The National Institutes of Health (NIH) rejects March-In Rights Petition Seeking Lower Cancer Drug Pricing

By Beatrice M. Nkansah 

Xtandi is an androgen receptor inhibitor generally used for a treatment of prostate cancer. Developed at UCLA, it was approved by the FDA in 2012 and then re-approved in 2023 for treatment of an additional class of patients.  In attempts to lower the price and increase access to this drug, patients Robert Sachs and Clare Love petitioned to the Health and Human Services (HHS), requesting the exercise of “march-in authority” be used lower the price of Xtandi under the Bayh-Dole Act.

  
The Bayh-Dole Act was enacted in 1980 to promote the availability of federally funded inventions for commercialization. The Act assigned intellectual property rights to the research entity receiving the funding rather that the federal government retaining the rights. This incentivizes the recipient of the funding to license out inventions to realize income and contribute to the public good.  

The Act carves out one exception to all rights being with the research entity. The federal government agency that funded the research retains “march-in rights” that allow the agency to exercise its march-in rights to the invention if four statutory conditions apply. If these rights are exercised, the university would be required to license the patent to third parties. This approach has long been opposed by the pharmaceutical industry contending exercising march in rights to reduce prices would discourage companies from undertaking research and development efforts in the future.  

The NIH rejected the petition, finding Xtandi to be “widely available to the public on the market”. Additionally, the NIH stated that they did not think “march-in authority” would be effective in lowering the price of the drug.  

Sachs and Love appealed the decision, and the HHS affirmed the NIH’s conclusion. Though not explicitly citing to the Xtandi decision of last year, the Federal Trade Commission (FTC) filed comments supporting the expansion to expand the criteria for “march-in authority/rights”. The FTC reasoned that there should be a more flexible approach for relying on “march-in authority” through the Bayh-Dole Act and that “agencies should be wary of imposing categorical limitations on the factors that can be considered for march in, such as price”.