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B.A. in economics and MBA from top 10 business school. I have over 10 years of M&A / corporate finance experience. Currently head the New York Shock Exchange, a youth mentorship program that teaches investment management skills and ... more

Mohawk Tribe Seeks To Dismiss Allergan Patent Case

Date: Saturday, September 23, 2017 8:04 PM EST

The fight to protect Allergan’s (AGN) Restasis patents is heating up. Friday the St. Regis Mohawk Tribe filed to have Mylan’s (MYL) challenge to the patents removed:

In a filing to the U.S. Patent Trial and Appeal Board, the Saint Regis Mohawk Tribe asked that Mylan’s case seeking to invalidate Allergan’s patents on dry-eye medicine Restasis be thrown out on the grounds that the board has no jurisdiction over the tribe.

The move was expected after Allergan announced on Sept. 8 that it had transferred Restasis patents to the tribe in order to protect them from administrative challenges.

… In its court filing on Friday, the tribe said it is sovereign government that cannot face litigation in an administrative court unless it expressly waives its immunity or the U.S. Congress abrogates immunity.

“Neither of these exceptions apply here,” the tribe said.

Earlier this month Allergan sold the patents to St. Regis in order to protect them from generic competition. Apparently, St. Regis’s sovereign immunity allows it to dismiss the inter partes review (“IPR”) requested by Mylan. Generic rivals have also file abbreviated drug applications (“ANDA”) pursuant to Restasis in federal court; the St. Regis partnership does not impact the ANDA, yet it could allow Allergan to forgo the double jeopardy of an IPR.

The Situation

Restasis has about 70% share of the $1.8 billion dry eye market; Shire’s (SHPG) controls about 20%. The drug was approved in 2002 to treat patients with keratoconjunctivitis sicca whose tear production is presumed to be suppressed due to ocular inflammation. It was set to lose exclusivity in Q2 2014, but Allergan was able to get it extended to 2024. Mylan asked the patent board to invalidate the patents late last year.

The sale of the patents to St. Regis could potentially thwart the IPR sought by Mylan. Last week Mylan called Allergan desperate and claimed the patent sale was a last minute attempt to shield the patents from inevitable cancellation. Mylan also vowed to fight Allergan’s delay tactics. The situation appears to be up to the U.S. Patent Trial and Appeal Board (“PTAB”). If the Tribe owns the patents then does the board have jurisdiction over the Tribe?

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