Photocure ASA v. Kappos
United States Court of Appeals for the Federal Circuit
603 F.3d 1372 (2010)
- Written by Mary Phelan D'Isa, JD
Facts
Photocure ASA (plaintiff), the assignee of a patent for Metvixia (MAL), a cream used in photochemotherapy to treat precancerous cell growths on the skin, sued the Director of the Patent and Trademark Office (PTO), David Kappos, when its application to extend its patent was denied. Under the patent-extension statute—35 U.S.C. § 156—a patent holder for a drug may apply to have its patent extended to restore a portion of the patent’s life that was lost during the process of regulatory review. Such extensions are only allowed for the first permitted commercial marketing of the drug product. The PTO denied Photocure’s extension because a similar drug, aminolevulinic acid (ALA), which PTO determined had the same active moiety as MAL, had previously been approved for a similar use and granted a patent, so Photocure’s MAL, which is an ester of ALA, was not the first permitted commercial marketing of the drug product. The district court, however, found that MAL and ALA were different drugs with different active ingredients, and thus Photocure qualified for a patent extension for MAL.
Rule of Law
Issue
Holding and Reasoning (Newman, J.)
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