Twenty years of change regarding US patent law...
As intellectual property plays an increasingly vital role in the modern economy, cases are brought to the Supreme Court on a more regular basis. In this book, experienced practicing patent lawyers offer accessible but thorough analyses of the most significant Supreme Court decisions in many key
areas of patent law since 2000. The volume begins with an overview of the Court's make-up, function, and role in the U.S. legal system. Each chapter covers another case, and the chapters describe the context of the decisions as well as outline or predict their implications for chemists. This will be
of interest to researchers considering careers in patent law, inventors, in-house legal groups, bench scientists looking for a clear summary of a relevant issue, and expert witnesses in a patent litigation.
Author(s): R. Bone
Series: ACS Symposium Series, 1363
Publisher: American Chemical Society
Year: 2022
Language: English
Pages: 158
City: Washington, D.C.
Chemistry and Patent Law: U.S. Supreme Court Decisions 2000−2020
ACS Symposium Series1363
Chemistry and Patent Law: U.S. Supreme Court Decisions 2000−2020
Library of Congress Cataloging-in-Publication Data
Preface
Glossary and Citation Format
Glossary
America Invents Act (AIA)
District Court
Ex Parte
En Banc
Federal Circuit
Patent Laws
Infringement
Patent Application
Patent Prosecution
Patent Trial and Appeal Board (PTAB)
Patent Trial
Supreme Court
United States Code (U.S.C.)
United States Patent and Trademark Office (USPTO)
A Note on Citations
Statutes
Case Law Citation: Overview
Party Names
Reporter
Court and Year
A Note on Citations to Recent Supreme Court Decisions
References
1
The U.S. Supreme Court and the Patent System:
An Overview of the Court’s Mechanics and a Survey of Recent Patent Cases by the Numbers
Part 1 U.S. Supreme Court and the U.S. Constitution
Constitutional Framework
Getting to the Court: Certiorari
The Court’s Members
The Court’s Opinions
Part 2 Supreme Court Patent Cases
What Is a “Patent Case”?
According to Jurisdiction
Figure 1. Routes on Appeal in Patent Cases.
The Subject of a Patent Case
Supreme Court Patent Cases by the Numbers
The Volume of Patent Cases Considered by the Supreme Court through History
Figure 2. Numbers of patent cases considered by the U.S. Supreme Court, averaged, decade by decade, from 1801–2020.
A Decade of Patent Cases 2007–2016
Origins
Figure 3. Supreme Court Patent cases, 2007–2016, by origin.
Areas of Law
Figure 4. Supreme Court patent cases, 2007–2016, according to area of law presented.
Split Opinions
Figure 5. Supreme Court patent cases, 2007–2016, according to split of opinion.
Opinions by Justice
Figure 6. Supreme Court patent cases, 2007–2016, by author of majority opinion.
Part 3 The Shifting Balance of Power in Patent Matters
How Does the Court Strengthen Patent Rights?
How Does the Court Weaken Patent Rights?
How Does the Court Leave the Balance Unchanged?
Overall Impact on Patent Rights
Figure 7. Supreme Court patent cases, 2007–2016, according to their effect on the rights of patentholders.
Disclaimer
Acknowledgments
Appendix
References
2
Merck v. Integra and the Patent Infringement Safe Harbor
Introduction
History of the Safe Harbor
The Common Law Experimental Use Exemption
History of the Statutory Research Exemption
Roche Products, Inc. v. Bolar Pharmaceutical Co.
Enacting the Hatch-Waxman Act
Interpreting the Safe Harbor of 35 U.S.C. § 271(e)(1)
Eli Lilly & Co. v. Medtronic, Inc.—The Supreme Court Broadly Interprets “Patented Invention” and “a Federal Law”
A Broad Interpretation of “Reasonably Related”
Further Broadening of “Patented Invention”
Potential Impact on Research Tools: The March toward Merck v. Integra
Merck v. Integra
Background
The District Court Case
The Federal Circuit Affirms
The Supreme Court Speaks
Back to the Federal Circuit
Scope and Limits of the Safe Harbor Post-Merck
Which Patented Inventions Fall under the Exemption?
Narrowing “Patented Invention”
Broadening “Patented Invention”
A Narrow Reading in the Trial Courts
What Activities Are Included in the Safe Harbor?
Upstream Activities
Downstream Activities
Remaining Uncertainties to Be Resolved by the Courts
Acknowledgments
References
3
The U.S. Supreme Court Teaches How to Decide When an Invention Is Obvious
Introduction
The Supreme Court Interprets the Law on Obviousness
KSR at the District Court
Teleflex Appealed Its Loss to the Federal Circuit
The U.S. Supreme Court Disagreed with the Federal Circuit
Post-KSR Opinions Issued by the Federal Circuit on Pharmaceutical Inventions
Takeda Chem. Ind. Ltd. v. Alphapharm Pty. Ltd.
The Litigation
Figure 1. The structure of pioglitazone.
Figure 2. The structure of compound b.
The “Lead Compound” Analysis
Not Obvious to Try
The Scope and Content of the Prior Art
Millennium Pharmaceuticals Inc. v. Sandoz Inc., et al.
The Drug: D-Mannitol Ester of Bortezomib
Figure 3. The active ingredient in Velcade.
The History of Development of Velcade
Figure 4. The structure of bortezomib.
The District Court Found the Compound Claim to Be Obvious
The Patentee Appealed to the Federal Circuit
The Prior Art Taught Away from Making the Mannitol Ester of Bortezomib
Claim 20 Was Not Obvious Because of the Unexpected and Superior Properties of the Mannitol Ester of Bortezomib
Conclusion
Disclaimer
References
4
Has the Sun Set for Life Science Patents?
Mayo, Myriad and the Patent Eligibility Divide
Introduction
Getting What You Deserve
The Patentable Subject Matter Divide
Mayo vs. Prometheus – Drug Metabolite Monitoring Is a Patent Ineligible Natural Process
Background
What Is the Law of Nature?
Assoc. for Molecular Pathology v. Myriad Genetics: Isolated DNA Is Not Patent-Eligible
Background
District Court Decision
Federal Circuit Decision
Supreme Court Decision
Going beyond the Natural
Acknowledgments
References
5
Into the Abstract:
The Court’s Long and Winding Road through Section 101
The Digital Economy
Before Alice
The Statutory Scheme
The Supreme Court’s Own Learning Process
The Federal Circuit’s Lonely Road
No Patent for Bilski
Mixing with Mayo
Alice: The Court’s Last Word
Alice in the Lower Courts
Alice at the Supreme Court: The Long-Awaited Test
Alice Extended: What Else the Court Said
Alice in the Real World
How Is Alice Applied?
Figure 1. Adapted from the USPTO’s flow-chart of applicability of Alice/Mayo.
Significant Post-Alice Decisions of the Federal Circuit
Claims That Are Not Abstract
Claims That Recite More
Decisions That Affect Litigation Tactics
Patent-Eligibility Reimagined
Disclaimer
Acknowledgments
References
6
Nautilus, Inc. v. Biosig Instruments, Inc.: Indefiniteness
Introduction
The Nautilus Standard
Determining Indefiniteness after Nautilus
Post-Nautilus Decisions with Examples
Best Practices to Ensure Sufficiently Definite Claims
Conclusion
References
7
One Patent Claim vs. Multiple Actors:
Divided Infringement after Limelight v. Akamai
Introduction
Induced Infringement
Examples of Divided Infringement
Limelight in the Lower Courts
Limelight at the Supreme Court
The Federal Circuit Clarifies Limelight
Applications of Limelight
Conclusion
Acknowledgments
References
8
Helsinn Healthcare v. Teva Pharmaceuticals and the Evolving On Sale Bar to Patentability
The On Sale Bar
Background of the On Sale Bar
The America Invents Act of 2011
Helsinn Healthcare v. Teva Pharmaceuticals
Background Facts and Procedural History
The Parties’ Arguments before the Supreme Court
The Court’s Opinion
Additional AIA Changes to the On Sale Bar
References
9
Supreme Court Decisions Involving Inter Partes Review
Introduction
Cuozzo Speed Technologies, LLC., v. Lee
SAS Institute v. Iancu
Oil States Energy Services, LLC v. Greene’s Energy Group, LLC
Disclaimer
References
Epilogue
A View from the Chamber
Editor’s Biography
Richard G. A. Bone
Indexes
Author Index
Subject Index
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