In the recent, nonprecedential Exergen opinion, a panel of the Federal Circuit considered the subject matter eligibility of a diagnostic method patent claim. The majority found a diagnostic method to be directed to patent-eligible subject matter, notwithstanding the Supreme Court's decision in Mayo and the Federal Circuit's subsequent decision in Ariosa.... Read more
There has been a lot of discussion recently regarding claims by the Saint Regis Mohawk Tribe ("Saint Regis") of sovereign immunity as a defense against inter partes review of certain patents owned by Saint Regis. The issue came about as a result of a deal made between Allergan and Saint Regis under which Allergan (the original owner of the six patents involved) paid Saint Regis $13.75 million to take ownerhip of the six patents for Allergan's Restasis drug, and license them back exclusively to Allergan, with the promise of ongoing royalties. When those six patents were challenged in an inter partes review at the Patent Trial and Appeal Board (PTAB), Saint Regis asserted that the patents were shielded from such inter partes review by the theory of tribal sovereign immunity, by extension of a 2017 PTAB ruling that the University of Florida (as a state entity of the state of Florida) was immune to such IPR challenge by Covidien LP. In other decisions, the PTAB has reiterated that state sovereign immunity applies in IPR's.... Read more
As patent prosecution practitioners, we often look for direction from the judges at the PTAB, particularly when agreement cannot be reached at the examining level. This is very evident when there is imprecise guidance as to what constitutes patent eligible subject matter for inventions including natural products following the Supreme Court's decision in Myriad as well as the various iterations of PTO guidance and training materials. Here is a tale of two cases with two different panels (yet each panel interestingly includes one common APJ (New)) and each panel renders very different decisions.... Read more
In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable. (A 10-K is an SEC filing that provides a summary of a company's financial performance).... Read more
The PTAB recently reminded Petitioners of the importance of properly framing prior art arguments, upholding all claims of U.S. Patent No. 8,664,231 in IPR2016-01370 in a final written decision issued yesterday.
The '231 patent—covering Rasuvo®, a rheumatoid arthritis drug containing high doses of methotrexate formulated for subcutaneous injection—was challenged based on two primary references: Grint (a U.S. patent) and Wyeth (a pharmaceutical label for conventional uses of methotrexate). The primary grounds for each reference were based on anticipation, and the PTAB determined that neither reference anticipated claim 1, the only independent claim of the '231 patent.... Read more