This morning the Federal Circuit released opinions in two related patent cases, one a precedential opinion and one a nonprecedential opinion. In the precedential opinion, the court affirmed a judgment of the Northern District of West Virginia that certain claims are invalid for lack of written description. Judge O’Malley dissented. In the nonprecedential opinion, the court affirmed a judgment of the Patent Trial and Appeal Board in an inter partes review addressing the same patent. Here are the introductions to the opinions.

Biogen International GmbH v. Mylan Pharmaceuticals Inc. (Precedential)

This appeal from the United States District Court for the Northern District of West Virginia concerns a patent-infringement dispute between Biogen International GmbH, Biogen MA, Inc., and Mylan Pharmaceuticals, Inc. Biogen owns United States Patent 8,399,514 (the ’514 Patent), which claims a method of treating multiple sclerosis with a drug called dimethyl fumarate. In 2017, Biogen filed a lawsuit against Mylan alleging patent infringement. Mylan counterclaimed for declaratory judgment that the patent was invalid and not infringed. Following a bench trial, the district court determined that the asserted claims of the ’514 Patent were invalid for lack of written description. Biogen challenges the district court’s decision on appeal.

For the reasons set forth in this opinion, we hold that the district court did not clearly err in determining that Mylan has established its burden of showing, by clear and convincing evidence, that the asserted ’514 Patent claims are invalid for lack of written description under 35 U.S.C. § 112. Accordingly, we affirm the judgment of the district court.

O’MALLEY, Circuit Judge, dissenting.

While I am loath to reverse district court determinations that rely heavily on credibility findings, I must respectfully dissent. There is no dispute over whether the district court erred in finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effects: it did. Mylan calls the error harmless and the majority finds it “ancillary” to its analysis. I, on the other hand, believe this threshold error impacted the district court’s entire written description analysis. I would therefore reverse and remand for reconsideration in light of a proper understanding of the distinction between the two effects and the written descriptions needed for each.

Mylan Pharmaceuticals Inc. v. Biogen MA Inc. (Nonprecedential)

Mylan Pharmaceuticals, Inc., appeals the Patent Trial and Appeal Board’s Final Written Decision of an inter partes review proceeding, in which Mylan challenged claims 1–20 of Biogen MA, Inc.’s United States Patent 8,399,514 (the ’514 Patent). See Mylan Pharms. Inc. v. Biogen MA Inc., No. IPR2018-01403, 2020 WL 582736, at *1–2 (P.T.A.B. Feb. 5, 2020). The ’514 Patent claims a method for the treatment of multiple sclerosis with a drug called dimethyl fumarate, a fumaric-acid ester compound, at a specific dose of 480 milligrams per day. ’514 Patent col. 27 ll. 59–67. The Board found that Mylan failed to demonstrate by preponderant evidence that the challenged claims were unpatentable as obvious over a combination of prior-art references. Mylan Pharms., 2020 WL 582736, at *1–2. The Board further determined that Biogen presented sufficient evidence of unexpected results to overcome Mylan’s obviousness challenge. Id. at *16–19, *23–24.

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In Biogen, the companion case to this appeal, we held that the ’514 Patent is invalid for lack of written description under 35 U.S.C. § 112, see Biogen Int’l GmbH v. Mylan Pharms. Inc., No. 20-1933, __ F.4th __ (Fed. Cir. 2021). Consequently, we need not reach the merits of the parties’ arguments in this case. The holding of lack of written description in Biogen is dispositive of the Board’s patentability determination. We have considered the parties’ remaining arguments and find no reason to hold otherwise.