Washington, DC -Today, House Oversight and Government Committee Chairman Trey Gowdy, Ranking Member Elijah E. Cummings, Rep. Dennis Ross (R- FL), and Rep. Peter Welch (D-VT) sent a letter to Allergan President and Chief Executive Officer Brent Saunders questioning whether the unconventional transfer of six patents related to its drug Restasis to the Saint Regis Mohawk tribe impairs competition from cheaper drugs.
“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," the Members wrote.
Many have raised concerns that Allergan’s patent transfer may impede generic competition because Native American tribes may be immune from legal claims generic drug makers use to challenge patents and bring cheaper drugs to the market quicker.
When Restasis was approved by the Food and Drug Administration in 2003, the patent on one of its active ingredients was set to expire in 2014. That same year, Allergan filed additional patents extending its protections to 2024. As Allergan’s second-best selling drug, Restasis reportedly generated nearly $1.5 billion in revenues for the company last year.
The Members asked Allergan to provide the following documents and information by Oct. 16, 2017:
* Agreements and communications between officials at Allergan and the Saint Regis Mohawk tribe, relating to the Restasis patents;
* Analyses conducted in connection with agreements regarding the Restasis patents, including projections for market share;
* Documents and communications concerning sales of Restasis through federal health care programs;
* Documents presented to the Board of Directors concerning agreements regarding the Restasis patents; and
* Documents and communications regarding considerations for similar arrangements for other Allergan products.
