324 F.3d 1322 (Fed. Cir. 2003), 02-1449, Allergan, Inc. v. Alcon Laboratories, Inc.

Docket Nº:02-1449
Citation:324 F.3d 1322
Party Name:Allergan, Inc. v. Alcon Laboratories, Inc.
Case Date:March 28, 2003
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

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324 F.3d 1322 (Fed. Cir. 2003)

66 U.S.P.Q.2d 1225

ALLERGAN, INC. and Allergan Sales, Inc., Plaintiffs-Appellants,


ALCON LABORATORIES, INC., Alcon Research, Ltd., and Alcon Universal, Ltd., Defendants-Appellees,


Bausch & Lomb, Incorporated, Defendant-Appellee.

No. 02-1449.

United States Court of Appeals, Federal Circuit

March 28, 2003

Rehearing En Banc Denied: May 22, 2003.

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Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner L.L.P., of Washington, DC, argued for plaintiffs-appellants. With him on the brief were Jonathan Singer, Fish & Richardson, P.C., of Minneapolis, Minnesota, and Dina Grinshpun, of San Diego, California. Of counsel on the brief was Paul W. Browning, Finnegan, Henderson, Farabow, Garrett & Dunner L.L.P., of Washington, DC.

Daniel J. Thomasch, Orrick, Herrington & Sutcliffe, LLP, of New York, New York, argued for defendants-appellees Alcon Laboratories, Inc., et al. With him on the brief was M. Veronica Mullally.

Edward W. Remus, McAndrews, Held & Malloy, Ltd., of Chicago, Illinois, argued for defendant-appellee Bausch & Lomb Incorporated. With him on the brief was Jonathan R. Sick.

Richard A. Samp, Washington Legal Foundation, of Washington, DC, for amicus curiae Washington Legal Foundation. With him on the brief was Daniel J. Popeo.

Before CLEVENGER, SCHALL, and LINN, Circuit Judges.

Opinion concurring in the judgment filed by Circuit Judge SCHALL, in which Circuit Judge CLEVENGER joins.


This appeal presents the question of whether the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355 and 360cc and 35 U.S.C. §§ 156 and 271) (the "Hatch-Waxman Act"), allows an action for induced infringement based upon the filing of an Abbreviated New Drug Application ("ANDA"), in the following circumstances: (i) The patent at issue claims a method of using a specified drug for a particular purpose, but that use has not been approved by the Food and Drug Administration ("FDA") based upon a New

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Drug Application ("NDA"); (ii) the ANDA applicant seeks approval for the production of a generic version of the drug for a use that is different from the method of use of the drug that is claimed in the patent; and (iii) the generic drug that is the subject of the ANDA is effective for the method of use that is claimed in the patent.

This question arises in the context of a suit by Allergan, Inc. and Allergan Sales, Inc. ("Allergan") against Alcon Laboratories, Inc., Alcon Research, Ltd., and Alcon Universal, Ltd. ("Alcon"), and Bausch & Lomb, Incorporated ("B & L") for infringement of United States Patent Nos. 6,194,415 (the "'415 Patent") and 6,248,741 (the "'741 Patent"). The '415 patent claims a method of protecting the optic nerve through the administration of the drug brimonidine, while the '741 patent claims a method of neural protection through the administration of brimonidine. Brimonidine itself is not patented, and the FDA has not approved brimonidine for the uses claimed in the '415 and '741 patents. However, brimonidine is effective for those uses. 1

Allergan initiated suit in the United States District Court for the Central District of California after Alcon and B & L submitted ANDAs to the FDA seeking approval for the production and sale of a generic version of brimonidine for the reduction of intraocular pressure, a use different from the uses for brimonidine claimed in the '415 and '741 patents. Allergan charged Alcon and B & L with induced infringement under the authority of 35 U.S.C. § 271(e)(2). 2 In due course, Alcon and B & L filed motions for summary judgment of non-infringement, arguing that a claim of induced infringement is not cognizable under section 271(e)(2) where, as here, the ANDA is for a use of the drug that is different from the use of the drug that is claimed in the asserted patent. The district court agreed. Accordingly, it granted Alcon's and B & L's motions, dismissed Alcon's and B & L's non-infringement and invalidity counterclaims without prejudice, and certified the case pursuant to Fed.R.Civ.P. 54(b). Allergan, Inc. v. Alcon Labs., Inc., 200 F.Supp.2d 1219, 63 USPQ2d 1427 (C.D.Cal.2002); Allergan, Inc. v. Alcon Labs., Inc., No. SA CV 02-40 DOC (ANx) (C.D. Cal. Jun 4, 2002).

Prior to January 16, 2003, the question presented in this case represented an issue of first impression. On that day, however, a panel of this court decided Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 65 USPQ2d 1481 (Fed.Cir. 2003). In Warner-Lambert, this court held that "it is not an act of infringement to submit an ANDA for approval to market a drug for a use when neither the drug nor the use is covered by an existing patent, and the patent at issue is for a use not approved under the NDA." Warner-Lambert, 316 F.3d at 1354-55, 65 USPQ2d at 1484. Based upon Warner-Lambert, we affirm the district court's decision that the action for induced infringement brought by Allergan is not cognizable under 35 U.S.C. § 271(e)(2).

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I. The Hatch-Waxman Act

We recently stated that, in the Hatch-Waxman Act, "Congress struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market." Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371, 61 USPQ2d 1414, 1415 (Fed.Cir. 2002). To accomplish the goals of the Act, Congress amended provisions of the patent statute and the Food, Drug, and Cosmetic Act ("FDCA").

Prior to the passage of the Act, all drug manufacturers, brand name and generic, had to perform controlled studies to demonstrate that a new drug would be safe and effective for its intended use. 3 This requirement resulted in long delays between the time when a brand name drug manufacturer received a patent for a new drug and the drug reached the market. It also resulted in long delays between the time when the patent expired and generic drug manufacturers were able to market a generic version of the drug. The Hatch-Waxman Act sought to address this situation by providing brand name drug manufacturers with limited extensions of their patent terms in order to restore a portion of the market exclusivity lost through the lengthy process of drug development and FDA approval. At the same time, to counter this benefit to the brand name manufacturers, the Act provided generic drug manufacturers with a patent infringement exemption for experimentation in connection with an application for FDA approval of a generic drug. It also provided a shortened FDA approval process for generic drugs. H.R.Rep. No. 98-857, pt. 1, at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48.

Before a drug manufacturer can market a new drug, it must obtain FDA approval. 21 U.S.C. § 355(a). The approval process requires the submission of a NDA, which is the result of extensive testing and which must include safety information, efficacy information, and composition data. 21 U.S.C. § 355(b). Pursuant to the Hatch-Waxman Act, the FDA, upon approval of a NDA, grants the applicant a five-year period of exclusive marketing for the approved drug, which can be extended by six months if the producer submits safety information relating to children. 21 U.S.C. §§ 355(c)(3)(D)(ii) and 355a(a)(1)(A)(i). This period of exclusivity was primarily designed by Congress to encourage the development and testing of unpatentable pharmaceuticals. H.R.Rep. No. 98-857, pt. 1, at 29 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647-48. The FDA approval process requires a NDA applicant to file with its NDA the following:

the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.

21 U.S.C. § 355(b)(1). The holder of an approved NDA must file the same information with respect to similar patents that are obtained after the NDA is approved. 21 U.S.C. § 355(c)(2). The FDA lists such patents in a book entitled "Approved Drug Products with Therapeutic Equivalence Evaluations." The book is commonly referred

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to as the "Orange Book." Andrx, 276 F.3d at 1371, 61 USPQ2d at 1415.

To attain a balance between the interests of brand name pharmaceutical companies and generic drug manufacturers, Congress, as part of the Hatch-Waxman Act, legislated that a generic drug manufacturer may, without liability for infringement, use a drug claimed in a patent or a method of using a drug claimed in a patent in order to prepare an application for FDA approval of a generic drug. 35 U.S.C. § 271(e)(1). At the same time, Congress extended the ANDA process to post-1962 pioneer drugs to couple with the NDA process. A generic drug manufacturer may file an ANDA to obtain approval for a generic drug. 21 U.S.C. § 355(j). The ANDA must be for the same drug that has been approved by the FDA, or it must be for a drug that is the bioequivalent of a drug that has been approved by the FDA. 21 U.S.C. § 355(j)(2).

The ANDA process imposes a certification requirement with respect to patents covering the drug that has been approved by the FDA. A generic drug manufacturer must certify in its ANDA the following with respect to each patent "which claims the [drug previously approved by the FDA] or which claims a use for [that] drug for which the applicant is seeking approval ... and for which information is required to be filed" for listing in the Orange Book: (i) such patent...

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