Varmus rejects CellPro Compulsory license

[James Love <love@cptech.org>]

  NATIONAL INSTITUTES OF HEALTH
                              FOR RELEASE
                              Friday, August 1, 1997
  
                                               Ann Thomas
                                               (301) 496-4461 
  
  
       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 | love@cptech.org