Advocacy - Intellectual Property

CLSA Letter to Rep. Flores in Support of the Hatch-Waxman Integrity Act of 2019 – February 2019

February 8, 2019 

The Honorable Bill Flores
United States House of Representatives
2228 Rayburn House Office Building
Washington, DC 20515

 Dear Representative Flores: 

 On behalf of California Life Sciences Association (CLSA) – the statewide public policy organization representing California’s leading life science innovators, including medical device, diagnostic, biotechnology and pharmaceutical companies, research universities and private, non‐profit institutes, and venture capital firms – I am writing in support of your legislation, the Hatch-Waxman Integrity Act of 2019 (H.R. 990).  This meticulously crafted legislation, as introduced, strikes a careful balance between preserving the intention of the America Invents Act (AIA) and Biologics Price and Competition Act (BPCIA), and protecting biomedical innovation by preventing a company that rightfully wins a Hatch-Waxman suit from “double jeopardy.” 

 As you know, the Hatch Waxman Act (1984) and Biologics Price Competition and Innovation Act (BPCIA) (2010) have been successful in both encouraging innovation in new drug technologies and fostering competition through incentivizing the development of generic drugs and biosimilars, respectively.  These laws also established a framework for patent challenges that balanced the competing interests of brand and generic drug and biosimilars manufacturers.  However, when the AIA was signed into law in 2012, it unintentionally formed an alternate pathway for pharmaceutical patent challengers through the administrative procedure, inter partes review (IPR).  The IPR process – which is an adjudicative proceeding before the Patent Trial and Appeal Board (PTAB) – was created to address abuse of the court system by patent trolls.  This second pathway for attacking a brand patent has upset the brand-generic balance struck by Hatch-Waxman and threatens to undermine innovation of new life saving medical discoveries. 

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