Warner-Lambert Company v. Apotex Corp.

Warner-Lambert Company (plaintiff) held a patent (the neurodegenerative-method patent) for a method of treating neurodegenerative diseases using compounds such as gabapentin. Warner-Lambert marketed gabapentin to treat epilepsy after receiving an approved New Drug Application from the United States Food and Drug Administration (FDA). Warner-Lambert also held an epilepsy-method patent claiming the use of gabapentin to treat epilepsy. The FDA did not approve any other uses for gabapentin, including any uses claimed under the neurodegenerative-method patent. Apotex Corporation filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to market a generic form of gabapentin for the use of treating partial seizures upon the expiration of the epilepsy-method patent. Apotex submitted a Paragraph IV certification stating that its proposal would not infringe on the neurodegenerative-method patent. The certification stated that the proposed use for partial seizures was approved under the epilepsy-method patent, the neurodegenerative-method patent did not claim the treatment of partial seizures, and Apotex’s generic gabapentin product would not fall within the bounds of the neurodegenerative-method patent. Warner-Lambert filed a patent-infringement suit against Apotex in federal court, asserting that Apotex’s ANDA submission was infringement. The district court granted summary judgment of noninfringement. Warner-Lambert appealed.