Haemonetics Corporation (NYSE: HAE) announced today that it has filed a new legal action to stop Fenwal Inc.'s continued patent infringement resulting from Fenwal's just released red cell collection kits, using a modified separation chamber. Fenwal allegedly modified its separation chamber to circumvent Haemonetics' patent and the injunction entered by the Court prohibiting Fenwal's continued sale of infringing products after December 1, 2010. According to statements made by Fenwal's counsel today in the United States District Court, Fenwal is determined to proceed with commercialization without 510(k) clearance from the U.S. Food & Drug Administration.
On December 7, 2009 Fenwal announced that it began shipping a red cell collection kit with a modified separation chamber, and that it is discontinuing sales of its original kit. Ten months ago, on January 31, 2009, a federal jury had determined that Fenwal's original collection kit infringes a Haemonetics patent, and found Fenwal liable to Haemonetics for over $15 million in damages. The United States District Court for the District of Massachusetts later added millions of dollars in pre-judgment interest and ordered the product removed from the market by December 1, 2010. The District Court also ordered that between January 31, 2009 and December 1, 2010, Fenwal must pay Haemonetics a 10% royalty on the offending product's sales. The damages have not been paid, and the royalties are being escrowed pending decision on Fenwal's appeal to the United States Court of Appeals for the Federal Circuit. A decision by the appellate court is not expected before late 2010 at the earliest.