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. – Today, U.S. Senators Peter Welch (D-Vt.), Josh Hawley (R-Mo.), and Amy Klobuchar (D-Minn.) teamed up to introduce the Eliminating Thickets to Improve Competition (ETHIC) Act, 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. U.S. Representative Jodey Arrington (R-TX-19) introduced companion legislation in the House. 

“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. It’s outrageous, and it’s gone on for far too long,” said Senator Welch. “I’m proud to join my colleagues in introducing the ETHIC Act to stop pharmaceutical companies from abusing the patent system and lower prescription drug prices for patients across the country. Congress must pass our legislation to cut drug costs for families and streamline access to care.” 

“Big Pharma knows exactly what it’s doing in monopolizing the U.S. patent system: driving up drug costs for Americans while preventing generic-drug manufacturers from getting their foot in the market. This bipartisan bill would break up the anticompetitive ‘patent thickets’ that pharmaceutical companies have abused to the detriment of the American patient,” said Senator Hawley. 

“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 Senator 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 necessity of strong IP protections. Groundbreaking research and development fuels our economy, improves quality of life for patients, and brings down healthcare costs – one of the drivers of our national debt. Unfortunately, loopholes in our current patent system allow manufacturers to file for duplicative patents that delay competition. I am proud to lead this legislation to ensure new patents include real innovation and bring additional value to patients,” said Rep. Arrington. 

The U.S. Patent system was designed to promote innovation and foster competition. However, pharmaceutical companies are exceedingly abusing 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.  

The ETHIC Act 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. 

The ETHIC Act is endorsed by the Association for Accessible Medicines and Generation Patient. 

“Patent thickets increasingly serve as a barrier to patient access to lower-cost generic and biosimilar medicines. This bill proactively addresses anticompetitive patent thickets by limiting brands to a single patent out of a duplicative patent family in Hatch-Waxman and biologics patent litigation, said John Murphy III, President and CEO, Association for Accessible Medicines. “In alignment with the Administration’s Executive Order on competition, this bill will accelerate generic and biosimilar launches and stop these problematic double patenting practices.”  

“As an organization representing over 25 million young adults with chronic conditions in the United States, we witness daily the barriers to accessing affordable, life-saving medicines. For young adults striving for financial security and independence, these obstacles to accessing necessary medicines are especially daunting. With the leadership of Senators Welch and Hawley, the ETHIC Act represents a pragmatic step toward closing loopholes that allow brand-name pharmaceutical companies to use overlapping patents to block competition. By limiting infringement claims to one patent per group of closely related patents, this legislation promotes fair competition and enables more affordable treatment options for our community. It is time to prioritize the health and futures of patients, and this legislation is a step forward in that direction,” said Sneha Dave, Founder and Executive Director, Generation Patient. 

Learn more about the ETHIC Act. 

Read and download the full text of the bill. 

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