Oslo, Norway, April 4 2009.
In September 2004, Photocure submitted to the United States Patent Office (USPTO) an application for patent term extension of its US patent covering its FDA-approved drug product Metvixia(TM). US law permits patent term extension due to the lengthy Food and Drug Administration (FDA) approval process, which had been the case for Metvixia(TM). The USPTO denied Photocure's application and Photocure sought judicial relief by appealing the USPTO's decision.
Based upon Photocure's appeal, the US Eastern District Court of Virginia has now granted summary judgment in Photocure's favour. In its decision the Court stated that the USPTO's interpretation of the law is not reasonable. The matter is now remanded back to the USPTO to take appropriate steps on granting the requested patent term extension for Metvixia(TM).
"This is a great result for Photocure", says Photocure's President and CEO Kjetil Hestdal, "and it helped to further strengthen Photocure's patent protection for Metvixia(TM) in the US".
Photocure has a patent covering Metvixia(TM) in USA until March 2016 and has applied for an extension of 871 days, about 29 months, until July 27 2018. Metvixia(TM) is approved for the topical treatment of pre-cancerous skin lesions (actinic keratosis) and is marketed by Galderma in USA together with the Aktilite® CL 128 lamp.
The USPTO may appeal the decision, such an appeal would be heard in the Federal Circuit Court of Appeals.
For further comments, contact: Photocure ASA
Kjetil Hestdal, President & CEO (firstname.lastname@example.org) Mobile: +47 913 19 535 Christian Fekete, CFO (email@example.com) Mobile: +47 916 42938
Photocure ASA is a Norwegian pharmaceutical company listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the treatment and diagnosis of different types of cancer. The products are based on proprietary photodynamic technologies, targeting specific dermatology and oncology markets.
Photocure has currently two pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix 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 and technologies. Photocure®, Metvix® and Aktilite® are registered trademarks of Photocure ASA.