Bills in House, Senate Seek to Address Role of Patents in High Prescription Drug Prices

Legislators on Capitol Hill are moving forward this month with bills that address patent issues pertaining to biosimilars.

Earlier this month, Representatives Hakeem Jeffries, D-New York, and Doug Collins, R-Georgia, introduced the bipartisan Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. The bills would limit patent evergreening, a tactic whereby drug companies make minor changes to a drug and file for a new patent on those small changes in order to extend their exclusivity and, in turn, charge more costly prices.

Under existing patent law, generic drug manufacturers must prove why a new patent should not be granted on an existing medication. The TERM Act shifts that burden of proof to pharmaceutical companies, who would have to demonstrate “distinct inventions” in order qualify a changed drug for a new patent.

In addition, the bill directs the director of the United States Patent and Trademark Office to send a report to the Judiciary committee in the House of Representatives a year after the bill becomes law. The report would contain a review and recommendations regarding best examination practices, guidance, and procedures to avoid patent evergreening.

“The bipartisan TERM Act will curb patent abuses in order to expedite the entrance of lower cost generic drugs to market,” Jeffries said in a statement.

“Competition in the pharmaceutical market decreases costs and increases options for patients. Pharmaceutical companies are great innovators that create life-saving cures and treatments for families everywhere. Unfortunately, some manufacturers simply file additional patents in order to delay generic drugs from coming to market,” Collins added.

The bill is co-sponsored by Representatives Debbie Mucarsel-Powell, D-Florida, and Ben Cline, R-Virginia.

On the Senate side, Lamar Alexander, R-Tennessee, and Patty Murray, D-Washington, recently introduced S 1895, the Lower Health Care Costs Act of 2019, which includes biosimilars’ role in reducing the prices of prescription drugs. Alexander is chairman and Murray is ranking member of the Senate Committee on Health, Education, Labor, and Pensions, which will vote on the bill on June 26.

One part of the legislation would require updates to the FDA’s Purple Book, which provides stakeholders with information on biologics. The legislation would codify the Purple Book as a single, searchable list of information that would include, among other information, materials related to patents on biologics.

Alexander’s committee has held 5 hearings on ways to reduce healthcare costs and 4 hearings on the cost of prescription drugs. The bill is made up of nearly 3 dozen discrete provisions from at least 16 Republican and 14 Democrat lawmakers.

Besides addressing certain aspects of prescription drug prices, the bill also seeks to end surprise medical bills, increase transparency in healthcare, improve public health, and improve the exchange of health information.

Another recently introduced Senate bill would give the Federal Trade Commission the authority to bring antitrust suits against pharmaceutical companies for blocking competition through the use of the patent system.