Merck & Co., Inc. v. Teva Pharmaceuticals Usa

• Decision Date: 28 August 2003
• Docket Number: No. CIV.A.01-048-JJF.,CIV.A.01-048-JJF.
• Citation: Merck & Co., Inc. v. Teva Pharmaceuticals Usa, 288 F.Supp.2d 601 (D. Del. 2003)
• Court: U.S. District Court — District of Delaware
• Parties: MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. Defendant.

288 F.Supp.2d 601

MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. Defendant.

No. CIV.A.01-048-JJF.

United States District Court, D. Delaware.

August 28, 2003.

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Mary B. Graham and Maryellen Noreika, Esquires of Morris, Nichols, Arsht & Tunnell, Wilmington, DE. Of Counsel: John F. Lynch, Nicolas G. Barzoukas, and Stephen E. Edwards, Esquires of Howrey Simon Arnold & White, LLP, Houston, TX. Paul D. Matukaitis, Edward W. Murray, and Gerald M. Devlin, Jr. Esquires of Merck & Co., Whitehouse Station, NJ, for Plaintiff.

Josy W. Ingersoll, and Adam W. Poff Esquires of Young, Conaway Stargatt & Taylor, LLP, Wilmington, DE. Of Counsel: James Galbraith, Maria Luisa Palmese and William G. James, II, Esquires of Kenyon & Kenyon, New York City, for Defendant Teva Pharmaceuticals, USA, Inc.

OPINION

FARNAN, District Judge.

I. Procedural Background

Plaintiff, Merck & Co., Inc. ("Merck") is a Delaware corporation with its principal place of business in New Jersey. Defendant, Teva Pharmaceuticals USA, Inc. ("Teva") is a Delaware corporation with its principal place of business in Pennsylvania. Merck is the owner of the entire right, title and interest in United States Patent No. 5,994,329, entitled "Method for Inhibiting Bone Resorption" (the "'329 Patent"), which issued November 30, 1999, naming as inventors Anastasia G. Daifotis, Arthur C. Santora I, and John Yates. Merck filed the application for the '329 Patent on July 22, 1997. The '329 Patent is set to expire on August 14, 2018. (PTX 1).

Merck listed the '329 Patent in the Federal Drug Administration's ("FDA") publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") in connection with its 70 mg and 35 mg dosage for alendronate sodium, which Merck markets under the name "Fosamax." On October 3, 2000, Teva filed a supplement to an existing Abbreviated New Drug Application ("ANDA") seeking FDA approval to market generic versions of Merck's 70 mg alendronate sodium product for weekly administration. Included with Teva's ANDA filing were "paragraph IV" certifications (21 U.S.C. § 355(j)(2)(A)(vii)(IV)) asserting that the Patents listed in the Orange Book, including the '329 Patent, are invalid, unenforceable or would not be infringed by the commercial marketing of Teva's proposed product. Merck filed this action on January 21, 2001, alleging that Teva's filing of its supplement was an act of infringement under 35 U.S.C. § 271(e)(2)(A). Thereafter, Merck listed U.S. Patent No. 6,225,294 (the "'294 Patent") in the Orange book and Teva filed a paragraph IV certification asserting that the '294 Patent is invalid, unenforceable or would not be infringed by the commercial marketing of Teva's proposed 70 mg alendronate sodium product. On October 4, 2001, Merck filed Civil Action No. 01-675-JJF, alleging that Teva's filing of its supplemental ANDA was an act of infringement of the '294 Patent under 35 U.S.C. § 271(e)(2)(A).

Subsequently, Teva filed another supplement to its ANDA, seeking approval to market a generic version of Merck's 35 mg Fosamax product. The supplement also included a paragraph IV certification asserting that all the listed patents were invalid, unenforceable or would not be infringed by Teva's commercial marketing of its proposed product. On November 6 2001, Merck filed Civil Action No. 01-728, alleging that the filing of Teva's supplement to the ANDA was an act of infringement under 35 U.S.C. § 271(e)(2)(A). On January 14, 2002, the Court consolidated all three cases under Civil Action No. 01-048.

One of the listed patents against which Teva certified was U.S. Patent No. 4,621,077 ("the '077 Patent"), which had already been the subject of litigation between the parties in this Court (Civil Action No. 00-035-JJF) in connection with Teva's application to market alendronate sodium for daily administration. The Court entered judgment in favor of Merck in that case on December 2, 2002, and an appeal from that judgment is now pending in the United States Court of Appeals for the Federal Circuit. (D.I.123-1). The parties agreed that they will be bound in this case, with regard to issues concerning the '077 Patent, by a final decision in the prior litigation. (D.I.128). Prior to trial Merck stipulated that the only claims at issue in this litigation are claims 23 and 37 of the '329 Patent and further stipulated that it would not allege an invention date for those claims prior to July 22, 1997. (D.I.128).

Teva stipulated that if found valid and enforceable, claims 23 and 37 of the '329 Patent would be infringed by the commercial marketing of Teva's proposed 70 mg and 35 mg alendronate sodium products for weekly administration. (D.I. 109, Pretrial Order, Tab 1, ¶¶ 8-9). The issues of validity and enforceability of the '329 Patent were tried before the Court from March 4-7, 2003.

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(c) and § 1400(b). Neither jurisdiction nor venue are contested by the parties. This Opinion constitutes the Court's Findings of Fact and Conclusions of Law with respect to the issues tried before the Court.

II. The '329 Patent and Bone Biology In General

The '329 Patent discloses less-frequent-than daily administration of bisphosphonates (e.g., alendronate) to inhibit bone resorption. (D.I. 143 at 8). Claims 23 and 37, the only asserted claims, relate specifically to the treatment and prevention of osteoporosis by once-weekly administration of alendronate. Osteoporosis is related to processes that are imbalanced in bone, and therefore, the Court will discuss the background of bone biology as it relates to osteoporosis and the use of alendronate for treatment of the disease.

Bone is the tissue that provides mechanical support to the body. It is made up of a protein matrix, which is overlaid with mineral to give it hardness. (Russell¹ at 108-109; DTX 523 at 2). Two principal types of cells maintain bone: 1) osteoclasts, which break down bone, and 2) osteoblasts, which build new bone. Id. The process of bone destruction and rebuilding is known as "remodeling." In the bone remodeling process, osteoclasts attach to the bone surface, become activated, and erode away the bone material beneath them, leaving defects in the bone structure. The destruction of bone by osteoclasts is called bone "resorption." Osteoblasts then attach to the eroded surface of these defects, lay down new bone, and then become inactive. In the normal healthy adult the remodeling process is balanced. In other words, bone is destroyed and built at the same rate. (Russell at 109-110; DTX 523 at 3-4).

In osteoporosis, bone destruction and formation are no longer balanced and bone is destroyed faster than it is replaced. Therefore, osteoporosis can lead to bone that is thinner, weaker, more fragile and porous. (Russell at 110-115; DTX 523 at 7, 8). Osteoporosis is treated primarily by inhibiting bone resorption-thus restoring the balance between bone destruction and formation. Alendronate inhibits bone resorption by blocking the bone destroying effects of osteoclasts. (Russell at 116-117). A small portion of the ingested drug makes its way to and adheres to the bone surface, where it resides until it is taken up by osteoclasts. The alendronate then inhibits the osteoclasts from resorbing bone. (Russell at 121-122; DTX 523 at 10).

Paget's disease is also a common bone disease characterized by increased bone resorption. In Paget's disease, increased bone remodeling occurs in localized areas of the skeleton. If Paget's disease is not detected and treated early it can lead to an increase in bone size, fractures, and deformity. (Russell at 97). Like osteoporosis, Paget's disease is treated by inhibiting bone resorption with alendronate. (Russell at 125-126).

III. Teva's Motion in Limine to Preclude Merck From Relitigating the Factual Findings Underlying the Decision in Teva Pharmaceuticals Ltd. et al. v. Instituto Gentili Spa et al. (D.I.113).

Teva filed a Motion in Limine to Preclude Merck from Relitigating the Factual Findings Underlying the Decision in Teva Pharmaceuticals Ltd et al. Istituto Gentili Spa et al., (High Court of Justice, Chancery Division, Patents Court, January 21, 2003)). (D.I.113). Accordingly, the Court will discuss the motion in limine before it delves into the issues of validity and enforceability of the '329 Patent.

Teva's principal defense in this case is that claims 23 and 37 are invalid because the claimed invention is anticipated or would have been obvious in view of the prior art. At the same time that the parties were litigating the validity of the '329 Patent in this Court, they were also involved in a case in the British High Court of Justice (the "High Court"). That case was a challenge by Teva and others to the validity of the European Patent No. 998,292 (the "'292 Patent"), which corresponds to the '329 Patent, and is based on the same provisional applications filed in July 1997. Teva, by its motion, contends that the '292 Patent covers the identical concept as the '329 Patent: the once-weekly dosing of alendronate sodium to treat osteoporosis, using seven times the normal daily dose.²

The High Court conducted a full trial on the merits from November 5-8, 2002, and heard further arguments from counsel on November 12-13, 2002. The trial involved live testimony from Merck's expert Dr. Socrates Papapoulos, who is Merck's expert in this case. In addition, Merck offered the testimony of Dr. Yates, the principal inventor of the '329 Patent, who also testified in this case. On January 22, 2003, Justice Jacob of the High Court found that the claimed invention was invalid because it would have been obvious to a person skilled in the art, it claims a method of treatment, and is incapable of...