At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more
Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more
Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
July 1, 2021 In a development having significant ramifications for many biopharma companies, the Federal Circuit has denied Amgen’s petition for rehearing en banc a decision invalidating a genus patent covering its antibody...more
An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more
In April, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) proposed a draft framework for legislation reformulating the standards for determining patent eligibility under § 101 of the Patent Act. The framework largely...more
On April 17, 2019, Senators Tillis (R-NC) and Coons (D-DE), along with a bipartisan group of three members of the House of Representatives, announced the release of a framework on Section 101 patent reform. Senators Tillis...more