Chemistry and Patent Law: U.S. Supreme Court Decisions 2000âˆ'2020

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. 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 H I L M N O U