[Ip-health] BNA: NGOs, Academics Seek Congressional Review Of March-in' Petition for HIV/AIDS Therapy

Thiru Balasubramaniam thiru at keionline.org
Thu Oct 17 04:29:16 PDT 2013

Reproduced with permission from Life Sciences Law & Industry Report, (Oct.
8, 2013). Copyright 2013 by The Bureau of National Affairs, Inc.
(800-372-1033) http://www.bna.com.


NGOs, Academics Seek Congressional Review Of ‘March-in' Petition for
HIV/AIDS Therapy

By Daniel Pruzin

Oct. 10 — A group of nongovernmental organizations and academics has asked
the U.S. Congress to hold a hearing to determine why the National
Institutes of Health has declined to review their “march-in” petition to
lift patent protection for the HIV/AIDS treatment ritonavir.

In a letter dated Oct. 8 and addressed to Senate and House leaders, the
group accused the NIH of failing to exercise its authority to protect the
public from abuses in federally funded inventions.

The request stems from a petition filed in October 2012 by four NGO groups
— the American Medical Students Association (AMSA), Knowledge Ecology
International (KEI), U.S. Public Interest Research Group (PIRG) and the
Universities Allied for Essential Medicines (UAEM) — asking the NIH to
grant march-in rights under the 1980 Bayh-Dole Act relevant to the
manufacture and sale of ritonavir, an NIH-funded invention (6 LSLR 1095,

Ritonavir, sold under the name Norvir, is priced four to 10 times higher in
the U.S. than in other high-income countries, the group said. The NIH has
yet to grant a hearing on the October 2012 petition, they added.

Patent rights for Norvir are held by the biopharmaceutical company AbbVie,
which was spun off from Abbott Laboratories in January (6 LSLR 380, 4/6/12).

The Bayh-Dole Act authorizes the Department of Commerce to create standard
patent rights clauses to be included in federal funding agreements with
nonprofits, including universities and small businesses. These groups can
retain patent rights by complying with certain formalities.

However, the march-in provision (35 U.S.C. Section 203) allows the federal
funding agency to override these rights and grant additional licenses to
applicants if the agency determines that the patent holder has failed to
take effective steps to achieve practical application of the invention or
fails to satisfy the health and safety needs of consumers.

Since the law was passed, the Department of Health and Human Services has
never granted a march-in petition to permit third parties to use patents
invented on federally funded research in response to abuses of the patent
rights, the group said. “We do not believe that any reasonable person would
conclude that in 32 years, there have been no abuses of patent rights.”

The letter was signed by the four NGOs that submitted the October 2012
petition as well as the activist group Public Citizen.

Academic signatories were Peter S. Arno, senior fellow and director of
health policy research at the University of Massachusetts-Amherst; James
Boyle, professor of law at Duke University; Michael Davis, professor of law
at Cleveland State University; Sean Flynn, associate director of the
American University Washington College of Law; and Mark McKenna, professor
of law at Notre Dame.

On July 12, Sen. Patrick J. Leahy (D-Vt.) wrote to NIH Director Francis S.
Collins asking that the agency exercise the march-in provisions to force
another company, Myriad Genetics Inc., to license its patents related to
testing for genetic mutations associated with breast and ovarian cancer (7
LSLR 781, 7/26/13).

Leahy said he was concerned that the health needs of the public “are not
reasonably satisfied by the patentee in this situation because testimony
presented to the [U.S. Patent and Trademark Office] made clear that many
women are not able to afford the testing provided by Myriad.”

By Daniel Pruzin

To contact the reporter on this story: Daniel Pruzin in Geneva at
correspondents at bna.com

To contact the editor responsible for this story: Randy Kubetin at
rkubetin at bna.com

For More Information

The letter to Congress is available at

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