U.S. Sen. Thom Tillis (R-NC) and U.S. Rep. Bill Flores (R-TX) this week reintroduced a bill in their respective houses to safeguard the pharmaceutical drug patent process.
The Hatch-Waxman Integrity Act of 2019, S. 344/H.R. 990, would amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the use of a specific review process for challenging pharmaceutical drug patents and subsequently decreasing competition in the pharmaceutical industry, according to the congressional record summary.
“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,” Sen. Tillis said on Wednesday. “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.”
The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, is a comprehensive legal framework enacted in 1984 by Congress to streamline approvals of generic drugs, maintain incentives for drug innovation, and establish a procedure for patent litigation involving generics, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). The Hatch-Waxman Act created the legal and economic foundation for the current generic pharmaceutical industry, according to PhRMA.
If enacted, the proposed bill would require a generic manufacturer that wants to challenge a brand-name drug patent to choose between the Hatch-Waxman framework and an inter partes review (IPR). The lawmakers said this process would preserve Hatch-Waxman as the standard path for generic manufacturers to challenge brand patents and retain IPR as an option when “other interests come into play,” according to a summary of the measure provided by the lawmakers.
Sen. Tillis and Rep. Flores also said that the bill would apply to patents on biologics, but would not affect the technology industry’s use of an IPR.
“The Hatch-Waxman Integrity Act ensures that America remains a leader in developing life-saving and accessible therapies, cures and treatments for patients,” said Rep. 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.”
Sen. Tillis pointed out that when they’re developing new drugs, the biotechnology and life sciences industry takes on a lot of risk and costs, while most of the manufacturers’ products never make it to the commercial market.
“These drugs save millions of lives every year and are a critical component of our nation’s healthcare system,” he said.
The same-named S. 3738 and H.R. 7251 were introduced in December 2018 but were not acted on before the 115th Congress ended. The U.S. Senate version was sponsored by U.S. Sen. Orrin Hatch (R-UT), while Rep. Flores sponsored the U.S. House bill.
“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 hard-working American families continue to benefit from health care innovation,” Rep. Flores said this week.
The new S. 344 has been referred to the U.S. Senate Health, Education, Labor, and Pensions Committee for consideration while H.R. 990 is being reviewed by both the U.S. House Energy and Commerce Committee and the U.S. House Financial Services Committee.