Texan judge invalidates Restasis patents

Genéricos/General | Posted 03/11/2017 post-comment0 Post your comment

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).

Judge William Bryson said a group of patents (No. 8,629,111; 8,648,048; 8,685,930 and 9,248,191) Allergan obtained on Restasis, which are set to expire in 2024, should not have been granted because they describe methods of treatment that were obvious in light of earlier patents granted to the company. The district court of Eastern Texas made the ruling as part of a decision over a longstanding dispute between Allergan and generic drugmakers Mylan, Teva Pharmaceutical Industries and Akorn.

The ruling comes as a blow to ophthalmic specialist Allergan who in an effort to protect its drug from generics competition made a deal with the Saint Regis Mohawk Tribe in September 2017. The deal involved transferring the patents on Restasis to the tribe with Allergan then making payments in order to exclusively license the patents back to the company [1].

The court also expressed concerns over the Saint Regis Mohawk Tribe deal, saying ‘the Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed’. Judge Bryson added that ‘sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities’.

Members of Congress have also expressed concerns about the deal, seeing it as an ‘anti-competitive attempt to shield its patents from review and keep drug prices high’. On 5 October 2017, Senator Claire McCaskill introduced a bill that aims to close the sovereignty ‘loophole’ and make such a manoeuver illegal.

The ruling in Texas, however, does not mean that generics will be available soon. Allergan said that it was ‘disappointed by the Federal District Court’s decision’ and that it will ‘appeal the Court’s ruling’. In addition, the US Food and Drug Administration has not yet approved a generic version of the drug.

Related article
Allergan objects to Restasis generics being accepted without human trials

1. GaBI Online - Generics and Biosimilars Initiative. US tribal patent deal could prevent generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Generics/General/US-tribal-patent-deal-could-prevent-generics

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Source: Allergan

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