Legislation would make it easier for generic and biosimilar drugs to enter the market, increasing competition and lowering the price of prescription drugs

WASHINGTON, D.C. – Senator Peter Welch (D-Vt.), Senator Mike Braun (R-Ind.), and Senator Amy Klobuchar (D-Minn.) today introduced bipartisan, bicameral legislation to streamline drug patent litigation, encourage fair market competition, and lower prescription drug prices by making it easier for generic and biosimilar companies to enter the market. Rep. Jodey Arrington (TX-19) introduced companion legislation in the House. 

“It’s egregious that because of Big Pharma’s greed, Vermonters pay three times more for prescription medications than people in other countries. For decades, Big Pharma has exploited U.S. courts and the patent system through anti-competitive practices that prevent generic and biosimilar competitors from entering the market, forcing Vermonters to pay more out of pocket for life-saving drugs,” said Sen. Welch. “This bipartisan legislation will be a step forward in the fight to stop pharmaceutical companies from abusing the patent system. That will lead to fair competition and lower prescription drug prices. Congress needs to keep working together to cut drug costs for families and streamline access to care.” 

“Protecting intellectual property is one of the things that makes the American economy so innovative, but often there are loopholes that allow the pharmaceutical industry to delay competition. Market competition is essential for keeping prices low, and this bill will go a long way to fixing one of those problems,” said Sen. Mike Braun. 

“Big Pharma is exploiting loopholes in our courts and patent system to block generic and biosimilar pharmaceuticals from the market, leading to higher out-of-pocket costs for everyone,” said Sen. Klobuchar. “Enough is enough. Our bipartisan bill will close these loopholes, strengthen competition, and lower prescription drug prices.”   

“America leads the world in medical innovation and Congress understands the role strong IP protections play in that leadership. Groundbreaking research feeds innovative products, fuels our economy, improves quality of life for patients, and drives down healthcare costs. Unfortunately, loopholes in our current patent system allow manufacturers to file for duplicative patents that can ultimately delay low-cost generic entry into the marketplace. This means that patients are stuck paying for higher priced drugs when a cheaper alternative could be readily available. Patients cannot access the cheapest options if companies artificially extend their patents creating a monopoly that kills competition. I’m proud to lead this legislation to improve our health care system and reduce the price of drugs for patients,” said Rep. Arrington. 

“As a researcher in the field of IP law, I applaud the sponsors of the bill for taking a narrow approach to combatting patent thickets by addressing the use of terminal disclaimers. This approach strikes a balance between fulfilling the public’s demand for cost-effective and readily available medications, while also providing manufacturers with the incentives to foster innovation. This bill will help drive competition. For generic and biosimilar firms, the bill will help get lower-cost drugs to market faster. For patients, the bill will promote better health outcomes. This legislation is also designed to avoid harming innovation because brand manufacturers will retain the ability to patent their inventions. However, they will be required to carefully select and enforce the most suitable patent,” said Dr. S. Sean Tu, Professor of Law at West Virginia University. 

“Patients For Affordable Drugs is pleased to endorse this bipartisan legislation to curb the abuse of patent thickets that drug companies use to block lower-priced competition. The legislation is an important complement to other bipartisan bills such as Cornyn-Blumenthal that are moving through the Senate and aim to ensure patents are used to reward innovation—not to extend unwarranted monopolies,” said Merith Basey, Executive Director of Patients For Affordable Drugs NOW. “We thank Senators Braun, Klobuchar, and Welch for their continued leadership in the fight to ensure Americans get the innovation we need at prices we can afford.” 

“This bill is important legislation to rein in drug company greed and make prescription drugs more affordable for the American people,” said Protect Our Care Chair Leslie Dach. “Under President Biden, Congress has made historic progress in lowering drug prices by passing the Inflation Reduction Act. This bill keeps the momentum by helping prevent drug companies from abusing the patent system and keeping costs unreasonably high for patients. Today marks another step in the right direction so people can access lifesaving drugs at an affordable cost.” 

The U.S. Patent system was designed to promote innovation and foster competition. Yet exceedingly, pharmaceutical companies abuse the patent system through patent extension strategies such as “patent thicketing,” a strategy in which pharmaceutical companies develop a “web” of patents around their most profitable drugs. These patent thickets deter generic and biosimilar drugs from entering the market, due to the high cost of challenging each patent in a thicket.  

This bill codifies the practice that many federal district courts across the country already apply to limit the number of patents or patent claims a company can assert in litigation.  

Specifically, this bipartisan bill: 

• Streamlines patent litigation by limiting to one, the number of patents per patent thicket a pharmaceutical company can assert in litigation. 
• Prohibits a patent owner from asserting multiple patents from the same thicket in separate actions against the same alleged infringer to circumvent the intent of the law. 
• Safeguards quality patents that improve existing drugs, benefiting patients. 

Learn more about the bill here. 

Read the full text of the bill here. 

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