A Medical Device Daily
Stratagene (La Jolla, California), a maker of specialized life science research and diagnostic products, said it has recently settled litigation and significantly strengthened its patent portfolio pertaining to proprietary enzyme blends.
On May 11, Stratagene reported that it had entered into a definitive settlement agreement with Takara Bio (Tokyo) to resolve the companies' patent disputes in the field of enzyme blends that are widely used in polymerase chain reaction (PCR) technology.
PCR technology allows users to amplify a small amount of DNA, making analysis much easier and is commonly used in both research and molecular diagnostics, including the detection of diseases such as cancer, heart disease, AIDS, viral hepatitis, and other infectious diseases, as well as paternity and forensic testing.
As a result of the settlement, all pending patent litigation in the U.S. District Court for the District of Maryland and actual and potential patent interference proceedings in the U.S. Patent & Trademark Office have been resolved.
Potential disputes in the future will be avoided through cross-licenses of the parties' respective patent rights relating to enzyme blends, the company said.
Stratagene will now own a broad U.S. patent portfolio covering its enzyme blends. The company said it will seek to establish a licensing program for competitors' products covered by its broad portfolio.
“We are very pleased with the outcome of our settlement agreement with Takara Bio Inc. as it significantly strengthens our patent position in PCR technology,” said Joseph Sorge, MD, president and CEO of Stratagene. “We believe that there are a number of competitors selling products that are covered under our patent portfolio. It is our intention to make limited licenses available and recognize resulting licensing revenue. We believe that the opportunities created by this settlement illustrate the inherent value of our intellectual property and our investment in protecting our proprietary technology.”
Lincare Holdings (Clearwater, Florida) reported that it had resolved several ongoing investigations by the Office of Inspector General and/or the U.S. Department of Justice.
The combined settlements provide for the company to pay a total of about $12.03 million to the government, without any admission of wrongdoing by the company.
The first investigation was the Florida investigation previously disclosed by the company in June 2000. The investigation focused on the company's relationships with certain physicians and other referral sources during the period from January 1993 through December 2000.
The Office of Inspector General of the U.S. Department of Health and Human Services had contended that certain items of value were improperly provided to physicians and others in violation of federal law. The remaining three investigations were separate investigations conducted in Massachusetts, Tennessee and Idaho and involved allegations that the company had inappropriately sought reimbursement under Medicare and other government healthcare programs or otherwise violated federal healthcare laws.
The periods covered by these investigations varied, ranging from January 1995 through March 2004. As a part of the above four settlements, the company has entered into a corporate integrity agreement with the Office of Inspector General.
“Lincare fully cooperated with the government during the course of their inquiries,” said John Byrnes, Lincare's chairman and CEO. “Our board of directors believes that it was in the best interests of the company to put these matters behind us.”
The company has reserved for a substantial portion of the settlement charges and related fees and expenses in its consolidated financial statements in prior reporting periods.