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
On January 13, we originally posted on this topic. An update was posted on February 5. This post provides the most recent update on this matter.
Yesterday, the Federal Circuit granted Teva’s petition for en banc rehearing....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