US introduces bill to close drug patent loophole

INICIO/Políticas y legislación | Posted 23/03/2018 post-comment0 Post your comment

The Preserving Access to Cost-Effective Drugs (PACED) Act was introduced to the US Congress on 7 March 2018.

Patent 1 V13E17

Senators Tom Cotton (Arkansas) and Claire McCaskill (Missouri), along with Senators Pat Toomey (Pennsylvania), Joni Ernst (Iowa) and David Perdue (Georgia), introduced the bipartisan bill (S.2514) in response to Allergan’s recent transfer of its patents covering its dry eye drug, Restasis, to the Saint Regis Mohawk Tribe in exchange for the tribe’s invocation of sovereign immunity against inter partes review [1].

Despite a Texan judge invalidating the Restasis patents [2] and the US Patent Trial and Appeal Board (PTAB) ultimately deciding that the tribe could not claim sovereign immunity in this case, the move has caused concern that this could lead to widespread patent abuse and increases costs for consumers.

Senator Cotton said that ‘it’s far past time that we crack down on patent abuse, which is raising costs for our seniors. This bill will make sure unscrupulous patent holders can’t game the system and block their competitors from entering the market. That’ll go a long way to help seniors get the drugs they need’.

Senator McCaskill added that ‘We watched a company brazenly try to exploit a potential legal loophole to game the system in an effort to protect their bottom line and keep Missourians from access to cheaper generic drug options in the process. That should be illegal, and our bipartisan bill would make it so by ending this astounding assertion of sovereign immunity to avoid patent review, before any other companies follow suit’.

The bill is supported by organizations including America’s Health Insurance Plans, Association for Accessible Medicines, Patients for Affordable Drugs Now, and BlueCross BlueShield Association.

This is not the first bill aimed at tackling anticompetitive behaviour that delays the market entry of more affordable generics. In 2017, the Fair Access for Safety and Timely (FAST) Generics Act, which also aims to accelerate market entry for generics, and the Creating and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES Act), which aims to prevent anticompetitive practices that delay or even block the market entry of generics, were also introduced to the US Congress [3].

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1. GaBI Online - Generics and Biosimilars Initiative. US tribal patent deal could prevent generics []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Texan judge invalidates Restasis patents []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. US Senate revives the CREATES Act []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from:

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Source: Tom Cotton, US Congress

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