Bioregnum

SCOTUS just turned its back on Allergan’s legal maneuver to take a blow at inter partes review. What did you expect?

It’s finally over.

Bioregnum Opinion Column by John Carroll

From the very beginning, Allergan’s attempt to safeguard its blockbuster Restasis franchise by handing over the patents to a Mohawk tribe in New York looked like a bad parody of a legal loophole maneuver. Now it’s a dead parody, after the Supreme Court on Monday shunned the company’s attempt to take its argument to the highest court in the land with a single line.

The tribe’s immunity would safeguard the patents from the inter partes review process, they reasoned, and they could basically lease back control of the drug while steering clear of a serious threat from generic drugmakers.

Brent Saunders speaking at an Endpoints event in 2017 Endpoints News

But this wasn’t just defended by the attorneys, who are paid to make arguments of all kinds. Allergan CEO Brent Saunders took up the standard and led the charge himself. He hurt himself at every turn, looking every bit like a Big Pharma exec who would try any gimmick to protect the cash cow. This was in 2017, as the industry’s rep was taking a turn for the worse — while the public and lawmakers began to raise a clamor over drug prices.

Allergan stuck to its legal guns, and the industry rep slid south right along with their argument.

“We can certainly agree to disagree,” Saunders told me back when this got started, adding adamantly that “everything we have done here is completely consistent with our social contract.”

You don’t hear much about the social contract these days, which dates back to the company’s attempt to get top players to show some restraint on drug prices. Allergan raised many of its drug prices 9.9% at the beginning of the year, within the guidelines of the social contract, and all you hear from the public now is a demand to cut prices.

Aside from a few biotech allies who are no bigger fans of IPR than Allergan, though, the biotech had few champions to help in the fight. Prominent lawmakers singled them out to scornfully accuse them of trying to run a sham. Activists would add this to their list of transgressions by Saunders as the stock price declined.

Instead of defeating the IPR process — eliminating a third party challenge to patents that has bedeviled biopharma for years — Allergan has helped enshrine it in federal law. The appeals court sided with the patent board, concluding that IPR was more in line with executive branch enforcement decisions than private party litigation in federal court — where immunity could be applied. 

On Monday, the Supreme Court wrote off Allergan’s case, denying their attempt to argue the case in front of the 9 justices. The appeals court decision stands. The Restasis fortune is slated for decimation, with Mylan and Teva pushing to get out cheap copycats. A federal judge had invalidated the patents in the fall of 2017, dissing the Mohawk move as illegitimate.

Enough said.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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