NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE PHARMACEUTICAL
- Dec 7 2018 |
- Category: CAFC Updates
This case involves patents directed to the compound everolimus, the active ingredient in Zortress® and Afinitor®, which can be used to treat certain cancers and prevent rejection in kidney and liver transplantations. A complicated, potential double patenting situation is presented in which the later-filed of two related patents, which share a common specification and effective filing date, expires before the term of the earlier-filed patent due to an intervening change in law by Congress defining a patent’s term. When the patent owner filed for the first patent, the governing law defined the patent term as 17 years from the date the patent issued. When the patent owner filed for its second, related patent, the governing law was amended to define the patent term as expiring 20 years from the patent’s earliest effective filing date. Because of the two patents’ relatively early effective filing date, the change in patent term law caused the second patent to expire earlier than the first patent. The patent owner concedes that the claimed inventions in the two related patents are obvious variants of each other. Applying the CAFC’s decision in Gilead Sciences, 753 F.3d 1208, 1212 (Fed. Cir. 2014), the district court found the post-URAA patent to be a proper double patenting reference for the pre-URAA patent and thus that certain claims of the pre-URAA patent were invalid. The legal question in this appeal is whether the law of obviousness-type double patenting requires a patent owner to cut down the earlier-filed, but later expiring, patent’s statutorily-granted 17-year term so that it expires at the same time as the later-filed, but earlier-expiring patent, whose patent term is governed under an intervening statutory scheme of 20 years from that patent’s earliest effective filing date. The CAFC applies the traditional obviousness-type double patenting practices extant in the pre-Uruguay Round Agreements Act of 1994 (“URAA”) era to the pre-URAA patent and look to the patent’s issuance date as the reference point for obviousness-type double patenting. Under this framework, and because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA patent, the CAFC holds that the post-URAA patent is not a proper double patenting reference for the pre-URAA patent. Accordingly, the CAFC reverses.