Ray “I can’t afford it.”
The words my grandmother said to me when she found out there was a medication that would regulate her heart condition, but it was too expensive.
“I can’t afford it, Rachel. I’m sorry.”
Her words underscore the crisis affecting countless Americans who face chronic, often life-threatening illnesses and unaffordable prescriptions. Patent gamesmanship, which allows drug companies to charge unjustifiably high prices, may seem far removed from the pharmacy counter, but it is one of the causes of outrageous prescription drug prices in the United States. Invalid patents aggravate the health are system’s flaws by empowering large companies to prioritize profits over people’s lives. And now, new policies are making the situation more dire.
Patents are intended to incentivize innovation by protecting groundbreaking inventions. With hundreds of thousands of patents issued annually, far too many offer nothing new, instead describing minor variations or obvious uses of old products. Pharmaceutical companies have become experts at exploiting patent system loopholes to maintain monopolies on medications long after patents on active ingredients expire. This strategy, called evergreening, inflates prescription prices by blocking competition from generic alternatives.
The case of the blockbuster drug Ozempic illustrates the type of exploitation that is possible when the U.S. Patent and Trademark Office (USPTO) upholds low-quality patents instead of cancelling them. Generic drug manufacturers used a standard review process at the USPTO to challenge an Ozempic patent’s validity, citing its lack of novelty or innovation. This was one of Ozempic’s last patents to expire, meaning that its cancellation would allow competition to start earlier, fast-tracking the possibility of generic alternatives and lower prices.
USPTO judges, who review patents as members of the Patent Trial and Appeal Board (PTAB), agreed with the petitioners that the patent in question was likely invalid and initiated a review. The board’s decision on the patent’s validity should have been issued in October 2024. The patent’s owner, Novo Nordisk, instead settled with the petitioners for an undisclosed amount. Together, they requested that the proceedings be shut down before the final decision was released.
The PTAB could have issued its final decision. Instead, the review was terminated without explanation.
The benefits that come from cancelling low-quality patents are significant. When patent monopolies end, generic alternatives, which typically cost 80 percent less than their brand-name counterparts, can then compete. Patents also block additional, related research while they are in effect. When a patent is valid, this exclusivity is justified; however, when a patent is invalid, exclusivity prevents new innovation and reduces consumer choices.
Data cannot capture the economic cost or lives lost due to innovations that go undiscovered because of patents that should never have been granted. By not completing the review of an Ozempic patent that the agency itself had determined was likely invalid, the USPTO failed to fulfill its mission to “drive U.S. innovation and global competitiveness for the benefit of all Americans.”
Something needs to change. The USPTO has the power and the tools to stop the proliferation of low-quality patents; instead, it has moved in the opposite direction. In fact, interim USPTO leadership recently enacted several procedures that make it more difficult for low-quality patents to be challenged and invalidated.
In March, the USPTO reinstated a policy that denies patent review requests for “discretionary” reasons, rather than considering the merits of each case. Then, the acting USPTO director released a memorandum that puts this broad denial authority in her own hands rather than in the hands of technically trained judges. As a result, many more challenges to low-quality patents will be rejected before they reach a formal review.
Cutting off the public’s access to patent review blunts the best tool available to combat the saturation of low-quality prescription drug patents. Patents should not be awarded like participation trophies for big drug companies, which already report nearly two times the profit of non-pharmaceutical companies. When the USPTO allows low-quality patents to remain in force, it enables unearned drug company profits, thus abandoning its obligation to promote competition for the good of all Americans.
“I can’t afford it, Rachel. I’m sorry.”
No one should be forced to experience the suffering these words entail. Ending unearned patent monopolies will encourage more groundbreaking research and make life-saving medication more affordable for people like my grandmother. That’s how the patent system operated for most of our country’s history. The USPTO needs to reclaim its mission by rolling back recent changes, reprioritizing patent quality, and putting innovation and competition ahead of pharma profits.
