The National Institutes of Health (NIH) Friday denied CellPro Inc.'s petition seeking a government order awarding the company a license to Johns Hopkins University patents related to stem cell selection technology.

On March 3, 1997, CellPro, of Bothell, Wash., asked the U.S. Health and Human Services Department and the NIH to invoke a federal "march-in" provision under the Bayh-Dole Act of 1980 to get rights to the technology, which is the focus of patent infringement allegations filed against CellPro by Johns Hopkins, of Baltimore, Baxter Healthcare Corp., of Deerfield, Ill., and Becton Dickinson & Co., of Franklin Lakes, N.J.

Baxter and its co-plaintiffs accused CellPro of violating the Johns Hopkins patents with regard to CellPro's FDA-approved Ceprate SC Stem Cell Concentration System, a device that restores bone marrow destroyed by cancer chemotherapy.

A federal court judge agreed with the plaintiffs and last week ordered CellPro to pay $7 million in damages. The court also issued an injunction preventing CellPro from selling its device, but delayed implementing the order until an alternative product is approved by the FDA. (See BioWorld Today, July 28, 1997, p.1.) CellPro has appealed the court decisions.

CellPro asked the NIH to invoke the Bayh-Dole march-in provision as a means of negating the court's rulings against the company.

Harold Varmus, director of the NIH, determined a march-in proceeding was not warranted and neither Johns Hopkins, the patent holder, nor Baxter, the licensee, will be required to grant a license for the disputed stem cell technology to CellPro.

Varmus said stem cell technology remains available to patients, therefore presenting no health threat. However, he said the NIH, of Bethesda, Md., will continue to follow the situation to ensure that patient access is not compromised.

The Bayh-Dole Act was designed to encourage universities and small businesses to invest the resources necessary to develop and commercialize inventions supported by public dollars.

Under the act, recipients of public funding have responsibility for patenting and licensing new discoveries arising out of publicly funded research. The act, however, reserves certain rights for the funding agency, including the march-in provision.

The march-in allows the funding agency to require the holder of the patent or its licensee to issue a license to another party in the interest of public health or safety. *