Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the
American Bar Association.
5
T
hree judges of the Federal Circuit recently dissented from the
denial of a petition for rehearing en banc in Biogen v. Mylan.
1
The dissenting judges
2
declared—without equivocation—that
Biogen’s patent claims3 were errantly invalidated on “lack of written
description” grounds in the court’s panel decision.
4
The claims that ran
afoul of the written description requirement were quite mundanely
directed to nothing more than the treatment of a specic disease
(multiple sclerosis) using a specic drug (monomethyl and/or dimethyl
fumarate) at a specied dosage (about 480 mg/day).
In denying the request to rehear the case, the Federal Circuit was
apparently unpersuaded by some impassioned pleas for rehearing from
a group of notable amici.
5
The impressive, although notably unsuc-
cessful, amici effort—when coupled with the long-standing divergence
Do You Really Need
to Make an Invention
before You Can
Patent It?
Managing “Written Description”
Issues aer Biogen v. Mylan
By Robert A. Armitage
Image: Getty Images
Robert A. Armitage is a consultant on IP strategy and policy
issues and can be reached at raarmitage@aol.com.
Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the
American Bar Association.
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