Regeneron perpetuated Eylea as a blockbuster by using its patents to block entry of lower-cost generics.  When those patents neared expiration, Regeneron launched a new formulation covered by at least one patent, namely, Eylea HD.  One of those patent only recently issued, but has already been challenged by at least one prospective generic in a Post-Grant Review (PGR) proceeding before the Patent Trial and Appeal Board of the Patent Office (PTAB).  Will that challenge succeed?  

Senator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit.  When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge?  Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.

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?