Eastern District of Virginia Court overturns USPTO denial of Patent Term Extension
A recent ruling in a Federal District Court in the Eastern District of Virginia could make patent term extensions available to many more patented pharmaceuticals.
First a little background: Generally, a patent issuing from the USPTO is given an enforceable term that begins on issuance of the patent and ends twenty years from the filing date of the patent. In some cases, however, the United States Patent and Trademark Office (“USPTO”) may grant an extension to the normal patent term ("Patent Term Extensions") for patents claiming pharmaceuticals. The Patent Terms Extensions may be granted to compensate for delays occurring during the approval process of the Food and Drug Administration. For successful pharmaceuticals, each day of patent term is extremely valuable and this approval process may consume a significant portion of the valuable patent term. To compensate for government delay, the patent term extension statute, 35 U.S.C. § 156(a)(5)(A), allows the patent owner to recapture some of the economic benefit or their patent term lost during the approval process. A patent term may be extended for a patent claiming a pharmaceutical if permission for the commercial marketing or use of the “product” is the first permitted commercial marketing or use of the “product” under the provision of law causing the delay. In PhotoCure, the ED VA had to consider what the term "product" means in the statute.
PhotoCure ASA patented (U.S. Patent No. 6,037,267) and applied for FDA approval of methyl aminolevulinate hydrochloride (“MAL hydrochloride”) for the treatment of actinic keratosis, a pre-cancerous skin lesion. After issuance, PhotoCure applied for a patent term extension in the USPTO to compensate for term "lost" during its FDA approval process, but the patent term extension was denied. In reaching their decision, the USPTO interpreted the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean an “active moiety.” An “active moiety” is considered by the USPTO to be a portion of a compound that is responsible for its pharmacological activity. The USPTO cited the commercial marketing for a different compound with the same “active moiety,” aminolevulinic acid ("ALA"), as the first permitted commercial marketing of the "product," MAL hydrochloride. The chemical structures or ALA and MAL hydrochloride are below:
ALA MAL hydrochloride
Though the compounds are not identical they are similar, the USPTO decided that MAL hydrochloride has the same “active moiety” as previously marketed ALA and is, therefore, not elgible for a patent term extension.
PhotoCure sued the USPTO in the Eastern District of Virginia. In its decision, the ED VA boldly struck down the USPTO interpretation of “product” as meaning merely an “active moiety. The ED VA held that sharing an active moiety should not be the test for whether “product” has already be permitted to be commercially marketed. The court held that by using the term "product" the statute requires a comparison of the entire “active ingredient." The court held that the compounds were structurally different and, therefore, different “products” under the law. The court further stated that the USPTO’s decision to deny a PTE based merely on an "active moiety" was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law” under the Administrative Procedure Act. It is expected that the USPTO will appeal the case to the Federal Circuit to provide clarity in this important issue to the patent bar and the pharmaceutical industry.
