Knowledge Ecology International and the Union for Affordable Cancer Treatment sent a letter to Secretary Tom Price of the Department of Health and Human Services, and to Secretary Jim Mattis of the Department of Defense, requesting that the Trump Administration reevaluate the January 2016 Xtandi petition that the government use its rights in patents under the Bayh Dole Act (35 U.S.C. §§ 200 et seq.) for the excessively-priced, blockbuster drug enzalutamide (marketed by Astellas Pharma as Xtandi). The initial petition highlighted the possibility of using either march-in rights under 35 U.S.C. § 203, or the royalty-free rights in the patents under 35 U.S.C. § 202(c)(4), in order to allow for generic competition and more affordable prices.
The letter notes the Trump Administration’s “promise to make great deals for Americans” as being particularly relevant to this issue, given that the U.S. continues to pay the highest prices in the world for access to a prostate cancer drug created with American tax dollars. It also calls the Obama Administration’s rejection of the petition a mistake to be rectified, noting that the letter sent by Director Francis Collins of the National Institutes for Health (NIH) failed to address the central argument regarding high prices and instead grounded the rejection on the absence of evidence of short supply — something not argued in the petition.
The letter additionally refers to relevant evidence submitted by KEI in separate proceedings addressing the Bayh Dole statutory phrase “practical application” and the meaning of “reasonable terms,” as interpreted by numerous courts within the United States and internationally.
The letter additionally requests that any reevaluation on the Xtandi petition be done by an impartial office, given the documented predisposition of NIH officials including Collins and Mark Rohrbaugh to avoid addressing issues of pricing.
UPDATE: On June 7, 2017, NIH Director Collins rejected the appeal, in spite of KEI/UACT’s explicit request that the appeal not be fielded by his office. As with his previous letter of June 20, 2016, Director Collins dodged many of the central points in the Xtandi petition, instead defending the government’s failure to act by pointing to evidence that Xtandi is “widely available on the market,” sales were increasing, and there were no public reports of shortages or that Xtandi was not being prescribed because of price. The letter from Collins is attached below.