`
`2008
`
`GREGORY J. BATTERSBY
`CHARLES W. GRIMES
`
`Grimes & Battersby, LLP
`Norwalk, Connecticut
`
`LICENSING UPDATE
`
`NEVVYORK THE NETHERLANDS
`
`
`
`Wolters Kluwer
`
`Law & Business
`
`AUSTIN
`
`BOSTON
`
`CHiCAGO
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1122, Pg. 1
`
`
`
`This publication is designed to provide accuralc and authoritative information in regard to
`the sttltjeet matter covered.
`It
`is sold with the understanding that
`the publisher is Iltll
`engaged in rendering legal. accounting. or other professional services. illegal advice
`or other professional assistance is required. the services of‘a competent professional person
`should he sought.
`
`—From a Declaration of Prim-Epics jointly adopted
`by a Committee of the Autericuu Bar Association
`and a Committee of Publishers and Associations
`
`© 2008 Aspen Publishers. All Rights Reserved.
`
`Printed in the United States of America
`
`ISBN 978-0-7355-749777
`ISSN 1538-876X
`
`No purl of Ihis publication may be reproduced or transmitted in any form or by any means.
`electronic or IueehztnieatL including photocopy. recording. or any information storage and
`retrieval system. without permission in writing from the publisher. Requests for permis-
`sinn to reproduce uontcul should he directed to the Aspen Publishers Website in norm
`nspcnpubiishm's.com. or a letter ofiutent should he fused to the permissions department at
`212-77l-0803.
`
`1234567890
`
`Merck Ex. 1122, Pg. 2
`
`
`
`
`
`PATENT LICENSES APPENDIX A
`
`APPENDIX A: SUPREME COURT OPINION BRIEF—
`MEDIMMUNE v. GENENTECH
`
`(Slip Opinion)
`
`OCTOBER TERM, 2006
`
`Syllabus
`
`NOTE: Where it is feasible, a syllabus (headnotc) will be released, as is
`being done in connection with this case, at the time the opinion is issued.
`The syllabus constitutes no part of the opinion of the Court but has been
`prepared by the Reporter of Decisions for the convenience of the reader. See
`United Stare: v. Detroit Timber & Lumber C0., 2000. S. 321, 337.
`
`SUPREME COURT OF THE UNITED STATES
`
`What’s interesting about the Brazil decision to break the Merck patent
`is that it underscores just this essential difference between private/public
`and private/private relationships with respect
`to intellectual property.
`There’s also a larger lesson here for businesses and, to be sure, for the
`lawyers who represent them. A patent is not an absolute in the sense that
`it cannot be compromised or put at risk under certain circumstances. In the
`last analysis, patents are business tools. As long as they can be shown to still
`be effective business tools in some areas, they may be negotiable in others.
`Lawyers who do not understand intellectual property in the broadest
`business context are disserving their clients. The role of the IP counselor
`is to help companies succeed.
`
`99
`
`Syllabus
`
`MEDIMMUNE, INC. v. GENENTECH, INC., ET AL.
`
`CERTIORARI TO THE UNITED STATES COURT OF
`APPEALS FOR THE FEDERAL CIRCUIT
`
`No. 05-608. Argued October 4, 2006—Decided January 9, 2007
`
`After the parties entered into a patent license agreement covering, inter
`alia, respondents’ then-pending patent application, the application matured
`into the “Cabilly II” patent. Respondent Genentech, Inc., sent petitioner a
`letter stating that Synagis, a drug petitioner manufactured, was covered by
`the Cabilly II patent and that petitioner owed royalties under the agreement.
`Although petitioner believed no royalties were due because the patent was
`
`Merck Ex. 1122, Pg. 3
`
`
`
`invalid and unenforceable and because Synagis did not infringe the patent’s
`claims, petitioner considered the letter a clear threat to enforce the patent,
`terminate the license agreement, and bring a patent infringement action
`if petitioner did not pay. Because such an action could have resulted in
`petitioner’s being ordered to pay treble damages and attomey’s fees and
`enjoined from selling Synagis, which accounts for more than 80 percent
`of its sales revenue, petitioner paid the royalties under protest and filed
`this action for declaratory and other relief. The District Court dismissed
`the declaratory—judgment claims for lack of subject—matter jurisdiction
`because, under Federal Circuit precedent, a patent licensee in good standing
`cannot establish an Article 111 case or controversy with regard to the patent‘ s
`validity, enforceability, or scope. The Federal Circuit affirmed.
`
`Held:
`
`
`
`APPENDIX A 2008 LICENSING UPDATE
`
`100
`
`1. Contrary to respondents’ assertion that only a freestanding patent—
`invalidity claim is at issue, the record establishes that petitioner has raised
`and preserved the contract claim that, because of patent invalidity, unen—
`forceability, and noninfringement, no royalties are owing. Pp. 3—6.
`2. The Federal Circuit erred in affirming the dismissal of this action
`for lack of subject—matter jurisdiction. The standards for determining
`whether a particular declaratory—judgment action satisfies the case-or—
`controversy requirement—Le, “whether the facts alleged, under all the
`circumstances, show that
`there is a substantial controversy, between
`parties having adverse legal interests, of sufficient immediacy and reality
`to warrant” relief, Maryland Casualty Co. v. Pacific Coal & Oil Co., 312
`U. S. 270, 273—are satisfied here even though petitioner did not refuse to
`make royalty payments under the license agreement. Where threatened
`government action is concerned, a plaintiff is not required to expose
`himself to liability before bringing suit to challenge the basis for the
`threat. His own action (or inaction) in failing to violate the law eliminates
`the imminent threat of prosecution, but nonetheless does not eliminate
`Article III jurisdiction because the threat—eliminating behavior was effec-
`tively coerced. Similarly, where the plaintiff‘s self—avoidance of imminent
`injury is coerced by the threatened enforcement action of a private party
`rather than the government,
`lower federal and state courts have long
`accepted jurisdiction. In its only decision in point, this Court held that
`a licensee’s failure to cease its royalty payments did not render nonjus—
`ticiable a dispute over the patent’s validity. Altvater v. Freeman, 319 U. S.
`359, 364. Though Altvater involved an injunction, it acknowledged that
`the licensees had the option of stopping payments in defiance of the
`injunction, but that the consequence of doing so would be to risk “actual
`[and]
`treble damages in infringement
`suits” by the patentees,
`a
`
`Merck Ex. 1122, Pg. 4
`
`