PhRMA Statement on the Hatch-Waxman Integrity Act of 2019
WASHINGTON, D.C. (February 6, 2019) – Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Nicole Longo issued the following statement:
“PhRMA welcomes action by Senator Thom Tillis and Representative Bill Flores to protect the integrity of the Hatch-Waxman Act, which was instrumental in the creation of today’s generic pharmaceutical industry. The Hatch-Waxman Integrity Act takes steps to eliminate an unintended consequence of the America Invents Act with the creation of the inter partes review (IPR) process that has resulted in duplicative proceedings for biopharmaceutical manufacturers. Requiring innovative companies to defend patents in multiple venues with differing procedural rules that are less fair to patent owners than a federal court creates significant business uncertainty for biopharmaceutical companies.
“PhRMA believes Hatch-Waxman should be the sole framework for resolving applicable patent disputes concerning generic medicines and welcomes the opportunity to work with Congress on efforts to ensure the future sustainability of the Hatch-Waxman framework and address concerns with the IPR process.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.