A Medical Device Daily

HemoCue (Angelhorn, Sweden/Lake Forest) reported that since 2003 it has been involved in a patent feud with EKF/Stanbio (Magdeburg, Germany/Boeme, Texas), charging infringement by an EKF/Stanbio product and that one of HemoCue’s patents has been questioned as to validity.

HemoCue said that “as a first step,” the U.S. patent office ruled that the claims in HemoCue’s patent are unpatentable (Medical Device Daily, Oct. 11, 2006). As a second step, it said it will now present its arguments.

“This was an expected outcome based on arguments submitted by EKF that, at this stage in the process, the Patent Office accepted at face value,” said Don DuBois, general manager of HemoCue (Lake Forest, California), the company’s U.S. operation. “The patent office has not yet considered HemoCue’s arguments, which we are confident will provide a strong basis for the patent office to hold that the claims are indeed patentable.”

DuBois said that HemoCue was not surprised that EKF initiated the reexamination process after EKF and Stanbio were accused of infringement.

“We expected this move ... and are confident that the validity of our patent will be confirmed. We will continue to aggressively enforce all of our patented technology against those who manufacture or sell infringing products.”

HemoCue recently received and enforced a judgment in a German Federal Court against EKF, which held that the German counterpart to the patent undergoing reexamination was infringed. EKF was enjoined from manufacturing and selling microcuvettes covered by the patent in Germany. That case is in appeal. As with the process in the U.S., final conclusions can only be drawn once the legal processes have come to their respective completion.

The HemoCue technology allows common blood tests at the point-of-care with, it says, “lab-quality” results.

HemoCue is owned by EQT (Helsinki/Stockholm), a private equity group in Northern Europe.

In other legalities: Align Technology (Santa Clara, California) reported that it has signed two agreements with OrthoClear , OrthoClear Holdings , and OrthoClear Pakistan (OrthoClear) to close the settlement reported on Sept. 28 (MDD, Sept. 29, 2006). The agreements executed include a settlement agreement and mutual releases and an intellectual property transfer agreement (the definitive agreement) ending all litigation between the parties and relates to Align’s purchase of OrthoClear for $20 million.

OrthoClear is now required to discontinue all manufacturing and sales of removable dental aligners worldwide.

Align is developing a program to start OrthoClear patients in Invisalign treatment at no charge to the patient or doctor.

“This ... allows us to extend a helping hand to the doctors and patients left stranded by OrthoClear’s decision to settle and cease operations rather than proceed with litigation and risk an ITC exclusion order,” said Thomas Prescott, president/CEO of Align. “Align is absorbing most of the cost and inconvenience doctors and patients would have incurred to replace their OrthoClear treatment.”

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