A Medical Device Daily

DePuy Spine (Raynham, Pennsylvania) reported that the U.S. District Court in Boston has granted a permanent injunction against Medtronic (Minneapolis) that prohibits that company from making, using and selling Vertex and Vertex Max polyaxial screws in the U.S., effective immediately.

The company said that the court also ordered that all Vertex and Vertex Max polyaxial screws in the possession of Medtronic's affiliates, subsidiaries and distributors be returned to the company immediately. All consignment and loaner inventory in the possession of any of Medtronic's customers must also be immediately returned to Medtronic under the order.

The ruling comes after a federal jury in Boston found that Medtronic infringed a patent directed to polyaxial screw technology owned by Biedermann Motech (Schwenningen, Germany) and licensed to DePuy Spine. The jury awarded Biedermann Motech and DePuy Spine $226.1 million in damages following a September 2007 trial.

Medtronic issued it own statement yesterday commenting on the order, saying it plans to file an appeal of that ruling and that the ruling does not effect the sale of a newer product in this spinal category, its Vertex Select multi-axial screw, an "improved" version of the screw system.

The company said that Vertex Select "is an improved, proprietary, multi-axial screw that is a substitute for the enjoined screws. The new design offers features and benefits that will allow surgeons to continue to perform complex spinal surgeries."

Pete Wehrly, senior VP/president of the Spinal and Biologics business unit of Medtronic, said, "We respectfully disagree with the judge's decision in this matter and will appeal. With the improved Vertex Select products now available, U.S. surgeons will not be impacted by supply issues of this important medical device system."

Medtronic's statement also said that the court's ruling has no effect on Medtronic's CD Horizon Legacy screw sets.

Gary Fischetti, U.S. president of DePuy Spine, said that the injunction issued by the court "supports the strength of our patent and represents the culmination of seven years of litigation with Medtronic Sofamor Danek."

And he said that DePuy "will oppose any effort by Medtronic to appeal the court's permanent injunction order and are prepared to supply the market with polyaxial screw systems and other products."

DePuy Spine, a business unit of Johnson & Johnson (New Brunswick, New Jersey), is focused on developing products for treating spinal pathologies. Biedermann Motech is a developer and supplier of medical and orthopedic products.