CELLPRO SEEKS BAYH-DOLE LICENSES FOR CEPRATE SC CELL CONCENTRATION SYSTEM.BOTHELL, Wash--(BUSINESS WIRE)--March 4, 1997--CellPro, Inc. (Nasdaq: CPRO CPRO Columbia Pike Revitalization Organization CPRO Connecticut Peer Review Organization, Inc. ) today sought licenses or other action from the Secretary of Health and Human Services Noun 1. Secretary of Health and Human Services - the person who holds the secretaryship of the Department of Health and Human Services; "the first Secretary of Health and Human Services was Patricia Roberts Harris who was appointed by Carter" to provide access at a reasonable rate to certain patents related to an antibody used in CellPro's CEPRATE(R) SC Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Concentration System. A license from the Secretary would also insure continued availability of the System if the company is enjoined from selling the antibody as a result of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. underway in the Federal District Court in Wilmington, DE. CellPro's petition was submitted pursuant to the "march in" provisions of the Bayh-Dole Act (35 U.S.C. Section 200 et seq et seq. (et seek) n. abbreviation for the Latin phrase et sequentes meaning "and the following." It is commonly used by lawyers to include numbered lists, pages or sections after the first number is stated, as in "the rules of the road are found in Vehicle Code .), which empowers the Secretary, in cases of compelling public interest, to issue licenses under privately held patents where such patents were based on government-funded research. Plaintiffs Baxter HealthCare, Becton Dickinson & Company and Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. allege that CellPro's CEPRATE SC System infringes certain of plaintiffs' patents. They have indicated they will seek to have the Court enjoin To direct, require, command, or admonish. Enjoin connotes a degree of urgency, as when a court enjoins one party in a lawsuit by ordering the person to do, or refrain from doing, something to prevent permanent loss to the other party or parties. CellPro from marketing the CEPRATE SC System. CellPro has denied plaintiffs' allegations. In a trial concluded August 1995, involving the same parties in the same court, a jury found all patents in dispute to be invalid and not infringed by CellPro. The Court, in response to plaintiffs' post-trial motions, declined to enter the jury verdict and instead ordered a new trial, which is to begin this week. Since the initial jury verdict, the CEPRATE SC System received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval in December 1996 for use in bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. . Breast cancer, multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility and lymphoma patients will be the primary groups treated with the CEPRATE SC System. Clinical trials showed that as compared to traditional bone marrow transplantation, use of the CEPRATE SC System reduced toxicities and side effects Side effects Effects of a proposed project on other parts of the firm. while maintaining equivalent regeneration of the body's immune system. More than 5,000 patients to date have been treated using the CEPRATE SC System. At the same time, plaintiffs' own efforts have not yet resulted in an FDA approved product and they have not provided any assurances whether they will ever do so. CellPro noted in its petition to the Secretary of Health and Human Services that these are precisely the circumstances under which the authors of Bayh-Dole envisioned the Department exercising the "march in" authority provided for in the Act. The Bayh-Dole Act was authored by Senators Birch Bayh and Robert Dole. Senator Bayh, now practicing law with the firm of Bayh Connaughton PC, signed the petition sent to the Secretary on CellPro's behalf. The initial jury verdict was based on the Court's interpretation of the claims in the patents under dispute. In ordering the new trial, the Court revised its interpretation of the claims, opening the possibility of new defenses for CellPro. However, the Court has since denied CellPro these defenses in a series summary judgment motions. The Court has ruled against CellPro on the issues of non infringement and invalidity that were previously decided by the jury in CellPro's favor. Since the order of a new trial was entered, plaintiffs have dropped two of their four initial infringement claims. In the trial commencing this week, the Court will limit jury consideration only to the issues of damages and willful infringement by CellPro on two outstanding patents. CellPro intends to seek review of the adverse decisions of the Wilmington District Court by the Federal Circuit Court of Appeals. "Our case is strong and we are confident of a favorable review by the Circuit Court. We are also confident of the grounds for our Bayh-Dole petition," said Richard Murdock, CellPro's president and chief executive officer. "All of our efforts -- at the trial court, on appeal and before the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS -- are aimed at ensuring that clinicians and patients in need will have unrestricted access to the CEPRATE SC System." Located in Bothell, WA, CellPro, Inc. is a biotechnology company specializing in the development and manufacture of proprietary continuous flow cell selection systems for a uses in a variety of therapeutic, diagnostic and research applications. Its CEPRATE SC Stem Cell Concentration System is approved for sale in the US, Canada and 18 European countries. CONTACT: CellPro, Incorporated Joann Reiter, 206/485-7644 invest@cellpro.com http://www.cellpro.com |
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