A Medical Device Daily

A California District Court has issued multiple rulings regarding the ongoing patent case between Cross Medical Products, a business unit of Biomet (Warsaw, Indiana), and two businesses of Medtronic (Minneapolis), Medtronic Sofamor Danek (Memphis, Tennessee) and Medtronic Sofamor Danek USA.

In one ruling, the court said that the new spinal implant polyaxial screw design of the Medtronic companies infringes Biomet’s U.S. patent No. 5,474,555 (the ’555 patent) owned by Cross. In other rulings, it favored the Medtronic companies in the ongoing dispute.

Medtronic issued a statement saying that it “disagrees with the court’s infringement decision on the ’555 patent” and intends to pursue all available legal remedies, including an appeal.

It added that final decisions on the issues will not be decided until May, and that the recent infringement decision has no “immediate impact” on its ability to market the named products for patients with spinal disorders.

The court previously found that Medtronic’s spinal implant polyaxial screws marketed under the names MAS, M8, M10, Sextant, Vertex, Legacy 4.5 and Legacy 5.5 infringe the ’555 patent and subsequently entered a permanent injunction. Cross said that the ruling found that Medtronic’s redesigned versions of those products, which appear to have been created in an attempt to design around the ’555 patent, also infringe the patent.

It noted also an existing appeal with the U.S. Circuit Court of Appeals in Washington of a prior infringement ruling on the ’555 patent which Medtronic said could “positively impact the infringement decision regarding the ’555 patent.” It said a ruling on this appeal “is anticipated in the coming weeks.”

Acknowledging Medtronic’s right to appeal, Cross said it would request a permanent injunction against the re-designed MAS, M8, M10, Sextant, Vertex, Legacy 4.5 and Legacy 5.5 polyaxial screws.

In a related ruling, the court said a Cross patent related to crosslinks used with spinal implants was invalid. The court recently ruled that Medtronic’s L.P. Crosslinks, Low Profile Crosslink, Low Profile Crosslink Plate, Anterior Low Profile Crosslink, Low Profile Crosslink Multi-Span Plate, Multi-Span LPC, and X-10 Crosslink products infringed the patent.

In other rulings:

The court said that Cross’ C-Tek anterior cervical plate infringed two Medtronic patents, and that those Medtronic patents are valid.

It also ruled that Medtronic’s Premier plate infringed a Cross anterior cervical plate patent but that the patent was invalid because Medtronic invented its Premier plate before Cross invented its C-Tek plate. Sales of the C-Tek plate are significantly less than 1% of Biomet’s net sales, it said.

Dane Miller, PhD, Biomet’s president and CEO, expressed satisfaction that the court “found that Medtronic Sofamor Danek’s redesigned polyaxial screws infringe our patent . . . . Although we were disappointed with C-Tek and crosslinks rulings, we intend to appeal those decisions. With respect to the C-Tek product, it represents a small percentage of our business and we have alternative product offerings.”

Biomet and the Medtronic Sofamor Danek units compete in various musculoskeletal specialties in both surgical and non-surgical sectors.