WASHINGTON, D.C. – Today, Senator Thom Tillis (R-NC) and Representative Bill Flores (R-TX) re-introduced the Hatch-Waxman Integrity Act in the Senate and House of Representatives. The legislation would help ensure that alternative procedures for challenging drug patents do not tilt the playing field contrary to Hatch-Waxman’s design. This bill will restore balance and integrity to the patent system and ensure drug manufacturers have the proper incentives to continue developing life-saving medications.
“The biotechnology and life sciences industry undertakes tremendous risk and costs to develop new, life-saving drugs, with the vast majority of products never making it to the market at great expense to the manufacturer. These drugs save millions of lives every year and are a critical component of our nation’s healthcare system. While it is important to call out bad actors who price gouge, we must allow sufficient time and balance so companies can continue to develop life-saving drugs and help people with the countless illnesses and diseases that affect millions of Americans,” said Senator Tillis. “The Hatch-Waxman Integrity Act will restore a proper balance in the market so that companies will continue to spend billions of dollars to develop life-saving and life-altering treatments. I want to thank Senator Hatch for his strong leadership on this issue and I look forward to building support for this bill within the Senate.”
"The Hatch-Waxman Integrity Act ensures that America remains a leader in developing life-saving and accessible therapies, cures and treatments for patients," said Representative Flores. "It restores an effective balance between the interests of brand-name and generic drug manufacturers so that innovation and competition will continue to flourish. It was fulfilling to work with Senator Hatch on this initiative during the last Congress; and I look forward to working with Senator Tillis to modernize the Hatch-Waxman Act so that hardworking American families continue to benefit from health care innovation."
The Hatch-Waxman Integrity Act of 2019 would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman framework, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and inter partes review, or IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process. The bill would apply similarly to patents on biologics.
The bill would preserve Hatch-Waxman as the standard path for generic manufacturers to challenge brand patents, while keeping IPR as an option where other interests come into play. It would not have any impact on the use of IPR by the tech community.
A copy of the bill text is available [here].