Merck & Co. v. Teva Pharmaceuticals Usa

• Decision Date: 04 November 2002
• Docket Number: No. CIV.A.00-052-JJF.,No. CIV.A.00-035-JJF.,CIV.A.00-035-JJF.,CIV.A.00-052-JJF.
• Citation: 228 F.Supp.2d 480
• Parties: MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. and ZENITH GOLDLINE PHARMACEUTICALS, INC., Defendants.
• Court: U.S. District Court — District of Delaware

228 F.Supp.2d 480

MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC. and ZENITH GOLDLINE PHARMACEUTICALS, INC., Defendants.

No. CIV.A.00-035-JJF.

No. CIV.A.00-052-JJF.

United States District Court, D. Delaware.

November 4, 2002.

COPYRIGHT MATERIAL OMITTED

Mary B. Graham and Maryellen Noreika, Esquires of Morris, Nichols, Arsht & Tunnell, Wilmington, DE, Howrey Simon Arnold & White, LLP, Houston, TX (John F. Lynch, Nicolas G. Barzoukas, Scott Garber and Marianna Burris, of counsel), Paul D. Matukaitis, Elizabeth A Giuliani, Esquires of Merck & Co., Whitehouse Station, NJ, for the Plaintiff.

Josy W. Ingersoll, Esquire of Young, Conaway Stargatt & Taylor, LLP, Wilmington, DE, Kenyon & Kenyon, New York, NY (James Galbraith, Maria Luisa Palmese and William G. James, II, of counsel), for Defendant Teva Pharmaceuticals, USA, Inc.

Harold Pezzner, Esquire of Connolly, Bove, Lodge & Hutz, Wilmington, DE, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, Westfield, NJ (William L. Mentlik, Stephen F. Roth, of counsel), for Defendant Zenith Goldline Pharmaceuticals, Inc.

MEMORANDUM OPINION

FARNAN, District Judge.

INTRODUCTION

This action was filed by Merck & Co., Inc. ("Merck") against Teva Pharmaceuticals USA, Inc. ("Teva"), and Zenith Goldline Pharmaceuticals, Inc. ("Zenith") (collectively, "Defendants") for infringement of U.S. Patent Number 4,621,077 (" '077 Patent"). Merck originally filed two separate actions against Teva and Zenith; however, the Court consolidated these actions on April 10, 2000. (D.I.17). The original claims alleged infringement of United States Patent Nos.: 4,621,077, 5,804,570, 5,358,941, 5,681,590, 5,849,726, and 6,008,207. (D.I.1, D.I.19, D.I.32). By stipulations signed by the Court on April 19, 2001, Merck dismissed all claims in the consolidated case except for infringement of the '077 Patent (D.I.53, 54). Additionally, at the September 6, 2001, pretrial conference, Merck confirmed that it would not pursue its claim of willful infringement with respect to the '077 Patent. (D.I.80).

The '077 Patent issued November 4, 1986, lists Sergio Rosini and Giorgio Staibano as inventors and is assigned to Instituto Gentili S.p.A., ("Gentili") an Italian Company. (D.I. 108 at 4). Merck is now the owner of the '077 Patent. (D.I. 108 at 4). The '077 Patent discloses and claims a method for treating urolithiasis and inhibiting bone reabsorption by administering 4-amino-1-hydroxybutane-1, 1-biphosphonic acid. Merck contends that Defendants' filing of an Abbreviated New Drug Application (ANDA) under section 505(j) of the Federal Food, Drug and Cosmetic Act, seeking approval to market tablets containing (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate before the expiration of the '077 Patent, literally infringes claim 1 of the '077 Patent. Alternatively, Merck contends that there is infringement under the doctrine of equivalents.

Defendants contend that Merck has not established that they infringe the '077 Patent. Specifically, Defendants contend that they do not infringe claim 1 of the '077 Patent because the claim requires the administration of alendronic acid and the use of Defendants' proposed product does not. Additionally, Defendants contend that their products have a substantial noninfringing use because they do not propose their products for the treatment of urolithiasis. Defendants also raise counterclaim and affirmative defenses. Specifically, Defendants allege that the '077 Patent is invalid on grounds of obviousness and anticipation and that the patent term extension is invalid.

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.

The Court conducted a four day bench trial in this action. This Memorandum Opinion constitutes the Court's findings of fact and conclusions of law.

BACKGROUND

I. The '077 Patent and Osteoporosis Generally

A. Osteoporosis

Osteoporosis is caused by an imbalance in the body's natural process of destroying (or resorbing) old bone, and laying down new bone in its place. (See Tr 69:16-71:5; PDX 8-9; D.I. 109 at 2). As people age, the resorption of bone remains active, but the cells for laying down new bone ("osteoblasts") begin to slow, so that not all the bone that is resorbed is replaced. Over an extended period, this imbalance can result in bones that are thin, brittle and prone to fracture. (See Tr 69:16-71:5; PDX 8-9; D.I. 109 at 2)

B. The Prosecution History of the '077 Patent

The initial application for the '077 Patent was filed on June 8, 1984. (DTX 2, Tab 1 at 38-39; D.I. 108 at 11). There were originally thirteen claims listed in the application. (DTX 2, Tab 1 at 38-39). The claims were rejected by the examiner pursuant to 35 U.S.C. § 112, for using language unwarranted by the specification and for indefiniteness. (DTX 2 Tab 5 at 2-5). Additionally, the claims were rejected under 35 U.S.C. § 102(b) as anticipated. Id. As a result, the patentee ("Gentili") deleted claims 1-13 and added claim 14 which stated:

A pharmaceutical composition useful for the treatment of urolithiasis and for inhibiting bone reabsorption, in unit dose form, which contains as the active ingredient 4-amino-1-hydroxybutan-1, 1-biphosphonic acid in the amount of 0.5-1.0 mg. per unit dose.

(DTX2 Tab 7 at 1). The examiner rejected this claim under 35 U.S.C. § 103 as obvious in light of prior relevant art. (DTX 2, Tab 9 at 2-4). Additionally, the examiner noted that "method claims using the specific compound set forth in claim 14 would be favorably considered." (DTX 2, Tab 10). Gentili, following the examiner's recommendation, then submitted only 1 method claim for the '077 Patent, which was approved by the examiner. (DTX 2, Tab 11).

C. Merck's Purchase of the '077 Patent

In the early 1980s, Merck formed a Bone Research Section in order to research osteoporosis and new drug therapies for the disease. (Tr. 68:1-69:10; D.I 109 at 2). Dr. Gideon Rodan was brought into Merck to lead the Section. Id. Dr. Rodan invited Dr. Herbert Fleisch, a researcher of bisphosphonates, to speak about the use of bisphosphonates for the treatment of bone diseases. (Tr. 88:1-89:12; D.I. 109 at 3). During his visit, Dr. Fleisch discussed with Dr. Rodan research by Sergio Rosini, a scientist at Instituto Gentili, in Pisa Italy involving the compound 4-amino-1-hydroxybutylidene bisphosphonate (later named "alendronate") which was a potential therapy for bone resorption. (Tr. 88:1-22; D.I. 109 at 3). Merck contends that, at the time of Dr. Fleisch's visit, experts in the field of treating bone diseases were skeptical about the use of bisphosphonates. (D.I. 109 at 3). Dr. Fleisch tested a compound called alendronate, a member of the bisphosphonate family, which Merck contends showed great and unexpected potential as treatment for osteoporosis and other bone resorption diseases. (D.I. 109 at 3). Subsequently, Dr. Rodan contacted Dr. Rosini at the Instituto Gentili and began the process of licensing and later purchasing the '077 Patent. (Tr. 90:4-5; D.I. 109 at 3).

In 1988, Merck filed a New Drug Application ("NDA") with the FDA seeking approval to market alendronate¹ sodium tablets, which were trademarked as Fosomax®. (Tr. 93:9-94:15; D.I. 109 at 120). Merck received approval to market Fosomax® in 1995. Id. Additionally, in 1995 Merck applied for and received a patent term extension of approximately three and a half years that was added to the original term of the '077 Patent. (PTX 2 at 244-45; D.I. 109 at 13). When the Patent and Trademark Office ("PTO") granted the term extension, it found that Fosomax® was covered by claim 1 of the '077 Patent. (PTX 2, at 242-43; PDX 33, 35; D.I. 109 at 13). The primary ingredient in Fosomax® is 4-amino-1-hydroxybutylidene bisphosphonic acid monsosodium salt trihydrate, a sodium salt of alendronate. (PTX 86; D.I. 109 at 13). Fosomax® is approved for use in the prevention and treatment of osteoporosis and Paget's disease. Id. The '077 Patent is set to expire on August 6, 2007. (D.I. 109 at 1).

II. The Accused Product-Defendants' Generic Version of Fosomax®

Teva and Zenith filed ANDA's with the FDA for approval to market generic forms of Merck's product, Fosomax®, on September 29, 1999. (DTX 104; DTX 103; D.I. 108 at 2). Defendants also challenged certain patents that Merck had listed in the FDA's "Orange Book" as covering Fosomax® or its use. (DTX 103; PTX 6; D.I. 108 at 2). Defendants then notified Merck of their ANDA filings. Id.

On January, 19, 2000, within the forty-five day statutory period, Merck filed a complaint against Teva alleging willful infringement of several patents, including the '077 Patent due to their ANDA filings (D.I.1). Merck also filed a similar complaint against Zenith. (D.I.18). However, as previously discussed, the two cases were consolidated and all claims except for infringement of the '077 Patent were dismissed. (D.I. 53, D.I. 54, D.I. 80; D.I. 17). The filing of Merck's complaints triggered the thirty month stay period during which the FDA cannot approve the Defendants' applications. This period will expire on March 29, 2003. (D.I. 108 at 2).

Both Defendants have the same active ingredient in their respective products which is a chemical compound called "alendronate monosodium salt trihydrate" or "(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate" which is sometimes abbreviated as "alendronate sodium" or "alendronate sodium trihydrate." ( DTX 92-95; 104, 105, 192, 204, 205 at ZA-012682, 206, 208, 209; D.I. 108 at 3). Defendants propose to market their respective products for: 1) the treatment of osteoporosis; 2) the prevention of osteoporosis; and 3) the treatment of Paget's disease of the bone. (DTX 192 at 39-40; DTX 204 at ZA-002927-29; D.I. 108 at 3).

DISCUSSION

I. INFRINGEMENT

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