A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that late last week an appeals court for the Federal Circuit has issued a ruling upholding a trial court's decisions in two cases of patent disputes with Medtronic (Minneapolis), those rulings determining that Boston Scientific's Taxus Express, Express2, and NIR stents do not infringe four Medtronic stent patents.

Medtronic had filed an appeal of the trial court decisions. In upholding the trial court, the Court of Appeals agreed that Boston Scientific's products were not within the scope of the Medtronic patents.

“This ruling reaffirms the strength and innovation of our drug-eluting stent technologies,” said Boston Scientific COO Paul LaViolette, in a statement.

Scott Papillon, Medtronic spokesman, told the Associated Press that Medtronic is reviewing the appeals court's decisions “and considering our options.” Other than that, he provided no further comment.

The Court of Appeals decision affirmed two 2005 rulings by the U.S. District Court in Delaware.

In the first decision, the trial court granted summary judgment of non-infringement in favor of Boston Scientific, finding that the company's Taxus and Express stents do not infringe four Medtronic patents. The Express stent is the platform for Boston Scientific's Taxus Express2 paclitaxel-eluting coronary stent system. In the other decision, the court also granted summary judgment of non-infringement in favor of Boston Scientific, finding that the NIR stent does not infringe the Medtronic patents.

The U.S. Court of Appeals for the Federal Circuit affirmed the ruling last year of a federal judge in Delaware who found that stents offered by Guidant (Indianapolis) and Boston Scientific did not infringe Medtronic's patents.

Guidant was acquired by Boston Scientific last month (Medical Device Daily, April 21, 2006). However, the Guidant stent-making business at issue in the case was divested separately to Abbott Laboratories (Abbott Park, Illinois).

In other legalities:

• ViaCell (Cambridge, Massachusetts) reported that, following a re-examination, the U.S. Patent and Trademark Office (PTO) issued two new office actions rejecting all of the claims of PharmaStem Therapeutics ' (Wayne, Pennsylvania), nos. 5,192,553 and 6,569,427 as being unpatentable over prior art.

Recently, the PTO issued initial office actions rejecting all the claims of PharmaStem patent nos. 5,004,681 and 6,461,645. All of these patents relate to certain aspects of the collection, cryopreservation, storage and use of hematopoietic stem cells from umbilical cord blood and have been asserted against ViaCell and several other defendants by PharmaStem in pending patent infringement cases.

“We believe the PTO's actions support our position that the patents are invalid based on prior art,” said Anne Marie Cook, general counsel and senior vice president, business and corporate development for ViaCell.

In 2002, PharmaStem brought suit against ViaCell, CBR (Cord Blood Registry; San Bruno, California), Cryo-Cell International (Oldsmar, Florida), CorCell (Philadelphia) and several other companies alleging infringement of U.S. patent nos. 5,192,553 and 5,004,681 (MDD, Feb. 27, 2002).

In 2004, PharmaStem brought a second suit against ViaCell and the other defendants alleging infringement of U.S. patent nos. 6,461,645 and 6,569,427. Separately, the PTO ordered re-examinations of these four patents based on prior art.

In 2004, a District Court judge, in overturning a previous jury verdict in the first case, found that PharmaStem had failed to prove infringement. PharmaStem appealed the decision and the U.S. Court of Appeals for the Federal Circuit heard oral argument in the appeal on April 4.

The second case has been stayed pending decisions from the Federal Circuit on the appeal and the PTO on the patent re-examinations.

In 2003, the European Patent Office revoked all the PharmaStem patent claims on collecting, freezing and using blood from umbilical cord blood for transplantation and therapeutic treatments.

• A Denver, Colorado, firm, Burg Simpson Eldredge Hersh & Jardine, has filed a lawsuit against Bausch & Lomb (B&L; Rochester, New York), makers of the contact lens solution ReNu with MoistureLoc. The suit charges that one of its clients, a Kentucky resident, contracted a Fusarium keratitis infection after using the company's lens cleaning solution ReNu with MoistureLoc.

The infection was so severe, it caused a re-shaping of her corneas, according to the law firm.

“These cases present very serious, painful, and life-long injuries to the victims,” said Michael Burg, founder and president of Burg Simpson and lead attorney on the case. “We believe at the end of the day the evidence will demonstrate that the company knew about the problem but delayed in making a disclosure, which, among other things, delayed a proper diagnosis and treatment. The company has repeatedly stated in its press releases that 'if there's a problem with our product, we'll fix it.' Removing the product from the market was only one step in the process to fix this problem, compensating the victims is another step that the company must take.”

Burg Simpson said it is investigating other cases on behalf of people who have used ReNu with MoistureLoc and allegedly “have suffered eye injuries as a result.”