A Diagnostics & Imaging Week

Given Imaging (Yokneam, Israel) and Olympus (Tokyo) reported that have signed a term sheet to settle their lengthy patent lawsuit in U.S. over their capsule endoscopy products.

The technology enables a patient to swallow a pill with an integrated camera, which makes its way through the gastrointestinal tract and captures images that a doctor can assess on a screen.

The term sheet includes certain worldwide cross-licenses under which each party receives a royalty-free license under all existing patents of the other party for its respective existing capsule endoscopy products.

The parties also exchanged covenants not to sue on currently available medical device products and agreed to a release of all past causes of action.

The term sheet also includes a cross-license under existing and future patents of each party for future capsule endoscopy products, which may include the payment of royalties by either party at a rate to be determined through an agreed upon mechanism.

Finally, the term sheet includes a payment to Given Imaging of $2.33 million and an agreement to cooperate in future mutually beneficial joint market-development projects.

In other legalities:

The Securities and Exchange Commission filed a civil injunctive action against Southwestern Medical Solutions (Tampa, Florida) and three of its executives last week.

Southwestern makes diagnostic testing devices for the detection of infections diseases.

The complaint against Southwestern, John Hedges, president/CEO, Richard Powell, VP, and Basil Meecham, a director, alleges that the company published false and misleading statements claiming that FDA had approved its Labguard diagnostic testing device, that it had received an order for several thousand units of the device, and that it had pending patents and trademarks.

The complaint also alleges that Southwestern submitted false and misleading information about its business to the Pink Sheets, an inter-dealer electronic quotation and trading system in the over-the-counter securities market. According to the complaint, Hedges, Powell and Meecham were responsible for preparing and disseminating the false statements and information.

• OraSure Technologies (Bethlehem, Pennsylvania) reported that it has received a complaint from Inverness Medical Innovations (IMI; Waltham, Massachusetts), Inverness Medical Switzerland and Church & Dwight, Co. (Princeton, New Jersey), filed in the U.S. District Court for the District of New Jersey, alleging that the manufacture and sale of the company's OraQuick Advance Rapid HIV-1/2 Antibody Test infringes U.S. patent No. 6,485,982.

OraSure said it believes that none of its products, including the OraQuick Advance Test, infringe the patent or other intellectual property rights of any party. The company also said it believes that the asserted patent is invalid and it intends "to defend this lawsuit vigorously."

OraSure makes oral fluid specimen collection devices using oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other devices.