As we always do in our final newsletter of the year, I want to pause and reflect on the work our movement has done over the last twelve months to restore the patent system’s integrity so that it serves the public good.
Before I begin, I feel like our particular political moment deserves some recognition. People in this country are very angry with systems that concentrate power in corporate hands while the public suffers.
At I-MAK, we are fighting for systemic transformation of the patent system to lower drug prices. The only way to win that change is by bringing the public in so they can interact with and influence the patent system, injecting the public’s interest into a system that has been dominated by corporate interests.
Patent abuse is the root cause of the American drug pricing crisis and the pharmaceutical industry’s unchecked power. To provide patients the relief they desperately need, we must do everything in our power to end it.
2024: The Year in Review
The year started with a powerful acknowledgement of the drug patent problem from The New York Times. Their article identifying the six reasons why drug prices are so high — nearly triple those in other well-off countries — acknowledged “patent gaming keeps prices high longer” while citing our work on tracking this issue.
In February, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing asking a similar question: “Why does the United States pay, by far, the highest prices in the world for prescription drugs?” I was asked to testify at that hearing. In my testimony, I reminded senators of two points: patients and taxpayers bear the burden of high drug prices, and patent abuse is the root cause driving prices higher.
In that hearing, Senator Sanders (I-VT) and Senator Lujan (D-NM) reaffirmed their commitment to holding branded drug companies accountable for product hopping. This commitment will be crucial moving forward, particularly in light of Merck’s ongoing efforts to mislead policymakers about its effort to extend its monopoly over its top-selling cancer treatment Keytruda by shifting patients to a patent-protected subcutaneous version of the drug.
The Senate continued to scrutinize pharmaceutical companies’ patent abuse throughout the year, with scrutiny coming from both Democrats and Republicans. After a May hearing, in which senators lambasted the industry for its patent games, NBC News clearly declared: “Senators blame sky-high drug prices on abuse of the patent system.” Later in the year, Senator Cassidy (R-LA) asked the questions many of us, including Lina Khan’s FTC, have been asking about why the FDA has failed to use its rulemaking power to rein in abuse of its Orange Book and provide clearer guidelines.
To help policymakers and journalists better understand the complicated specifics of the drug pricing world, we published Biologics, Biosimilars and Patents: A Beginner’s Guide. This report provides an entry point for anyone wanting to learn more about how the biologics regulatory system works for biosimilar drugs and its intersection with the patent system.
Progress this year wasn’t linear, though. In the second half of the year, we fought back against industry-friendly legislation PREVAIL and PERA, which could further restrict public participation in the patent system, raise drug prices, and harm health care access. The United States Patent and Trademark Office also proposed amending rules that could help curb some of the abusive tactics that pharmaceutical companies use to build up their patent thickets. Unfortunately, the agency withdrew the rule earlier this month, citing a “lack of resources”.
Now, winter is upon us and a new administration will bring uncertainty.
Our work of educating lawmakers and the public about the urgent need for comprehensive patent reform continues. We’ve been publishing a series of videos and Op-Eds to foster more nuanced discussion on the policies that incentivised our current system to prioritize private interests over the public’s, while exploring solutions for the future. We also just partnered with Politico for an expert roundtable that features Generation Patient’s Sneha Dave, ICCR’s Meg Jones-Monteiro, and myself. Together, we examine why patent reform is essential to lowering drug prices in the U.S.
As we approach the year’s end, we are energized by the momentum behind patent reform and policymakers’ increasing scrutiny of the industry’s abuses. With the addition of our newest team member, our legal associate, Namita Dhawan-Muren, and the expanded capacity we have through new partners and allies, we are well-positioned to accelerate this momentum.
To every supporter, partner, and ally who stands with us at I-MAK: thank you. Together, we remain resilient and committed.
In solidarity,
Tahir