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Biden Administration Proposes Using March-In Rights to Lower Prescription Drug Prices

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Ayanna Amadi
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Biden Administration Proposes Using March-In Rights to Lower Prescription Drug Prices

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March-In Rights as a Tool to Lower Prescription Drug Prices

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The Biden administration has announced a new proposal that could significantly impact the cost of certain prescription drugs in the United States. The proposal involves the implementation of 'march-in' rights, a policy that allows the federal government to grant licenses to third parties for products developed with federal funding if the original patent holder does not make them available to the public at a reasonable price.

The Biden Administration's Framework for March-In Rights

According to statements released by the White House, the Biden administration is working on a framework to enforce the government's march-in authorities on drugs developed with taxpayer dollars. This move declares that if drug manufacturers refuse to make their products reasonably available, the government is prepared to give other companies the license to produce those drugs at a lower cost. This framework is based on the Bayh-Dole Act of 1980, which retains certain rights for the government on any products produced through public-private partnerships using federal funding. The legislation allows federal agencies that provided the funding to compel companies to provide a 'nonexclusive, partially exclusive, or exclusive' license to a responsible applicant.

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The Impact of March-In Rights on Drug Patents

The government's march-in rights could change the landscape of the pharmaceutical industry by potentially allowing the seizure of drug patents. The Biden administration has outlined a set of factors that federal agencies should consider when deciding whether or not to use these rights. The primary goal is to promote more pharmaceutical competition and reduce the high costs of drugs. If the public cannot reasonably access certain medications, the government may seize patents for those drugs and share them with other pharmaceutical companies.

New Actions to Lower Prescription Drug Costs

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The Biden-Harris administration is taking definitive steps to promote competition in healthcare and support the lowering of prescription drug costs for American families. These steps include the proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions. The proposed framework specifies that price can be a factor in considering whether a drug is accessible to the public.

March-In Rights and Publicly Funded Inventions

The federal government spends billions of dollars annually on biomedical research that often leads to the development of prescription drugs. Activists have long pushed for the government to use march-in rights when a taxpayer-funded invention isn't publicly available on reasonable terms. The White House's support for a policy that allows the government to sidestep patent protections for drugs developed with federal funding marks a significant shift.

Consideration of Price in Invoking March-In Rights

Under the new draft guidelines published by the National Institutes of Standards and Technology, government agencies are permitted to consider the 'reasonableness of the price' when evaluating whether to invoke march-in rights. This means that the government can suspend patents when federally funded inventions aren't made available to the public, thereby creating an opportunity for other companies to produce these drugs at a lower cost.

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