NIH Rejects Request To Override Abbott’s Norvir Patent After 400% Price IncreaseNIH on Wednesday rejected a request from the consumer group Essential Inventions to override patents on Abbott Laboratories' antiretroviral drug Norvir to allow the production of a generic version of the drug, "effectively allowing" Abbott's recent 400% price increase for the drug to stand, the AP/ABCNews.com reports (AP/ABCNews.com, 8/5). In December 2003, Abbott quadrupled the per-patient wholesale price of Norvir, which is known generically as ritonavir. Norvir is used primarily as a booster for other protease inhibitors, such as Bristol-Myers Squibb's Reyataz and Merck's Crixivan. Essential Inventions in April filed a request for a license to produce a generic version of the drug while it is still under patent, saying that the drug was developed using federal funding and is being sold at an unreasonably high price. According to the group, under the 1980 Bayh-Dole Act, the government has the authority to grant licenses to other manufacturers to produce patented medicines that were developed using federal funding. In such cases, the government also reserves the right to demand reasonable prices from the drug maker (Kaiser Daily HIV/AIDS Report, 5/26). According to Abbott, although a $3.47 million federal grant funded early research on Norvir, the company spent a total of $300 million to bring the drug to market, the Wall Street Journal reports (Abboud, Wall Street Journal, 8/5). NIH concluded that Abbott is adhering to the intent of the law and that Norvir is made available to patients on "reasonable terms," the Chicago Tribune reports (Japsen, Chicago Tribune, 8/5). Therefore, there is no health-related reason to intervene, NIH Office of Technology Transfer Deputy Director Bonny Harbinger said (Neergaard, AP/Las Vegas Sun, 8/4). "The issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively," NIH Director Elias Zerhouni said in the decision (Chicago Tribune, 8/5).
Other Cases, Reaction
NIH in its decision said that the Federal Trade Commission is the appropriate agency to address allegations that Norvir's pricing is anti-competitive, the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 8/4). However, FTC has told Abbott that it will not address such complaints, Abbott spokesperson Jennifer Smoter said (Connolly, Washington Post, 8/5). The ruling is "good news for patients who will continue to benefit from both the current and future innovations that result from the advent of the Bayh-Dole Act," Abbott said in a statement, adding that the company will "continue to focus on developing and delivering innovative treatments that help people live better" (Chicago Tribune, 8/5). "The decision ... was the only decision they could make under the law," Joseph Allen, president of the National Technology Transfer Center -- which helped write the Bayh-Dole Act -- said (Washington Post, 8/5). "The NIH erred in today's decision," Robert Weissman, an attorney for Essential Inventions, said, adding, "The plain language of the Bayh-Dole Act says that government-funded inventions should be made 'available to [the] public on reasonable terms.' There is nothing reasonable about paying five to 10 times more in the United States for Norvir than Abbott charges consumers anywhere else on Earth" (Essential Inventions release, 8/4). Rep. Sherrod Brown (D-Ohio) said that the decision implies that it "doesn't matter what drug makers charge for a taxpayer-subsidized drug, as long as they continue to sell it" (AP/Las Vegas Sun, 8/4). Essential Inventions and Brown said they plan to ask HHS Secretary Tommy Thompson to reverse the ruling, according to the Post (Washington Post, 8/5).