Photocure wins patent case against the US Patent and Trademark Office

Oslo, Norway, In the US, the Federal Circuit Court of Appeals (CAFC) upheld the lower court’s decision stating that the United States Patent and Trademark Office’s (USPTO) interpretation of the law when refusing Photocure’s request for patent term extension was not reasonable.

In September 2004, Photocure submitted to the USPTO an application for patent term extension of its US patent covering the FDA-approved drug Metvixia®. US law permits patent term extension due to the lengthy Food and Drug Administration (FDA) approval process, which had been the case for Metvixia®. The USPTO refused Photocure’s application, Photocure sought judicial relief by appealing to the US Eastern Court of Virginia and the Court granted summary judgment in Photocure’s favour.

The USPTO appealed the Court’s decision and the case was now decided by the CAFC. The matter is now remanded back to the USPTO to take appropriate steps on granting the requested patent term extension.

In October 2009, Photocure entered into agreements with Galderma S.A. under which Galderma has purchased global rights, assets and liabilities related to Metvix® and Metvixia®. Metvix®/Metvixia® was the first PDT product developed and commercialized by Photocure and is approved in the US for the treatment of actinic keratosis.

“Although we no longer own Metvixia®, this ruling is very important for Photocure”, says Photocure’s President and CEO Kjetil Hestdal. “It will require the USPTO to change its interpretation of the law and thus open the way for a future patent term extension for Hexvix®.”

The USPTO may ask for an en banc decision and/or may appeal the CAFC’s decision; such an appeal would be heard by the US Supreme Court.

www.photocure.com

About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.

Photocure’s commercial activities includes own marketing and sales in selected markets as well as out-licensing on a regional or global basis prior to phase III.

Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for the diagnosis of bladder cancer. Hexvix is approved in EU. In addition, the company has developed a proprietary light source, which is used in combination with the Visonac(TM) cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products based on the Photocure Technology(TM)platform.

For more information about Photocure, visit our website at www.photocure.com.

Photocure®, the Photocure logo and Hexvix® are registered trademarks of Photocure ASA.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)