PTO Denies PTE for SYMBICORT Patent; Decision Puts to Rest the Notion of PTE Availability for Synergistic Combination having Previously Approved drugs

In June, the U.S. Patent and Trademark Office (“PTO”) determined that AstraZeneca’s U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, is ineligible for a Patent Term Extension (“PTE”). The PTO’s decision is important in that it clarifies the Office’s position that a PTE is not available for a drug product containing two previously approved active ingredients that purportedly act synergistically to create a new product.

Under the PTE statute at 35 U.S.C. § 156, the term of a patent claiming a drug shall be extended from the original expiration date of the patent if: (1) the term of the patent has not expired; (2) the patent has not been previously extended; (3) the PTE application is submitted to the PTO by the owner of record within 60 days of New Drug Application (“NDA”) approval; (4) the product, use, or method of manufacturing claimed has been subject to a “regulatory review period” before it is commercially marketed; and (5) the NDA is the first permitted commercial use of the drug product. In this case, the PTO denied AstraZeneca’s PTE request because the SYMBICORT NDA was not the first permitted commercial use of budesonide or formoterol fumarate dihydrate, and also because the PTE application was not submitted within the 60-day statutory period. (Spoiler Alert: While this post deals solely with the first basis for the PTO’s denial, the second basis – i.e., not meeting the 60-day period criterion – is another issue simmering at the PTO that we will post on in the near future.)

The details can be read here.

The whole decision can be read here.