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US court overturns Allergan's controversial attempts to avoid Restasis patent review

Published on 23/07/18 at 10:55am

The US Court of Appeals for the Federal Circuit has seen fit to authorise a US Patent and Trademark Office (PTO) tribunal to review the validity of Allergan’s controversial patents covering its dry eye drug Restasis (cyclosporine), foiling the company’s efforts to shield them from scrutiny.

Allergan attracted criticism in September last year when it moved to transfer the patents for Restasis to New York’s Saint Regis Mohawk Tribe, with the company arguing that the Native American tribe’s sovereign status would mean that the patents would be protected from administrative review. The tribe then licensed the drug back to Allergan, who in return paid $13.75 million and provided ongoing royalty payments to the value of up to $15 million.  

The company had taken the decision following legal challenges the previous year from Mylan, which was looking to market its own generic version of the drug.

But the move was widely criticised across both political aisles and was not enough to impede a tribunal reviewing the patents back in February of this year. The latest decision this week once again threatens Allergan’s ongoing attempts to maintain its revenues from lower-priced competitors. Restasis generated $1.5 billion for the company throughout 2017 – 9% of its total sales.

The Saint Regis Mohawk Tribe has rejected the ruling. “The Tribe is reviewing the decision and consulting with our attorneys,” said Brendan White, a spokesperson for the tribe.

Matt Fellows

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