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www.fdanews.com/articles/176022-nonprofit-puts-pressure-on-nih-for-march-in-rights

Nonprofit Puts Pressure on NIH for March-in Rights

April 5, 2016

A nonprofit group is pressing NIH to bypass the patent rights of a company in a bid to lower the drug’s price, marking at least the third time the group has attempted this.

A petition sent to NIH in January by Knowledge Ecology International asked it to exercise march-in rights  —  a regulatory mechanism for bypassing exclusivity rights to a patent if it was developed with public funding  — over the price of Astellas Pharmaceuticals’ cancer drug Xtandi. Joining the group in this effort is the Union for Affordable Cancer Treatment.

The pair proposed the use of this little-known provision — which NIH has never exercised — of the 1980 Bayh-Dole Act to force Astellas to drop the price of the drug, which costs $88 per pill, or $129,000 per year.