In a letter to Allergan’s CEO on 3 October, the Committee on Oversight and Government Reform described the patent deal in which Allergan transferred its entire portfolio of Restasis dry eye treatment patents to the Native American tribe, as an “unconventional maneuver”.
The committee requested that Allergan cooperate with a Congressional evaluation by disclosing all terms and documents relating to the agreement.
Bob Bailey, chief legal officer at Allergan, previously described the move as a “sophisticated opportunity to strengthen the defense of our Restasis intellectual property in the upcoming IPR proceedings before the US Patent Trial and Appeal Board”.
He added: “Allergan evaluated this approach closely, with expert counsel in patent and sovereign immunity law.”
The committee said the sovereign status of Native American tribes added complexity to the contesting status of the patents in question, “because tribes may be immune from the legal claims generic drug makers use to challenge patents and bring less costly drugs to market more quickly”.
It added: “The implications of Allergan's patent transfer raise questions for Congress as the exchange may impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs.”
Last week, US senators Margaret Hassan, Sherrod Brown, Robert Casey and Richard Blumenthal penned a letter to the US Judiciary committee describing Allergan’s deal as “a blatantly anti-competitive attempt to shield its patents from review and keep drug prices high”.
They added: “Allergan’s actions directly circumvent the inter partes review process, established by Congress in the America Invents Act of 2011. We are deeply concerned with the numerous patent law and anti-competitive implications of Allergan’s deal, which harm patients’ ability to afford medications.”
“We believe that sovereign immunity is a fundamental precept of our legal structure and that there should be parity among States and Tribes,” they said, “Companies should not be allowed to pay States and Tribes simply to invoke their sovereign immunity, and companies like Allergan should not be allowed to exploit sovereign immunity at the expense of patients.”