Archus Orthopedics, Inc. has announced that the European Patent Office has confirmed the validity of its patent number EP-B-1223872 following an Opposition that concluded with oral proceedings on January 10, 2007 in Munich, Germany.
This patent, originally issued to Archus on December 22, 2004, discloses the surgical method of replacing the natural facet joint with a prosthesis carried by the pedicle.
Unlike the United States, European patent law allows a nine-month period after the grant of a patent during which third parties can challenge the patent. This challenge, called an Opposition, requires the opposing party to file written briefs and, eventually, make oral arguments before a three-member board of examiners. To overturn the grant of a patent, the arguments must successfully convince the examiners that the patent is invalid. In this Opposition case, the examiners upheld the validity of the Archus patent.
"We are delighted that the examiners reaffirmed this important European patent," said Jim Fitzsimmons, chairman and chief executive officer, commenting on the decision. "Since the pedicle is the preferred site for fixation of posterior spine implants, this patent extends our leading intellectual property position in the facet joint replacement market worldwide," he added. In August, 2006 Archus announced that it was awarded a United States Patent disclosing the surgical method of removing some or all of a natural facet joint and replacing it with a prosthesis anchored in the pedicle.
Archus is currently conducting a U.S. clinical trial of its Total Facet Arthroplasty System(R), "TFAS(R)", a novel spinal implant designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS(R) replaces the degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. In addition to TFAS(R), Archus is developing a suite of products to address other important and attractive applications for facet joint replacement.
While the regulatory approval path for novel spine implants in the United States is lengthy and requires extensive clinical trials, the TFAS(R) and competing devices have already received CE Mark approval, allowing immediate commercialization in the European Union. "To our knowledge, all currently available facet replacement devices attach to the spine through the pedicles," said Fitzsimmons. "We intend to vigorously defend our patent rights and this decision bodes well for that strategy," he added.