US tribal patent deal could prevent generics

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US tribal patent deal could prevent generics

Generics/General | Posted 06/10/2017 0 Post your comment

A deal made between Allergan and a native American tribe could potentially protect the company from challenges on its dry eye drug Restasis (cyclosporine ophthalmic emulsion) and prevent competition from generics in the US.

Ophthalmic specialist Allergan announced on 8 September 2017 that it had made a deal with the Saint Regis Mohawk Tribe regarding the patents on Restasis. Allergan has transferred the patents to the tribe and will make payments in order to exclusively license the patents back to the company.

Since the tribe is a recognized sovereign tribal government Allergan expects the ongoing inter partes review (IPR) to be stopped, as the tribe has sovereign immunity from IPR challenges and is filing a motion to dismiss. The IPR is a process used by the US Patent Trial and Appeal Board to cancel patents.

Allergan has said that it would not claim immunity in an ongoing lawsuit in federal court by generics makers, which is also seeking to revoke the patents on Restasis. However, judges in the US have previously ruled that tribal immunity applies to litigation in federal court. Rather worryingly it could just be the beginning of a serious problem for generics if other brand-name companies follow Allergan’s lead and transfer their patents to tribes, as this could severely limit the ability of generics makers to challenge those patents.

Allergan has been fighting to protect Restasis since 2013, when it objected to Restasis generics being accepted without human trials. The company was responding to draft guidance published by the US Food and Drug Administration in June 2013 that suggested that the bioequivalence requirements for generic cyclosporines may be fulfilled by an in vitro study and that clinical trials in humans may not be necessary in all cases [1].

Under the terms of the agreement with the Saint Regis Mohawk Tribe, the tribe will receive US$13.75 million upon execution of the agreement. It will also be eligible to receive US$15 million in annual royalties.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Allergan objects to Restasis generics being accepted without human trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Generics/News/Allergan-objects-to-Restasis-generics-being-accepted-without-human-trials

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Source: Allergan