Bases, And Esters, And Salts, Oh My! Limits On PTE Benefits Provide A Drug Applicant With A Winning Non-Infringement Position

Chief Judge Stark granted a defendant's Rule 12(c) motion for judgment on the pleadings based on non-infringement, holding that plaintiff's patent term extension (PTE) did not extend to the accused product because the PTE was based on approval of one active ingredient while the accused product was a metabolite of that ingredient.

Biogen International GmbH obtained a patent for methods of treating multiple sclerosis using a fumarate diester (DMF) or fumarate monoester (MMF). Biogen developed and received FDA approval in March 2013 for a DMF-based drug called Tecfidera after submitting extensive data on both DMF and MMF. Tecfidera DMF capsules do not contain MMF, but the DMF in Tecfidera is converted into MMF after it is administered to a patient, and MMF is the active moiety that produces a therapeutic effect. Due to delays in FDA approval of Tecfidera, Biogen obtained 811 days of PTE under 35 U.S.C. § 156, thereby extending the expiration date of the patent from April 1, 2018 to June 20, 2020.

On January 18, 2018, Banner Life Sciences LLC submitted a new drug application (NDA) for an MMF-based drug called Bafiertam. Banner's application relied in part on Biogen's MMF data.

In December 2018, after receiving notice of Banner's application, Biogen sued Banner for infringing its patent. Banner filed an answer and then moved for judgment on the pleadings, arguing that as to MMF, Biogen's patent expired on April 1, 2018, and was therefore not infringed. In other words, the patent term extension to June 20, 2020 was limited to only methods of treatment in which DMF is the administered drug.

The Court began its analysis by setting out § 156's statutory scheme for PTE. In particular, the Court explained that § 156(a) extends the term of the patent, but § 156(b) limited the benefit of the extension to those claims that covered a method of using a particular drug product, which, under § 156(f) meant the active ingredient of a new drug, including any salt or ester of the active ingredient. Of note here, DMF is an ester of MMF, but MMF is neither an ester nor a salt of DMF.

Next, the Court turned to the parties' competing arguments as to whether the PTE applied to only methods of treating multiple sclerosis using DMF, or whether PTE applied to any method claim in the patent, including the use of MMF. The Court reasoned that both Federal Circuit caselaw and statutory text compelled the more narrow benefit of PTE. The Federal Circuit ruled in the context...

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