During its October 1, 2016 to June 30, 2017 Term, the Supreme Court handed down eight IP decisions, six in patent cases, one in a copyright case, and one in a trademark case. The eight are summarized below, in alphabetical order.
1. Amgen v. Sandoz, and Sandoz v. Amgen.
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The Supreme Court’s 2016-2017 Term – An IP Case Summary
The Supreme Court’s 2016-2017 Term – An IP Case Summary
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NEWSLETTER ARCHIVE
Volume 48, Issue 3
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Jim-Lampert
Under §262(l) of the Biologics Price Competition and Innovation Act (BPCIA), an applicant seeking FDA approval of a biosimilar must provide its application and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review, and must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially. These two cases raised the same two questions. One was whether the requirement that an applicant provide the information to the manufacturer of the biologic is enforceable by injunction. The Federal Circuit held that no injunction was authorized under either the BPCIA or state law. The Supreme Court agreed that there was no right to injunctive relief as a matter of federal law. But it disagreed with the Federal Circuit’s reasoning regarding a possible injunction under California state law, and remanded the case to the Federal Circuit to determine whether California law would treat noncompliance with the BPCIA as “unlawful,” and, if so, whether the BPCIA pre-empts any additional state-law remedy. The second question was whether an applicant must give notice to the manufacturer after, rather than before, obtaining a license from the FDA for its biosimilar. The Federal Circuit said that an applicant could provide effective notice of commercial marketing only after the FDA had licensed the biosimilar. The Supreme Court reversed, holding that an applicant may provide notice before obtaining a license.
Index
Community Calendar Read more >
Table of Contents
Message from the President Monica Grewal
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Harvesting Innovation: 3 Tips for IP Managers
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Save the Date: BPLA Annual PCT Seminar and Madrid Protocol Seminar
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The Annual Dinner to Honor the Federal Judiciary, May 12, 2017
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Patent Attorneys Give Back to Local Entrepreneurs and Artists
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PTAB/Hatch-Waxman Parallel Proceedings
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Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc.
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In memoriam of Douglas C. Doskocil
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On-Sale Bar to Patent Protection Under the AIA
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Chemical Patent Practice Lamplighter Brewery tour
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Fashion and Intellectual Property: Many Options to Protect Your Design, But No One-Stop Shop
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Patent Eligibility as a Function of New Use, Aggregation and Preemption Through Application of Principle
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“Making Connections in Boston’s IP Community”
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Settlement Agreements Can Provide a Yardstick for Measuring Damages in Subsequent Patent Infringement Lawsuits
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The Federal Circuit Limits the Scope of Covered Business Method Proceedings
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The Supreme Court’s 2016-2017 Term – An IP Case Summary
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Members On The Move
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Message from the Editor-in-Chief
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BPLA Biotechnology Committee Announcement
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Officers and Board of Governors
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Community Calendar
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Announcement of BPLA’s 7th Annual Invented Here! Program
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Save The Date: BPLA’s Second Annual PTAB Summit
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