www.fdanews.com/articles/177250-nih-shoots-down-request-to-override-xtandi-patent
NIH Shoots Down Request to Override Xtandi Patent
June 24, 2016
The U.S. National Institutes of Health shot down a request from nonprofit groups to bypass the patent for Astellas Pharmaceuticals’ prostate drug Xtandi in an effort to lower the drug’s price.
In a letter dated June 20, the agency noted that there is no information suggesting that Xtandi is in short supply and has decided against the request for a march-in investigation.
In April, Knowledge Ecology International petitioned the agency to exercise march-in rights — a method used to override the exclusivity rights to a patent developed with public funding — over the price of Xtandi. Xtandi has a list price of $88 per pill, or $129,000 per year.