A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that the U.S. District Court of Marshall, Texas found two patents of Medtronic, (Minneapolis) unenforceable for inequitable conduct during the prosecution of the patents before the U.S. Patent and Trademark Office.

A result of the latest verdict is a $167 million reduction in a patent lawsuit won by Medtronic in May. The damages are reduced to nearly $19 million. Following a prior decision by the court, Medtronic and Boston Scientific had already agreed to reduce the jury verdict to nearly $186 million.

During the trial in May, it was found that Boston Scientific balloon catheters and stent delivery systems infringed three Medtronic patents and that the patents were valid. The jury originally awarded damages of $250 million to Medtronic (Medical Device Daily, May 29, 2008).

Medtronic originally sued Boston Scientific in 2006, asserting that Boston Sci's Taxus Express2, Express2, Libert , Maverick, Maverick2 and Quantum Maverick products infringed the Fitzmaurice and Anderson catheter patents owned by Medtronic.

Boston Scientific plans to appeal the remaining $19 million damage award to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. The company said it is confident it will prevail on appeal.

The lawsuit in Texas is one of several between the two device makers. Medtronic this month sued Boston Scientific and Abbott Laboratories (Abbott Park, Illinois) accusing them of infringing a patent for a stent.

In other legalities:

• Terumo Cardiovascular Systems (Terumo CVS; Ann Arbor, Michigan) reported that it filed a patent infringement complaint on August 21 in the Northern District of California against Maquet Cardiovascular (Quincy, Massachusetts).

The complaint alleges that Maquet's Vasoview Endoscopic Vessel Harvesting Systems infringe a patent for which Terumo CVS owns the rights. The complaint also requests an injunction against further sales of the product in the U.S.

Terumo CVS sells the VirtuoSaph Endoscopic Vessel Harvesting System in the U.S. The VirtuoSaph system is distributed in Japan and Asia by Terumo and in Europe by Terumo's European subsidiary.

"Terumo respects the valid intellectual property of others and expects that its competitors will do the same," said Mark Sutter, president/CEO, Terumo CVS.

The VirtuoSaph system is used during coronary artery bypass grafting (CABG), the most common cardiac surgery procedure. During the procedure, the surgeon removes a healthy artery or vein from elsewhere in the body, most often the saphenous vein in the leg, and uses it to route blood around a blockage in a coronary artery.

The VirtuoSaph system allows the surgical team to remove the saphenous vein using very small incisions. Endoscopic procedures have been shown to minimize scarring, morbidity and infection associated with traditional longitudinal incisions.

Terumo CVS makes devices for cardiac and vascular surgery.

• The law firm of Vianale & Vianale reported that it filed a class-action lawsuit on Aug. 28 on behalf of purchasers of the securities of Signalife, (Studio City, California) between Jan. 29, 2004, and April 11, 2008, inclusive. The complaint names Signalife and several of its present and former officers as defendants.

Signalife claims to research, develop and market wireless heart monitoring devices in the U.S. The complaint alleges that Signalife (formerly known as Recom Managed Systems and before that, Mt. Olympus Enterprises), violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The plaintiff alleges that Signalife issued false positive statements about the company's ability to manufacture and market its Fidelity 100 Monitor System, a supposedly wireless heart monitoring device.

The law firm said that despite years of highly positive statements about its heart monitor, Signalife has had virtually no sales, and the company has never had a product that was commercially viable. As a result, Signalife's stock was artificially inflated during the class period. Signalife's stock dropped on April 11, 2008, on unprecedented volume of 3,752,100 shares, when the truth came to light that Signalife's Fidelity 100 monitor system was unsalable. The company recently reported its imminent delisting from Amex, and its stock price has slumped to 6 cents.

Signalife reported yesterday that it would have a response this morning to the lawsuit.