A Medical Device Daily
ThermoGenesis (Rancho Cordova, California), a supplier of cryogenic devices used by cord blood banks, and Netcord (Dusseldorf, Germany), an international network of public cord blood banks, reported that the U.S. Patent and Trademark Office (PTO) has reexamined U.S. patent No. 5,192,553 (Patent '553) and rejected all its claims.
The action by the PTO was praised by ThermoGenesis and Netcord, with Netcord's president, Peter Wernet, MD, director of the Cord Blood Bank of Duesseldorf University in Germany, saying that the decision supports the claim that the PharmaStem (Wayne, Pennsylvania) patent "is not justified in view of the knowledge existing at the time of its original submission."
Pablo Rubinstein, MD, director of the National Cord Blood Program at the New York Blood Center and vice president of Netcord, "The PTO decision will be of great help both to the patients who need blood and immune system stem cell transplantation to overcome lethal disease and to the development of therapies based on umbilical cord blood stem cells, by disallowing an unnecessary drain of resources to pay for unwarranted license fees."
The organizations said that PharmaStem's patents have been attacked in the U.S. owing to the existence of prior art. In Europe, a single PharmaStem patent that consolidated all claims of both U.S. patents ('553 and 5,004,681 [Patent '681]) had all claims rejected, without further appeal, in 2003, as a result of actions brought on the same basis before the European Patent Office by Netcord, ThermoGenesis and others. In Japan, the same prior art, filed in opposition by ThermoGenesis, led to the rejection of all PharmaStem patent claims by the Japanese Patent Office in 1999.
Netcord said that the reexamination "opens a new chapter in the history of the controversial patent rights claimed by PharmaStem on the invention of a therapeutic composition including human cord blood and the use of cord blood-derived cells for marrow reconstitution." It said that patent '553 is derived from earlier Patent '681, already much reduced in the breadth of its claims as a result of PTO actions stemming from a 1993 reexamination request currently undergoing a second PTO reexamination at the request of ThermoGenesis.
ThermoGenesis develops technologies enabling the production of biological products from single units of blood. Umbilical cord blood banks are using the company's BioArchive System for cryopreserving and archiving cord blood stem cells for transplant; its CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patient blood in about an hour.
The Netcord Foundation is a network of non-profit public cord blood banks in the U.S., Europe, Israel, Japan and Australia. Its quality standards were developed in collaboration with the Foundation for the Accreditation of Cellular Therapy (Omaha, Nebraska) in North America, related to the collection and management of cord blood units.
Brieflt NOtedCREST trial expansion reported
The University of Medicine and Dentistry of New Jersey (UMDNJ; Newark) said it expanded the scope of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) study to include asymptomatic participants, and that it has expanded trial sites from 70 to 110. Prior to January, only participants with symptomatic carotid disease were included in the randomized arm of CREST.
Sponsored by the National Institute of Neurological Disorders and Stroke and the National Institutes of Health (both Bethesda, Maryland), CREST is a randomized clinical trial to evaluate – in patients who are at normal risk for surgery – the efficacy of carotid artery stenting (CAS) compared to carotid endarterectomy (carotid surgery) in preventing stroke, myocardial infarction and death in the 30-day period following the procedures, and ipsilateral stroke (occurring on the same side of the brain in which the stent was placed) during a multi-year follow-up.
More than 1,000 participants have been enrolled in the lead-in phase, and more than 400 participants have been enrolled in the randomized phase. Patients in the CAS arm are receiving the Acculink stent and Accunet embolic protection device, both made by Guidant (Indianapolis).
Robert Hobson II, MD, principal investigator, said that inclusion of asymptomatic patients "will benefit more patients, enhance clinical understanding and allow us to better gauge the safety and effectiveness of carotid stenting vs. surgery in the broad-base population currently receiving surgical treatment."
New division for Millipore
Millipore (Billerica, Massachusetts) reported that it has formed a new Bioscience Division that will focus on life science research and general laboratory applications of its products and services. The new division combines Millipore's Life Sciences Division and Laboratory Water Division, which essentially served the same customer base. The intent, the company said, is to provide "more organizational clarity, improve sales effectiveness, better serve customers and focus R&D investments in the laboratory area."
Dominique Baly, who has served as president of the Laboratory Water Division, will lead the new organization.