- Allergan and the St. Regis Mohawk Tribe aim to continue their legal battle in defense of a controversial patent agreement struck a little over a year ago, appealing last week to the Supreme Court to review a federal appeals court decision which had undermined the deal's main rationale.
- Last July, the U.S. Court of Appeals for the Federal Court ruled the St. Regis Mohawk Tribe couldn't claim tribal sovereign immunity to sidestep certain patent challenges from would-be generic rivals to Allergan's dry eye drug Restasis. Allergan had previously handed the tribe rights to the top-selling medicine in a highly unusual legal maneuver designed to shield the top-selling drug from competition.
- The deal, which attracted public and Congressional scrutiny, has so far proved for naught. But Allergan and the tribe now argue the appeals court got it wrong, incorrectly interpreting prior rulings by the Supreme Court which the two say support use of sovereign immunity in inter partes review cases brought before the U.S. Patent Trial and Appeal Board (PTAB). The Supreme Court will decide by Feb. 11 whether to hear the case.
Defeated by both the PTAB and a federal appeals court, Allergan and the tribe aren't yet ready to give up their defense of a deal which has attracted sharp criticism.
At the heart of the agreement is Allergan's chronic dry eye treatment Restasis (cyclosporine), a drug which ranks second only to Botox (botulinum toxin) in sales for the pharma.
In 2015, Allergan sued generic drugmakers, including Mylan, Teva and Akorn, for infringing on patents it held on Restasis. The three later petitioned for what's known as an inter partes review or IPR, a separate legal process overseen by an arm of the U.S. Patent Office.
IPRs have become a thorn in the side of branded drugmakers, offering rivals another forum outside of district court litigation to challenge drug patents.
Seeking to protect Restasis from such challenges, Allergan constructed an unusual deal, sending the St. Regis Mohawk Tribe rights to its patents on Restasis that the drugmaker then licensed back for an annual sum of $15 million.
Driving the deal was a legal argument that the tribe's sovereign immunity could be used to force the dismissal of the IPR challenges from Mylan, Teva and Akorn.
It hasn't worked. In February last year, the PTAB denied the Tribe's motion to dismiss the IPR on Restasis. That set up the appeals court ruling in July, which upheld the PTAB's decision and further setback Allergan's legal strategy.
While this process has unfolded, Allergan's monopoly for Restasis has been brought to the brink. A federal district court judge invalidated four patents protecting the drug in October 2017, opening the door to the entry of generic copies to the drug despite the ongoing litigation tied to the PTAB decision.
Copycat versions were expected to enter earlier in 2018, but have so far been delayed. Analysts currently predict generics will be available beginning this month, but note that could change.
Sales, meanwhile, are already sliding, down 19% year over year in the third quarter due to lower net pricing and demand in the U.S.