The U.S. Court of Appeals for the Federal Circuit has upheld the grant of summary judgment of non-infringement of a patent claiming a method of using the drug gabapentin to treat "neurodegenerative diseases" where the defendant applied to use the drug for the treatment of epilepsy. Warner-Lambert Co. v. Apotex Corp., Case No. 01-1073 (Fed. Cir. Jan. 16, 2003),

Warner-Lambert (now Pfizer, Inc.) sued Apotex under 35 U.S.C. § 271(e)(2)(a), alleging that Apotex’s filing of an abbreviated new drug application (ANDA) to market a generic gabapentin for the treatment of epilepsy infringed Warner-Lambert’s patent. It was undisputed that epilepsy is not a neurodegenerative disease and the FDA has approved the use of gabapentin for treatment of epilepsy only.

Although Apotex never sought or received approval for the use of gabapentin to treat neurodegenerative diseases, Warner-Lambert argued that Apotex’s filing of the ANDA constituted infringement of Warner-Lambert’s patent because patients had used Warner-Lambert’s product for treating neurodegenerative diseases and would likely use Apotex’s gabapentin for this purpose as well.

Warner-Lambert urged a broad application of § 271(e)(2)(a), asserting that it prohibits submission of an ANDA seeking approval to make, use or sell a drug for an approved use if any other use of the drug is claimed in a non-expired patent. The Federal Circuit rejected this argument, holding 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 [by the FDA]."

The Court also rejected Warner-Lambert’s allegation that Apotex was inducing infringement simply because it was foreseeable that doctors would prescribe gabapentin to treat neurodegenerative diseases according to the method claimed in the patent even if those uses are not approved by the FDA. The Court stated that "mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven."

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