Extension under § 156 does not include claimed metabolite not listed on Tecfidera® label


Biogen Int. GmbH v. Banner Life Sciences LLC

Docket No. 2020-1373
LOURIE, MOORE, CHEN
April 21, 2020

Brief Summary: DC judgment that patent extended under § 156 does not included metabolite covered by claim but not listed in Tecfidera® label affirmed.

Summary: Biogen appealed DC judgment that Banner does not infringe the portion of US 7,619,001 that was extended by 811 days under the Hatch-Waxman Act (35 USC § 156) regarding the multiple sclerosis drug Tecfidera® (“DMF”, the dimethyl ester of fumaric acid). The FC panel explains that ‘001 method of treatment claim 1 covers administration of a “pharmaceutical preparation comprising” DMF as well as methyl hydrogen fumarate (MMF which includes only one methyl ester group)) into which DMF is metabolized upon administration and “before the compound reaches its pharmacological site of action.” “The question” in this appeal is whether MMF “covered by the claim, is covered by the extension.” The DC concluded it was not, and the FC panel agreed. The FC panel explained that § 156(b) “limits the scope of the patent extension to ‘any use approved for the product,’ and further, for method of treatment patents, to uses also ‘claimed by the patent’” and that § 156(f) “defines ‘product’ as ‘the active ingredient of…a new drug…including any salt or ester of the active ingredient’” (§ 156(b)(2)). Biogen argued that the DC “misinterpreted ‘product’ in § 156(f)” as not encompassing a deesterfied form of an approved product”, citing Pfizer (FC 2004), and contending that “‘active ingredient’ means ‘active moiety’” (Glaxo, FC 2004 (separate ester compound, not the same active ingredient as its previously approved carboxylic acid); PhotoCure, FC 2004). “But this case”, the FC panel wrote, “is neither a Glaxo case nor a Pfizer case” and “is governed by statute” and “[t]he active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label”, which does not include MMF (“not the approved product”, not “specified on the Tecfidera® label”). Further, while “[e]sters are included in the statutory definition of what can be extended,” “MMF is the de-esterfied form of DMF, not an ester of DMF” and “does not fall within the scope of the ‘001 patent’s term extension under § 156(b)(2). The FC panel also wrote that “[a]ll..precedents, and now this case, rest on the same holding: the term ‘product,’ defined in § 156(f) as the ‘active ingredient…including any salt or ester of the active ingredient,’ has a plain and ordinary meaning that is not coextensive with ‘active moiety’” (Merck, FC 1996; “encompasses the active ingredient that exists in the product as administered and approved-as specified by the FDA and designated on the product’s label-or changes to that active ingredient which serve only to make it a salt or an ester” but not “a metabolite of the active ingredient or its desterfied form”). Biogen’s argument that the DC erred in rejecting its infringement under DOE claim was also rejected because “a product or process cannot logically infringe an extended patent claim under equivalence if it is statutorily not included in the extension under § 156.”

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