VOICES: “March-in” authority should be withdrawn to protect patients

More than 100,000 Americans are living with sickle cell disease; about one in every 365 African American infants are born with this condition and face an increased likelihood of being born with congenital heart defects. Living with sickle cell disease elevates the risk of developing various health complications, including childhood leukemia, organ failure, and, later in life, the onset of Alzheimer’s disease.

The Ohio Sickle Cell and Health Association (OSCHA) plays a crucial role in supporting individuals living with sickle cell disease and their families. OSCHA helps to ensure access to state-of-the-art treatments and lifesaving therapies and advocates for continued breakthroughs to enhance overall quality of life.

OSCHA is concerned about a proposal from the Biden administration released in December, suggesting upending the 1980 Bayh-Dole Act (Patent and Trademark Law Amendments Act), which empowered research universities and federal laboratories to control the patents on their inventions. This legislation was groundbreaking, as it incentivized the private sector to partner with universities to bring government-backed inventions to the marketplace.

Since the law’s passage, the public has benefitted from thousands of innovations that might otherwise collect dust on university shelves, including more than 200 medicines, dozens of technologies inside our phones, tablets, and TVs, and a host of agricultural advances.

The proposal would allow the government to “march in” and take over a university’s patents if the price of a commercialized technology is deemed unreasonable. How exactly an unreasonable price would be determined is unknown. But what is known is that already, the investors that back the early-stage technologies that spin out of universities are retreating.

In this case, uncertainty stifles investment. The uncertainty caused by this proposal — especially if finalized — is sure to jeopardize the careful equilibrium of public-private collaboration that has been instrumental in the development of many breakthroughs, including two gene therapy treatments for sickle cell disease approved by the FDA in the last year.

The crucial factor in developing new treatments lies in the assurance of intellectual property rights, particularly patents. Without such protection guaranteeing a period of market exclusivity, investors will be hesitant to fund the development of fundamental scientific discoveries into approved treatments for patients. After all, the financial risks associated with this process are extraordinarily steep. Considering that only around 10% of medications entering clinical trials secure FDA approval, the average cost of developing a new medication exceeds $2 billion.

Presently, investors are willing to take such risks due to the security of their patents. But the proposed “march-in” framework would allow government officials to step in and forcibly relicense innovators’ patents whenever they deem a product too expensive. The law does not support this interpretation of Bayh-Dole’s march-in authority and would cast a shadow over all pharmaceutical development to the detriment of patients.

Although, notably, the Biden administration has expressed its intention to use the framework to reduce prescription drug costs, however, the concerns outweigh the negative consequences for patients and innovation. OSCHA urges the Biden administration to carefully weigh the proposed “march-in” framework and withdraw the proposal.

Annie J. Ross-Womack is the executive director for the Ohio Sickle Cell and Health Association.

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