With ruling, Restasis could soon face generic competition

MARSHALL, Texas — Allergan’s recent patent claims on its Restasis eye drops were thrown out Monday with a ruling from the United States District Court for the Eastern District of Texas. The 135-page decision found that Allergan’s patent protection for the drug ended in 2014, and that “Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection.”

“While Allergan has pointed to evidence of objective considerations such as commercial success and long-felt unmet need, the force of that evidence is considerably blunted by the fact that, based on protection from a succession of patents, Allergan was able to foreclose competition in cyclosporin/glyceride emulsion formulations from the early 1990s until 2014,” the decision said. “And the issuance of the Restasis patents has barred any direct competition for Restasis since then.”

The lawsuit listed Teva, Mylan and Akorn as co-defendants, all of whom are hoping to market generic versions of Restasis. None of the generic versions have been approved by the Food and Drug Administration, but Mylan CEO Heather Bresch welcomed the decision.

“We couldn't be more pleased with today's federal court ruling invalidating the Restasis patents. For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients,” she said.

Allergan said that the decision was not the end of the road for their intellectual property protection efforts around Restasis.

"We are disappointed by the Federal District Court's decision on the Restasis patents. We are carefully reviewing the decision and are considering all options," Allergan chief legal officer Robert Bailey said. "Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients."