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Fenwal Responds to New Lawsuit From Haemonetics; Reiterates Commitment to Blood Centers

Wednesday, December 16, 2009 General News J E 4
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LAKE ZURICH, Ill., Dec. 15 Fenwal Inc., a global leader focused on improving blood collection, safety and availability for patient care, reiterated its commitment to provide blood centers with Alyx® system supplies needed to collect lifesaving blood products, despite a new lawsuit filed yesterday against Fenwal by Haemonetics Corporation (NYSE: HAE). The Fenwal® Alyx® system, introduced in 2003, is an advanced medical instrument used worldwide to collect two units of red cells from a single donor in about 30 minutes.

Fenwal will ask the court to expedite the legal process to reduce the impact of delays on customers and the blood supply. The new lawsuit filed against Fenwal follows an earlier motion made by Fenwal before the same judge seeking a decision of non-infringement on its modified Alyx® separation chamber. In filing a second lawsuit now, Haemonetics has chosen to prolong the litigation.

Fenwal will vigorously defend itself in this new litigation and has taken several actions to assure uninterrupted product supply to blood centers. As previously announced, the company has modified the separation chamber in Alyx® kits to avoid infringing the disputed patent claim and to comply with the earlier court's judgment and injunction. Fenwal has openly informed Haemonetics of its redesign and introduction plans, including providing Haemonetics with drawings last April and production samples last September. In developing the modified Alyx® separation chamber, Fenwal followed strict design control procedures in accordance with all U.S. Food and Drug Administration regulations and guidance.

"We are committed to working with customers and assuring their operations are not disrupted as we continue to work through the steps required to resolve this," said Dean Gregory, Fenwal senior vice president of Commercial Operations. "We have said 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."

Earlier this month, Fenwal began shipping Alyx® kits with the modified chamber and began discontinuing U.S. sales of the original chamber, nearly a year ahead of the December 2010 injunction date.

In addition, as previously announced, Fenwal has appealed the original judgment of infringement on several strong grounds. It has also asked the U.S. Patent Office to reconsider the validity of the disputed patent.

Fenwal developed and introduced the Alyx® system independent of the disputed patent. Haemonetics, which purchased the patent from a third-party inventor, has not incorporated the technology into any commercial product.

About Fenwal

Fenwal Inc. is a global medical technology company focused on improving blood collection, separation, safety and availability for patient care. Fenwal became an independent company in 2007, but its roots go back to 1949 with the founding of Fenwal Laboratories. Fenwal developed the first flexible, disposable container for blood collection, eliminating complications associated with glass containers and allowing blood to be separated into therapeutic components. Today, the company's products and advanced collection and separation technologies are used throughout the world to help ensure a safe and available supply of lifesaving blood and blood products. Fenwal Inc. is based in Lake Zurich, Illinois. For more information, please visit www.fenwalinc.com.

SOURCE Fenwal Inc.
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