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Rep. Flores, Sen. Tillis Introduce Bill to Restore Balance and Integrity to the Patent System

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WASHINGTON, D.C. , February 6, 2019 | Andre Castro (202-225-6105) | comments

Today, Representative Bill Flores (R-TX) and Senator Thom Tillis (R-NC) re-introduced the Hatch-Waxman Integrity Act in the House of Representatives and Senate. 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.

“Innovative pharmaceutical companies continue to develop new and exciting therapies to help change the lives of patients around the world,” said Representative Flores. The Hatch-Waxman Integrity Act supports continued innovation by restoring an effective balance between the interests of brand-name and generic drug manufacturers. By ensuring a balanced process to challenge pharmaceutical patents, we make certain that American patients will continue to benefit from research, new discovery and medical innovation.”

“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 leadership on this issue and I look forward to building support for this bill within the Senate.”

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.


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The Lower Costs, More Cures Act uses bipartisan reforms to lower out of pocket spending, protect access to new medi…