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Merck & Co. v. Teva Pharms. USA, Inc.

United States Court of Appeals for the Federal Circuit

January 28, 2005, Decided



 [***1642]   [*1365]  GAJARSA, Circuit Judge.

Teva Pharmaceuticals USA, Inc. ("Teva") appeals the final judgment of the United States District Court of Delaware, which, after a bench trial, found Merck & Co.'s ("Merck") U.S. Patent No. 5,994,329 (issued  [***1643]  Nov. 30, 1999) ("the '329 patent")  [*1366]  not invalid as anticipated or obvious. The district court further found the '329 patent to be enforceable, and the '329 patent claims 23 and 37 constructively infringed by Teva's Abbreviated [**2]  New Drug Application ("ANDA") under 35 U.S.C. § 271(e)(2)(A) of the Hatch-Waxman Act. Merck & Co., Inc. v. Teva Pharms. USA, Inc., 288 F. Supp. 2d 601 (D. Del. 2003) ("Merck"); Merck & Co., Inc. v. Teva Pharms. USA, Inc., No. 01-CV-0048, Order (D. Del. Sept. 24, 2003) (Final Judgment Order Pursuant to Fed. R. Civ. P. 54(b)) ("Final Judgment Order"). 1 

We disagree with the district court's construction of the claim term "about" in claims 23 and 37 of the '329 patent. Because we further hold claims 23 and 37 obvious in light of the prior art, we vacate the judgment of the district court and hold the claims invalid and not infringed.


A. '329 Patent

Merck owns the '329 patent. The '329 patent, entitled "Me thod for Inhibiting [**3]  Bone Resorption," teaches a method of treating and preventing osteoporosis through less-than-daily administration of bisphosphonate compounds. '329 patent, col. 1, ll. 15-25. The patent was filed on August 14, 1998, and Merck stipulated at trial that it would not allege an invention date prior to July 22, 1997 for the claims at issue. Merck, 288 F. Supp. 2d at 606.

Bisphosphonates are a family of chemical compounds that are known to selectively inhibit the bone destruction process that contributes to osteoporosis and other bone diseases. '329 patent, col. 1, ll. 45-50. Bisphosphonates include, among other compounds, alendronate, risedronate, tiludronate, pamidronate, ibandronate, zolendronate, and etidronate. Id. at col. 1, ll. 54-65; col. 2, ll. 28-31. At issue in this case are once-weekly dosages of alendronate monosodium trihydrate.

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395 F.3d 1364 *; 2005 U.S. App. LEXIS 1400 **; 73 U.S.P.Q.2D (BNA) 1641 ***

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

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by Merck & Co. v. Teva Pharms. USA, Inc., 405 F.3d 1338, 2005 U.S. App. LEXIS 6814 (Fed. Cir., 2005)

US Supreme Court certiorari denied by Merck & Co. v. Teva Pharms. USA, Inc., 546 U.S. 972, 126 S. Ct. 488, 163 L. Ed. 2d 384, 2005 U.S. LEXIS 7831 (2005)

Prior History:  [**1]  Appealed from: United States District Court for the District of Delaware. Judge Joseph J. Farnan, Jr.

Merck & Co. v. Teva Pharms. USA, Inc., 288 F. Supp. 2d 601, 2003 U.S. Dist. LEXIS 15235 (D. Del., 2003)

Disposition: Reversed.


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Civil Procedure, Appeals, Standards of Review, Clearly Erroneous Review, Criminal Law & Procedure, De Novo Review, General Overview, De Novo Review, Patent Law, Nonobviousness, Evidence, Fact & Law Issues, Claims, Claim Language, Specifications, Enablement Requirement, Pleadings, Complaints, Requirements for Complaint, Description Requirement, Standards & Tests, Elements & Tests, Claimed Invention as a Whole, Reversible Errors, Ordinary Skill Standard, Prior Art, Inferences & Presumptions