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 long 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.