In the ongoing debate about how to address skyrocketing prescription drug prices, experts are at odds over whether the federal government should grant “march-in” rights for patents on the prostate cancer drug enzalutamide (Xtandi).
Supporters, including prostate cancer patients who are currently petitioning HHS for a hearing on the matter, say granting march-in rights to allow other manufacturers to produce a generic enzalutamide would reduce its price substantially, allowing greater access to a life-saving treatment.
However, those who oppose the move, such as a group of research and scientific organizations and those involved in commercializing new products, argue it goes against longstanding legislation designed to foster innovation.
The back-and-forth centers on the Bayh-Dole Act, a federal law enacted in 1980 to use the patent system to promote inventions arising from federally supported research or development, such as enzalutamide. But the Bayh-Dole Act also grants march-in rights by specifying that the federal government protect the public against “unreasonable use” of such inventions, and that particular language has inspired differing interpretations.
Enzalutamide, an androgen receptor inhibitor developed by Astellas Pharma, has been on the market for about a decade, first approved by the FDA in 2012 for treating metastatic castration-resistant prostate cancer. It was subsequently approved to treat non-metastatic castration-resistant prostate cancer in 2018, followed by an indication for metastatic castration-sensitive prostate cancer in 2019.
It was invented with NIH funding, and the FDA’s Orange Book currently lists three patents for the drug, which are set to expire between May 2026 and August 2027, according to the petition.
Enzalutamide currently costs more than $150,000 per year in the U.S., according to the petition, which holds that the price is “demonstrably unreasonable.” However, those who oppose granting march-in rights for the patents on enzalutamide state that the Bayh-Dole Act was “never intended as a means for the government to impose arbitrary price controls on resulting products.”
Though petitions for march-in rights have been brought, unsuccessfully, many times before, the arguments on either side of the current case appear to be heating up. For one, experts told MedPage Today, enzalutamide is a clear example of an invention developed from federal research that is now commercialized to meet a huge public health need. (In 2022, there are estimated to be nearly 270,000 new cases of prostate cancer in the U.S., according to the American Cancer Society.)
Additionally, political pressures continue to mount for the federal government to address excessive prescription drug prices. Some say the Biden administration has signaled subtle support for hearing out the case on march-in rights, including through issuing an executive order on competition, which opposes narrowing Bayh-Dole march-in rights.
“The fact that you’re getting this amount of attention suggests to me that people are worried,” Liza Vertinsky, PhD, JD, an associate professor at Emory University School of Law, told MedPage Today. “This is a huge industry where one could dig in and find some problems with pricing.”
Earlier this week, Vertinsky published a piece in Health Affairs arguing that, “Biomedical public-private partnerships will only achieve their potential as vehicles for transformative change in public health if they are structured in a way that allows for the robust balancing of public interests with private incentives.”
The current petition to have a hearing on granting march-in rights for the patents on enzalutamide would signal a “more balanced conversation on innovation,” Vertinsky said. Though any potential impact would be small on companies, it could provide “significant cost savings for individuals who can’t afford to pay their cancer bills,” she added.
Peter Arno, PhD, a health economist at the University of Massachusetts-Amherst, concurred. Arno, who co-authored an op-ed in STAT on march-in rights along with one of the petitioners, told MedPage Today that the issue affects not only taxpayer dollars, but also the approximately 25% to 30% of people who don’t take their medication because of the costs.
“That has very adverse health effects for people,” Arno said. “It’s one step in the long-term battle to get some control over drug pricing like they do in every other developed country.”
In contrast, Joseph Allen, executive director of a group called the Bayh-Dole Coalition, which was formed in 2019 in support of the federal law, said the issue of drug pricing is a separate one altogether.
The federal law has been successful in commercializing technologies for 42 years, Allen explained. The group isn’t arguing in favor of high drug prices, he said, rather that the law shouldn’t be used for a purpose that it wasn’t intended.
In response to the petition to HHS requesting that the federal government grant march-in rights for the patents on enzalutamide, the Bayh-Dole Coalition submitted its own response to the agency. It reads in part: “The Bayh-Dole Act laid the groundwork for the unprecedented partnerships between your department and the private sector, including those that helped lead to the development of life-saving vaccines and therapies to fight COVID-19. Misusing the law as the critics are now urging in the pending march-in petition threatens these relationships, as the government would appropriately no longer be viewed as a trustworthy partner.”
Allen told MedPage Today that the coalition is hopeful that the federal law is upheld. Many people are nervous, he said, “because once you misuse this, you lose that confidence and you will never get it back again.”
The companies “bet the farm” to commercialize technologies, Allen said. If that is made “even riskier,” he added, “they’re just going to walk away.”
Astellas declined to make Mark Reisenauer, president of U.S. commercial operations, available for an interview. However, Reisenauer wrote in an op-ed for STAT that “despite the clear health benefits and broad availability of Xtandi, some individuals and organizations want to use it as a test case for disrupting the technology transfer and medical innovation ecosystem that is the pathway to the treatments of tomorrow.”
Reisenauer noted that in 2021, “the majority of Medicare beneficiaries paid $20 or less per month out of pocket for Xtandi,” and that, “Retired military service members and their families enrolled in TRICARE can access Xtandi for co-pays ranging from $0 to $14 per month, with active-duty TRICARE members having no co-pay.”
In response to MedPage Today‘s request to HHS regarding consideration of the petition to grant march-in rights for patents on enzalutamide, the NIH — to which the request for analysis has been delegated — responded that the petition is still under analysis.
NIH further noted that, depending on the facts and circumstances that are reviewed, the federal government’s march-in right allows the funding agency to conduct an administrative proceeding. If the government finds that one of four criteria are met, it can grant additional licenses to other applicants. The most common considerations are failure to take “effective steps to achieve practical application of the subject invention” or failure to satisfy “health and safety needs.”
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