A Diagnostics & Imaging Week

Saliva Diagnostic Systems (SDS; Framingham, Massachusetts) said it received a favorable ruling in connection with litigation brought against it by Chembio Diagnostic Systems (New York) in U.S. District Court for the Eastern District of New York.

Saliva said that Judge Joanna Seybert issued on Sept. 27 a claim construction ruling on the interpretation of the patent claims in the suit. The court ruled that SDS’ broader interpretation of its patent claims was correct, and rejected Chembio’s arguments seeking to narrow coverage afforded by the ’864 patent held by Saliva Diagnostic Systems.

Chembio originally brought the suit, seeking a ruling that its Sure Check device does not infringe SDS’ patent, as well as other relief. SDS has countersued for patent infringement.

SDS said that with the broad scope of the ’864 patent now established, it will seek an expedited court schedule for the remaining proceedings to recover damages and to enjoin Chembio from selling or offering for sale the Sure Check device.

Saliva Diagnostic Systems said it considers the judge’s ruling a “major victory” in the dispute.

SDS manufactures a rapid point-of-care testing device for infectious diseases, as well as oral fluid specimen collection devices using a volume adequacy indicator for drugs-of-abuse testing and other clinical uses.

The Invader technology developed by Third Wave (Madison, Wisconsin) was the center of two legal actions last week, the subject of a new lawsuit and also requiring a defense of court decisions in its favor.

Third Wave issued a response on Sept. 30 to a lawsuit filed against it by Innogenetics (Ghent, Belgium), that alleges that it is infringing one of Innogenetics’ hepatitis C virus (HCV) patents. Innogenetics also filed a similar suit against Abbott Laboratories (Abbott Park, Illinois). Both suits were filed in U.S. District Court for the Western District of Wisconsin in Madison.

“Third Wave is well-versed in the HCV patent landscape and has taken great care to understand and respect all the major patents in the field, including those held by Innogenetics,” said Kevin Conroy, vice president and general counsel of Third Wave. “Innogenetics’ suit lacks a basic understanding of the uniqueness of Third Wave’s Invader chemistry and how it is configured in our HCV analyte-specific reagents. It appears that Innogenetics filed suit against Third Wave without first understanding how our product is designed. In addition to our belief that Third Wave is not infringing Innogenetics’ patent, we believe the Innogenetics patent is invalid.”

Third Wave and Innogenetics are marketing partners in Europe and have been in discussions about the possible expansion of their distribution partnership.

In other court action, Stratagene (La Jolla, California), a manufacturer of life science research and diagnostic products, said it would appeal a jury ruling that its FullVelocity QPCR and its Full Velocity QRT-PCR products infringe patents held by Third Wave. It also filed a countersuit vs. Third Wave.

On Sept. 2, the jury awarded to Third Wave a total of $5.29 million in damages. Post-trial motions are to be filed and a final court decision is expected before the end of the year, Stratagene said.

The injunction requires that Stratagene must notify its customers and collaborators that its FullVelocity products infringe Third Wave patents.

“The permanent injunction entered by the court today details the actions that are required of Stratagene to eliminate any confusion and damage it has caused with customers in the marketplace,” said John Puisis, president and CEO of Third Wave. “The court’s action today validates the strength of Third Wave’s patents.”

When the jury decision was reported last month, Third Wave said that, based on the verdict of willful infringement, it would seek additional damages. It characterized the ruling as bolstering its “unique position in nucleic acid testing.” It said that with the expiration of patents for basic polymerase chain reaction (PCR), it is “one of a very few companies that can leverage its nucleic acid testing chemistry – the Invader technology – with basic PCR.”

Stratagene said it believes that the jury’s verdict, the damages awarded and the injunction were not supported by the facts.

Sales of these products, Stratagene said in a statement, have been less than $400,000 since their launch in early 2004. The company also said it has “other embodiments” of its FullVelocity technology that do not infringe Third Wave patents, and it believes these can be used in both the research and diagnostics marketplaces.

Stratagene said it will file its appeal in the Court of Appeals for the Federal Circuit in Washington “as soon as practicable” and will seek to lift the injunction and have the damage amounts reduced or eliminated.

The company said it also has served Third Wave with the lawsuit that Stratagene filed on May 6 for infringement of Stratagene’s patents covering its FullVelocity technology for the quantitative detection of nucleic acids in the U.S. District Court for the District of Delaware. That suit seeks monetary damages as well as a permanent injunction against continued infringement by Third Wave for the sale of its Invader Plus products.