NIH: No March-In Rights for Costly AIDS Drug

On July 29, 2004, the National Institutes of Health (NIH) determined that it will not initiate a march-in proceedings for the protease inhibitor Ritonavir based upon pricing concerns raised by members of Congress and the public.

The "march-in" provisions of the Bayh-Dole Act, 35 U.S.C. § 203, authorize the federal Government to require federal funding recipients to license their inventions to a responsible applicant. Section 203(a) of the Act provides, in part, that march-in rights may be exercised by the funding Federal agency based on any of four conditions:

1) when "practical application" of the invention is not expected to
be achieved in a reasonable time,

(2) when the action is necessary to alleviate health or safety needs,

(3) when action is necessary to meet requirements for public use
specified by Federal regulation that the contractor has failed to meet or

(4) when the U.S. industry preference of Section 204 of the Act has not
been met.

According to the determination, Norvir® has been available for use by patients with HIV/AIDS since 1996 and is being actively marketed by Abbott and prescribed by physicians as standalone protease inhibitor and a booster to increase the effectiveness of other drugs. Accordingly, this drug has reached practical application and met health or safety needs as required by the Bayh-Dole Act. 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. The NIH also maintains that the FTC is the appropriate agency to address the question of whether Abbott has engaged in anti-competitive behavior.