White House Unveils Proposal to Exercise Patent 'March In' Authority for Expensive Medications

In a renewed effort to address soaring prescription drug prices, the Biden administration is targeting drugs developed with taxpayer-funded inventions. Announcing a proposal, the administration aims to use the long-dormant "march-in" rights, a provision allowing the government to license certain patents of expensive drugs to other companies, potentially making them available at more affordable prices. The federal government invests billions annually in biomedical research, often leading to the development of prescription drugs.

While activists have long urged the government to exercise march-in rights, such requests have been consistently declined, even for high-cost drugs like the prostate cancer medication Xtandi earlier this year. The proposed framework provides guidelines for government agencies to determine when to use march-in authorities, specifically when a drug's price is deemed excessively high.

White House National Economic Advisor Lael Brainard emphasized the administration's commitment to ensuring that drugs developed with taxpayer funds are sold at reasonable prices. The move follows a comprehensive review by the Department of Health and Human Services and the Department of Commerce of the government's march-in authorities under the Bayh-Dole Act of 1980.

The proposal now enters a 60-day public comment period, allowing stakeholders and the public to weigh in on the potential implementation of march-in rights for addressing exorbitant drug prices. Critics argue that march-in rights were not intended to tackle pricing issues and that the Bayh-Dole Act is essential for fostering public-private partnerships and innovation. They contend that reinterpreting the law may have adverse consequences for collaboration in advancing new treatments and cures.

As the proposal sparks debate, it represents a significant step in the administration's efforts to make prescription drugs more affordable and accessible, raising crucial questions about the balance between incentivizing innovation and ensuring widespread access to critical medications.

Ameet Sarpatwari, assistant director of the Program on Regulation, Therapeutics, and Law at Harvard Medical School, clarified that the term "march-in" may sound forceful, but it doesn't imply the government seizing or stealing anything. Instead, it involves the government exercising its rights within a voluntary agreement entered into with a private company or university that accepted federal funding for research. The proposed framework seeks to make use of this existing authority if the price of a government-funded drug is deemed excessively high, a power the National Institutes of Health has refrained from using for many years. Sarpatwari emphasized that the new proposal transforms this previously dormant government power into an active tool.

While the Biden administration has not identified specific drugs for which it intends to exercise march-in rights, the mere indication that the government is willing to employ this authority could influence companies' behavior, especially concerning potential price hikes. However, some critics, such as James Love from Knowledge Ecology International, believe the framework could take a more robust stance against high drug prices, expressing concerns about subjective terms like "extreme" and "exploitative" in the criteria for intervention.

The framework's limitations are acknowledged, particularly in the context of complex intellectual property surrounding drugs, often protected by multiple patents. Sarpatwari highlighted that marching in on one or two government-funded patents might not be sufficient to enable another company to produce a more affordable competing product. The intricacies of intellectual property present challenges, and march-in authority has its constraints in reaching a comprehensive solution to high drug prices.

In conclusion, the proposed framework by the Biden administration to utilize "march-in" rights for drugs developed with taxpayer-funded inventions signifies a significant shift in addressing high prescription drug prices. Ameet Sarpatwari from Harvard Medical School clarifies that "march-in" doesn't involve seizing or stealing but is the government exercising its rights in voluntary agreements with entities that received federal funding for research.

The framework aims to activate a previously dormant government power, allowing intervention if the price of a government-funded drug is deemed excessively high. While the Biden administration has not specified drugs for potential march-in actions, the mere indication of willingness to use this authority could impact companies' pricing strategies.

Critics, like James Love from Knowledge Ecology International, express concerns about the framework's criteria, particularly the subjective terms like "extreme" and "exploitative." Additionally, the limitations of march-in authority are acknowledged, with complexities in intellectual property potentially hindering the effectiveness of intervention.

As the proposal enters a 60-day public comment period, stakeholders and the public will have the opportunity to provide input. The outcome of this initiative will likely shape the balance between promoting innovation and ensuring affordable access to critical medications, navigating the intricate landscape of drug pricing and intellectual property.