A Medical Device Daily

Applera (Norwalk, Connecticut) and Beckman Coulter (BC; Fullerton, California) yesterday reported that they have established the terms of a settlement to resolve all legal disputes between them regarding claims to certain Beckman Coulter patented capillary electrophoresis technology and PCR instrumentation technology and Applera's allegations of breach of contract of certain licensed technology.

The parties will grant royalty-bearing licenses to each other. Beckman Coulter will grant Applera licenses to its patents for replaceable gels for capillary electrophoresis instruments and DNA sequencers and to its patent for a heated lid for thermal cyclers.

Applera will grant Beckman Coulter licenses conferring rights in the diagnostics market to its patents for nucleic acid sequencing and real-time PCR thermalcycling. Additionally, Applera's Applied Biosystems (Foster City, California) group will make a $35 million special payment to BC on signing for release of any and all claims of infringement relating to DNA sequencer and thermal cycler products.

BC will make a $20 million payment over 10 quarters to Applera's Celera Genomics (Norwalk, Connecticut) group for rights in the diagnostics market to the referenced Applera technology.

“Based on recent external industry estimates, the worldwide market for molecular diagnostics testing is estimated to be about $2 billion, growing at more than 15% per year,“ said Scott Garrett, president and CEO. “Through this agreement with Applera, Beckman Coulter will be in a position to add nucleic acid sequencing to the menu of molecular diagnostic tests available on our recently launched Vidiera NsD capillary electrophoresis systems and CEQ family of instruments.

The U.S. District Court for the Central District of California said it will stay its proceedings for 90 days pending completion of definitive agreements based on these terms.

On March 7, David Carter, U.S. District Judge for the Central District of California, granted the SEC's motion for summary judgment and entered a final judgment against Anthony Sciuto, the president and CEO of BodyScan (Irvine, California), permanently enjoining Sciuto from violating sections of the Securities Exchange Act of 1934, ordering him to pay $120,000, and barring him from serving as an officer or director of any company.

The court found that Sciuto had disseminated false statements concerning the number of imaging centers operated by BodyScan, the company's prospects for growth and anticipated earnings.

Previously, on March 17, 2005, the SEC filed a complaint against BodyScan and Sciuto, charging them with making a series of false and misleading statements. On Aug. 30, 2005, the court entered a final judgment by default against BodyScan, permanently enjoining it from violating the same antifraud provisions of the federal securities laws and ordering it to pay a civil penalty of $600,000.

In other legalities:

Monitoring technology developer Masimo (Irvine, California) reported that Dolphin Medical (Hawthorne, California) has agreed that it will discontinue its Dolphin ONE product line. The discontinuation is part of an agreement between Dolphin and Masimo, in which Masimo has agreed to release Dolphin and its affiliates from certain patent infringement claims.

Dolphin is an OEM manufacturer of pulse oximetry sensors and digital pulse oximetry instruments.

• Lumenis (Yokneam, Israel), a developer of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, said a settlement agreement with the SEC has been approved. The company previously reported the agreement in principle with the SEC's Division of Enforcement in March (Medical Device Daily, March 9, 2006).

Lumenis consented, without admitting or denying the allegations, to a permanent injunction against future violations of the antifraud, reporting, books and records, and internal control provisions of the federal securities laws.

No fines were imposed on the company, but the company consented to the entry of an SEC order revoking the registration of its registered securities. When the order is effective, its shares cannot be quoted or traded in the U.S. until it re-registers with the SEC. The company said it intends to file to begin the re-registration process in 2Q07.

Lumenis is also required to continue its cooperation with the SEC's ongoing investigation of others, it said.

“With the SEC's approval of the settlement agreement, we can now put these matters behind us and focus completely on our customers and the future, with a solid state-of-the-art portfolio of products and technologies, building on what is already a thriving, growing business,“ said Avner Raz, president and CEO of Lumenis.

The civil complaint filed by the SEC includes the company's former COO, who is no longer with the company, and its senior vice president of marketing and business development, who continues to be employed by Lumenis, and relates to transactions during the period in which he was formerly the CFO.

Aviva launches EPOD service

Aviva Biosciences (San Diego) launched its Electrophysiology on Demand (EPOD) service using an expanded bank of PatchXpress automated electrophysiology instruments.

EPOD encompasses all “necessary activities“ for drug discovery targeted or associated with ion channels, the company said.