NIH rejects March-In petition, also rejects proposed rules on pricing of and access to government funded inventions | Knowledge Ecology International

'In a decision dated November 1, 2013, and signed by NIH Director Francis Collins, the NIH has rejected the 2012 petition to the NIH to uses its powers under the Bayh-Dole Act to protect U.S. consumers from high prices and restrictive licensing of NIH funded inventions. The 2012 March-In petition (copy here: http://keionline.org/2012ritonavir) centered on ritonavir, a drug used to treat HIV/AIDS and Hepatitis, but also asked the NIH to adopt policies that would apply to any drug or medical invention, and raised two issues of broad policy ramifications. The first issue concerned the price of the drug, and was fairly straightforward -- Abbott was charging US private sector consumers 4 to 10 times more for the use of ritonavir than the prices the company charged in other high income countries. The petition asked the NIH to adopt a policy that considered price discrimination against U.S. citizens to be an abuse of the patent right. The second issue concerned the obligation to license NIH funded patents for use in follow-on inventions, when the patented invention could be useful to 'prevent, treat or diagnose medical conditions or diseases involving humans.' In the NIH March-In case, KEI, PIRG, UAEM and AMSA proposed specific rules to address these cases. On the pricing issue, the petitioners presented evidence that 13 of 14 surveyed drugs with NIH funded patents were significantly more expensive in the United States than in other high income countries. (http://keionline.org/node/1541). Note that the law on federally funded inventions includes an oblgiation for the patent owner to make the invention 'benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.' [35 USC 201(f)] The NIH rejection included this conclusion: 'Conclusion The NIH is sensitive to the impact of the pricing of drugs and their availability to patients. As in 2004, when similar pricing and availability issues were raised and discussed at public hearings, the NIH's role in the present case is limited to compliance with the Bayh-Dole Act, including its march-in criteria, outlined and discussed in detail (above). Drug pricing and patient access are broad and challenging issue in the United States. The NIH continues to agree with the public testimony in 2004 that the extraordinary remedy of march-in is not an appropriate means of controlling prices of drugs broadly available to physicians and patients. In conclusion, as set forth in this determination, the information and justification provided in the Request, as well as publicly available information, do not support re-consideration of the NIH determination to decline to initiate a march-in proceeding for the Subject Patents used by AbbVie in the production of Norvir and other combination products. As stated in previous march-in considerations, the general use of drug pricing is appropriately addressed through legislative and other remedies, not through the use of the NIH's march-in authorities. The exercise of the Government's use license to the Subject Patents is not appropriate in this case. Finally, the NIH declines to set the rules proposed by the Requestors directing the initiation of such proceedings based on certain price disparities between the United States and other developed countries.' KEI will have a more extensive analysis of the NIH decision, but our initial comment is as follows ..."