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.

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.

To qualify for a patent term extension under section 156, there are several requirements that must be satisfied. Section 156(a)(5)(A) provides:

(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b) if— (5)(A) except as provided in subparagraph (B) or (C), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred;

Based on this statutory language, one of the eligibility requirements for a patent term extension is that the permission for the commercial marketing or use of the product be the first permitted commercial marketing or use of the product.  The term “product” is defined as a single entity or in combination with another active ingredient.

In this case, the PTE Application indicated that Symbicort contains two active ingredients: formoterol fumarate dihydrate and budesonide. The FDA official records indicate that formoterol fumarate dihydrate and budesonide were each approved for commercial marketing or use before the approval of Symbicort:

Because both active ingredients in Symbicort have been previously approved for commercial marketing or use before the approval of Symbicort, Applicant’s approval of Symbicort does not qualify as the first permitted commercial marketing or use of either active ingredient, as required by section 156(a)(5).  Therefore, the ‘860 patent is ineligible for patent term extension based on the regulatory review period of Symbicort.

AstraZeneca argued that since the product 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 Manual of Patent Examining Procedure (“MPEP”) which states: “Furthermore, 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.” MPEP § 2751.

The Patent Office begged to differ:

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.”).

AstraZeneca could appeal.

See the entire decision here.

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    In house counsel was fortunate that the patent term extension was invalidated on two points. The invalidation of the patent because the first commercial use of both ingredients having already occurred was a Godsend to counsel. Missing a filing date deadline by one day (the second reason given for invalidation) would have cost the attorney his job.