A Medical Device Daily

Less than a month after the FDA approved Medtronic’s (Minneapolis) Endeavor drug-eluting stent (Medical Device Daily, Feb. 4, 2008), both Wyeth (Madison, New Jersey) and Johnson & Johnson (J&J; New Brunswick, New Jersey) filed suit over the product.

The companies filed a patent infringement suit in the U.S. District Court for the District of New Jersey last month alleging the zotarolimus-eluting stent infringes on the claims of three patents owned by Wyeth and licensed to J&J — the ’781, ’146 and ’728 patents.

These patents relate to the use of rapamycin, or sirolimus, and its analogues — including zotarolimus. The ’781 patent describes a method of treating restenosis in humans undergoing a percutaneous transluminal angioplasty procedure with an effective amount of rapamycin. The ’146 and ’728 patents both describe a method of preventing or treating hyperproliferative vascular disease by administering rapamycin.

The plaintiffs have asked the court to enjoin Medtronic from selling the stent in the U.S.

In other legalities:

• Medegen (Ontario, California), a maker of infusion therapy medical products, said it is pursuing an appeal in the United States Court of Appeals for the Federal Circuit in Washington, D.C., of a judgment of patent non-infringement entered in favor of ICU Medical (San Clemente, California) by a district court judge in the Central District of California.

Medegen said it continues to believe that ICU’s valve product, CLC-2000, infringes on the company’s patent for its proprietary valve technology (U.S. Patent No. 5,730,418). This patent covers a number of Medegen’s inventions in luer-activated valves, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications.

“Medegen’s intellectual property is valuable and we feel strongly about protecting our innovations and are confident we will prevail in the appeal process,” said Jeffrey Goble, president of Medegen.

Medegen filed suit gainst ICU for the patent last year (MDD, Sept. 17, 2007).

The law firm Cohen, Milstein, Hausfeld & Toll said it has filed a lawsuit in the United States District Court for the District of Massachusetts on behalf of its client and on behalf of other similarly situated purchasers of American Dental Partners (ADP; Wakefield, Massachusetts) securities between Aug. 10, 2005 and Dec. 13, 2007.

The complaint charges ADP and certain of its officers and directors with violations of the Securities Exchange Act of 1934. ADP is a business partner and provider of services to dental group practices.

More specifically, the complaint alleges that the company failed to disclose and misrepresented the following material adverse facts which were known to defendants or recklessly disregarded by them: that the company engaged in tortious and unlawful conduct towards Park Dental Group (PDG; Denver); that as a result of this conduct, the company booked a large portion of earnings and revenue which materially inflated financial figures; that the company’s financial statements were not prepared in accordance with Generally Accepted Accounting Principles; that the company lacked adequate internal and financial controls; and that, as a result of the foregoing, the company’s financial statements were materially false and misleading at all relevant times.

Beginning on January 1, 1999, ADP subsidiary PDHC (PDHC; Wakefield) entered into a service agreement with PDG. The service agreement was amended January 1, 2001 and again on August 10, 2005. According to the company’s financial statements, the relationship with PDG accounted for about 30% of the company’s consolidated net revenue between 2004 and 2006. No other customer of ADPI accounted for more than 10% of the company’s consolidated net revenue.

On Dec. 12, 2007, investors learned that a judgment had been awarded in favor of PDG, against PDHC and ADP. The jury in the case awarded PDG $88 million in compensatory damages and $42 million in punitive damages for a total of about $130 million.

Upon the release of this news, the company’s shares declined $5.36 per share, or 27.21%, to close on Dec. 12, 2007 at $14.34 per share, on unusually heavy trading volume. The following day, the shares declined another $9.72 per share, or 67.78%, to close at $4.62 per share.