Tribe defends Allergan deal in letter to senators
The Saint Regis Mohawk Tribe has launched a fierce defence of its patent licensing deal with Allergan, giving the Senate Judiciary Committee six main reasons which justify the agreement.
In a letter sent on Friday, October 13, the tribe told Charles Grassley, chairman of the committee, and Dianne Feinstein, a ranking committee member, that it plays a vital role in providing healthcare services.
The letter was sent a day after the head of the Biotechnology Innovation Organization (BIO), James Greenwood, also wrote to the two senators. He raised concerns about the inter partes review (IPR) process and its impact on the pharmaceutical industry.
Allergan paid the tribe $13.75 million to license the company’s patents covering Restasis (cyclosporine ophthalmic emulsion), a dry eye treatment. The agreement itself was made after Mylan had filed IPRs against the patents.
The agreement has received much criticism, and in the letter to the senators, the tribe said it wants to clarify claims and misperceptions in a September 27 letter that asked the Senate Judiciary Committee to investigate the deal with Allergan.
That letter was sent by four senators, Maggie Hassan, Bob Casey, Sherrod Brown and Richard Blumenthal.
Opening the message to Grassley and Feinstein with “Tekwanonhwerá:tons”, which means “Greetings” in the tribe’s native tongue, the authors first said that tribal governments should be able to maintain parity with states and public universities.
The tribe said: “We encourage you to look at the practices of your own states and the positive impacts that state and public university ownership of Orange Book-listed patents are having on your constituents.”
Next, the letter focused on the need to protect a revenue stream that directly benefits the tribe’s citizens, saying that the partnership with Allergan opens a new source of funding that will help offset budget shortfalls for issues such as housing, healthcare and education “due to inadequate annual funding levels”, among other problems.
It added: “It is the tribe’s job, as a sovereign government, to provide healthcare services to its community members and it is acutely aware of the cost of pharmaceutical drugs and the financial challenges faced by so many families.”
The tribe also claimed that, “like public universities who own patents”, tribal governments will not cause a spike in companies transferring patents to tribes.
The day before, Greenwood of BIO wrote to the senators to complain about the IPR, which he said was “highly controversial”.
He emphasised that BIO takes “no particular position” on Allergan’s deal with the tribe and added that “we are aware of no instance where sovereign immunity has ever interfered with or delayed resolution of innovator-generic patent disputes in federal court”.
Instead, “it is the misuse of IPR, not the assertion of sovereign immunity, that has introduced imbalance into the Hatch Waxman Act framework. We remain committed to restoring that balance through reasonable, but urgently-needed reforms of the IPR system”.
Giving an example, Greenwood said generic drug companies already receive benefits under the act that exist in “no other industry”, including a safe harbour from infringement liability during drug development.
“Generic companies now use IPR to game the system in pursuit of further advantages—for example, by litigating the innovator company’s patents for about a year in federal district court, and then using what they have learned to open a parallel challenge to the same patents in an IPR proceeding.”
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