Biogen loses Tecfidera case at CAFC

The case concerns Tecfidera, a drug used to treat multiple sclerosis [MS]:


Biogen holds the New Drug Application (“NDA”) for the
active ingredient dimethyl fumarate (“DMF”), which was
approved by the Food and Drug Administration (“FDA”) in
2013 as Tecfidera®, a twice-daily pill indicated “for the
treatment of patients with relapsing forms of multiple sclerosis”
at a daily dose of 480 mg. J.A. 1123. DMF is the
dimethyl ester of fumaric acid. An ester is a compound derived from
the combination of a carboxylic acid and an alcohol, minus a molecule of water.



The dispute:


In December 2018, 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
things. 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.”



Banner had prevailed at the district court level:


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. Decision, 2020 WL
109499, at *4–5. The district court also reasoned that this
court’s interpretation of “product” in § 156 forecloses Biogen’s argument that MMF is the same product as Tecfidera®. Id. at *9–10 (citing Glaxo Ops. UK Ltd. v. Quigg, 894
F.2d 392, 395 (Fed. Cir. 1990)).



As far as legal argument:


We agree with Banner that the extended portion of Biogen’s patent does not encompass its MMF product.
The parties here argue that either Glaxo or Pfizer helps
their case. But this case is neither a Glaxo case nor a Pfizer
case. It is governed by the statute.



The nub of the issue:


All these precedents, and now this case, rest on the
same holding: the term “product,” defined in § 156(f) as the
“active ingredient . . . including any salt or ester of the active ingredient,” has a plain and ordinary meaning that is
not coextensive with “active moiety.” It encompasses the
active ingredient that exists in the product as administered
and as approved—as specified by the FDA and designated
on the product’s label—or changes to that active ingredient
which serve only to make it a salt or an ester. It does not
encompass a metabolite of the active ingredient or its deesterified form. This case is unlike Glaxo or Pfizer in that
it concerns a de-esterified compound, not an ester or salt.



The ruling against Biogen was affirmed.