A Medical Device Daily

Align Technology (Santa Clara, California) reported that the Federal Circuit Court of Appeals has affirmed Align’s victory on 86 out of 92 claims in four Ormco patents that Ormco, a division of Sybron Dental Technologies (Orange, California), had asserted were infringed by Align.

The District Court for the Central District of California had previously ruled that these 86 claims are not infringed by Align’s Invisalign system. The federal circuit agreed with the district court and ruled that each of the 86 claims is invalid as not enabled by the specification of Ormco’s four asserted patents, according to Align. These are all of Ormco’s asserted claims regarding automatic computer design of orthodontic appliances. The Federal Circuit returned only six out of the original 92 asserted claims to the district court for consideration of validity and infringement. The federal circuit did not find that any of the six claims are valid or infringed by Align, the company noted. If pursued, those issues will be decided upon remand by the district court. Align said it believes that the six remaining claims will also be found invalid and not infringed.

Ormco sued Align in 2003, claiming that the company’s manufacturing process infringes Ormco patents dating back to 1992 (Medical Device Daily, Jan. 16, 2003).

“We are extremely pleased with the court’s confirmation of the previous ruling,” said Roger George, VP of legal affairs and general counsel for Align. “We have every confidence that if Ormco chooses to litigate the six claims not yet found invalid in their case, we will prevail on those claims as well.”

The federal circuit also considered a cross-appeal by Align and affirmed the district court’s finding that six out of 71 claims in Align’s U.S. Patent No. 6,398,548 were invalid. The majority of the claims in the ‘548 patent, including claims that address methods of fabricating aligners, digital data sets or computer-generated models to fabricate appliances, are unaffected by the federal circuit’s ruling.

“Contrary to some erroneous reports, today’s decision is an overwhelming victory for Align and does essentially nothing to diminish the strength of our patent portfolio or of our unique technology,” George said.

Align Technology designs a method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position, according to the company. Because it does not rely on the use of metal or ceramic brackets and wires, Invisalign significantly reduces the aesthetic and other limitations associated with braces, Align said. According to the company, Invisalign is appropriate for treating adults and older teens.