Biotechnology

In two decisions on Dec. 7, the Federal Circuit clarified the law of obviousness-type double patenting, or ODP, and provided certainty to biopharmaceutical patent owners. In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension, or PTE, granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the court clarified that its holding in Gilead Sciences Inc. v. Natco Pharma Ltd.[1] i.e., that a later-issuing, earlier-expiring patent can invalidate an earlier-issuing, later-expiring patent for ODP, applies only to post-Uruguay Round Agreements Act, or URAA, patents. Under Breckenridge, where a later patent expires earlier only because of the URAA’s change in patent term, the post-URAA patent is not an ODP reference against the pre-URAA patent. The two decisions put an end to post-Gilead ODP challenges to pre-URAA patents and patents with PTE based on term granted by Congress.

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