Biogen Int’l GmbH v. Banner Life Sciences LLC

Because plaintiff’s patent rights were limited to the “active ingredient” in its FDA-approved product at the time of administration, before the product is consumed by a human patient, PTE did not apply and the court granted defendant’s motion to dismiss.

January 07, 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (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: Biogen’s 001 patent claimed a method of treating multiple sclerosis (“MS”) with pharmaceutical preparations of dimethyl fumarate (“DMF”) and/or methyl hydrogen fumarate (“MMF”). Of the compounds listed in the 001 patent, the “active moiety” was MMF. After administration, DMF metabolize into the active moiety, MMF. DMF was an ester of MMF, but MMF was not an ester or salt of DMF.

In 2013, Biogen received FDA approval to market Tecfidera. This drug was administered as DMF, but after administration, the DMF cleaved an ester to become MMF. The 001 patent was originally set to expire on April 1, 2018, but Biogen sought, and received, a patent-term extension (“PTE”) of 811 days under 35 U.S.C. § 156.

Banner filed a Rule 12(c) motion, arguing that the PTE was inapplicable because its product practiced only an expired portion of the 001 patent. In particular, Banner contended that Biogen’s PTE applied only to the claimed embodiment, which constituted Biogen’s FDA-approved DMF product. Because Banner’s product contained MMF, and not DMF, Banner argued that it was entitled to judgment on the pleadings. The court granted Banner’s motion.

Why Banner Prevailed: The court began its analysis by analogizing to § 156(b)(1), which applied to extensions “of a patent which claims a product.” Under § 156(b)(1), the Federal Circuit previously provided that a PTE “does not extend to all products protected by the patent but only to the product on which the extension was based.” By analogy, the court concluded that § 156(b)(2)—which used substantially similar language and applied to method claims—did not extend to all products protected by the patent, but only those on which the extension was based.

The court was then tasked with determining the identity of Biogen’s FDA-approved “product.” The relevant statute defined “drug product” as “the active ingredient of … a new drug … including any salt or ester of the active ingredient.” Banner argued that the “active ingredient” was the molecule found in the drug product before administration to the patient, meaning the “active ingredient” of Tecfidera was DMF (as well as the salts and esters of DMF). But Biogen argued that Tecfidera’s active ingredient was the active moiety, which was MMF (as well as the salts and esters of MMF). Based on competing Federal Circuit cases, the court concluded that it must look at the “active ingredient” of Biogen’s FDA-approved product at the time of administration, before the product was consumed by a human patient. Here, it was undisputed that the “active ingredient” in Tecfidera at the time of administration (i.e., before ingestion by a human patient) was DMF. As a result, Biogen’s enforceable patent rights—those subject to the PTE—were limited to only DMF. Banner did not infringe, and the court granted its Rule 12(c) motion.

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