Proctor & Gamble Co. v. Teva Pharmaceuticals Usa

• Decision Date: 28 February 2008
• Docket Number: Civil Action No. 04-940-JJF.
• Citation: 536 F.Supp.2d 476
• Parties: The PROCTOR & GAMBLE COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
• Court: U.S. District Court — District of Delaware

536 F.Supp.2d 476

The PROCTOR & GAMBLE COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.

Civil Action No. 04-940-JJF.

United States District Court, D. Delaware.

February 28, 2008.

COPYRIGHT MATERIAL OMITTED

William F. Lee, Esquire, David B. Bassett, Esquire, and Vinita Ferrera, Esquire of Wilmer Cutler Pickering Hale and Dorr, Boston, MA, Frederick L. Cottrell, III, Esquire, and Steven J. Fineman, Esquire of Richards, Layton & Finger, Wilmington, DE, for Plaintiff.

James Galbraith, Esquire, Maria Luisa Palmese, Esquire, and A. Antony Pfeffer, Esquire of Kenyon & Kenyon, New York, NY, Adam W. Poff, Esquire, Josy W. Ingersoll, Esquire, and Karen L. Pascale, Esquire of Young, Conaway, Stargatt & Taylor, Wilmington, DE, for Defendant.

OPINION

JOSEPH J. FARNAN, Jr., District Judge.

INTRODUCTION

This action was filed by. The Proctor & Gamble Company ("Proctor & Gamble") against Teva Pharmaceuticals USA, Inc. ("Teva"), alleging patent infringement. Proctor & Gamble's original Complaint, filed on August 13, 2004, alleged that Teva's efforts to market, a generic version of risedronate sodium infringed on United States Patent Nos. 5,588,122 ("the '122 Patent") and 6,096,342.¹ (D.I. 1.) On August 25, 2004, Proctor & Gamble amended its Complaint to limit its infringement allegations to only the '122 Patent. (D.I. 5.)

Proctor & Gamble is the owner by assignment of the '122 Patent, entitled "Pharmaceutical Compositions Containing Geminal Diphosphonates." (JTX 1.) The '122 Patent issued on December 10, 1996, eleven years after Proctor & Gamble filed a supporting application with the U.S. Patent and Trademark Office ("PTO"). The '122 Patent expires on December 10, 2013. (D.I. 1.) The claims at issue describe the compound 2-(3-pyridyl)-1-hydroxyethane diphosphonic acid ("risedronate"). (JTX 1.)

Proctor & Gamble has listed the '122 Patent in the Federal Food and Drug Administration's ("FDA") publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") in connection with 5 mg, 30 mg and 35 mg dosages of risedronate sodium, which Proctor & Gamble commercially markets as Actonel ®. (D.I. 1.) Actonel ® is marketed for the treatment and prevention of osteoporosis, and for the treatment of Paget's Disease.

By letter dated July 2, 2004, Teva notified Proctor & Gamble that it had submitted an Abbreviated New Drug Application ("ANDA"), No. 77-132, to the FDA seeking approval to manufacture, use, and market generic risedronate sodium tablets in the same doses as Actonel ® before the expiration of the '122 Patent. Included with Teva's ANDA filing was a "paragraph IV certification" (21 U.S.C. § 366(i)(2)(A)(vii)(IV)) asserting that, in Teva's opinion, the '122 Patent is invalid, unenforceable, or would not be infringed by the commercial marketing of the proposed risedronate sodium tablets. After receiving Teva's ANDA notice letter, Proctor & Gamble brought this timely action within the forty-five day statutory period, alleging patent infringement and seeking a declaration that the '122 Patent is valid and enforceable.

By stipulation signed by the Court on November 6, 2006, Proctor & Gamble declared that it would only pursue judgment with respect to claims 4, 16 and 23 of the '122 Patent. (D.I. 86.) By stipulations signed by the Court on January 27, 2006 and November 6, 2006, Teva stipulated that, for purposes of this action, the manufacture and marketing of generic risedronate sodium tablets would infringe those claims. (D.I. 63, 86.) The only remaining issue in this action is the validity of claims 4, 16, and 23 of the '122 Patent.

The Court has jurisdiction over the parties and the subject matter pursuant to 28 U.S.C. § 1338(a). Additionally, venue is appropriate under 28 U.S.C. §§ 1391 and 1400(b). Neither jurisdiction nor venue are contested by the parties. The Court conducted a bench trial from November 6, 2006 to November 9, 2006. This Memorandum Opinion constitutes the Court's findings of fact and conclusions of law on the issues raised during trial.

II. The Parties Contentions

Teva challenges the validity of the '122 patent on the basis of obviousness under 35 U.S.C. § 103. In particular, Teva contends that the '122 patent is obvious in light of U.S. Patent 4,761,406, entitled "Regiment for Treating Osteoporosis" (the "`406 Patent"). In the alternative, Teva contends that the '122 Patent is invalid for obviousness-type double patenting. Specifically, Teva contends that the structural similarities between risedronate and 2-pyr EHDP render the relevant claims of the '122 patent patentably indistinct from claim 15 of the '406 patent.

In response, Proctor & Gamble contends that the '122 patent is not invalid, because at the time risedronate was invented, the idea of synthesizing that compound was not obvious to a person of ordinary skill in the art. Proctor & Gamble also contends that the '406 patent is not properly considered prior art for purposes of Teva's invalidity arguments, and in any event, the '406 patent claims subject matter, different than that claimed in the '122 patent.

SUMMARY OF THE EVIDENCE ADDUCED AT TRIAL

I. Teva Witnesses

A. Dr. George P. Lenz

1. Background

Doctor George R. Lenz has over forty years of experience in medicinal chemistry. He received, a Bachelor of Science degree in Chemistry from the Illinois Institute of Technology in 1963. Dr. Lenz attended the University of Chicago, receiving a Master of Science in Physical Science, with a chemistry emphasis, in 1965, and a Ph.D. in Organic Chemistry in 1967. These degrees were followed by fellowships at the Yale University National Cancer Institute and the University of Geneva (Switzerland). Currently Dr. Lenz heads GRLEN R & D Associates, a company which provides consulting services in medicinal chemistry as well as drug discovery and development assistance to small companies interested in small molecules. His appearance at this trial was his first appearance as a retained expert witness.

2. Opinion

Dr. Lenz opined that the '406 Patent describes general bisphosphonates, and in so doing, reveals 2-pyr EHDP as the most potent of the compounds listed therein. (Lenz 88, 90.) With respect to the '122 patent, Dr. Lenz understood the subject matter to be the use of bisphosphonate compositions in treating abnormal calcium and phosphate metabolism. (Lenz 68.)

To Dr. Lenz a person of ordinary skill in the art for purposes of an obviousness inquiry would have a Ph.D. in chemistry, several years of experience in the pharmaceutical industry, experience with drug discovery and design, and particularized experience interpreting activity and toxicity results of new compounds. (Lenz 77-79.) He did not believe that a person of ordinary skill in the art would need to be an organaphosphorous chemistry specialist. (Id.) Rather, he testified, that the person should be a medicinal chemist with bisphosphonate knowledge and experience.

Even by his own definition, Dr. Lenz admitted he was not a person of ordinary skill in the art in the mid-1980s. (Lenz 203.) Until preparing for the present case, Dr. Lenz had no specialized experience in the area of bisphosphonates. (Lenz 154, 203.) He has never synthesized bisphosphonates, and until Teva retained him for this case, he was unfamiliar with the structural mechanics of bisphosphonates, and the tests used to interpret their activity and toxicity. (Lenz 154-166, 176.)

However, Dr. Lenz believed that in preparing for this trial he, had acquired enough contemporary knowledge to retrospectively understand what a medicinal chemist would have known about bisphosphonates in the mid-1980s. (Lenz 203.) Dr. Lent thought he was qualified to Make this assessment after comparing the disputed patent claims, reviewing the available literature regarding what knowledge medicinal chemists familiar with bisphosphonates would have had in the mid-1980s, reviewing patents for other drugs with pyridyl rings, and applying his own medicinal chemistry experience. (Lenz 95,)

With the above knowledge and qualifications, Dr. Lenz opined that risedronate would have been obvious to medicinal chemists in the mid-1980s. He testified that the job of a medicinal chemist is to dissect molecules, identify their molecular components, and rearrange or substitute each molecular component, with the goal of creating new compounds with optimal properties. (Lenz 71.) Dr. Lenz opined that medicinal chemists, when working with bisphosphonates as a class, would try to make structural alterations to the tails of `compounds while preserving the bone lividity inherent in the head. (Lenz 72:16-20.) The result of this routine practice, when applied to a hydroxyethane bisphosphonate, would be that a medicinal chemist would, "upon seeing one active compound with a [pyridyl ring], would automatically make the other two positional isomers, having a strong expectation of success in having similar activities." (Lenz 105:8-12.) According to Dr. Lenz, synthesis of the additional isomers would only require minor alterations, and would be obvious given the expectation that the isomers would have at least some activity. (Lenz 97.) To support this conclusion, Dr. Lenz referred to eight other patents covering drugs marketed in 1985 that had pyridyl rings. Each drug was patented, and each patent claimed the active drug and at least one other positional isomer. (Lenz 98-105.) Thus, in light of the propensities of medicinal chemists, the presence of a pyridyl ring in compounds at issue, and the pattern of other inventors claiming multiple positional isomers in other patents available at the time, Dr. Lenz concluded that a medicinal chemist aware of 2-pyr EHDP from the '406 patent would have found risedronate to be an obvious modification with a reasonable expectation of success and few surprising differences from its other isomers. (Lenz 95-97, 120.)

Dr. Lenz's expert opinion regarding the obviousness of the '122 Patent...