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IP Alert: Extended Patent Term Does Not Conflict with Double Patenting

December 7, 2018

Today, in Novartis AG v. Ezra Ventures LLC, the Federal Circuit issued a significant decision on the relationship between obviousness-type double patenting and patent term extension under 35 U.S.C. § 156.

Section 156 allows a drug manufacturer to elect a five-year extension for a patent covering one of its drugs. This extension is intended to offset the term of the patent during which the drug was subject to regulatory review by the FDA and thus was not marketable. A patentee may elect only one patent term extension under section 156 for any single drug. Where the assignee has multiple patents covering the same drug, the assignee can select which patent qualifies for the patent term extension.

In 1997, Novartis received U.S. Patent No. 5,604,229, which claimed a drug for treating multiple sclerosis. Novartis elected this patent to receive the five-year term extension. The ’229 patent was a GATT transitional patent filed in 1994, and its normal expiration date was 17 years from its 1997 issue date. With the section 156 extension, the ’229 term was thus extended from 2014 to 2019.

Novartis also owned U.S. Patent No. 6,004,565, which covered the same drug as the ’229 patent. The ’565 patent was filed in 1997 and its 20-year term expired in 2017.

Novartis sued Ezra alleging infringement of the ’229 patent. Ezra asserted that the ’229 and ’565 patents conflicted for obviousness-type double patenting, arguing that the ’229 patent was invalid, or else Novartis should have disclaimed the patent term extending past the 1997 expiration date of the ’565 patent. Specifically, Ezra asserted that the section 156 extension effectively created an improper extension of the term of the ’565 patent. The district court ruled in favor of Novartis.

On appeal, the Federal Circuit affirmed. Reviewing the statutory scheme of allowing the patentee to elect which patent to extend, the court concluded that Congress had expressed a decision to provide “a flexible approach which gave the patentee the choice” of which patent to extend for an individual drug. The court reasoned that Congress had acknowledged scenarios in which an entity will own multiple patents covering the same drug, only one of which is extended. For this reason, the court concluded, the section 156 extension of one patent cannot be vitiated by obviousness-type double patenting.

The Federal Circuit further relied on one of its earlier decisions, Merck & Co. v. Hi-Tech Pharmacal Co., which found that patent term extension under section 156 extended the life of a patent despite a terminal disclaimer filed during prosecution. In Merck, the court distinguished 35 U.S.C. § 156 from 35 U.S.C. § 154, which governs patent term adjustment. Section 154 “expressly excludes patents in which a terminal disclaimer was filed from the benefit of a term adjustment for PTO delays.” The court reasoned that the absence of such provision in section 156 supported its position.

This decision provides some clarity for the interplay between patent term extension and the doctrine of obviousness-type double patenting. For more information, please contact Fitch Even attorney Donald R. Bunton, author of this alert.


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