Pharmacies hit Allergan with Restasis competition claims

Four US pharmacies have filed an antitrust lawsuit against Allergan over the drug company’s “unlawful scheme” to maintain its patent monopoly over dry-eye treatment Restasis (cyclosporine ophthalmic emulsion).

Walgreen, The Kroger Company, Albertsons Companies and Heb Grocery Company filed the lawsuit (pdf) at the US District Court for the Eastern District of New York yesterday, May 17.

The suit claimed Allergan made “about $3.3 billion” selling Restasis in the US for more than 11 years, during which time the drug was protected by US patent number 5,474,979.

Allergan is currently in battle at the US Court of Appeals for the Federal Circuit in relation to a patent deal it signed with the Saint Regis Mohawk Tribe. Last year, Allergan paid the tribe $13.75 million to acquire Restasis patents from Allergan, with the company then being granted an exclusive licence to the treatment.

The Patent Trial and Appeal Board has since rejected the tribe’s attempt to dismiss inter partes reviews (IPRs) filed against Restasis based on sovereign immunity claims, saying sovereign tribal immunity doesn’t apply in IPR proceedings. The case is on appeal to the Federal Circuit.

According to the pharmacies’ new lawsuit, Allergan “unlawfully maintained its monopoly” by making material misrepresentations and omissions to the US Patent and Trademark Office (USPTO) that allowed it to obtain follow-on patents to which it was not entitled.

The lawsuit claimed that Allergan sued generic competitors for alleged infringement of “invalid and unenforceable patents” and then transferred ownership of the patents to the tribe “in order to avoid judicial scrutiny of the patents”.

According to the pharmacies, when Allergan sued several generic competitors for patent infringement in 2015, “it did so knowing that the data the USPTO had relied on in issuing the patents was neither new nor unexpected”.

It added that Allergan entered into an “unlawful contract” with the Saint Regis Mohawk Tribe to transfer ownership of patents to the tribe.

“This unlawful agreement was another attempt to maintain its monopoly in the relevant market by insulating the invalid follow-on patents from review. Allergan’s only reason for transferring ownership to the tribe was to avoid a review of the patents that Allergan knew it was certain to lose,” the lawsuit claimed.

The pharmacies alleged that had it not been for these actions, generic Restasis would have been available in the US on or shortly after May 17, 2014, and that they (and other purchasers) would have purchased less expensive generic Restasis rather than the branded product “for the vast majority” of their cyclosporine ophthalmic emulsion requirements.

The pharmacies want a permanent injunction against Allergan and triple damages, among other forms of relief.

An Allergan spokesperson said the company does not comment on litigation.