Allergan Agrees to $13.75 Million Deal with Tribe to Protect Restasis Patents

September 8, 2017: By Joan McKenna

Allergan-logoAllergan announced Sept. 8 that it has agreed to a $13.75 million deal with the Saint Regis Mohawk Tribe that transfers all FDA Orange Book-listed patents covering Restasis to the tribe and gives Allergan an exclusive license to the patents.

The move is designed to protect the patents, as Allergan faces increasing competition from developers of generic versions of its dry eye treatment.

Allergan was set to go before the US patent office Sept. 15 for an inter partes review by petitioners Mylan, Teva, and Akorn.

The tribe has sovereign immunity from patent challenges and will now file a motion to dismiss the inter partes review proceedings, Allergan said.

Bob Bailey, Allergan’s chief legal officer, said the tribe, located in Franklin County, New York, approached Allergan with the idea. Bailey said Allergan was impressed with the tribe’s thoughtful and enterprising approach, which would allow the tribe to achieve its goals of self-reliance and help it to address the most urgent needs in its community.

Under the deal, the tribe also is eligible to receive $15 million in annual royalties.

The deal has no affect on Allergan’s suit against Mylan, Teva Pharmaceuticals, Akorn, and Pfizer’s Inno Pharma division related to their abbreviated new drug applications for generic versions of Restasis. A five-day trial bench trial in the case just concluded in US District Court in Marshall, Texas.

Patents on Restasis run through Aug. 27, 2024. The drug was US FDA approved in 2003.

Allergan’s Restasis sales in 2017 totaled nearly $1.5 billion. However, Q2-2017 sales were about $354 million, a 9.4 percent decline over the same quarter last year due to pressure from Shire’s new Xiidra.

Also on Aug. 29, Allergan agreed to settle with generics drugmaker Famy Care, allowing Famy to market a Restasis generic in February 2024 or earlier if certain undisclosed circumstances are met.

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