is the owner of the relevant patents where Purdue Pharma L.P., and Purdue Pharmaceutical Products L.P.² are exclusive licensees under these patents. Plaintiffs offer that Transcept is currently known as "Paratek Pharmaceuticals, Inc." (See e.g. Pls.' Proposed Findings of Fact, ("PFOF") ¶42). TheCourt, however, for purposes of this Opinion, refers to the named assignee of the patents-in-suit as "Transcept."

While there are five Defendants in this action, two of said Defendants, Par Pharmaceutical, Inc. (hereinafter "Par"), and TWi Pharmaceuticals, Inc. (hereinafter "TWi"), entered into stipulations wherein both agreed to be bound by the outcome of the trial without them actually participating. That is, TWi "agree[s] to be bound by the Final Judgment ... including any related injunctions, of the District Court in the Intermezzo Action resolving all claims and counterclaims of infringement, validity and enforceability of the '131 patent following litigation on the merits." (Stipulation, ECF No. 332, ¶4). Similarly, Par, "agree[s] to be bound by the Final Judgment ... including any related injunctions, of the District Court in the Intermezzo Action resolving all claims and counterclaims of infringement, validity and enforceability of the '131 and '809 patents following litigation on the merits." (Stipulation, ECF No. 323, ¶3). Both TWi and Par stipulated to personal jurisdiction for purposes of this action. The remaining Defendants in this action are Actavis Elizabeth, LLC (hereinafter "Actavis"), Dr. Reddy's Laboratories, Inc., and Dr. Reddy's Laboratories, LTD, (hereinafter collectively "Dr. Reddy's" or "DRL"), and Novel Laboratories, Inc., (hereinafter "Novel").

II. Intermezzo and the Patents-in-Suit

Intermezzo® is a drug manufactured for the treatment of insomnia when middle-of-the-night (or "MOTN") awakening is followed by difficulty returning to sleep. (PTX-225 at 1). Intermezzo® is intended for use only if the patient has four hours or more remaining before the planned time of waking. Intermezzo® is in the form of a tablet that is placed under the tongue to disintegrate. This formulation is for transmucosal absorption. The three relevant patents at issuecovering Intermezzo are U.S. Patent No. 8,242,131 (the "'131 patent"), U.S. Patent No. 7,682,628 (the "'628 patent"), and U.S. Patent No. 8,525,809 (the "'809 patent"). Nikhilesh N. Singh is the sole named inventor of each of the three relevant patents, except regarding the '131 patent only, where Sathasivan Indiran Pather is named as a co-inventor.

The '809 patent is a patent indicated for the treatment of MOTN insomnia. The '131 patent is directed to a method of treating MOTN insomnia where the '628 patent is directed to a method of treating insomnia. The '131 Patent is entitled "Methods of Treating Middle-of-the-Night Insomnia" and was issued by the PTO on August 14, 2012. The '628 Patent is entitled "Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof" and was issued by the United States Patent and Trademark Office ("PTO") on March 23, 2010. The '809 Patent is entitled "Compositions for Treating Insomnia" and was issued by the PTO on August 28, 2012. The priority dates are: 1) for the '628 Patent, February 17, 2004; 2) for the '131 Patent, May 25, 2005; and 3) for the '809 Patent, May 25, 2005.

III. The Claims at Issue and Relevant Markman Construction

A. Claims of the '131 Patent

Plaintiffs claim all Defendants will induce infringement of Claims 8, 10, 18 and 19 of the '131 patent. Because Claims 1 and 12 of the '131 patent are independent claims, and therefore Claims 8, 10, 18, and 19 depend therefrom, a detailed analysis of Claims 1 and 12 is applicable to the infringement and validity inquiries. Claims 1 and 12 are distinct insofar as Claim 1 applies to non-elderly patients and Claim 12 applies to elderly patients. Defendants argue that that the claims of the '131 patent are obvious. Defendants also argue that limitation found in Claims 1 and 12, namely, "without residual sedative effects" is indefinite. These claims state the following:

Claim 1: A method of treating middle-of-the night insomnia in a non-elderly patient without prophylactically administering zolpidem, comprising: dosing the patient with a pharmaceutical composition comprising about 0.5 to about 4.75 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects.

Claim 12: A method of treating middle-of-the-night insomnia in an elderly patient without prophylactically administering zolpidem, comprising dosing the patient with a pharmaceutical composition comprising about 1.5 to 2.5 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects.

This Court construed "without residual sedative effects" to mean "with no or minimal subjective feelings of sedation, as evaluated by: (a) testing acceptably in at least one test exploring psychomotor performance, attention, information processing, and memory used by those of skill in the art; and/or (b) demonstrating plasma levels of zolpidem, at an appropriate time point, below about 20 ng/ml." (Opinion, ECF No. 185 at 5-7). A list of appropriate psychomotor performance, attention, information processing, and memory used by those of skill in the art are exemplified in the patent specification.

Claim 8 depends from Claim 1 and is substantially identical to such except it refers to the 3.5mg dose. (JTX 1, Claim 8). Claim 10 of the '131 Patent recites: "The method of claim 8, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa." (JTX 1, Claim 10). Claim 18 depends from Claim 12 and is substantially identical to such except it refers to the 1.75mg dose. Claim 19 of the '131 Patent recites: "The method of Claim 18, wherein the pharmaceutical composition provides delivery of zolpidem across the patient's oral mucosa."

B. Claims of the '628 Patent

Plaintiffs claim Defendants will induce infringement of Claims 9, 16 and 17 of the '628 patent. The '628 patent contains an independent Claim 1 which states the following:

Claim 1: A method for treating insomnia, comprising the steps of: administering a solid pharmaceutical composition comprising zolpidem or a pharmaceutically acceptable salt thereof to a subject prone to insomnia, the pharmaceutical composition further comprising a buffer, wherein the buffer raises the pH of saliva to a pH of about 7.8 or greater, wherein zolpidem is absorbed across a permeable membrane of the

...