Mylan has had no shortage of critics over the last year as it suffered from a stinging EpiPen pricing scandal. Now, the generic giant is dishing out barbs of its own, blasting Allergan for a new licensing deal with the Saint Regis Mohawk Tribe that’s designed to shield eye drug Restasis from competition.
In a federal court filing, the generic player called the licensing maneuver “desperate” and a “last minute attempt to shield the patents-in-suit from inevitable cancellation.” Mylan is among the companies seeking to market copycats of Restasis, which generated $1.5 billion in sales for Allergan last year.
“Mylan will vigorously oppose this transparent delay tactic before the Patent Trial and Appeal Board,” the drugmaker said in a filing.
Allergan unveiled the licensing deal on Friday, announcing the transfer of Restasis patents to the Saint Regis Mohawk Tribe in New York. The tribe will receive $13.75 million up front and up to $15 million annually as part of the deal. Because it’s a sovereign nation, it can claim immunity from a type of patent challenge called an inter partes review at the U.S. Patent Trial and Appeal Board (PTAB). Under the deal, Allergan will license the patents from the tribe and continue to sell Restasis.
Critics blasted the tactic on social media while some industry watchers felt it was innovative and likely to spread to other drugs facing similar patent challenges.
Despite likely challenges from various groups, Allergan's chief legal officer Bob Bailey told FiercePharma early this week he believes his company will prevail. After reviewing a separate case involving a patent co-owned by the University of Minnesota and automaker Toyota, however, Bernstein analyst Ronny Gal said there's a chance the inter partes review could go forward.
"In that case, the PTAB found the case can continue despite the sovereign immunity of the state because Toyota was a co-defendant and able to proceed in the case and because Toyota had real economic interest," Gal wrote in a note to clients, pointing out Allergan's economic interest in Restasis patents.
In addition to the inter partes review at the U.S. Patent and Trademark Office, the sides recently wrapped up a Restasis patent trial in Marshall, Texas. Allergan CEO Brent Saunders said his company did the patent deal with the Mohawk tribe to avoid a “double jeopardy” of attacks under a “flawed” system. A decision on the just-finished trial hasn’t been handed down. An Allergan spokesperson said in a statement that the licensing deal has "no impact" on the proceedings in Marshall.
In the wake of the deal announcement, analysts and industry watchers pegged Pfizer’s Prevnar 13, Amgen’s Enbrel, Eli Lilly’s Alimta and AbbVie’s Humira as medical products that could benefit from a similar licensing arrangement.