Do You Really Need to Make an Invention before You Can Patent It? Managing -Written Description- Issues after Biogen v. Mylan

• Date: 01 September 2022
• Author: Robert A. Armitage

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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T

hree judges of the Federal Circuit recently dissented from the

denial of a petition for rehearing en banc in Biogen v. Mylan.

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The dissenting judges

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declared—without equivocation—that

Biogen’s patent claims3 were errantly invalidated on “lack of written

description” grounds in the court’s panel decision.

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The claims that ran

afoul of the written description requirement were quite mundanely

directed to nothing more than the treatment of a specic disease

(multiple sclerosis) using a specic drug (monomethyl and/or dimethyl

fumarate) at a specied 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.

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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 aer 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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