On September 8, a group of more than 100 national and state-based advocacy organizations sent a letter to the House and Senate Judiciary Committees urging Congress to amend H.R. 9 to preserve protections of the Hatch-Waxman Act and to avoid weakening the patents that sustain medical research.
In the letter, advocates argue that the Innovation Act does little to address current abuses in the Inter Partes Review (IPR) process that threaten the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA).
According to the letter:
The Inter Partes Review (IPR) proceedings were intended to be a more efficient way to address patent challenges, but IPR opened the door to abuses that threaten the unique and specialized mechanisms under the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) and the Biologics Price Competition and Innovation Act (BPCIA). Congress established these carefully-crafted patent dispute resolution frameworks to balance the interests of innovators, generic and biosimilar manufacturers, and, most importantly, the individuals waiting for a treatment or cure. This system generally works well. Many generic medications are entering the market while, at the same time, innovative R&D is delivering new treatments to patients. These trends are helping individuals with chronic and complex conditions live longer, healthier lives.
The letter goes on to state:
Congress never intended for the IPR proceedings to undermine the patent dispute resolution frameworks in Hatch-Waxman and BPCIA. We urge Congress to include language in H.R. 9 that would preserve the highly-detailed and sophisticated systems designed by Hatch-Waxman and BPCIA to avoid weakening the patents that sustain medical research. Strong patents will ensure that innovative ideas make it from the lab to the people who need them most.