Novartis AG v. Ezra Ventures, LLC

A patent-term extension of a continuation does not violate 35 U.S.C. § 156 because a patentee can extend the term for one chosen patent.

October 25, 2016

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) 

Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229 (“the ’229 patent”)

Nature of the Case and Issue(s) Presented: The issue before the court was whether the ’229 patent was invalid as a matter of law because Plaintiffs had obtained a patent-term extension of the ’229 patent (an apparatus patent) while a continuation patent in the same family (a method patent using the claimed apparatus) had expired. Ezra argued that § 156(c)(4) limits the ability of patent owner to obtain a patent term extension when such extension would improperly extend the life of other necessary patents to practice the claimed invention. Ezra also argued that if the patent-term extension was proper, the patent was invalid for obviousness-type double patenting over the method patent.

Plaintiffs argued that the plain language of § 156(c)(4) limits the patentee to seek extension as to only one patent that covers a product. The court agreed with Plaintiffs that § 156(c)(4) was limited to only one patent that covered a product.

Why Plaintiffs Prevailed: The district court found that § 156(c)(4) was not subjected to a ‘de facto’ limitation as argued by Ezra because Congress did not use such language. Further, the plain language of § 156(c)(4) was limited to only one patent that covers a product, and Ezra did not assert that Plaintiffs sought extension of more than one patent. The district court also rejected Ezra’s public-policy argument that extension of the apparatus patent precludes the use of the expired method patent using the claimed apparatus because a patent is not the right to practice the claimed invention but rather a right to preclude others from practicing the claimed invention.

As to Ezra’s argument concerning obviousness-type double patenting, the district court rejected the argument at the pleading stage as there was not sufficient evidence to find as a matter of law that the asserted patent was invalid.

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