Biotechnology Law, A Primer for Scientists by Morrison, Alan J. -- Read -- Imperial Library of Trantor

Index

Cover Title Page Copyright Contents Preface Introduction

Biotechnology Law Scientists and the Study of Biotechnology Law Who Is a Scientist for the Purpose of This Book? Why Should Scientists Learn About Biotechnology Law? How Should They Learn About It? What This Book Covers How This Book Covers It Biotechnology Law in the Scheme of U.S. Law Three Branches and a Constitution Statutes, Rules, and Common Law Patent Law Regulatory Law Contract Law

Section I: Patent Law

1. The Patent as a Negative Right and the Claim as Its Business End

Territoriality and a Quid Pro Quo The Anatomy of a Patent Patent Claims Claim Structure Claim Scope and Language The Patent as a Negative Right: A Counterintuitive Notion

2. Construing the Patent Claim 3. The Patentable Invention

Patent-Eligible Subject Matter Utility Novelty Nonobviousness

4. The Patent Document’s Role in Supporting a Claimed Invention

Written Description Enablement Definiteness

5. The Long Road to Getting a Patent

The Scientific Event Defining the Invention Determining Inventorship Preparing and Filing a Patent Application What Kind of Patent Application Should Be Filed? Provisional Applications Nonprovisional Applications PCT Applications Tactical Considerations Where Should the Application Be Filed? Examining the Patent Application Restriction Practice: One Invention per Patent Substantively Examining the Patent Application Allowing the Application and Issuing the Patent

6. Lengthening and Shortening a Patent’s Term

Extending a Patent’s Term Adjusting a Patent’s Term Double Patenting Statutory Double Patenting Obviousness-Type Double Patenting and Terminally Disclaiming a Patent’s Term

7. Continuing-Application Practice and the Making of a Patent Family

The Continuing Application Defined Divisional Applications Continuation Applications CIP Applications Strategy and the Making of a Patent Family

8. The Murky World of Inventorship

Conception: The Sine Qua Non of Inventorship If It’s Not Conception, It’s Not Inventorship Authorship Providing a Goal Performing Experiments Explaining Technology and Elucidating an Invention’s Mode of Action Getting Inventorship Right Inclusion and Omission Joint Conception Agendas Business Consequences of Incorrect Inventorship Liability for Willfully Omitting an Inventor

9. Patent Infringement and its variations

Not All Roads Lead to Litigation Avoiding Infringement Patent Licensing When Patent Infringement Litigation Is the Answer What Is Patent Infringement? Types of Infringement Direct Infringement Inducement to Infringe Contributory Infringement Literal Infringement Infringement Under the Doctrine of Equivalents

10. Defenses and Preemptive Challenges

Defenses to an Infringement Suit Infringement Assertions Generally Noninfringement Invalidity Unenforceability Duty of Candor Inequitable Conduct and Patent Unenforceability Challenging a Patent Preemptively The Declaratory Judgment Action The Inter Partes Review

11. Patent Opinions

What Is a Patent Opinion? Noninfringement Opinions Infringement Opinions Invalidity Opinions Validity Opinions Freedom-to-Operate Opinions Risks of Relying on a Patent Opinion Benefits of Relying on a Patent Opinion

12. The Patent Portfolio

The Patent Portfolio Defined Managing a Patent Portfolio Valuing a Patent Portfolio

13. The Interplay between Trade Secrets and Patents

The Trade Secret Defined Patent or Trade Secret?

Section II: Regulatory Law

14. The Innovator Drug: From Development to Approval

Small-Molecule Drugs Research and Preclinical Development The Investigational New Drug Application Testing a Drug Candidate in Humans The Phase 1 Clinical Trial The Phase 2 Clinical Trial The Phase 3 Clinical Trial Clinical Trial Variations FDA Approval and the New Drug Application Postapproval Studies and Monitoring New Indications for Approved Drugs Biologic Drugs

15. Generic Drugs

The Early Days and the Need for Change The Hatch–Waxman Act and Today’s Generic Drug Industry Rewarding Innovators Patent-Term Extension Regulatory Exclusivity NCE Exclusivity CI Exclusivity Orphan Drug Exclusivity Pediatric Exclusivity The Interplay Between Regulatory and Patent Exclusivities The Orange Book Rewarding Generic Competitors The ANDA The §505(b)(2) Application Patent Certification Skinny Labeling Safe Harbor Hatch–Waxman Litigation ANDA Exclusivity Prolonging the Innovator’s Market Dominance Evergreening Trademark Protection

16. Biosimilars

What Price Biologics? Two Realms European Biosimilars and Sober Expectations in the United States The BPCI Act Rewarding Biosimilar Competitors Biosimilarity Interchangeability Exclusivity for First Licensed Interchangeable Biologics Rewarding Biologic Innovators Innovator Exclusivity Is Twelve Years Too Long? The Patent Dance Biobetters: A Third Way

Section III: Contract Law

17. The Contract: An Enforceable Promise

Elements of an Enforceable Contract Lawful Purpose Legal Capacity Offer and Acceptance Mutual Consideration Breach Remedies Expectation Reliance Restitution The Anatomy of a Contract Recitals Definitions Control Ownership Patents Payments Confidentiality Warranties and Indemnification Termination Principles of Note People Come and Go The Devil Is in the Details

18. Biotechnology Agreements

Confidentiality Agreements Material Transfer Agreements Patent License Agreements The Grant Clause The Concept of Exclusivity Exclusive Licenses Nonexclusive Licenses Field of Use Territory License Payments Up-Front and Milestone Payments Royalty Payments Collaboration Agreements Defining the Collaboration Intellectual Property Collaboration Costs and Profits Collaboration Payments Termination

Acknowledgments Further Reading Glossary of Legal Acronyms and Abbreviations Index

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