Chairman Nadler Statement for the Markup of H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
Washington, September 30, 2021
Washington, D.C. - Today, House Judiciary Committee Chairman Jerrold Nadler (D-NY) delivered the following opening statement, as prepared, during the markup of H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act:
"H.R. 2884, the 'Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act,' is the final bipartisan measure we are considering today to address ever-increasing medical costs and to help make healthcare more affordable.
"This legislation concerns some of the most cutting-edge medicines being developed today, called biologics. These are complex, large-molecule drugs made from living organisms. Biologics are expensive to develop and bring to market, and these dynamics are reflected in their high costs and spending totals. The costs for some biologics can reach hundreds of thousands of dollars per patient, per year.
"One way to address the particularly high price of this class of drugs is to encourage the entry of generics, or 'biosimilars.' In 2010, the Biologics Price Competition and Innovation Act established an important mechanism for getting biosimilars to market. However, the process set forth in that legislation for addressing patent disputes between the company that created the biologic drug and the company or companies that want to market biosimilar versions of that drug has so far failed to live up to its promise of streamlining litigation.
"The streamlining of patent disputes is especially complicated by an emerging practice referred to as 'patent thicketing.' This is when a manufacturer seeks to prolong its exclusive rights to market a drug by seeking a voluminous number of patents with an eye towards fending off biosimilars attempting to enter the market.
"For example, years after a brand-name biologic’s release, the manufacturer may file claims to the subject biologic that do not incorporate significant changes or claims to a method of manufacturing that the manufacturer does not itself use. These claims tie up biosimilars in litigation and keep them off the market.
"H.R. 2884 will help to address these tactics and ultimately, to lower drug prices. The legislation limits the number patents that the brand-name manufacturer can assert in litigation, which forces the manufacturer to focus on its key patents with the goal of streamlining the resolution of disputes with companies that want to sell biosimilar versions of that biologic.
"When biosimilars can get to the market quickly, consumers get to see those savings faster."I was pleased to see this legislation advance through the Senate Judiciary Committee earlier this year, and I hope it will see similar action in this Committee today. I applaud Mr. Johnson and Mr. Issa, the Chairman and Ranking Member of the Subcommittee on Courts, Intellectual Property, and the Internet for their bipartisan work to address high drug prices, and I urge my colleagues to support this legislation."