The Biden administration’s plan to seize some drug patents would likely result in legal challenges contesting its authority to take over intellectual property.
On Thursday, the administration presented a framework for the potential takeover of patents for certain drugs if their prices are deemed too high. This move, which would be the first time the US government has sought to use “march-in rights” for patents on drugs developed with federal funding, has raised questions about whether these rights can be used to influence prices.
Legal challenges questioning the administration’s exercise of march-in rights are anticipated, and it’s likely that the issue will eventually be decided by the Supreme Court. The pharmaceutical industry, which has a history of litigation against the government over drug prices under Medicare, is expected to challenge this move.
Supporters of the plan argue that it would spur more drug competition and lower costs, while opponents argue that it would be an improper application of the law and could dissuade investors from backing innovative new medications.
The administration’s interpretation of march-in rights has also been scrutinized under the 1980 Bayh Dole Act, which allows the government to take the rights to a taxpayer-funded product if it isn’t available to the public on reasonable terms. However, critics argue that the law can’t be used to control drug prices.
The proposed framework is currently open for public comment, where stakeholders will have the opportunity to voice their support or opposition. Despite expected opposition from the drug industry, some believe that the framework is a step in the right direction and should be further expanded.
Ultimately, the plan is likely to spark a complex legal battle and could have far-reaching implications for the pharmaceutical industry and consumers.