HIV Treatment Bulletin - Vol. 5, No. 7, August/September 2004

AIDS activists in the US expressed disappointment with a recent decision of the National Institutes of Health (NIH) regarding the patent for ritonavir (Norvir®), made by Abbott Laboratories. In an official statement released yesterday, Dr Elias A Zerhouni, NIH Director, stated the NIH’s official decision not to override the patent on ritonavir. The NIH held a public hearing on 25 May as a result of a petition claiming that a 400% increase in the drug’s price in December 2003, which was developed in part with government funding, adversely affected reasonable consumer access to the drug.

The petition was filed under the Bayh-Dole Act, which allows the government to exercise “march-in” rights on a patented agent thereby allowing the drug to be produced by generic competitors. This authority has never been exercised since the Act was passed in 1980. The petition was filed by Essential Innovations Inc, a nonprofit corporation, with the support of healthcare providers, some members of Congress, and patient advocacy groups such as the AIDS Treatment Activists Coalition (ATAC).

Robert Huff, of Gay Men’s Health Crisis (GMHC) in New York, said, “It’s disappointing that the NIH rejected this petition without an on-the-record examination of the issues.” Huff testified during the hearing last May in Bethesda, Maryland.

Transcripts form the hearing and the final NIH report:
http://www.atac-usa.org/Abbottpricehike.html

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