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

• Decision Date: 30 October 2003
• Docket Number: No. 03-1168.,03-1168.
• Citation: 347 F.3d 1367
• Parties: MERCK & CO., INC., Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant, and Zenith Goldline Pharmaceuticals, Inc., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

347 F.3d 1367

MERCK & CO., INC., Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant, and Zenith Goldline Pharmaceuticals, Inc., Defendant-Appellant.

No. 03-1168.

United States Court of Appeals, Federal Circuit.

Decided October 30, 2003.

Rehearing and Rehearing En Banc Denied December 29, 2003^*.

John F. Lynch, Howrey Simon Arnold & White, LLP, of Houston, Texas, argued for plaintiff-appellee. With him on the brief were Nicolas G. Barzoukas, Richard L. Stanley, and Scott J. Garber. Of counsel on the brief were Paul D. Matukaitis, Edward W. Murray, and Gerard M. Devlin, Merck & Co., Inc., of Rahway, New Jersey.

James Galbraith, Kenyon & Kenyon, of New York, New York, argued for defendant-appellant Teva Pharmaceuticals USA, Inc. With him on the brief were Maria Luisa Palmese and William G. James, II. William L. Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, argued for defendant-appellant Zenith Goldline Pharmaceuticals, Inc. With him on the brief was Stephen F. Roth.

Before MAYER, Chief Judge, NEWMAN and PROST, Circuit Judges.

Opinion of the Court filed by Circuit Judge PAULINE NEWMAN. Dissent by opinion filed by Chief Judge MAYER.

PAULINE NEWMAN, Circuit Judge.

Teva Pharmaceuticals USA, Inc., and Zenith Goldline Pharmaceuticals, Inc., (collectively "Teva") appeal the judgment of the United States District Court for the District of Delaware, ruling that Teva infringes United States Patent No. 4,621,077 ("the '077 patent") owned by Merck & Co., and that the patent is not invalid.¹ We affirm the judgment.

Standard of Review

We review a district court's judgment, following a bench trial, to determine whether there were errors of law or clearly erroneous findings of fact. Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1343-44 (Fed.Cir.2002); Manville Sales Corp. v. Paramount Sys. Inc., 917 F.2d 544, 549 (Fed.Cir.1990).

In determination of patent infringement, as the first step the claims are construed; then, the construed claims are compared to the alleged infringing device. Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1323 (Fed.Cir.2002). Claim construction is a matter of law, and receives plenary review on appeal. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456 (Fed.Cir.1998) (en banc). Anticipation is a question of fact, and after a bench trial is reviewed under the clearly erroneous standard. Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed.Cir.1984). A factual finding is clearly erroneous when "although there is evidence to support it, the reviewing court on the entire evidence is left with the definite and firm conviction that a mistake has been committed." United States v. U.S. Gypsum Co., 333 U.S. 364, 395, 68 S.Ct. 525, 92 L.Ed. 746 (1948).

DISCUSSION

Merck acquired the '077 patent from its original owner Istituto Gentili, S.p.A. The patent issued on November 4, 1986. Its term has been extended for 1,371 days, measured as a portion of the time consumed by regulatory review and approval by the Food and Drug Administration. See 35 U.S.C. § 156. The sole claim of the '077 patent is:

1. A method of treatment of urolithiasis and inhibiting bone reabsorption which consists of administering to a patient in need thereof an effective amount of 4-amino-1-hydroxybutane-1,1-biphosphonic acid.

The product has been given the common name alendronic acid.

Merck's product, marketed under the brand name Fosamax®, is 4-amino-1-hydroxybutane-1,1-biphosphonic acid monosodium salt trihydrate, also called alendronate salt. In September of 1995 Merck received Food and Drug Administration approval to market Fosamax ® for treatment of osteoporosis and Paget's disease. Teva, a generic drug manufacturer, filed an abbreviated new drug application (ANDA) to sell a generic version of Fosamax®. Merck duly sued Teva in accordance with 35 U.S.C. § 271(e)(2). Teva's defense was that the '077 patent is invalid or not infringed, and alternatively that Merck is not entitled to any extension of the patent term because the approved product is not the acid but the monosodium salt. Teva stated that it did not literally infringe because the claim requires 4-amino-1-hydroxybutane-1,1-biphosphonic acid and Teva's ANDA is for the monosodium salt. Teva also raised the defense that United States Patent No. 4,407,761 to Helmut Blum et al. anticipates the claim.

I INFRINGEMENT

The district court ruled that the claim is infringed by Teva's product. The court found that the claimed method whereby 4-amino-1-hydroxybutane-1,1-biphosphonic acid is used to treat urolithiasis and bone reabsorption disorders (such as osteoporosis) is infringed by administration of the acid salt. The therapeutic agent of the claim is 4-amino-1-hydroxybutane-1,1-biphosphonic acid, whose application is exemplified in the specification in formulations that include the salt and admixtures of the biphosphonic acid with a salt-forming material. The patent refers to formulation of various biphosphonic acids for administration "as the sodium salt," "in the salt form," "in the form of Na salt," and as "4-amino-1-hydroxybutan-1,1-biphosphonic acid, sodium salt."

Specification Table 6 is headed: "Some typical pharmaceutical formulations containing amino-butan-diphosphonic acid," and shows the diphosphonic acid formulated in three ways: (1) as "opercolated capsules" containing "4-amino-1-hydroxybutan-1,1-biphosphonic acid, sodium salt"; (2) as "effervescent granulates" where the formulation includes 4-amino-1-hydroxybutan-1,1-biphosphonic acid, sodium carbonate, and sodium bicarbonate; and (3) "formulations suitable for injection" where the ingredients include 4-amino-1-hydroxybutan-1,1-biphosphonic acid and sodium hydroxide. The witnesses qualified in the field of the invention testified that a pharmacologist of ordinary skill in the field would understand that the active agent is 4-amino-1-hydroxybutane-1,1-biphosphonic acid, and that the method of treatment of bone disorders includes use of the active agent in the form of the salt.

This usage is clearly presented in the specification. In addition to the formulations in Table 6, patent Tables 7 and 8 compare the potency of various biphosphonates that are listed as the acids "in the form of" the salt, and the specification describes various biphosphonic acids "in the form of" the salt; e.g.:

difluoromethanebiphosphonic acid in the form of the Na salt

dichloromethanebiphosphonic acid in the form of the sodium salt

'077 patent, col. 9, lines 26-51. The specification describes the unusually high activity of 4-amino-1-hydroxybutane-1,1-biphosphonic acid in an in vivo rat model for inhibition of bone resorption, exemplified in application as the salt. The footer in Table 7 refers to the compounds as "various aminobiphosphates" and includes the compound "AHBuBP," which is defined as the biphosphonic acid here at issue, although the "phosphate" terminology generally refers to salts. Thus throughout the specification the inventors described the acid active agent as encompassing the acid and its salt forms.

In evidence were several technical publications that describe treatment with biphosphonic acids in terms that include treatment using the salt form. In an article entitled "Alendronate: A New Biphosphonate for the Treatment of Osteoporosis," the caption names the product "4-amino-1-hydroxybutylidene-1,1-bisphosphonic acid" and Figure 1 depicts the sodium salt. In an article entitled "Rationale for the Use of Alendronate in Osteoporosis," a diagram of the structure of the sodium salt is labeled both as "Alendronate" and as "4 amino 1 hydroxybutylidene 1,1 bisphosphonic acid." An article entitled "Advances in the Management of Paget's Disease of Bone" refers to three different diphosphonates by their common names, using a description encompassing the acid and salt forms: "eudronic acid (disodium eudronate)," "clodronic acid (clodronate)," and "pamidronic acid (pamidronate)." These are the same usages employed in the '077 specification.

In construing patent claims, the court must apply the same understanding as that of persons knowledgeable in the field of the invention. "Patents are written not for laymen, but for and by persons experienced in the field of the invention." Voice Techs. Group, Inc. v. VMC Sys., Inc., 164 F.3d 605, 615 (Fed.Cir.1999). See Hoechst Celanese Corp. v. B.P. Chems. Ltd., 78 F.3d 1575, 1578 (Fed.Cir.1996) ("A technical term used in a patent document is interpreted as having the meaning that it would be given by persons experienced in the field of the invention, unless it is apparent from the patent and the prosecution history that the inventor used the term with a different meaning.").

The district court found that a person skilled in the treatment of osteoporosis and urolithiasis would have a medical degree, knowledge of the methods of treatment of patients with these disorders, and knowledge of the pharmacology and usage of biphosphonates. The court determined how such persons would understand the claim in light of the specification, its prosecution history, and customary usage in the field of the invention. See Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299 (Fed.Cir.1999).

A fundamental rule of claim construction is that terms in a patent document are construed with the meaning with which they are presented in the patent document. Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1267-68 (Fed.Cir.2001); Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed.Cir.1998). Thus claims must be construed so as to be consistent with the specification, of which they are a part. Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 770 (Fed. Cir.1996); Slimfold Mfg. Co. v. Kinkead Indus. Inc., 810 F.2d 1113, 1117 (Fed.Cir. 1987).

The claim herein is directed to a method of treatment of urolithiasis and inhibiting...