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Varmus rejects CellPro Compulsory license
NATIONAL INSTITUTES OF HEALTH
Friday, August 1, 1997
NIH Director Harold Varmus, M.D., today denied the petition of
CellPro, Inc. (CellPro) that the NIH initiate "march-in" procedures
under the Bayh-Dole Act in order to give CellPro a license to certain
patents owned by the Johns Hopkins University and licensed to Baxter
Healthcare Corporation (Baxter).
CellPro asserted that march-in was necessary to alleviate health
needs that arise because a Federal District Court found the stem cell
separation device developed by CellPro to infringe the patents. The
Court has issued an order in that case allowing CellPro to keep its
product on the market until an alternative is approved by the Food and
Drug Administration and made available for sale.
Dr. Varmus concluded that the initiation of march-in procedures is
not warranted based on the available information, but that the NIH will
continue to monitor the situation until a comparable alternative product
becomes available for sale in the United States. Although the petition
was originally sent to DHHS Secretary Donna Shalala, the authority for
march-in is delegated to the head of the funding agency, in this case,
Dr. Varmus at the NIH.
"The patient care implications of this matter were our first
priority and concern," said Dr. Varmus. "Our review indicated that
patient needs would be met as ong as one or the other cell separation
device is available to people in treatment or clinical research
programs. Since both devices are currently available under the terms of
the Court Order, I do not believe march-in proceedings are warranted."
Dr. Varmus added, "The NIH will continue to follow the situation to
ensure that patient access to this technology is not compromised."
The NIH recognizes that its decision today will not resolve the
legal dispute between CellPro and Baxter, which has been the subject of
complex patent litigation. It is the position of the NIH that these
companies have full power and authority to resolve this dispute on their
own. The NIH has encouraged and will continue to encourage them to
negotiate a resolution.
For more information, please read the accompanying backgrounder at
(http://www.nih.gov/news/pr/aug97/niha-01.htm). The full text of the
determination is available via the Internet at
(http://www.nih.gov/news/pr/aug97/nihb-01.htm) or through the NIH Office
of Communications at (301) 496-8740.
James Love | Center for Study of Responsive Law
P.O. Box 19367 | Washington, DC 20036 | 202.387.8030
http://www.cptech.org | email@example.com