Synergistic combinations of active ingredients doesn't save patent term extension in the US

The aroma of a recent patent term extensions decision by the US PTO has reached this side of the pond with the Patent Baristas report of AstraZeneca's attempt to obtain a patent term extension for Symbicort, an asthma drug comprised of a combination of the active ingredients formoterol fumarate dihydrate and budesonide:

AstraZeneca filed an application for a patent term extension (PTE) of the patent term of U.S. Patent No. 5,674,860 under 35 U.S.C. § 156 in the United States Patent and Trademark Office. They tried to get the extension based the time for FDA review under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) of Symbicort®, having the active ingredients, formoterol fumarate dihydrate and budesonide. [n.b. both of these active ingredients were each approved for commercial marketing or use before the approval of Symbicort]

The Patent Office determined that the ‘860 patent was ineligible for patent term extension based upon the regulatory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort (formoterol fumarate dihydrate and budesonide) under the provision of law under which such regulatory review period occurred, and (2) the PTE Application was not timely filed.

AstraZeneca had argued that, since Symbicort is a synergistic combination of formoterol fumarate dihydrate and budesonide, it should be considered as a single active ingredient for patent term extension purposes.

The Patent Office disagreed with the synergistic combination argument:

Applicant’s argument is incorrect. The synergistic effect of the active ingredients formoterol fumarate dihydrate and budesonide has no relevance in determining “first permitted commercial marketing or use of the product” as required by 35 U.S.C. § 156(a)(5)(A). The term “product” as used in 35 U.S.C. § 156 includes any new drug or antibiotic drug, “as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic. See Arnold Partnership v Dudas, 362 F.3d 1338, 1343 (Fed. Cir. 2004) (”Moreover, this court doubts that synergistic effects are an appropriate distinction for term extension policies, particularly where the statutory language does not distinguish at all between synergistic and nonsynergistic combinations.”).

Read more here.

Although the corresponding SPC for Symbicort (SPC/GB02/033) was granted in the UK in 2003, the patent was revoked in appeal proceedings at the European Patent Office in 2007.