Last week, Representative Hakeem Jeffries (NY-08) and Representative Doug Collins (GA-09) introduced the bipartisan “Terminating the Extension of Rights Misappropriated” (TERM) Act of 2019. This legislation would address the rising cost of prescription drugs by significantly limiting the process known as “evergreening”, whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices. The bill is co-sponsored by Representative Debbie Mucarsel-Powell (FL-26) and Representative Ben Cline (VA-06).
Under existing patent statute, generic drug manufacturers must prove why a new patent should not be granted on existing medication. This process adds significant costs to generic manufacturers and slows the ability of lower cost drugs to be released. The TERM Act shifts that burden of proof to pharmaceutical companies, who would have to reasonably demonstrate why changes to a drug qualify it for a new patent.
Representative Jeffries said: “In the United States of America, access to high quality, affordable health care should be a right, not a privilege. The bipartisan TERM Act will curb patent abuses in order to expedite the entrance of lower cost generic drugs to market. It is time for us to put people over profits. Reps. Collins, Mucarsel-Powell and Cline are to be commended for their efforts in this regard.”
Representative Collins said: “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. I cosponsored the TERM Act to make it easier and fairer for generic pharmaceutical companies to challenge trivial patents, which ultimately means that patients get access to more drug options faster. I appreciate the partnership of Representatives Jeffries, Cline and Mucarsel-Powell on this important health care legislation.”
Representative Mucarsel-Powell said: “Americans are paying too much for prescription medications, and I’ve always been committed to working with anyone — Democrat, Republican, Independent — to lower prescription drug costs. That’s why I’m proud to introduce the bipartisan TERM Act to take on drug manufacturers’ shady practice of amassing endless patents to prevent more affordable generic medicines from reaching the market and to stop these companies from increasing their profits at the expense of hardworking Americans. We need a comprehensive strategy to tackle our skyrocketing health care costs and taking on drug companies’ anti-competitive patent practices is an important step in doing so.”
Representative Cline said: “I am proud to introduce the Terminating the Extension of Rights Misappropriated Act with my colleagues, Representatives Doug Collins, Hakeem Jeffries, and Debbie Mucarsel-Powell. This bipartisan legislation would help limit the practice of ‘evergreening,’ or extending the period of exclusivity well beyond the term of the first patent with mere trivial changes to the original patent, which will allow the quicker introduction of generic medication to market.”
Today, prescription drug expenses constitute nearly 20 percent of health care costs and are growing faster than any other health care expenditures. As of 2017, Americans spend more on prescription drugs — average costs are about $1,200 per person per year — than anyone else in the world.