Biogen Int'l GmbH v. Mylan Pharms., Inc.

Biogen Int'l GmbH v. Mylan Pharms., Inc.

Opinion

 [*1335]  Reyna, Circuit Judge.

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 [**2]  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  [*1336]  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.

I. Background

] Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), a manufacturer of a new generic drug that is bioequivalent¹ to a previously approved drug may seek approval from the US Food and Drug Administration (FDA) to market the generic product by filing an Abbreviated New Drug Application (ANDA). See Pub. L. No. 98-417, § 101, 98 Stat. 1585, 1585-86 (1984) (codified as amended [**3]  at 21 U.S.C. § 355(j)(2)(A)). The statute requires the generic-drug manufacturer to submit a certification regarding the status of any patent that purportedly protects the brand-name drug, including information as to whether no such patent exists or the patent already expired, and if the patent has not expired the manufacturer must indicate the date on which the patent will expire. 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(III).

] If a patent that covers the brand-name drug has not expired, the generic-drug manufacturer may file what is known as a paragraph IV certification, attesting that the "patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." Id. § 355(j)(2)(A)(vii)(IV). The manufacturer filing the ANDA and paragraph IV certification must promptly notify the owner of any patent subject to the certification. Id. § 355(j)(2)(B)(iii). And the FDA must approve the ANDA, unless the patent owner objects by filing an action for patent infringement against the generic-drug manufacturer within forty-five days of receiving notice of the paragraph IV certification. Id. § 355(j)(5)(B)(iii). If the patent owner brings the infringement suit under the Hatch-Waxman Act within the statutory period, the law triggers an automatic, thirty-month stay in the FDA-approval process of the generic drug, pending the outcome of the litigation. See id. § 355(j)(5)(B)(iii).

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