Manatt’s Yasser El-Gamal, co-chair of the firm’s intellectual property practice, was quoted on Allergan’s patent transfer in an article by The Street. Allergan announced it would transfer patents for Restasis—its long-standing dry eye medication—to the Saint Regis Mohawk Tribe, which would shield the drug from patent challenges being waged by competitors including Mylan.
When it announced the transfer on Sept. 8, Allergan received criticism from key players in the biotech industry. The publication noted that critics felt the move would draw unwanted attention from Washington in a time when the industry is already facing heavy scrutiny surrounding price gouging of branded drugs and the slow approval pace for lower-cost generics.
The legal battle surrounding Allergan’s patent transfer could set precedent for similar cases in the future. One key legal question is whether the Saint Regis Mohawk Tribe’s sovereign immunity is in effect. El-Gamal explained that it’s uncertain whether the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board will agree the sovereign immunity that applies to universities also applies to Native American tribes.
“The analysis Allergan is making and whether the jurisprudence being relied on applies to Native American tribes is untested,” he said.
It is also unclear whether Congress will view the transfer as indicative of a loophole in the America Invents Act that needs to be closed.
“We’re just at the front end of developing the jurisprudence that ultimately governs in these types of situations,” said El-Gamal.
Read the article here.