House of Representatives committee probes Allergan IPR deal
A US House of Representatives committee has begun a probe into Allergan’s patent deal with a Native American tribe.
The deal, announced in September, saw the Saint Regis Mohawk Tribe acquire the patent rights to Restasis (cyclosporine ophthalmic emulsion), a dry eye treatment.
Allergan paid the tribe $13.75 million in the deal and the tribe has now granted Allergan an exclusive licence to the treatment.
Soon after, the tribe filed a motion to dismiss inter partes reviews (IPRs) brought by Mylan, based on the tribe’s sovereign immunity from IPR challenges.
Numerous commentators have questioned whether the deal was a misuse of sovereign immunity.
Mylan, the company that had requested six IPRs of the patents, claimed it was a desperate and transparent delay tactic, in a filing at the US District Court for the Eastern District of Texas, Marshall Division (where the patents are also being litigated).
The tribe is not the first party to employ this strategy.
In May this year, the Patent Trial and Appeal Board held that a heart valve patent owned by the University of Maryland, Baltimore is immune to IPR.
The Saint Regis Mohawk Tribe said: “It appears that the strategy is a concern only when a tribe decides to enter the same business for the benefit of its community.”
Yesterday, October 3, the House Committee on Oversight and Government Reform sent a letter to Allergan, stating that the deal was an “unconventional manoeuvre”.
According to the letter, the patent transfer raises 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 group of four representatives who wrote the letter asked Allergan to provide a number of documents, including communications between the parties concerning the patents and documents outlining whether Allergan is considering similar arrangements for its other drugs.
Allergan said it will comply with the request and that, while it fully recognises the need for information, the committee’s focus should be on the IPR process and its “negative impact on life sciences innovation”.
“To be clear, if the district court ruling is adverse to Allergan’s patent position, and there is a Food and Drug Administration approval of a generic version of Restasis, that product could enter the market many years in advance of the listed patent expiry dates,” the company added.
Brenton Saunders, CEO of Allergan, sent a letter on the same day to four senators that had asked the Senate Judiciary Committee to investigate the agreement.
“Allergan along with the biopharmaceutical industry and others have, for the past several years, expressed concerns to Congress about how the IPR process … has created unintended and negative consequences,” said Saunders.
He added that the deal is helping protect the patents from the “flawed and broken” IPR process.
“Allergan urges the Judiciary Committee to review the IPR process, particularly in light of the forthcoming US Supreme Court review, to rectify its infirmities and protect the innovation that is the lifeblood of the biopharmaceutical industry and the US economy,” he concluded.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
