A Medical Device Daily
Fenwal (Lake Zurich, Illinois), a company focused on blood collection, safety and availability for patient care, said it will appeal the decision by a Boston court in a patent lawsuit brought by Haemonetics (Braintree, Massachusetts) in 2005.
Fenwal said it believes it has strong grounds for a successful appeal.
In conjunction with this litigation, Judge Nathaniel Gorton of the U.S. District Court for the District of Massachusetts decided on June 1 that beginning Dec. 1, 2010, Fenwal will be enjoined from selling current Alyx disposable kits that contain an infringing component. The order, which also specifies royalties, applies only to these disposable kits and not to the Alyx system itself, nor to any future Alyx products that do not contain the infringing component.
Fenwal will appeal the final judgment when entered. To assure continued supply for customers, Fenwal also will modify the component found to infringe. The company plans to introduce the modified kit, which is currently in development, before the end of 2009, well in advance of the injunction date.
This kit will be fully compatible with the existing Alyx system. No changes will be required to the Alyx system itself. Fenwal expects no procedural changes will be required, nor new validation will be recommended for customers.
Fenwal is taking these actions to assure that blood centers are able to maintain an adequate blood supply for patients through uninterrupted access to Fenwal's blood-separation technology. Blood centers around the world rely on the Alyx system to collect red cells needed by patients who require blood transfusions.
"We are committed to working closely with customers and assuring their operations are not disrupted as we continue to work through the next steps in resolving this litigation," said Dean Gregory, Fenwal senior vice president of commercial operations. "We have believed from the beginning that the claims against Fenwal have no merit and we will defend our position on behalf of our customers and employees. We also are continuing to develop new innovations for the Alyx system that further improve the donor experience and help blood centers fulfill their mission with greater safety, quality and productivity."
Fenwal developed the Alyx system independent of the Haemonetics patent. Haemonetics, which purchased the patent from a third-party inventor, has never incorporated the technology into any commercial product.