Dimethyl fumarate /Monomethyl fumarate – USA

On Apr. 21, 2020, Federal Circuit affirmed Delaware district court’s decision and found Banner’s 505(b)2 product containing monomethyl fumarate non infringing Biogen’s extended patent.

Plaintiff Biogen International GmbH owns U.S. Patent No. 7,619,001 which is listed in OB for Tecfidera® (Dimethyl fumarate). US’001 patent originally set to expire on April 1, 2018 but Biogen filed patent term extension (PTE) and thus term was extended till June 20, 2020. On January 18, 2018, Banner submitted NDA under§ 505(b)(2), seeking approval for Bafiertam (monomethyl fumarate "MMF") delayed-release capsules for the treatment of Multiple Sclerosis. Biogen sued Banner for infringement of the '001 Patent on December 27, 2018 within 45 days & obtained an automatic 30-month stay of FDA approval of Banner's Bafiertam product. Banner then moved under Rule 12(c) for judgment on the pleadings on the basis of non-infringement, reasoning that the '001 Patent's extension does not cover Banner's tentatively-approved product. On Jan 07, 2020, the district court agreed with Banner’s interpretation of 35 U.S.C. § 156 and rendered a judgment of noninfringement. You can read the detailed summary previously "reported here".

Biogen appealed.

During appeal Federal Circuit said that the Hatch-Waxman Act provided for patent term extensions in § 156 to partially compensate NDA applicants for the loss of patent life occurred during review period. Under § 156, an NDA holder is entitled to extend the term of only one patent for the corresponding approved product. Critically, for the purposes of this appeal, subsection (f) defines “product” as “the active ingredient of . . . a new drug . . . including any salt or ester of the active ingredient.”

Biogen argued that the district court misinterpreted “product” in § 156(f) as not encompassing a de-esterified form of an approved product. Biogen further argued that this court decided in Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., 359 F.3d 1361 (Fed. Cir. 2004), that “product” has a different meaning under § 156(b), encompassing the de-esterified form. In that circumstance, “active ingredient” means “active moiety.” On the contrary, Banner argued that § 156(f) provides a consistent definition of “product” for the entire statute, a definition that this court expressly held in Glaxo and PhotoCure ASA v. Kappos, 603 F.3d 1372 (Fed. Cir. 2004), excludes a de-esterified form of the active ingredient.

Federal Circuit said that neither a Glaxo case nor a Pfizer case governs this particular case. It is governed by the statute. “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.” [Hoechst-Roussel Pharm., Inc. v. Lehman, 109 F.3d 756, 759 n.3 (Fed. Cir. 1997) (citation omitted)]. The active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label. 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).