U.S. Patent and Trademark Office Grants Artes Medical's Request for Reexamination of Competitor's Patent

Business Wire, Jan 6, 2005

SAN DIEGO -- Artes Medical Inc., a privately-held specialty pharmaceutical and medical device company, announced today that the U.S. Patent and Trademark Office (USPTO) has granted its request for reexamination of the Aventis patent that covers injectable skin fillers using poly-lactic-acid (PLA) microspheres, marketed in the U.S. under the Sculptra(TM) trademark and in Europe as New-Fill(TM). Reexamination is a USPTO procedure through which a patent that may have been granted as the result of error or oversight can be reconsidered and, if warranted, canceled. In granting the request, the USPTO agreed with Artes Medical that there was a substantial question of whether the subject matter claimed in Aventis' Patent No. 6,716,251, which issued April 6, 2004, was actually patentable. This especially in view of Artes Medical's own patent that was issued nearly ten years earlier covering injectable microspheres for soft tissue augmentation made from either polymeric or non-polymeric materials. The request for reexamination submitted by Artes Medical cited an additional seven scientific articles and/or patent documents, all of which the USPTO agreed raised at least twelve new issues that question the novelty of the Aventis technology and place in question the validity of the corresponding Aventis patent.

About Artes Medical, Inc.

Artes Medical helps physicians in the facial aesthetics market significantly improve patient outcomes through Aesthetic Tissue Engineering(TM) and partners with physicians to build their practices.

The company's lead product is ArteFill(TM). ArteFill is a unique combination of precision filtered synthetic microspheres (20%) evenly suspended in Ultra-Purified Collagen(TM) (80%). After ArteFill is injected, the microscopic spheres stimulate the body's own natural collagen production to replace the purified collagen. The autologous collagen builds volume and encapsulates each permanent microscopic sphere to achieve enduring wrinkle correction. The ArteFill Progressive Enhancement Procedure(TM) allows for treatment in stages, giving patients the exact look they desire, and will only be available from Artes-certified physicians. ArteFill's pre-market approval application (PMA) received an approvable letter from the FDA in January 2004. Once ArteFill receives final approval, it will be the only FDA-approved permanent injectable implant for the treatment of smile lines or naso-labial folds on the market. Over the last decade, Artecoll, ArteFill's predecessor, has been used in over 250,000 patients outside the United States to correct a wide variety of facial wrinkles and scars.

For more information about the company and its products, visit the company's website www.artesmedical.com. Artes Medical, Artecoll, ArteFill, Ultra-Purified Collagen and ArteFill Progressive Enhancement Procedure are trademarks of Artes Medical, Inc.