Washington, D.C. –Today, House Judiciary Committee Chairman Jerrold Nadler (D-NY) delivered the following opening remarks during the markup of H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019:
"H.R. 3991, the 'Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019,' is the second bipartisan measure we are considering today that aims to stem the tide of rising medical costs and make healthcare more affordable.
"This legislation concerns consumer alternatives to brand-name biologics, which are complex, large-molecule drugs, such as genetically modified proteins that have to be grown and extracted from cell cultures. Biologics are expensive to develop and bring to market, and these dynamics are reflected in their high costs and spending totals.
"In 2018, spending on biologics surpassed $125 billion in the United States, and costs for some biologics can reach hundreds of thousands of dollars per patient, per year.
"In 2010, the Biologics Price Competition and Innovation Act established an important mechanism for getting biosimilars to the market.However, that process is not working as effectively as it could be to streamline the patent litigation process and get biosimilars on the market more quickly, part of which is hampered by what is known as 'patent thicketing.'
"'Patent thicketing' is when a manufacturer prolongs its exclusive rights to market a drug by filing numerous patent claims to fend 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. 3991 takes an important step toward addressing these tactics and ultimately, lowering drug prices for this particularly costly class of drugs. The legislation limits the number of patents that the brand-name manufacturer can assert in litigation, which forces the manufacturer to focus on its key patents and streamline the litigation process.
"When biosimilars can get to the market quickly, consumers get to see those savings faster.
"I applaud Mr. Johnson and Ms. Roby, the Chairman and Ranking Member of the Subcommittee on Courts, Intellectual Property, and the Internet for their bipartisan work on this issue. I likewise applaud Senators Blumenthal and Cornyn for leading on companion legislation in the Senate, which has passed out of the Senate Judiciary Committee unanimously.I urge my colleagues to support this legislation."