MARSHALL – A federal judge on Oct. 16 ruled that patents for a medicinal product to alleviate a condition called dry eye were invalid after Allergan, a global pharmaceuticals company, attempted to extend the patents by transferring them to a Native American tribe in upstate New York.

The case opens up development of the product produced by Allergan, Restasis, to competitors who wish to market their own generic imitations.

Called an “ophthalmic emulsion,” Restasis is a substance that helps the eyes to produce tears and prevent the symptoms of dry eye, or the inability to produce tears, including stinging, burning, sensitivity to light and potential vision loss, according to the court's Oct. 16 findings of fact and conclusions of law.

According to the website fiercepharma.com, Restasis was the second best-selling drug for Allergan last year with nearly $1.5 billion in revenue.

A patent for the product was acquired back in 2002. Patents expire over time (usually 20 years) and a review of the product was set by the U.S. Patent Office (PTO) for this year.

In September, Allergan filed a letter with the Marshall Division of the Eastern District of Texas announcing it had assigned its patent rights to the Saint Regis Mohawk Tribe. The tribe would be granted exclusive license to the patents and would receive $13 million, then become eligible to receive $15 million annually in royalty payments, according to Oct. 16 memorandum opinion and order.

Defendants Mylan Pharmaceuticals Inc., et al. challenged the agreement in court asserting the intent was to cut off challenges with the PTO by shielding invalid patents that would otherwise be cancelled under the protective immunity offered by Native Americans, the order stated.

Representatives of the Mohawk Tribe appeared at a hearing before the PTO and requested dismissal of the court proceedings based on their status of sovereign immunity, the order stated.

The court found in reviewing information submitted by the competing parties it was clear Allergan’s alleged motivation for the agreement with the tribe was to avoid patent proceedings pending before the PTO by invoking the tribe’s sovereign immunity as a block.

“Allergan purports to have sold the patents to the tribe,” the Oct. 16 memorandum opinion and order read. “In reality it has paid the tribe to allow Allergan to purchase----or perhaps more precisely to rent---the tribe’s sovereign immunity to defeat the pending (patent) proceedings in the PTO.”

The court further referred to the plan as a “ploy” adding that other companies could employ similar tactics to avoid patent reviews.

The court decided Allergan was not entitled to renewed patent rights for Restasis in the form of a second wave of patent protection, and that the patent claims are invalid.

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