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Biogen International GmbH v. Banner Life Sciences LLC

156(b) Term Extension for Regulatory Review Limited to Active Ingredient and Corresponding Salts/Esters

Biogen International GmbH v. Banner Life Sciences LLC, __ F.3d __, 2020 WL ___ (Fed. Cir. Apr. 21, 2020) (LOURIE, Moore, Chen) (D. Del.: Stark) (2 of 5 stars)

Fed Cir affirms judgment of no infringement. Biogen’s patent claims a method of treating multiple sclerosis with dimethyl fumarate (“DMF”), and Biogen holds the NDA for Tecfidera, which is FDA-approved. The patent was to expire in 2018, but its term was extended under § 156 to compensate Biogen for regulatory review. In 2018, Banner submitted a “paper NDA” to market a multiple sclerosis treatment comprising monomethyl fumarate (“MMF”). When DMF is administered to a patient, normal metabolism will transform it into the “de-esterized” compound MMF before reaching the pharmacological site of action. Banner’s paper NDA claimed bioequivalence to Tecfidera, and relied on Biogen’s Tecfidera clinical data for safety and efficacy.

The opinion describes how extension of a method of treatment patent under § 156(b)(2) is limited to claimed uses approved “for the product.” Per § 156(f), the “product” may be a drug’s active ingredient, or an ester or salt of the active ingredient. Because MMF is not DMF, and is not an ester or salt of DMF, it is not addressed by the term extension. Glaxo, 894 F.2d 392 (Fed. Cir. 1990), is not contrary because that case addressed a compound that was an ester of a previously approved product. Pfizer, 359 F.3d 1361 (Fed. Cir. 2004), is also not contrary because in that case the compound was a salt of the approved active ingredient. The reference to “the product” in § 156(b)(2) (extending term for “any use claimed by the patent and approved for the product”) means the approved product (i.e., DMF), not any product (which might include MMF). Nor may Biogen proceed under the doctrine of equivalents. “[A] product or process cannot logically infringe an extended patent claim under the doctrine of equivalence if it is statutorily not included in the extension under § 156.” Op. at 10–11.

KEYWORDS: PAPER NDA; METHOD OF TREATMENT; PATENT TERM EXTENSION; INFRINGEMENT (NO)