BIO Statement on Hatch-Waxman Integrity Act of 2019

Washington, D.C. (February 6, 2019) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the Hatch-Waxman Integrity Act of 2019:

“The groundbreaking law known as the Hatch-Waxman Act (HWA) was the single most important piece of legislation ever crafted to broaden patient access to life-saving treatments. However, unforeseen gamesmanship of the system has forced many of the innovators of these therapies to defend their intellectual property in multiple court systems under differing rules, and often unfair standards.

“BIO applauds the leadership of Senator Thom Tillis (R- NC) and Congressman Bill Flores (R-17 TX) for introducing the “Hatch-Waxman Integrity Act of 2019” to preserve the time-tested approach of the HWA while strengthening the ability of patent owners to fairly defend against abusive efforts to invalidate patents for innovative life-saving medical therapies.

“The majority of biotechnology companies are small companies that have no products on the market, and thus their research and development activities are funded through massive amounts of private sector investment over many years, sometimes even decades. Without strong, predictable and enforceable protections for patented inventions, investors will shy away from investing in biotech

innovation, degrading the ability to provide solutions to the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world.

“BIO supports the balanced reforms within the Hatch-Waxman Integrity Act of 2019 and will continue to advocate for its passage.”

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