December 7, 2018

Judicially Created Double Patenting Does Not Limit Statutory Patent Term Extension

In Novartis AG v. Ezra Ventures, LLC, [2017-2284] (December 7, 2018), the Federal Circuit affirmed the district court’s determination that obviousness-type double patenting does not invalidate an otherwise validly obtained patent term extension (PTE) under §156.

After Ezra filed an Abbreviated New Drug Application (ANDA) relating to a generic version of Novartis’s Gilenya® multiple sclerosis drug, Novartis sued Ezra for infringement of claims 9, 10, 35, 36, 46, and 48 of U.S. Patent No. 5,604,229. Ezra responded by attacking the validity of the patent.

Ezra first argued that Novartis violated § 156(c)(4) because, two patents were extended as the extension of the ’229 patent’s term “effectively” extended U.S. Patent No. 6,004,565’s term as well, because the ’229 patent covers a compound necessary to practice the methods claimed by the ’565 patent. Ezra argued that this violated its “right” to practice the ‘565 patent upon its expiration.

The Federal Circuit rejected this argument finding that §156 gives the patent owner discretion to select which of several patents to extend, and that additional words should not be read into the statute to limit this discretion.

Ezra also argued that the ’229 patent is invalid due to obviousness-type double patenting because the term extension it received causes the ’229 patent to expire after Novartis’s allegedly patentably indistinct ’565 patent. The Federal Circuit noted that a straightforward reading of §156 mandates a term extension so long as the other enumerated statutory requirements for a PTE are met. The Federal Circuit further noted that the difference in language for patent term adjustment (PTA) under §154(b) and PTE under §156 support the conclusion that a patent term extension under § 156 is not foreclosed by a terminal disclaimer.

The Federal Circuit noted that obviousness-type double patenting is a “judge-made doctrine” that is intended to prevent extension of a patent beyond a “statutory time limit,” and declined Ezra’s invitation to use the judge-made doctrine to cut off a statutorily-authorized time extension.