A Medical Device Daily

A federal appeals court recently revived an earlier patent infringement ruling about pacemakers against St. Jude Medical (STJ; Saint Paul, Minnesota), possibly leaving the medical devices company on the hook for significant damages.

The U.S. Federal Circuit Court of Appeals, which handles patent appeals, sent the case back to the district court so a judge can award damages to Guidant and Cardiac Pacemakers, which filed the suit against St. Jude in 1996. Guidant is now a unit of Boston Scientific (Natick, Massachusetts).

Cardiac alleged in its original lawsuit that St. Jude infringed on its patent for a pacemaker, an electronic device implanted in someone's chest that gives pulses or shocks to the heart to help it beat. A jury in 2001 awarded Cardiac $140 million in royalties for patent infringement but another court overturned the ruling.

The court ruled Wednesday that the infringement applies only when the product was used in the U.S., not internationally. St. Jude said the product in question was infrequently used in the U.S. As a result, the company says damages will be immaterial.

In other legalities:

• Aerocrine (Solna, Sweden) reported that the U.S. District Court has accepted Aerocrine's motion for leave to add a third patent to its October 2008 patent infringement complaint against Apieron (Menlow Park, California).

The founders of Aerocrine made the original discovery in 1991 through 1993 that nitric oxide (NO) in exhaled breath is elevated in patients with asthma. Based on proprietary technology, Aerocrine has pioneered the development of medical devices and the method to monitor airway inflammation by measuring exhaled NO.

Aerocrine's first device, NIOX, received CE marking in Europe in 2000 and FDA clearance in the U.S. in 2003. NIOX MINO, the first handheld device for exhaled NO monitoring in clinical practice, received CE marking in 2004 and FDA clearance in early 2008. To date, more than 2.5 million patient tests have been performed around the world using Aerocrine's exhaled NO monitoring systems.

Aerocrine has applied for and received numerous patents that protect its inventions for monitoring airway inflammation by measuring exhaled NO. Following Apieron's initial U.S. commercialization in 2008 of its first exhaled NO device Insight Aerocrine filed complaints against Apieron on the grounds that Aerocrine considers three of its U.S. patents to be infringed.

Apieron recently made public that it has filed a complaint against Aerocrine in Germany on the grounds that Apieron considers the German part of its European patent EP 0 892 926 to be infringed. This patent, originally filed in 1996, was acquired by Apieron in 2004 and does not relate to discoveries made by Apieron. Apieron's product is not sold in Europe.

• Shalov Stone Bonner & Rocco (New York) reported that a class action lawsuit has been filed on behalf of all persons or entities who purchased Align Technology (Santa Clara, California) common stock between Jan. 30, 2007 and Oct. 24, 2007, inclusive. The suit is pending in the Northern District of California against Align and Thomas Prescott, Align's president/CEO.

The complaint alleges that, throughout the class period, defendants misrepresented or failed to disclose or indicate that the company was experiencing a considerable decrease in the number of new case starts, which resulted from Align having shifted the focus of its sales force to clearing backlog. As a result, the statements defendants made during the class period regarding Align's business, operations and financial prospects were materially false and misleading.

The complaint also alleges that on Oct. 24, 2007, during a conference call with analysts, certain of Align's executive officers shocked the market when they acknowledged that, among other things, in an effort to clear backlog, the company failed to focus sufficient efforts on garnering new case starts. Consequently, the company had to refocus its field and channel marketing teams to generate new case growth. On this news, the price of Align's shares fell more than 33%, closing at $19.07 per share, on Oct. 25, 2007.