The US Congress’ Committee on Oversight and Government Reform on Tuesday sent a letter to Allergan (AGN) requesting information on the company’s agreement to transfer six patents for its Restatis dry eye treatment to the Saint Regis Mohawk Tribe.
Allergan said in September that it was approached by the tribe “with a sophisticated opportunity” to strengthen the defense of its Restasis intellectual property in the upcoming inter partes review proceedings before the Patent Trial and Appeal Board.
“The unconventional maneuver has received considerable criticism from the generic competitors challenging the drug’s patents,” the Committee said in its letter to Allergan. “The sovereign status of Native American tribes adds time and complexity to contesting the 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.”
The committee went on to say that the implications of the patent transfer raise questions as the exchange may “impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs.”
It asked Allergan to provide documents to the committee covering “agreements and communications” between the company and the tribe; analysis conducted on the agreement, documents related to the amount of money received by Allergan from sales of Restasis through federal health care programs, including state programs that receive federal funding; documents presented to the board regarding any agreements related to the patents; and documents on considerations for a similar arrangement and transaction for other products.
The committee asked Allergan to provide the documents no later than by 5 pm ET on Oct. 17.