BIO Statement on 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.”
Source: Biotechnology Innovation Organization