A Medical Device Daily

HemoCue AB (Angelholm, Sweden) has claimed victory resolving a two-year-old patent dispute with EKF-diagnostics (Magdeburg, Germany). It reported that a Dusseldorf district court found that an EKF testing product infringes HemoCue's patent, registered in 1995.

The patent in dispute is licensed to HemoCue, a developer of point-of-care testing. It said the product is a Swedish invention and “an established standard in near-patient hemoglobin testing globally. From a single drop of capillary blood, the product determines the concentration of hemoglobin, used to diagnose acute blood loss, detect anemia and screen blood donors.“ The system consists of an instrument and a disposable microcuvette used with each test.

Thomas Glanzmann, CEO of HemoCue, said that the ruling provides “a decisive first-instance ruling on an issue included also in other legal proceedings.“ HemoCue said it will initiate preliminary enforcement of the decision so that no further sales or manufacturing of the infringing product will be allowed.

Clas Runnberg, responsible for legal processes at HemoCue, said, “For years, we are making considerable efforts in research and development of new products. The court ruling . . . shows that this protection, in spite of the long wait, has a value.“

HemoCue says that in 1982 it introduced the first system making accurate hemoglobin testing possible outside the hospital environment and has installed more than 200,000 systems delivering about 100 million tests annually.

In other legalities, blood substitute manufacturerBiopure (Cambridge, Massachusetts) reported reaching an agreement in principle with the staff of the SEC to settle previously disclosed litigation, filed in September 2005, concerning disclosures the company made in 2003.

As part of the proposed settlement, Biopure would consent, without admitting or denying the allegations, to an injunction against future violations of securities laws, with no payments required. The company also would agree to retain an independent consultant to review and make recommendations about the company's disclosure procedures.

A proposed settlement was also reached with the company's general counsel. If approved, this agreement would involve a dismissal by the SEC of all intent-based allegations in the complaint, a consent, without admitting or denying any allegations, and a civil penalty.

Neither proposed settlement would affect the general counsel's employment or officer status, Biopure said.

Biopure manufactures called oxygen therapeutics.