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ANDA Submission for Unpatented Use of Drug Covered by Patent Does Not Infringe

January 16, 2003

Decision icon Decision

Last Month at the Federal Circuit - February 2003

Judges: Lourie (author), Michel, and Plager

In Warner-Lambert Co. v. Apotex Corp., No. 02- 1073 (Fed. Cir. Jan. 16, 2003), the Federal Circuit affirmed the district court’s SJ of noninfringement on the ground that submission of an Abbreviated New Drug Application (“ANDA”) for an FDAapproved, off-patent use of a drug does not constitute a § 271(e)(2)(A) act of infringement when a different claimed use is still under patent protection.

Warner-Lambert Company (“Warner-Lambert”) is the assignee of several patents regarding the drug gabapentin, sold under the trade name Neurontin®. The first patent, expired U.S. Patent No. 4,024,175, claimed the actual compound. The second patent, expired U.S. Patent No. 4,087,544, claimed a method of treating certain cranial dysfunctions, such as epilepsy, with gabapentin. The third patent, U.S. Patent No. 5,084,479 (“the ‘479 patent”), claims the use of gabapentin for the treatment of neurodegenerative diseases such as stroke, Alzheimer’s disease, Huntington’s disease, and Parkinson’s disease.

Warner-Lambert obtained FDA approval for the use of gabapentin to treat seizures in adults with epilepsy in 1993. The FDA has not approved gabapentin for any other uses, notably not for use in treatment of neurodegenerative disorders.

Apotex Corporation (“Apotex”) filed an ANDA in 1998, seeking FDA approval to market a generic form of gabapentin for use as a treatment for epilepsy upon the expiration of Warner-Lambert’s epilepsy method patent in early 2000. Included in the ANDA was a certification that its proposed manufacture, sale, and use of gabapentin would not infringe the ‘479 patent, declaring that its labeling would not include any indication for use in treatment of neurodegenerative diseases.

Warner-Lambert filed suit, alleging that Apotex’s submission of its ANDA was an act of infringement of the ‘479 patent. Despite the lack of FDA approval for the use of gabapentin for neurodegenerative diseases, they argued, patients and doctors will use and prescribe the Apotex generic for all the purposes which Neurotin® is customarily used. The district court granted Apotex’s motion for SJ, and Warner-Lambert appealed.

The Federal Circuit stated that this case presented an issue of first impression: whether it is an act of infringement under 35 U.S.C. § 271(e)(2)(A) to submit an ANDA seeking approval for an FDAapproved use of a drug if any other use of that drug is claimed in a patent.

Warner-Lambert argued that the statutory definition of “act of infringement” extends to cover ANDAs filed for a drug having any claimed use in a patent. The Court rejected Warner-Lambert’s reading of the statute, concluding that it eviscerated an important part of the statutory provision by conflating the first and second clauses of § 271(e)(2)(A) in its quotation. Specifically, the phrase “before the expiration of such patent” cannot be read apart from the phrase “if the purpose of such submission is to obtain approval under such act.” The Court noted that the statute may be somewhat unclear, but nevertheless found no merit in Warner- Lambert’s interpretation. “It is abundantly clear that the statute does not make the filing of an ANDA prior to patent expiration an act of infringement unless the ANDA seeks approval to make, use, or sell the drug prior to expiration of a patent that would otherwise be infringed by such manufacture, use or sale, apart from the provisions of § 271(e)(2).” Warner-Lambert, slip op. at 9-10 (emphasis in original).

The Federal Circuit also looked to the legislative history to support its reading of § 271(e)(2)(A). If Warner-Lambert’s interpretation were correct, and an ANDA filing constituted an act of infringement for any use of the drug that was still covered by a patent, a New Drug Application (“NDA”) holder would be able to maintain exclusivity in the market by regularly filing new applications claiming methods of use not covered by its NDA, the Court concluded. This would frustrate one of the stated purposes of the Act: allowing market entry by generic manufacturers. The Court pointed at language in the House Report demonstrating that Congress recognized that a single drug could have more than one indication, and yet that the ANDA applicant could seek approval for less than all of those indications.

The Federal Circuit also considered the question of whether Warner-Lambert had demonstrated the existence of a genuine issue of material fact with respect to inducement to infringe under § 271(b). Warner-Lambert argued that the district court had erred in requiring proof of Apotex’s knowledge that physicians were prescribing gabapentin for treatment of neurodegeneration, contending that the correct standard is “should have known.” The Court responded that specific intent and action to induce infringement must be proven. In the absence of any evidence that Apotex has or will promote or encourage doctors to infringe the neurodegenerative method patent, the Court found no genuine issue of material fact. The Court observed that especially where a product has substantial noninfringing uses, intent to induce cannot be inferred, even when the defendant has actual knowledge that some users of its products may be infringing the patent.