The Situation
Allergan accused generics rivals of patent infringement in federal court last year. It also faced an inter partes review (“IPR”) from Mylan pursuant to Restasis. To thwart the IPR Allergan sold the Restasis patents to the St. Regis Mohawk Tribe in September 2017. One month later Judge William Bryson invalidated the patents due to obviousness. According to Judge David Ruschke the University of Minnesota waived its immunity in an IPR by filing patent infringement charges in federal court. That case could imply Allergan waived its sovereign immunity as well, hurting its chances of winning an IPR.
It appears the only hurdle left for Mylan’s launch of generic Restasis is FDA approval. Per the company’s Q3 earnings call management expected its generic version of Restasis to meet FDA guidelines by the end of last year:
Regarding our generic form of RESTASIS, we have made good progress on our application, and we believe that we have a product that adheres to the FDA’s latest new guidance. Our bridging goal date is December 31 of this year. With this district court verdict behind us, we look forward to bring this very important product to patients soon.
That implies Mylan could receive FDA approval within weeks. I believe the news of FDA approval could send AGN lower. The question remains, “Will Mylan launch generic Restasis with an IPR still pending?” We will not know the full impact on Allergan’s revenue and earnings until the generic version is finally launched.
