A Diagnostics & Imaging Week

Hologic (Bedford, Massachusetts), a provider of diagnostic and digital imaging systems for women's health, reported that it has signed a consent agreement with the Federal Trade Commission (FTC) resolving a dispute with the commission regarding its acquisition of the Mammotest prone-bed breast biopsy system intellectual property (IP) acquired as part of the mammography intellectual property assets acquired from Fischer Imaging (Denver).

Hologic last September acquired all of Fischer's intellectual property and other assets related to its mammography and breast biopsy businesses, including patents, trademarks, and customer and vendor lists for Fischer's prone stereotactic breast biopsy systems (SBBS) product, Mammotest, a deal valued at $32 million and first unveiled in June 2005.

In its settlement with the FTC, Hologic agreed to sell all IP relating to Mammotest to Siemens (Munich, Germany) for $6.5 million in cash but will retain a royalty-free, non-exclusive, perpetual worldwide right and license to use the IP relating to Mammotest.

The FTC charged that Hologic's acquisition of Fischer's SBBS business harmed American consumers by eliminating its only significant competitor for the sale of SBBS products in the U.S.

"Left unchallenged, Hologic's purchase from Fischer would have deprived American women of the benefits of competition for these critical healthcare services," Jeffrey Schmidt, director of the FTC's Bureau of Competition, said in a statement.

Prone SBBSs are integrated systems enabling minimally invasive breast biopsies using X-ray guidance. The FTC said that while there are other methods of performing breast biopsies, "including other minimally invasive systems and surgical biopsies, none are viable economic substitutes for prone SBBSs. Most hospitals, in fact, have the capability to perform breast biopsies using multiple methods to ensure that the most appropriate system is used for each patient's procedure. Both the Hologic and Fischer SBBSs perform potentially life-saving services by enabling doctors to detect breast cancer at a critical early stage of development."

The FTC said that although another firm, Giotto USA, sells a prone SBBS unit in the U.S., it is not a significant competitor, with just "minimal sales" three years into the market. And the FTC contended that Giotto would be unable to expand its U.S. sales because it does not have access to critical prone-SBBS patents and lacks the "infrastructure, track record and reputation to compete in this market."

Additionally, it said that the strength of Hologic's IP portfolio "effectively insulate[s] the U.S. market from new entry. In fact, Hologic's MultiCare prone SBBS product . . . could only compete in the U.S. market under a license to the Fischer patents that Hologic acquired as part of the settlement of patent infringement litigation." It cited R&D and regulatory hurdles as other barriers to the market.

The agreements exclude the Senoscan digital mammography intellectual property assets purchased by Hologic in the Fischer acquisition, which will continue to be retained by Hologic.

If the FTC does not give final approval to the divestiture of IP to Siemens, the order would require Hologic to divest the assets to another FTC-approved buyer within six months. If Hologic does not complete the divestiture within six months, the commission may appoint a trustee to divest the assets.

"We are pleased the Fischer dispute is behind us and even more excited that we have been cleared to proceed with our Suros acquisition," said Jack Cumming, CEO and chairman of Hologic. "Suros represents a unique opportunity that we are looking to capitalize on with the strength of our expanded distribution and product fit."

With the IP sale, Hologic will record an impairment charge and said the net impact of the charge and the proceeds to be received from Siemens should have a positive impact on its results.

Hologic is focused on osteoporosis assessment, mammography and breast biopsy, and mini C-arm and MRI imaging for orthopedic applications.

In other legalities:

• Applera (Norwalk, Connecticut) and Beckman Coulter (Fullerton, California), a maker of instrument systems, tests and supplies that simplify and automate laboratory processes, jointly reported that they have entered into a definitive agreement to resolve all outstanding legal disputes between the parties regarding claims to certain Beckman Coulter patented capillary electrophoresis technology and instrumentation technology and Applera's allegations of breach of contract of certain licensed technology.

The agreement terms are consistent with those described in the joint announcement of a preliminary agreement made on April 26.

• The U.S. Federal Trade Commission has approved the issuance of a final consent order concerning Fresenius AG (Bad Homburg, Germany), the world's largest provider of products and services for individuals undergoing dialysis because of chronic kidney failure, and its subsidiary, Renal Care Group. The commission vote to issue the final order was 5-0.