NIH chooses not to use ‘march-in rights’ in prostate drug row

The US National Institutes of Health (NIH) has decided not to exercise its “march in-rights” for the Xtandi (enzalutamide) prostate drug, which is marketed by Astellas Pharma, despite calls from politicians to license the drug in a bid to lower its price.

According to pharmaceutical industry news website  BioPharma Dive, the NIH decided yesterday, June 20, against using the march-in-rights for the drug.

In March this year, LSIPR reported that US presidential hopeful Bernie Sanders had co-signed a letter, along with several Democratic senators, urging Francis Collins, director of the NIH, to intervene and hold a public meeting to license the drug in a bid to lower its price.

The drug, according to the letter, costs $129,000 in the US but is sold in Japan and Sweden for $39,000 and Canada for $30,000.

Under the Bayh-Dole Act, federal agencies can enact what are known as march-in rights. These are granted to authorities to license a patent when action is necessary to “alleviate health or safety needs which are not reasonably satisfied” or if the invention is not “available to the public on reasonable terms”.

The letter, sent on March 28, argued that this is a case that warrants such action.

It added that the patent covering the drug should be overridden because the drug was developed at the University of California with help of taxpayers’ money before it was licensed to Medivation, a biotechnology company that agreed a marketing deal for the drug with Astellas.

Non-profit organisation Knowledge Economy International also sent a letter to Collins on June 7 asking the government to license the drug.

Collins responded yesterday and said the NIH declines to initiate a “march-in investigation or utilise the government’s licence in the patents”.