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Vysis to defend patent licensed to Gen-Probe.

Vysis, Inc. (Downers Grove, IL), reported that Gen-Probe, Inc. (San Diego, CA; 619-546-8000) has filed suit against Vysis in the United States District Court in San Diego, California, seeking a declaration of invalidity and non-infringement of Vysis' United States Patent 5,750,338 for "Target and Background Capture Methods with Amplification for Affinity Assays," issued May 12, 1998 to M. L. Collins et al. The Collins patent covers a method that enables substantial improvement in clinical sensitivity for enzyme amplification technologies, such as Gen-Probe's transcription mediated amplification technology, and was licensed to Gen-Probe as part of a June 1999 settlement of patent litigation between Vysis and Gen-Probe. Gen-Probe's suit seeks to eliminate it's obligation to pay license royalties to Vysis on Gen-Probe's nucleic acid testing test kits for HIV and HCV, currently in large scale clinical trials for blood screening and to be marketed by Chiron Corporation (Emeryville, CA; 510-923-2412). Even though it filed the suit, Gen-Probe has not terminated its license under the Collins patent. In addition, concurrently with filing the suit, Gen-Probe exercised options to extend its license under the patent to its partnerships with Chiron and Bayer (Pittsburgh, PA). Vysis has not yet responded to the complaint but intends to defend its patent rights vigorously.

"In our view, this suit has been brought because the anticipated royalty payments to Vysis under the Collins license greatly exceed the cost of a lawsuit to try to invalidate the patent," stated John L. Bishop, Vysis president and CEO. "Although no one likes litigation, the significant technological advance of the Collins patent makes us confident of a favorable outcome."

The patented technology was invented in the mid-1980's and relates to pathogen detection methods that achieve high clinical sensitivity by coupling Vysis' reversible target capture technology with enzymatic nucleic acid amplification techniques, such as the polymerase chain reaction, Q-beta replicase, and transcription mediated amplification. The utility of the patented technology was proven by Vysis in clinical trials using an automated DNA probe testing instrument in 1994-95, as reported by Smith, et al. in the Journal of Clinical Microbiology Vol. 35, No. 6, June 1997 at 1477-83 and 1484-91, where use of the patented technology greatly improved the clinical sensitivity of the assay.

Chiron has announced that the clinical trials of the Gen-Probe nucleic acid testing product currently encompass testing of approximately 70 percent of the United States blood supply, and financial analysts expect its FDA approval in mid-2000. "We are confident that our patent rights will be sustained and that Gen-Probe's HIV/HCV product will be found to infringe those rights," stated Norval B. Galloway, Vysis patent counsel.

In November 1999, Vysis announced goals of achieving break-even status of its operations in the fourth quarter of 2000, and profitability for the full year 2001. "We have evaluated these goals in light of the litigation expense we estimate for this suit and we have decided not to adjust these goals. Vysis has recently significantly reduced its operating expenses in Europe by the appointments of exclusive distributors in France and Italy, and we believe these reductions mitigate the financial impact from the expected cost of the suit," stated Bishop.

Vysis is a genomic disease management company that develops, commercializes and markets clinical products providing information critical to the evaluation and management of cancer, prenatal disorders and other genetic diseases. The company has direct sales operations in the United States and Europe, a marketing partnership in Japan with Fujisawa Pharmaceutical Co. (Osaka, Japan; 06-202-1141), and a worldwide distribution network.
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Comment:Vysis to defend patent licensed to Gen-Probe.
Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:Jan 1, 2000
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