BECAUSE DEFENDANT’S NDA PRODUCT DOES NOT INCLUDE ANY SALT OR ESTER OF THE ACTIVE INGREDIENT IN PLAINTIFF’S REFERENCE DRUG, PATENT TERM EXTENSION DID NOT APPLY AND JUDGMENT OF NON-INFRINGEMENT WAS AFFIRMED.

Case Name: Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. April 21, 2020)(Circuit Judges Lourie, Moore, and Chen presiding; Opinion by Lourie, J.) (Appeal from D. Del., Stark, J.)

Drug Product and Patent(s)-in-Suit: Tecfidera® (dimethyl fumarate); U.S. Patent No. 7,619,001 (“the ’001 patent”)

Nature of the Case and Issue(s) Presented: The Hatch-Waxman act provides branded drug makers with an extension of the patent term (“PTE”) pursuant to 35 U.S.C. § 156. This is because while awaiting FDA approval, a patent holder may not commercialize its product, thereby losing part of the patent term. Under Section 156, Biogen obtained a PTE on the ’001 patent, which claimed methods for treating multiple sclerosis using dimethyl fumarate (“DMF”) and monomethyl fumarate (“MMF”). Upon administration, one of DMF’s methyl ester groups was metabolized to yield (MMF) before reaching its pharmacological site of action. Prior to the expiration of Biogen’s PTE, Banner submitted a new drug application application under 21 U.S.C. 355(b)(2), for its MMF drug product that it claimed was bioequivalent Biogen’s DMF product Tecfidera®. Biogen brought a patent infringement action against Banner in the District of Delaware, and Banner moved for a judgment of non-infringement. The issue in Biogen was whether Biogen’s PTE covered the MMF metabolite. The district court agreed with Banner’s interpretation of § 156 and rendered a judgment of non-infringement. It rejected Biogen’s argument that extension of a method of treatment patent under § 156(b)(2) is not limited to uses of the approved product.. Analyzing the language of Section 156, the Federal Circuit affirmed, finding that the patent term extension applied to DMF only.

Why Banner Prevailed: Biogen argued that Section 156’s extension applies to any compound that shared an “active moiety” with the approved compound, and that because DMF and MMF shared an active moiety, Banner’s proposed product infringed the extended ’001 patent. Biogen emphasized this point by pointing to Banner’s reliance on Tecfidera’s clinical data. Relying on the language of the statute, the Federal Circuit rejected this argument, noting that Section 156 limited the scope of the extension to “any use approved for the product” and defined “product” as “the active ingredient of … a new drug … including any salt or ester of the active ingredient.” As MMF was not an ester of DMF, but rather a de-esterified version of DMF, the Federal Circuit found that Section 156 “did not encompass a metabolite of the active ingredient or its de-esterified form.”