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
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
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 November 11, 2020, I had the pleasure of participating in a virtual fireside chat with Dr. Jeremy Levin at the first AdvanSE Life Sciences Conference held by the Southeast Life Sciences Association. Dr. Levin has a long...more