Manufacturers Appreciate the Hatch-Waxman Integrity Act’s Tailored Solution to a Biopharmaceutical Challenge

The process of defending a patent for an innovative biopharmaceutical product is fraught with uncertainty and is procedurally complex. It does not have to be this way.

Yesterday, Senator Thom Tillis (R-NC) and Representative Bill Flores (R-TX) reintroduced the Hatch-Waxman Integrity Act. This legislation clarifies how patent disputes can be resolved, while maintaining the foundational principles and integrity of the Hatch-Waxman Act, a 30-plus year-old statute that created a critical approval pathway for generic drug products and ensured patient access to even more generic prescription drugs as well as greater competition between branded and generic products. Moreover, Hatch-Waxman included a specific procedure for generic companies to challenge patents in court.

In 2011, another patent appeal process known as inter partes review, or IPR, emerged as part of the American Invents Act. While not intended, this second opportunity to challenge innovative biopharmaceutical patents under IPR undermined the original tenets of Hatch-Waxman added needless layers of proceedings and different standards for innovative pharmaceutical patent holders. Protecting incentives to innovation through the Hatch-Waxman Integrity Act will maintain our mantle of economic and health care leadership.

This year, the United States has returned as one of world’s top ten innovative countries according the Bloomberg Innovation Index. Let’s keep going and make sure we properly align incentives and protections for biopharmaceutical manufacturers who are leading on research and development (R&D).

Robyn Boerstling

Robyn Boerstling is the Vice President of Infrastructure, Innovation and Human Resources Policy at the National Association of Manufacturers.

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