President Donald Trump and lawmakers have vowed to address high drug prices, and Rep. Ben Cline is working across the aisle on legislation aimed at addressing one aspect of that problem.
Cline, R-Rockbridge, is a co-sponsor of Terminating the Extension of Rights Misappropriated, or TERM, Act, designed to strip away a layer of protection pharmaceutical companies have against competition from generic drug manufacturers.
The legislation, introduced this month by Reps. Hakeem Jeffries, D-New York, and Doug Collins, R-Georgia, is addressing what is known as “evergreening.” Cline said drug companies make minor changes to a drug and then file for a new patent on these trivial changes in order to extend their exclusivity and maintain high prices.
Currently, generic drug manufacturers must prove a new patent should not be granted on an existing medication. It’s difficult and costly for generic drug manufacturers to challenge these patents in court, hindering the competition that could lower drug prices.
Cline said the process has been abused, and patents should be extended to manufacturers that have proven they have created something truly innovative that is in need of property protection.
“When these are private drug companies, they’re making decisions that are in the name of the company and shareholders and not the public at large,” Cline said Tuesday.
The legislation proposes flipping the existing patent statute used by drug companies . The TERM Act would shift that burden of proof to pharmaceutical companies, which would have to demonstrate why changes to a drug qualify for a new patent.
“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. “It is time for us to put people over profits.”
The TERM Act also would have the director of the U.S. Patent and Trademark Office send a report to the House Judiciary Committee a year after the bill becomes law containing a review and recommendations regarding best examination practices and guidance, along with procedures to avoid patent evergreening.
The bill has been referred to the House Judiciary Committee, of which Cline is a member.
Slowing the relentless rise of drug prices to provide some relief to consumers has been a bipartisan issue in Washington.
House Democratic leaders are expected to unveil legislation soon, which may include enabling the Department of Health and Human Services to negotiate the price of some prescription drugs covered by Medicare, the program for older Americans. Currently, private insurers negotiate with drug companies.
In the Senate, Sens. Lamar Alexander, R-Tennessee, and Patty Murray, D-Washington, have introduced legislation to reduce health care costs. It addresses a host of issues, including surprise medical bills and prescription drug prices.
For Cline, a first-term congressman, working on patent issues is familiar territory. His predecessor, Rep. Bob Goodlatte, was known for his work on patent reform.
Before Cline went to University of Richmond School of Law, he served as Goodlatte’s chief of staff. Under Goodlatte’s guidance, Cline worked on patent and intellectual property issues.
“These are issues I’m familiar with and have worked on in the past, and I recognize that continued efforts to improve the laws need to be made to ensure the public is able to gain access to these drugs , which have received the benefit of intellectual property protection,” Cline said.