US government will not override Abbott's ritonavir patent

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The US government’s National Institutes of Health yesterday rejected a petition to override Abbott’s patent on Norvir (ritonavir), saying that it did not have the authority to intervene in a case that is essentially a dispute over the price of the drug rather than its availability.

The National Institutes of Health was responding to a petition by Essential Inventions, a company formed by the Consumer Project on Technology to exploit any relaxation of patent restrictions on the drug.

Essential Inventions filed the petition following a decision by Abbott Laboratories, manufacturer of ritonavir, to raise the wholesale price of ritonavir fivefold last December. Essential Inventions asked to be allowed to manufacture a cheaper version on the grounds that Abbott’s price increase was restricting research, reducing patient access to the drug and was an abuse of the US taxpayer contribution to the development of the drug (early research into ritonavir was funded with a $3.5 million NIH grant).

Essential Inventions asked that the NIH use the `march-in` provision of the Bayh-Dole Act, a US statute which permits the US government to require a funding recipient or exclusive licensee of a federally funded invention to license it to other applicants.

After reviewing the case and hearing testimony from AIDS advocates, pharmaceutical lobbyists and the original drafters of the Bayh-Dole act, NIH announced yesterday that the petition did not meet the provisions of the Bayh-Dole act because the main complaint concerned the price of the drug rather than its availability.

"The NIH believes that the issue of drug pricing is one that would be more appropriately addressed by Congress, as it considers these matters in a larger context," NIH Director Elias A. Zerhouni stated. Click here for full text of the NIH decision.

NIH also said that any complaints about anti-competitive behaviour should be dealt with by the Federal Trade Commission (FTC). However, Abbott told Associated Press yesterday that the FTC does not plan to pursue these complaints.

NIH reviewed the complaint in relation to four provisions within the Bayh-Dole act that might allow a `march-in` on the patent:

  • Practical application of the invention: Norvir has been licensed since 1996, so the invention has already been put into provision.
  • Health and safety needs: NIH interprets the health and safety provision of the Bayh-Dole Act to mean that march-in may only be permitted if it can be demonstrated that Abbott has failed to exploit the product to meet legitimate health needs or failed to carry out appropriate safety studies. No grounds, says NIH.
  • The product is not being made available in the United States: clearly irrelevant to this complaint since the drug is licensed.