On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye.  RESTASIS® is "a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca."  The FDA issued a press release that stated:

"Restasis has been approved for use in the US for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes," said Sally Choe, PhD, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research.  "Today's approval reflects the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts."

As a reminder, a little more than four years ago, innovator pharmaceutical company Allergan caused a stir by entering into an assignment agreement with the St. Regis Mohawk Tribe over Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; and 9,248,191, that protected its Restasis® product (see "Allergan Avails Itself of Sovereign Immunity").  These patents had been challenged by Mylan in inter partes review proceedings and St. Regis moved for the Patent Trial and Appeal Board (PTAB) to dismiss these IPRs on sovereign immunity grounds (see "Mohawk Nation Exercises Sovereign Immunity in Inter Partes Review").  The PTAB denied the motion (see "PTAB Denies St. Regis Mohawk Tribe's Motion to Terminate IPRs based on Sovereign Immunity") and the Federal Circuit affirmed (see "Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.").  In parallel ANDA proceedings, the District Court (Federal Circuit Judge William Bryson, sitting by designation) granted the St. Regis Tribe's motion to be named as a party (see "District Court Allows Mohawk Tribe to Join ANDA Litigation, Finds Patents at Issue Invalid") but, as the post title indicates, found the patent-in-suit to be invalid for obviousness.

The value of the RESTASIS® product provides ample motivation for trying to protect the RESTASIS® franchise and while that profitability will surely be reduced in the face of generic competition between now and 2025, it is countered by the lack of generic competition between 2017 and now.  More significantly, the Board's decision and the Federal Circuit's affirmance of that decision (followed by Federal Circuit decisions in Regents of the University of Minnesota v. LSI Corp. and Board of Regents of the University of Texas System v. Baylor College of Medicine and PTAB decisions in Ericsson Inc. and Telefonaktiebolaget LM Ericsson v. Regents of the University of Minnesota) effectively ended sovereign immunity as a basis for an assignee sovereign to avoid validity challenged by IPR (and thus eliminated any motivation or impetus for patentees to use assignment as a tool for protecting their patents from IPR challenges).