Placeholder Banner

BIO Statement on Hatch-Waxman Integrity Act of 2018

December 14, 2018

BIO Statement on Hatch-Waxman
Integrity Act of 2018

Washington, DC (December 14, 2018) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the Hatch-Waxman Integrity Act of 2018:

“For almost 40 years, the groundbreaking law known as the Hatch-Waxman Act (HWA) has been highly successful in spurring the development of life-saving new treatments while at the same time vastly broadening the availability of low-cost generic pharmaceuticals.  However, in recent years the law’s carefully-crafted balance has been undermined by unforeseen gamesmanship which forces innovators of new therapies to defend their intellectual property against needlessly repetitive attacks, in multiple court systems under differing rules.

“BIO applauds the leadership of Senator Orrin Hatch (R-UT), Congressman Bill Flores (R-17 TX), and Senator Thom Tillis (R-NC) for introducing the Hatch-Waxman Integrity Act of 2018 to preserve the time-tested approach of the HWA while restoring 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 preservation of the Hatch-Waxman Act and thanks the sponsors for their important efforts.”

Discover More
Healthcare Ready, Biotechnology Innovation Organization, and Wakefield Research release data  Washington (March 30, 2023) -- The last several years have shown that preparing for a public health emergency is vital to protect the public, our…
Biotechnology companies are hard at work on the cutting-edge innovations we need, but those breakthroughs are at risk from current tax policy. The Biotechnology Innovation Organization, which represents more than 1,000 biotech companies, thanks…
Mr. Delacourt is a senior litigator and regulatory counselor with more than a decade of experience advising biotech companies WASHINGTON – (March 15, 2023) – The Biotechnology Innovation Organization (BIO) welcomes John Delacourt as Deputy General…