A Medical Device Daily

Biomet (Warsaw, Indiana) — giving its side of the story — reported on a ruling issued this week by the U.S. Court of Appeals for the Federal Circuit in the ongoing patent infringement litigation between Biomet subsidiary, Cross Medical Products (Dublin, Ohio) and the Spinal business of Medtronic (Memphis, Tennessee).

The Federal Circuit vacated a summary judgment ruling previously issued in Medtronic's favor by the U.S. District Court for the Central District of California, Biomet said. The district court had ruled that Medtronic's spinal implant polyaxial screws marketed under the names MAS, M8, M10, Sextant, Vertex, Legacy 4.5 and Legacy 5.5 did not infringe claim 7 of Cross's U.S. Patent No. 5,474,555 (the "`555 patent").

In vacating that ruling, the Federal Circuit remanded the matter to the district court for reconsideration. The Federal Circuit also ruled that Medtronic's newly redesigned polyaxial screws do not infringe claims 5 or 7 of the '555 patent. This decision, however, does not impact Medtronic's prior versions of its polyaxial screws.

Biomet's President/CEO Jeffrey Binder said, "Although we are disappointed with the court's decision related to the redesigned polyaxial screws, we are very pleased that the Federal Circuit vacated the district court's prior ruling in favor of Medtronic on the original polyaxial screw designs, and we intend to pursue this claim."

A trial on whether Medtronic is liable to Cross for infringement of the '555 patent, and damages owed to Cross on that patent and another spinal patent that the district court already ruled Medtronic has infringed, is expected to take place later this year, Biomet said.

Biomet and its subsidiaries make products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy.

In other patent news:

• Lifeline Biotechnologies (Reno, Nevada) said that it is nearing a patent filing on its technology in the early detection of breast cancer.

Jim Holmes, CEO of Lifeline, said, "This technology . . . means that, potentially, breast cancer could be identified in a greater number of patients, that is the accuracy could reduce the number of false positives and also reduce the number of needless biopsies."

The company said there are about 35 million mammograms a year in the U.S., from which there are about 1 million biopsies. From theses biopsies, about 200,000 to 250,000 cancers are identified. "In other words, there are some 750,000 to 800,000 biopsies from which there are no cancers," Holmes said. "We think our system has the potential of substantially reducing this number."

• Patient Safety Technologies (PST; Temecula, California) said that its wholly-owned subsidiary, SurgiCount Medical, has received confirmation from the U.S. Patent and Trademark Office that a Reexamination Certificate will be granted affirming the validity of the reexamined patent with certain amendments to the claims.

In addition to the reexamined patent and the European patent, the company has filed another U.S. Patent application and one international patent application covering improved methods and systems for the automated counting and tracking of surgical articles, that would provide SurgiCount's Safety-Sponge System with an additional level of protection to prevent competitors from attempting to replicate and market a similar version of the company's system.

William Horne, CEO of PST, said, "On the heels of a nationwide sales campaign, not only has the validity of the Safety-Sponge patent been upheld, but more levels of protection have been afforded."

The SurgiCount Safety-Sponge System is a "turn-key array of modified surgical sponges, line-of-sight scanning SurgiCounters, and printPAD printers integrated together to form a comprehensive counting and documentation system," the company said.