Astrazeneca Ab v. Mutual Pharmaceutical

• Decision Date: 30 September 2004
• Docket Number: No. 04-1100.,04-1100.
• Citation: 384 F.3d 1333
• Parties: ASTRAZENECA AB, AKTIEBOLAGET HASSLE, KBI-E, INC., KBI, Inc., and Astrazeneca LP, Plaintiffs-Appellees, v. MUTUAL PHARMACEUTICAL COMPANY, INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

384 F.3d 1333

ASTRAZENECA AB, AKTIEBOLAGET HASSLE, KBI-E, INC., KBI, Inc., and Astrazeneca LP, Plaintiffs-Appellees, v. MUTUAL PHARMACEUTICAL COMPANY, INC., Defendant-Appellant.

No. 04-1100.

United States Court of Appeals, Federal Circuit.

DECIDED: September 30, 2004.

Appeal from the United States District Court for the Eastern District of Pennsylvania, Michael M. Baylson, J Lisa B. Pensabene, Fitzpatrick, Cella, Harper & Scinto, of New York, NY, argued for plaintiffs-appellees. With her on the brief were Michael P. McGraw and Christopher P. Borello.

H. Michael Hartmann, Leydig, Voit & Mayer, Ltd., of Chicago, IL, argued for defendant-appellant. With him on the brief were Robert F. Green, Christopher T. Griffith and Paul J. Filbin.

Before MICHEL, Circuit Judge, ARCHER, Senior Circuit Judge, and BRYSON, Circuit Judge.

MICHEL, Circuit Judge.

Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP (collectively, "Astrazeneca") sued Mutual Pharmaceutical Co., Inc. ("Mutual") pursuant to 35 U.S.C. § 271(e)(2), under which it is an "act of infringement" to submit an Abbreviated New Drug Application ("ANDA") to the Food and Drug Administration ("FDA") to obtain approval to market a drug that is claimed in a nonexpired patent. Astrazeneca alleged that Mutual infringed U.S. Patent No. 4,803,081 (the "'081 patent"), titled "New Pharmaceutical Preparations With Extended Release," by submitting an ANDA to the FDA seeking approval of extended-release felodipine tablets. After construing the asserted claims of the '081 patent, the United States District Court for the Eastern District of Pennsylvania granted Astrazeneca's motions for summary judgment on infringement and validity. Astrazeneca AB v. Mut. Pharm. Co., Inc., 278 F.Supp.2d 491 (E.D.Pa.2003) (granting Astrazeneca's motion for summary judgment on Mutual's counterclaims and affirmative defenses concerning validity); 250 F.Supp.2d 506 (E.D.Pa.2003) (granting Astrazeneca's motion for summary judgment of infringement); 221 F.Supp.2d 535 (E.D.Pa.2002) (construing asserted claims). Holding that the district court erred in its claim construction by not recognizing the limiting effect of the ' 081 patent's specification and prosecution history, we reverse and remand for entry of judgment of noninfringement. Because we hold that the term "solubilizer" is limited to surfactants, we affirm the district court's judgment in favor of Astrazeneca on invalidity.

BACKGROUND

Astrazeneca markets extended-release felodipine tablets under the trade name PLENDIL(R), for use in treating hypertension. Astrazeneca has obtained two patents related to PLENDIL(R): U.S. Patent No. 4,264,611 (the "'611 patent") and the '081 patent. The '611 patent was directed to certain chemical compounds — including felodipine — having antihypertensive qualities. The application that matured into the '611 patent was filed on June 19, 1979; the patent issued on April 28, 1981, and is now expired. The '081 patent is directed to extended-release formulations for felodipine and other drugs having low solubility in water, with the formulations designed to increase the solubility and bioavailability of the drugs. The application that matured into the '081 patent was filed on April 3, 1987; the patent issued on February 7, 1989, and has not expired.

Mutual hopes to market generic felodipine tablets for treating hypertension. To this end, on June 6, 2000, Mutual filed an ANDA for extended-release 10 mg felodipine tablets. Mutual subsequently amended its ANDA to add extended-release 2.5 mg and 5 mg felodipine tablets. Mutual avers that the FDA approved the ANDA in 2004.

On September 19, 2000, Astrazeneca sued Mutual for infringement of the '081 patent. On August 19, 2002, the district court issued its claim construction opinion. On March 14, 2003, the district court granted Astrazeneca's motion for summary judgment of infringement. On August 21, 2003, the district court granted Astrazeneca's motion for summary judgment on Mutual's counterclaims and affirmative defenses concerning validity, and denied Mutual's cross-motion for summary judgment on these same counterclaims and affirmative defenses. On November 14, 2003, the district court entered final judgment in favor of Astrazeneca.

Mutual timely appealed to our court, which has jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). We heard oral argument on August 5, 2004.

DISCUSSION

On appeal, Mutual challenges the district court's rulings on claim construction, infringement, and validity. Mutual's challenge to the district court's rulings on validity is contingent on our affirming the district court's claim construction; Mutual concedes that if our court were to accept Mutual's position as to the proper scope of the asserted claims — and reverse the district court's broader construction — the claims as narrowed would not be invalid. We thus begin with claim construction.

The '081 patent has sixteen product claims and one process claim, of which Astrazeneca asserts product claims 8, 12, 14, and 15, and process claim 17. The asserted product claims are dependent directly or indirectly on claim 1:

1. A solid preparation providing extended release of an active compound with very low solubility in water comprising a solution or dispersion of an effective amount of the active compound in a semi-solid or liquid nonionic solubilizer, wherein the amount by weight of the solubilizer is at least equal to the amount by weight of the active compound, and a release controlling system to provide extended release.

'081 patent, col. 8, ll. 43-51 (emphasis added). Claim 17 is the process claim:

17. A process for making a solid preparation that provides extended release of an active compound with very low solubility in water comprising dissolving or dispersing an effective amount of the active compound in a semi-solid or liquid nonionic solubilizer, the amount by weight of said solubilizer being at least equal to the amount by wight [sic] of the active compound, and incorporating the resulting solution or dispersion into a suitable release controlling system to form a pharmaceutical dosage unit.

Id. at col. 10, ll. 12-22 (emphasis added).

The claim construction dispute centers on the term "solubilizer," which is common to all asserted claims. The parties agree that as a general matter, artisans would understand the term "solubilizer" to embrace three distinct types of chemicals: (1) surface active agents (also known as "surfactants"), (2) co-solvents, and (3) complexation agents.¹ But Mutual has contended that in the context of the '081 patent's specification and prosecution history, "solubilizer" comprehends only surfactants. Because it is undisputed that Mutual's ANDA sought approval for extended-release felodipine tablets that use a co-solvent, not a surfactant, as a solubilizer, Mutual has argued that filing its ANDA was not an act of infringement under § 271(e)(2). The district court rejected Mutual's argument. Relying on the parties' agreement as to artisans' general understanding of "solubilizer," and on certain general-usage dictionary definitions of "solubilizer" and "solubility," the district court held that the "ordinary meaning" of "solubilizer" embraced the three types of chemicals noted above. See Astrazeneca, 221 F.Supp.2d at 543-44. The district court held that the evidence intrinsic to the patent did not curtail this ordinary meaning. See id. at 543-48. The district court's lengthy and careful opinions relied extensively on our recent case law, which is unfortunately complex and inconsistent.

I. Applicable Law

We review the district court's claim construction de novo. E.g., Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-56 (Fed.Cir.1998) (en banc). It is axiomatic that the claims mark the outer boundaries of the patent right to exclude. The critical challenge is to determine the meaning of the claims, i.e., their scope.

A long line of cases indicates that evidence intrinsic to the patent — particularly the patent's specification, including the inventors' statutorily-required written description of the invention — is the primary source for determining claim meaning. We have embraced that proposition frequently. See, e.g., Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). Indeed, that proposition has been accepted doctrine in patent law for many years. See, e.g., Autogiro Co. of Am. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 397-98 (1967) ("The use of the specification as a concordance for the claim is accepted by almost every court, and is a basic concept of patent law. Most courts have simply stated that the specification is to be used to explain the claims; others have stated the proposition in different terms, but with the same effect."); Musher Found. v. Alba Trading Co., 150 F.2d 885, 888 (2d Cir.1945) (Hand, J.) ("As in the case of any other claim, a product claim may, and indeed must, be read upon the specifications: its terms are no more than a shorthand from the fuller explanation which the specifications should contain."). On this view, the patent is an integrated document, with the claims "pointing out and distinctly claiming," 35 U.S.C. § 112, the invention described in the rest of the specification² and the goal of claim construction is to determine what an ordinary artisan would deem the invention claimed by the patent, taking the claims together with the rest of the specification. See, e.g., United States v. Adams, 383 U.S. 39, 49, 86 S.Ct. 708, 15 L.Ed.2d 572 (1966) ("[I]t is fundamental that claims are to be construed in the light of the specifications and both are to be read with a view to ascertaining the invention."). Under this approach to claim construction, evidence extrinsic to the patent is useful insofar as it "can shed useful light on the relevant art — and...