Milan Pharmaceuticals Case Summary

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The case between Milan Pharmaceuticals and the St. Regis tribe relates to the patents that the tribe received from Allergan for its Restasis eye drops and the Tribe’s motion to dismiss the proceedings of the IPR system based on its sovereign immunity. American drugmaker Allergan made a pact with the St. Regis Mohawk Tribe (“the Tribe”) in September 2017 that officially transferred six of the company’s controverted patent ownerships for Restasis to the Tribe. The deal outlined that Allergan was to pay the tribe an annual royalty of $15 million each year, including an upfront charge of $13.75 million, to retain a license to particular rights to the patents. So, Allergan gave the Tribe the rights to Restasis, and the tribe licensed them back to Allergan. The transfer, however, came just a week before the reviewing of the patents by the Patent Trial and Appeal Board (PTAB) following challenges …show more content…

filed a case against the move by the Tribe. The PTAB denied the Tribe’s move to dismiss the pending IPR reviews, holding that the tribal sovereign immunity doctrine did not apply to IPR proceedings. This holding contradicted PTAB’s decisions that involved state sovereign immunity in line with the Eleventh Amendment, all of which assert that Eleventh Amendment can be used as a defense in IPR, as was the case in Covidien LP v. University of Florida Research Foundation, Neochord, Inc. v. University of Maryland, and Reactive Surfaces LTD. V. Toyota Motor Corp. The PTAB claimed that the sovereignty of an Indian Tribe was subject to the whole and superior control of Congress and that Congress had purposed IPR to apply to any patent notwithstanding the ownership in the enactment of the America Invents Act. The Board further alluded to the Santa Clara Pueblo v. Martinez case and reasoned that no evidence was available to show that Congress had intended that patents owned by the Indian tribe be immune to the IPR because of tribal sovereign immunity

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