Jan 10, 2022Legal
Fresh From the Bench: Latest Federal Circuit Court Case


Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. January 3, 2022)‎

In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a).  This is the latest in a series of recent precedential opinions addressing written description issues associated with claimed dosages and dosage ranges, such as we’ve previously reported on here and here.

In this case, appellee Novartis’s patent claimed a method of treating relapsing remitting multiple sclerosis (“RRMS”) with a daily dose of 0.5 mg of the compound fingolimod, without an immediately preceding loading dose regimen.  Appellants HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (“HEC”) appealed the district court’s determination that the 0.5 mg daily dosage and the negative limitation excluding a loading dose were adequately supported by the specification.

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By Jason Wrubleski

Edited by: Scott D. Eads and Nika Aldrich, Schwabe Williamson & Wyatt

Contributor: Jason Wrubleski

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