Biovail Corp International v. Galephar Inc

• Decision Date: 13 February 2001
• Citation: 239 F.3d 1297
• Parties: (Fed. Cir. 2001) BIOVAIL CORPORATION INTERNATIONAL, BIOVAIL LABORATORIES,INC., and GALEPHAR P.R., INC. LTD., Plaintiffs-Appellants, v. ANDRX PHARMACEUTICALS, INC., Defendant-Appellee. 00-1260 DECIDED:
• Court: U.S. Court of Appeals — Federal Circuit

Page 1297

239 F.3d 1297 (Fed. Cir. 2001)

BIOVAIL CORPORATION INTERNATIONAL, BIOVAIL LABORATORIES,INC., and GALEPHAR P.R., INC. LTD., Plaintiffs-Appellants, v. ANDRX PHARMACEUTICALS, INC., Defendant-Appellee.

00-1260

United States Court of Appeals for the Federal Circuit

DECIDED: February 13, 2001

Appealed from: United States District Court for the Southern District of Florida Judge William P. Dimitrouleas

Eric C. Cohen, Welsh & Katz, Ltd., of Chicago, Illinois, argued for plaintiffs-appellants. With him on the brief were A. Sidney Katz, Robert B. Breisblatt, Philip D. Segrest, Jr., and Charles R. Krikorian. Of counsel was Benedict P. Kuehne, Sale & Keuhne, P.A., of Miami, Florida.

James V. Costigan, Hedman, Gibson & Costigan, P.C., of New York, New York, argued for defendant-appellee. With him on the brief were Martin P. Endres, andAlanaB. Clement. Of counsel on the brief was Gerald J. Houlihan, Houlihan & Partners, P.A., of Miami, Florida.

Before NEWMAN, CLEVENGER, and GAJARSA, Circuit Judges.

GAJARSA, Circuit Judge.

DECISION

Biovail Corporation International, Biovail Laboratories, Inc., and Galephar P.R., Inc., Ltd. (collectively "Biovail") appeal the decision of the United States District Court for the Southern District of Florida, Biovail Corp. Int'l v. Andrx Pharm., Inc., No. 98-CV-7096 (S.D. Fla. Mar. 6, 2000), which determined after a bench trial that Andrx Pharmaceuticals, Inc. ("Andrx") does not infringe United States Patent No. 5,529,791 ("the '791 patent") either literally or under the doctrine of equivalents. We affirm.

BACKGROUND

Biovail Corporation International and Biovail Laboratories, Inc. are the exclusive licensees of the '791 patent, which is owned by Galephar P.R., Inc., Ltd. The '791 patent is directed to a once-a-day drug used to treat hypertension and angina. Claim 1 is the only independent claim of the '791 patent and is the only claim at issue in this case. It reads:

1. An extended-release galenical composition of one or more pharmaceutically-acceptable salts of Diltiazem which comprises

beads containing an effective amount of one or more of said Diltiazem salts as the active ingredient,

each bead containing one or more of the Diltiazem salts and an effective amount of a wetting agent in admixture with one or more Diltiazem salts to maintain the solubility of the Diltiazem in each bead, ensuring that the solubility of the Diltiazem is unaffected by the pH of the gastrointestinal tract or other adverse conditions which the composition will meet therein,

said beads being coated with a microporous membrane comprising at least a water-soluble or water-dispersible polymer or copolymer, and a water-, acid-, and base-insoluble polymer and a pharmaceutically-acceptable adjuvant, and

wherein the wetting agent is selected from the group consisting of sugars, C12-C20 fatty acid esters of sucrose or xylose, glycerides of sucrose, fatty acid esters of polyoxyethylene, esters of fatty alcohols and polyoxyethylene, esters of sorbitan, esters of polyoxyethylene sorbitan, alcohol-polyglycide esters, glyceride-polyglycides, lecithins and a combination thereof.

U.S. Patent No. 5,529,791 (issued June 25, 1996) (emphasis and paragraphing added). Biovail markets the drug described in the '791 patent under the trade name Tiazac .

On June 22, 1998, Andrx filed an Abbreviated New Drug Application ("ANDA") with the United States Food and Drug Administration ("FDA") pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for a generic version of Tiazac . See 21 U.S.C. § 355(j) (1994). Andrx also filed a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), asserting that its ANDA product does not infringe the '791 patent and that the '791 patent is invalid.

Andrx's product comprises a bead encapsulated by a microporous membrane. This bead contains both diltiazem hydrochloride (a diltiazem salt) and sugar. Unlike Biovail's product, in Andrx's beads these components are not mixed during the manufacturing process. Rather, as produced, Andrx's bead is comprised of a sugar/starch core surrounded by a mixture of diltiazem hydrochloride, ethylcellulose, and polyvinylpyrrolidone.

On October 7, 1998, Biovail filed an action in the United States District Court for the Southern District of Florida alleging patent infringement pursuant to 35 U.S.C. § 271(e)(2)(A), which provides that it is an act of infringement to submit an application under section 505(j) of the FD&C Act for a drug claimed in a patent. Andrx denied infringing the '791 patent and counterclaimed that the '791 patent is invalid. The district court denied cross-motions for summary judgment. It subsequently held a bench trial, conducting both claim construction and infringement analyses.

The court construed the term "admixture" in claim 1 of the '791 patent to describe "two or more items [that] are commingled and interdispersed to obtain a homogeneous product." Citing expert testimony, it construed the term "wetting agent" as "any of a group of surface active agents which, when added to a liquid, cause the liquid to spread more easily over, or penetrate into, a solid surface."

The court proceeded to make several findings of fact. It determined that: "Biovail has failed to prove that an admixture between the sugar and the diltiazem [in Andrx product] forms in the body." The court found Biovail's tests unreliable and further stated: "Biovail's own tests . . . do not show that a homogeneous admixture is formed in the Andrx product."

Based on its factual findings and claim construction, the district court determined that Andrx's product did not literally infringe the '791 patent. It also found that Biovail amended its claims during prosecution to "exclude a sugar core not in admixture with the diltiazem . . . in response to a prior art rejection." Therefore, the district court concluded that "Biovail is estopped from asserting that the inert sugar core of the Andrx formulation is a 'wetting agent' within the scope of the claims of the '791 patent" and consequently held that such prosecution history estoppel "operates as a complete bar to infringement by [the] doctrine of equivalents."

DISCUSSION

A. Standard of Review

Claim construction is a matter of law that this court reviews de novo. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979, 34 USPQ2d 1321, 1329 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). Literal infringement is a question of fact that we review under the clearly erroneous standard. Amhil Enters. Ltd. V. Wawa, Inc., 81 F.3d 1554, 1562, 38 USPQ2d 1471, 1476 (Fed. Cir. 1996). "A 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." Id. at 1562, 38 USPQ2d at 1476 (quoting United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948)). Prosecution history estoppel is a legal question subject to denovo review on appeal to this court. Cybor Corp. v. FAS Techs. Inc., 138 F.3d 1448, 1460, 46 USPQ2d 1169, 1178 (Fed. Cir. 1998) (en banc). Infringement under the doctrine of equivalents is a factual finding reviewed for clear error. Ryco, Inc v. Ag-Bag Corp., 857 F.2d 1418, 1426, 8 USPQ2d 1323, 1329 (Fed. Cir. 1988).

B. Claim Construction

To construe a patent claim, a court first analyzes the intrinsic evidence of recorda -- the claims and written description of the patent itself, and, if in evidence, the prosecution history. Markman, 52 F.3d at 979, 34 USPQ2d at 1329. When intrinsic evidence unambiguously describes the scope of a patented invention, reliance on extrinsic evidence is improper. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583, 39 USPQ2d 1573, 1577 (Fed. Cir. 1996).

"Although words in a claim are generally given their ordinary and customary meaning, a patentee may choose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition is clearly stated in the patent specification or file history." Id. at 1582, 39 USPQ2d at 1576. Therefore, we review both the specification and the applicable prosecution history to determine whether the patentee defined claim terminology in a manner inconsistent with its ordinary meaning. Id. at 1582, 39 USPQ2d at 1577.

It is not necessary for this court to construe the term "wetting agent." That is, the outcome of this case does not hinge on whether the sugar used in the core of Andrx's product meets the "wetting agent" limitation of claim 1 of the '791 patent. ¹

This court also need not determine whether claim 1 of the '791 patent is limited to the product in its dry state or extends to the form of the product in vivo, because the outcome of this case does not turn on that issue. This case turns on whether the "admixture" limitation in claim 1 of the '791 patent must be "homogeneous." As a general proposition, a limitation that does not exist in a claim should not be read into that claim. See McCarty v. Lehigh Valley R. Co., 160 U.S. 110, 116 (1895). Neither the claims nor the specification of the '791 patent require the "admixture" to be "homogeneous." Claim language, however, must be read consistently with the totality of the patent's applicable prosecution history. Vitronics, 90 F.3d at 1582, 39 USPQ at 1577; Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 978, 52 USPQ2d 1007, 1112-13. (Fed. Cir. 1999).

The '791 patent results from a series of continuation applications stemming from Application No. 721,396 ("the '396 application"), which was filed on June 26, 1991. After multiple amendments, certain claims of the '396 application issued as claims in United States Patent No. 5,288,505 ("the '505 patent") on February 22, 1994. Biovail also filed a continuation of the '396 application on May 28, 1993 -- Application No. 68,951 ("the '951 application"). After the '951 application was rejected for, inter alia,...