The long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone.  The case also represents another milestone in the changing landscape for patents covering biologic drugs.  The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement.  The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®.  The takeaway is clear:  as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.

Amgen ($AMGN) is about to square off once again against Regeneron ($REGN) and Sanofi over whether Praluent® should be pulled from the market.  Having prevailed at another jury trial earlier this year showing that Amgen’s PCSK9 protein patents are both valid and infringed, Amgen has renewed its bid for a court order enjoining Praluent® from the market.  The injunction hearing is scheduled for June 2019.  Over two years ago, Amgen prevailed after an earlier injunction hearing where the court ordered Praluent® to be barred from the market.  Will Amgen be able to prevail again? 

On January 18, the District Court in Delaware issued an opinion resolving multiple summary judgment motions filed by both parties.  The key takeaway from that decision is that the case is now teed-up for trial beginning on February 19. But the Court didi highlight some key issues likely to be the focus of the trial.

Amgen’s ($AMGN) patent fight against Regeneron ($REGN) and Sanofi has been quiet for much of this year.  But it is likely to heat up again shortly.  What is coming up?

Novartis has filed a patent lawsuit against Regeneron seeking damages for sales of Eylea® and Zaltrap®.  On March 19, 2018, Novartis sued Regeneron in the Southern District of New York, White Plains Division, for infringing U.S. Patent No. 5,688,688.  The ‘688 patent claims gene expression constructs for the expression of polypeptides in mammalian cells.  How strong is Novartis’ case, and what is Regeneron’s exposure?