April 21, 2020

The Scope of Patent Term Extension under 35 USC §156 Only Includes the Active Ingredient of an Approved Product

In Biogen International GmbH v. Banner Live Sciences, LLC, [2020-1373] (April 21, 2020), the Federal Circuit affirmed the district court’s determination that Banner does not infringe the extended portion of U.S. Patent No. 7,691,001.

The ‘001 patent covers the administration of dimethyl fumarate, methyl hydrogen fumarate, or combinations thereof, and both the dimethyl ester and monomethyl ester forms are covered by this claim.

Biogen asserted the ’001 patent in an infringement action against Banner in the District of Delaware. Banner immediately moved for a judgment of noninfringement, arguing that § 156(b)(2) limits the scope of the ’001 patent’s extension to methods of using the approved product as defined in § 156(f) — in this case, DMF, its salts, or its esters — and that MMF is none of those. Biogen responded that § 156(b)(2) does not limit extension of a method of treatment patent to uses of the approved product, but instead only to uses of any product within the original scope of the claims. Biogen further argued that, in any event, “product” in § 156 has a broader meaning encompassing any compound that shares with the approved product an “active moiety.”

The district court agreed with Banner’s interpretation of § 156 in both respects and rendered a judgment of noninfringement. 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.

The Federal Circuit explained that under § 156, an NDA holder is entitled to extend the term of only one patent for the corresponding approved product. Subsection (a) places several conditions on term extension for an NDA holder, including that the applicant’s approved NDA must be “the first permitted commercial marketing or use of the product.”

Subsection (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.” The Federal Circuit said that critically, for the purposes of the appeal, subsection (f) defines “product” as “the active ingredient of … a new drug … including any salt or ester of the active ingredient.” 

The Federal circuit said that “Active ingredient” is a term of art, defined by the FDA as “any component that is intended to furnish pharmacological activity or other direct effect,” 21 C.F.R. § 210.3(b)(7), and it “must be present in the drug product when administered.” The active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label. The Federal Circuit noted that MMF is not the approved product, nor is it specified as the active ingredient on the Tecfidera® label. Esters are included in the statutory definition of what can be extended, but MMF is the de-esterified form of DMF, not an ester of DMF. Thus, it is not the same product under § 156(f) and does not fall within the scope of the ’001 patent’s term extension under § 156(b)(2).