This summer, one topic is gaining steam in Washington health care conversations: Big Pharma’s abuse of its patents has to end. 

Last month, the Supreme Court unanimously ruled in favor of a generic drugmaker in a “skinny labeling” case, providing a victory for patients tired of paying high prices for brand drugs. Skinny labels allow generic and biosimilar competitors to launch products for non-patented indications, helping accelerate market entry while avoiding infringement claims tied to patented uses. Health economist Alex Brill remarked on the positive impact this decision will have on patients:

“The potential consequences of this decision in terms of healthcare savings are meaningful. Prior research has pointed to significant Medicare Part D savings–nearly $15 billion from 2015 to 2021–associated with skinny label generics… While the Supreme Court’s ruling is good news, there is work to be done to address this gamesmanship.”

An op-ed from David Marin, President and CEO of the Pharmaceutical Care Management Association, added to the growing choir of voices calling on Congress to act. Marin made the case for Congress to take action to end Big Pharma’s War on Generics. Marin wrote:

“The high prices are part of Big Pharma’s masterclass in patent loopholes and legal maneuvering. They are waging a war on generic drug competition and artificially keeping prices too high for too long for too many.

“Congress has an opportunity and a responsibility to address these practices and restore competition… Let’s reform a system that forces people to sacrifice their health and financial security to grow brand drugmaker profits. End the war on generics.”

The Federal Trade Commission filed an amicus brief to protect Americans from pharmaceutical monopolies. It argued that drug companies should be held accountable for conduct that harms competition and delays access to more affordable treatment. 

This follows a recent markup by the Senate Health, Education, Labor, and Pensions (HELP) Committee of several bills, including three aimed at expediting access to lower-cost drugs for American families. During the markup, Chairman Bill Cassidy argued that patents “should be time-limited, and abuses can unfairly extend brand monopolies and keep drug prices higher than they should be.” Senator Josh Hawley said drugmakers are gaming the system, “and because they’re gaming it, they’re keeping prices high for Americans all across this country.”

The House Judiciary Committee joined the party with a hearing to examine the patent system for prescription drugs and expand access to generics and biosimilars echoed these concerns. Chairman Darrell Issa (R-CA) highlighted the importance of balancing innovation and lower prices, and Ranking Member Hank Johnson (D-GA) emphasized the importance of competition in the prescription drug market, stating:

“Competition helps lower drug costs, expand access, and deliver enormous cost savings to patients… Getting this balance right is extremely important because the cost of prescription drugs has soared too high for too long in this country.”

Witness Michael Carrier, Board of Governors Professor at Rutgers Law School, voiced concerns that patent abuses can delay competition:

“Patent thickets are most concerning in the pharmaceutical industry. There’s no other industry in which the company can collect as many patents as it wants just to keep competitors off the market…”

Rachel Goode, Senior Vice President and Head of Legal and Intellectual Property, Fresenius Kabi, pushed back on claims that patent thickets are overstated, stating:

“Patent thickets are not a myth. They have been proven to exist by numerous pieces of empirical research that have been rigorously peer reviewed and published in highly reputable journals.”  

The message across Washington is clear: it’s time for Congress to restore real competition in the prescription drug market by finally tackling the never-ending abuse of patents by brand drugmakers.