A Medical Device Daily

Visicu (Baltimore) said that the U.S. Patent and Trademark Office issued a notice that it intends to issue an ex parte reexamination certificate in the pending reexamination proceeding allowing all 26 of the amended claims of the company's patent, titled "System and method for providing continuous, expert network critical care services from remote location(s)."

The company's patent covers a system and method for the care of critically ill patients receiving hospital care that combines a real-time, multi-node telemedicine network and an integrated, computerized patient care management system.

The company was issued its patent, No. 6,804,656, in October 2004, but at the request of a third party seeking to challenge the patentability of Visicu's originally issued patent claims, the U.S. Patent Office commenced an ex parte proceeding in 2005 to reexamine all 26 claims of its patent.

During the reexamination proceeding, the company made amendments to the originally issued claims of the patent, which it said were "minor in nature."

In its March 8 notice of intent, the U.S. Patent Office indicated that the two independent claims of Visicu's amended patent "define over the cited prior art patents and printed publications" and that the remaining dependent claims "are patentable for the same reason."

The company is awaiting the formal issuance of the reexamination certificate by the U.S. Patent Office.

"We are pleased that the U.S. Patent Office has decided to allow all 26 of our amended patent claims after a rigorous review through the reexamination proceeding," remarked Frank Sample, chairman and CEO of Visicu. "This once again reinforces for us and our clients that our system for the advanced remote monitoring of ICU patients is a novel invention worthy of patent protection."

While the specific third party was not named, Visicu revealed in its SEC filing for an initial public offering earlier this month (Medical Device Daily, April 5, 2006) that a competitor, iMDsoft (Needham, Massachusetts), had requested that the U.S. Patent Office declare an interference and revocation of Visicu's single issued U.S. patent and a patent with identical claims issued to iMDsoft. Additionally, it noted that Cerner (Kansas City, Kansas) had filed suit against the company seeking invalidity of the company's patent.

Visicu is a company focused on improved monitoring of patients in the intensive care unit.

A slew of class action lawsuits have recently been filed in the United States District Court for the District of Minnesota against St. Jude Medical (St. Paul, Minnesota).

The complaints allege that defendants violated sections of the Securities Exchange Act of 1934 by issuing a series of material misrepresentations to the market during the class period, which runs from Jan. 25 through April 4 thereby artificially inflating the price of the company's stock.

Specifically the lawsuit charges that defendants including St. Jude and certain of its top officers and directors. made misstatements and omitted information regarding the sales success and prospects of a major St. Jude product, its implantable cardioverter defibrillator (ICD) systems.

On Jan. 25, the company reported that 4Q05 ICD product sales were $280 million, a 62% increase over the comparable quarter of 2004 and that ICD product sales for the full-year 2005 were $1.007 billion, representing a 72% increase over 2004.

The company emphasized that these "results continued to underscore the competitiveness of St. Jude Medical's ICD product portfolio and program."

On April 4, the complaint says that "St. Jude shocked the market by announcing that its financial and operating results were well below analysts' expectations and the declining sales of ICDs," news that was reported by Medical Device Daily (MDD, April 6, 2006).

On this news, shares of St. Jude fell $5.05 per share, on extremely high volume, to close at $36.25.

The complaint goes on to say that the company pushed sales of ICDs into 4Q05 so as to inflate the stock price and achieve extraordinary personal benefits for top insiders, such as CEO Daniel Starks, who "sold an unusual number of shares in the open market in the early months of 2006, and received a substantial boost in his compensation for 2005's performance, including a grant of 216,000 restricted shares worth [at the time] about $10 million."

In other court-related news:

• Two new class action lawsuits were recently brought against embattled blood substitute maker Northfield Laboratories (Evanston, Illinois), alleging that the company issued a series of materially false and misleading statements concerning the safety and history of the company's sole product, a blood substitute called PolyHeme.

Specifically, the complaints against Northfield allege that the company failed to disclose that a significant portion of patients taking PolyHeme in a clinical study suffered heart attacks within seven days of taking PolyHeme - as compared to zero heart attacks from patients receiving real blood in the same study. As a result of these statements, the stock price of Northfield was artificially inflated causing investors to suffer damages.

Both lawsuits were filed in the United States District Court for the Northern District of Illinois, on behalf of purchasers of the common stock of Northfield and include the same class period of Feb. 20, 2004 through Feb. 21, 2006.

The law firms involved in the most recent filings are Spector, Roseman & Kodroff and Cohen, Milstein, Hausfeld & Toll.