The U.S. Patent and Trademark Office (USPTO) has now determined that Astra Zeneca’s patent, which claims the combination drug product Symbicort, is ineligible for patent term extension (PTE). Astra Zeneca had sought extension of the patent term under 35 U.S.C. § 156 based on the time for Food and Drug Administration (FDA) review of Symbicort, a drug which contains two active ingredients that purportedly act synergistically, under § 505 of the Federal Food, Drug and Cosmetic Act.

The Patent Office determined that the patent was ineligible for PTE based on the regulatory review period of Symbicort because Symbicort does not constitute the first permitted commercial marketing or use of the product and because Astra Zeneca’s application for PTE was not filed in a timely manner. The USPTO’s determination clarifies that PTE is not available for drug products containing two previously approved active ingredients even though the active ingredients act synergistically.

To qualify for PTE under 35 U.S.C. § 156, several requirements must be met, including the following: the term of the patent has not expired; the patent has not previously been extended under § 156; an application for PTE is submitted to the USPTO by the owner of record within 60 days of approval of the New Drug Application (NDA); the product was subject to regulatory review before being commercially marketed; and the NDA is the first commercial use of the product. Under the statute, a product is defined as a single active ingredient or a combination of active ingredients.

The FDA records showed that the two active ingredients that comprise Symbicort, formoterol fumarate dehydrate and budesonide, had each been separately approved for use or commercial marketing before the approval of Symbicort. As a result, the USPTO determined that the subject patent was ineligible for PTE.

Astra Zeneca, relying on language in the Manual of Patent Examining Procedure (MPEP), which states that “an approved product having two active ingredients, which are not shown to have a synergistic effect or have pharmacological interaction, will not be considered to have a single active ingredient made of the two active ingredients,” took the position that the synergistic activity of the previously approved active ingredients in Symbicort yielded a single new product, which should be eligible for PTE. The USPTO disagreed, explaining that synergy of active ingredients has no relevance in a determination of “first permitted commercial marketing or use of a product,” pointing specifically to § 156 (f)(2), where the term “product” means any new drug “as a single entity or in combination with another active ingredient.”

The USPTO also denied the PTE on the basis that Astra Zeneca had missed the filing deadline by one day; counsel simply miscounted.