Bioregnum, Legal

Allergan and its Mohawk allies pitch their sovereign immunity case to SCOTUS. And the timing couldn’t be worse

Allergan {AGN} is taking its case against inter partes review all the way to the Supreme Court — provided SCOTUS agrees to hear their attorneys.

John Carroll at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

Bioregnum Opinion Column by John Carroll

The biotech company made its pitch to the Supreme Court alongside the Mohawk tribe that took the patents on Restasis, Allergan’s big blockbuster, as the company tried to wall itself off from generic manufacturers. But the courts, including a federal appeals court, have ruled against the company and the tribe.

That leaves one last stop to see if the highest court in the land will back them up.

There’s no guaranteeing that Allergan will get its day in the Supreme Court. The court still has several weeks to determine if they want to put it on the calendar. But its attorneys are giving it their best shot, arguing that the federal appeals court overlooked key decisions by the Supreme Court that they believe back their case. They also asked the court to provide some clarity on the extent of sovereign immunity that Indian tribes ppossess, which the Mohawks used in their legal gambit to ward off the generic rivals.

Allergan and the Mohawks have made little progress in their heated quest against IPRs, which they believe creates a kind of double jeopardy for drug developers trying to protect their drugs. Their argument involving the Mohawks — that the tribe controls the patents and they are immune to the IPR process — has been ridiculed by lawmakers who back the notion that Allergan CEO Brent Saunders was simply leasing out sovereign immunity to guard its biggest drug franchise.

In the pitch to the Supreme Court, though, Allergan asserted that the transaction — paying $13.75 million upfront for the deal with $15 million a year due in quarterly installments — isn’t a sham. The tribe, for example, has the real authority to conduct trials of its own using this drug for other indications outside the patent. But this pitch along with many of their other arguments have tested the credulity of longtime observers — as well as judges — watching the case proceed.

The timing couldn’t be worse for the industry.

Right now there’s growing evidence that the pharma industry is one of the least-liked groups in the country. Arguing to SCOTUS about deals with Indian tribes to protect branded drugs, while boosting the price of their top therapies by 9.5%, is exactly the kind of event pharma would likely prefer to live without in 2019.

For the industry, the only thing worse about making this case would be winning it.


Image: Brent Saunders. AP IMAGES


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