The Flip Side of Reasonable Expectation of Success is Unpredictability
The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1925.Opinion.10-4-2019.pdfreversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:
Prior Art Introduced During Prosecution Has Important Implications for 101 Challenges
Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.
Prosecution History Estoppel And Amendments Tangential To Patentability
The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.
Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure
Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.
Invalidity of Broad Claims for Lack of Enablement in the Absence of Sufficient Disclosure of the Structure/Function Correlation and Unpredictability in the Art
Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.
ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY
In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that:
Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?
In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101.
Commercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-Obviousness
During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.
SOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORY
Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"