In 2023, the Supreme Court issued a decisive opinion that undermined the validity of broad functional genus claims for patents directed to biological antibodies. I published an article on IPWatchdog that examines numerous alternative strategies for patenting antibodies that can survive enablement and written description challenges, with a focus on paratope mapping with CDR-scanning technology. Go to IPWatchdog for full article.

Earlier this year, in October, the Federal Circuit vacated Amgen’s hard-earned injunction against Praluent®, the only other PCSK9 drug competing with its own, Repatha®.  The case has been remanded to the District Court of Delaware for a new trial on the validity of Amgen’s patents.  Before that could happen, however, earlier this week Amgen petitioned the Federal Circuit for en banc review of its October 5, 2017 decision that cut against Amgen.  What are Amgen's chances?