As the 118th Congress convenes this month in D.C., many pundits and advocates have little faith that much will get done with the GOP taking control of the House and Democrats maintaining their hold of the Senate.
But historically, we have reason to be optimistic: United States lawmakers have passed more legislation when the government is divided between the two parties. Our leaders can — and must — work across the aisle to bring down the cost of health care through patent reform, an area where our elected representatives can find common ground and deliver for the common good.
Our nation’s patent system is distorted, one manifestation of a market system wildly out of balance. Intended to fairly reward inventors for their contributions to society, our patent system now incentivizes and legitimizes corporate gamesmanship at the expense of the public interest. And when it comes to prescription drug patents, the consequences are devastating.
Today, many drugmakers are less focused on researching and developing new drugs than protecting their monopolies on old ones — to such an extent, in fact, that pharmaceutical companies file for an average of more than 140 patents on top-selling drugs.
Many companies delay or block more affordable competitors from entering the market for far longer than the 20-year protection allowed by law.
Unencumbered by competition, these companies then exercise free rein over drug pricing. Indeed, over just 10 years, the average price paid per brand-name prescription has more than doubled.
Meanwhile, nearly 1 in 3 Americans has opted not to fill a prescription — or to split pills, ration doses, or take an over-the-counter drug instead — because of the cost. Some 34 million reported that a friend or family member died after they could not afford medical treatment.
The good news is, Americans of every political persuasion recognize that our system is crashing into its limits. Nearly 6 in 10 Republicans and 7 in 10 Democrats want more regulation of drug prices. And 8 in 10 people in both parties believe drug prices are driven largely by pharmaceutical company profits.
Lawmakers, too, agree across the aisle that patent abuse is aggravating the crisis. A bipartisan group of senators even wrote to the U.S. Patent and Trademark Office (USPTO) last summer, asking it to stop the charade of granting multiple patents for a single drug — a practice our organization has connected directly to soaring drug prices for Americans.
Now, Congress must lead the way in making the patent system more accountable to the public. Legislators should start with three simple steps.
First, Congress must put an end to the abuse of the patent system.
The U.S. Constitution affirms that time-limited monopolies should be reserved for original discoveries that promote progress in science and the arts. Consistent with this aspiration, Congress can course correct by authorizing the executive branch to raise the bar for patents and provide oversight that incentivizes real competition, and thus lower prices.
Second, lawmakers must expand public participation in the patent system.
Until recently, only patent holders and applicants weighed in on patent policy and decision-making — and public participation is still limited to the bare minimum. Congress should give the American people multiple seats on the USPTO’s advisory committee, and create a new public-led committee that can regularly identify emerging issues and propose solutions. After all, if the patent system affects all Americans, all Americans should be able to affect the patent system.
Finally, Congress must ensure a return on investment for public funding of pharmaceutical research and development — a basic tenet of virtually any other investor-inventor partnership.
For nearly a decade, taxpayers helped to fund every new drug the Food and Drug Administration approved. Yet the American people are denied the benefits of those successes, while pharmaceutical companies profit handsomely. Moderna, for example, has earned about $36 billion in sales for its COVID vaccine — which was nearly 100 percent publicly funded. New regulations could help the government negotiate better contracts, so it can maintain its ownership share for taxpayer-funded treatments — and ensure they are accessible and affordable.
To be sure, some argue that such regulations would stymie medical innovation; that cures for cancer or other diseases will be farther from reach if drug companies face any market constraints.
In reality, however, patent-system reforms will bolster waning creativity — the product of exponential increases in the rate at which the USPTO issues patents. Simply put, these and other reforms might encourage drugmakers to value the quality of new intellectual property more than the quantity of protections they can secure.
Surely, to earn special privileges in the marketplace, companies should be required to do more than merely change a tablet into a capsule, branding it as “innovation.” Strategic reforms toward that end would promote healthy competition.
The fact is, the public helps subsidize most pharmaceutical progress, and it deserves the relief that should come from scientific advancement, but also a fairer, more democratic kind of capitalism.
Patent system reform is not a partisan issue; it’s an American issue. The new Congress has an opportunity to address it, once and for all.
Tahir Amin and 2022 MacArthur Fellow Priti Krishtel are co-executive directors of the Initiative for Medicines, Access & Knowledge (I-MAK), a nonprofit organization working to address structural inequities in how medicines are developed and distributed.