|
Apotex Praises Appeals Court Opinion of Acular Patent Invalidity
Federal Appeals Court Reverses and Remands Judgment for Further Consideration
Weston,
FL (May 18, 2005) — Corp. today announced that a three judge panel of the United States Court of Appeals for the Federal Circuit found that the District Court of the Northern District of California had erred in its 2003 decision regarding the validity of the'493 patent held by Syntex LLC, covering Allergan's Acular Ophthalmic Solution.
In 2001, Apotex filed to market a generic version of Acular, and was subsequently sued for patent infringement by Syntex. Apotex argued that the formulation of the patent claim was obvious and therefore the patent was invalid. The district court determined that Apotex’ generic infringed the claims of the Acular patent and that the patent was valid.
On appeal, the Federal Circuit found “clear error by the district court in several of the grounds that led it to conclude that the invention claimed by the claims in suit would not have been obvious.” They therefore reversed the court’s non-obviousness determination and remanded that issue to the district court for further consideration of obviousness.
“We are very pleased with the Appeals Court opinion, which agrees with our position that the formulation claimed in the ‘493 patent is legally obvious and therefore, the patent is invalid, “ said Tammy McIntire, President of Apotex Corp. We look forward to offering our customers a more affordable version of ketorolac ophthalmic solution,” McIntire said.
Apotex believes it is first-to-file a paragraph IV certification for ketorolac and as such is entitled to 180 days of marketing exclusivity. The Food and Drug Administration (FDA) granted tentative approval of Apotex’ product in May 2003.
The Appeals Court also affirmed the district court’s determination that there was no inequitable conduct In the prosecution of the ‘493 patent.
Acular® is a registered trademark of Roche Palo Alto LLC.
About Apotex Corp.
Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of generic pharmaceuticals. Through its sales and marketing headquarters in Weston, Florida, operations center in Indianapolis, and research facility in Lincolnshire, Illinois, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit
apotexcorp.com.
# # #
|
