A Medical Device Daily

Competitive Technologies (CTT; Fairfield, Connecticut) reported that a homocysteine assay license has been granted to Axis-Shield (Dundee, Scotland) under CTT’s U.S. patent No. 4,940,658 relating to homocysteine medical tests and will pay royalties on U.S. sales of Axis-Shield homocysteine assays.

The agreement, which includes payment for past homocysteine tests sold by Axis-Shield and its client, Bio-Rad Laboratories (Hercules, California), and an up-front license fee, settles patent infringement actions brought by CTT against Axis-Shield and Bio-Rad.

Axis-Shield’s homocysteine assay customers, other than those with unsettled litigation matters, will be covered by the Axis-Shield license from CTT. The suits filed by CTT in U.S. District Court against Axis-Shield and Bio-Rad for patent infringement, as well as Axis-Shield’s countersuit, will be dropped.

The settlement and license does not relieve Axis-Shield customers for royalties on past or future assays for methylmalonic acid, for which CTT will separately require a license to perform such assays.

CTT has signed license agreements with and is collecting royalties from companies performing the majority of homocysteine assays in the marketplace. These companies now include Axis-Shield, Bayer, Abbott, Roche, Quest and Diagnostic Products.

The homocysteine assay patent is derived from discoveries made by CTT’s clients, Drs. Robert Allen and Sally Stabler from the University of Colorado Health Sciences Center (Denver) and the late Dr. John Lindenbaum from Columbia University (New York).

Axis-Shield is an international in vitro diagnostics company.

CTT identifies and commercializes technologies in life, digital, nano and physical sciences developed by universities, companies, independent research institutions and individual inventors.

In other legalities:

• R2 Technology (Sunnyvale, California), a developer of computer-aided detection (CAD) systems, reported its issuance of a notice of dispute between it and competitor iCAD (Nashua, New Hampshire), regarding alleged patent infringements by iCAD.

iCAD last week reported receiving the notification of claims concerning three U.S. patents licensed to R2. While acknowledging the notification and asserting a “strong” patent position, it said it had not yet analyzed the claims (Medical Device Daily, April 29, 2005).

The notification to iCAD, before proceeding to litigation of the matter, was required by an earlier settlement agreement between the two companies. R2 said that the patents involved are “fundamental and broad and relate to film-based or digital CAD or both.”

R2’s ImageChecker CAD system was first approved by the FDA in 1998 for use with screening mammography to assist in the early detection of breast cancer. R2 says it was the first company to receive FDA approval, in 2004, for CAD for chest multi-slice CT (computed tomography). R2 reports owning or having rights to more than 150 U.S. patents and patent applications.

“R2 strongly believes that healthy competition is in the best interest of our customers and the patients they serve. During the past 12 years, [we have] made a significant investment in the research and development of computer-aided detection technology designed to help detect cancer earlier,” said John Pavlidis, president and CEO, promising a “vigorous effort” to protect its rights.

• Tenet Healthcare (Dallas) said last week that it is co-operating with a subpoena for documents it has received from the U.S. Attorney’s office in Memphis, Tennessee, concerning physician relocation agreements entered into since January 1999, at Tenet’s Saint Francis Hospital in Memphis. The subpoena, it said, was issued under provisions of the Health Insurance Portability and Accountability Act.

E. Peter Urbanowicz, Tenet’s general counsel, said that the subpoena “is consistent with previously disclosed federal reviews of Tenet’s physician relationships at a number of its hospitals in several states” and added that Tenet is talking with the federal agencies “regarding a resolution of physician relocation and other issues.”

Tenet is an owner/operator of acute-care hospitals.