But the fight is far from over. The tribe immediately challenged the ruling by taking it to the Federal Circuit Court of Appeals and by requesting a delay in the IPR, pending resolution of the matter in the judicial system. According to the tribe, the board got a lot of things wrong in what has been acknowledged to be a novel legal issue. It "effectively usurped the power of Congress to abrogate tribal immunity, created the fiction of an 'effective' patent owner to further its efforts to move the case forward, and misapplied the well-established law of tribal sovereignty," a motion for a stay read. Noting that the "final" IPR hearing was scheduled for next Tuesday, the Federal Circuit agreed to grant the tribe's motion. The court also agreed to expedite the case by holding oral arguments sooner rather than later. "The stay shall remain in effect until the day after oral argument in the appeals in June 2018," the court's order on Wednesday read. The stay had been opposed by three companies that are challenging the RESTASIS® patents. Before the Patent Trial and Appeal Board even reached its decision, a federal judge in Texas invalidated the patents owned by Allergan, the original developer. At the time, Heather Bresch, the CEO of Mylan, one of the challengers, said the judge's ruling was "binding" on the tribe. Following the patent board's ruling last month, she said Allergan's deal with the tribe was a "sham." The tribe and Allergan have been upfront about their arrangement, saying it was intended to block the ongoing IPR. Their deal, announced last September, drew significant attention in the mainstream media before members of Congress got mad about it. “This is one of the most brazen and absurd loopholes I’ve ever seen, and it should be illegal,” McCaskill, who is the top Democrat on the Senate Homeland Security and Governmental Affairs Committee, said as she introduced a bill to abrogate tribal sovereign immunity in IPRs.
Concerns appear to be financial in nature. The tribe received an immediate $13.75 million payment for taking on the patents in dispute. By licensing the product back to Allergan, the tribe stands to make up to $15 million in royalties a year. "To ensure the strength and vigor of our regional economy and to protect against persistent threats to our tribal general fund and federal funding, we have been forced to diversify our investment strategies," the tribe said in a letter to lawmakers who raised questions about the deal. But it looks like Allergan remains the real winner. According to the Republican and Democratic leaders on the House Committee on Oversight and Reform, which has launched an investigation into the "unconventional deal," the firm benefits greatly from the tribe's claim of immunity. "As Allergan's second best-selling drug, Restasis generated nearly $1.5 billion in revenues for the company last year," the lawmakers wrote in a letter to the firm in October.
Rep. Issa, who is retiring from Congress later this year, previously served as chairman of Oversight and Reform. He was frank with his take on the controversy, saying the tribe was no better than the University of California in his district, which he described as a "major troll" when it comes to patents. "States are doing wrong," Issa told tribal leaders at NCAI. "States are, in fact, trolls in many cases." Issa said universities license their patents to law firms "who do nothing but sue people frivolously" for allegedly violating those patents. "What they are saying is, 'Heads I win, I take your money. Tails, I lose, you can't go after me or invalidate my patent,'" he added. "Most people kind of get it -- that really isn't fair." Issa pointed out that Allergan, which is headquartered in Ireland, operates an office in his district and is one of the major employers there. Nevertheless, he said the firm engaged in a "cute trick" by bringing the tribe on board in an attempt to quash the IPR. "Was it the tribe's patent or the did the tribe take money and put it behind a firewall? Well, the answer was the latter," he said of the Allergan-Mohawk arrangement. Related Stories:
Native Sun News Today: Oglala Sioux Tribe joins heated debate over drug patents (December 8, 2017)
The Conversation: Saint Regis Mohawk Tribe stirs controversy with patent deal (November 27, 2017)
Sen. McCaskill unveils unprecedented bill to abrogate tribal sovereign immunity (October 5, 2017)
St. Regis Mohawk Tribe acquires drug patents in attempt to end legal dispute (September 8, 2017)