We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims. But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to address Question 2...more
We first posted about a potential waiver of patent rights related to COVID-19 medical tools on May 6, 2021 (Patents on COVID-19 Vaccines Feel free to infringe (kilpatricktownsend.com)). A recent version of the waiver released...more
There was big news from the Biden administration yesterday regarding patent protection for COVID-19 vaccines. Katherine Tai, United States Trade Representative, announced in an official statement dated May 5, 2021 that the...more
As we reported last month, the Federal Circuit panel in Amgen v. Sanofi affirmed the district court’s judgment as a matter of law invalidating genus claims in U.S. Patent Nos. 8,829,165 and 8,859,741 that recite functional...more
In a law review article entitled “The Death of the Genus Claim,” which published in the aftermath of the Federal Circuit decision in Idenix v. Gilead, 941 F.3d 1149 (Fed. Cir. 2019), the authors stated that, “in the past...more
Statutory Basis For Label Carve-Outs -
Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more
On June 7, 2018, the USPTO issued a memorandum to patent examiners based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018). The memorandum...more