Intellectual Property Practice [3 ed.] 1575899361

Table of contents :
Preliminary Pages
ACKNOWLEDGMENTS
ABOUT THE EDITOR
ABOUT THE AUTHORS
TABLE OF CONTENTS
TABLE OF EXHIBITS
Chapter 1
Metes and Bounds of Intellectual Property
§ 1.1 INTRODUCTION TO INTELLECTUAL PROPERTY
§ 1.1.1 Forms of U.S. Intellectual Property
(a) Basic Types
(b) Other Types
(c) Extended Effects
§ 1.1.2 International Dimensions
§ 1.2 CONTENT OF THIS BOOK
§ 1.2.1 Patents
§ 1.2.2 Trade Secrets
§ 1.2.3 Trademarks/Trade Identities/Anticounterfeiting
§ 1.2.4 Copyrights
§ 1.2.5 FDA Practice
§ 1.2.6 Ethics and Loss Prevention for IP Attorneys
§ 1.3 LIMITATIONS OF IP, COMPARISONS, COMMON ISSUES, AND ADJUNCT ISSUES OF DIVERSE IP TYPES
§ 1.3.1 Duration
§ 1.3.2 Scope and Exceptions
§ 1.3.3 Perfection of Rights
(a) Nationally
(b) Internationally
§ 1.3.4 Enforcement/Defense
§ 1.3.5 Exploiting IP
§ 1.4 PUBLIC POLICY AND IP
§ 1.5 CAREERS IN RELATION TO IP
Chapter 2
Developing and Realizing Value from a Patent Portfolio
§ 2.1 PATENTS AS A BUSINESS ASSET
§ 2.1.1 Developing a Patent Portfolio
§ 2.1.2 Realizing Value from Patents
(a) “Licensed Products” or “Licensed Processes” (or Both)
(b) “Patent Rights”
(c) “Technology”
(d) “Field”
(e) “Territory”
(f) “Net Sales”
§ 2.1.3 Assuring Commercialization
§ 2.2 OWNERSHIP OF PATENTS
EXHIBIT 2A—Mononucleosis Detection Technology License Agreement (Version A, Tending to Favor Licensor)
EXHIBIT 2B—Viral Detection Technology License Agreement (Version B, Tending to Favor Licensee)
EXHIBIT 2C—Form of Agreement for Confidential Disclosure to a Third Party
EXHIBIT 2D—Form of Patent Assignment
EXHIBIT 2E—Employee Noncompetition, Nonsolicitation, Nondisclosure, and Assignment of Inventions
EXHIBIT 2F—Form of Agreement for Two-Way Exchange of Confidential Information
EXHIBIT 2G—Form of Assignment Accompanying Patent Application
EXHIBIT 2H—Biological Material Transfer Agreement
EXHIBIT 2I—UBMTA Form of Biological Material Transfer Agreement
EXHIBIT 2J—Form of Agreement for Employees and Consultants
Chapter 3
Understanding Patents for the Legal Advisor
§ 3.1 PRELIMINARY CONSIDERATIONS
§ 3.1.1 “Patent” Defined
§ 3.2 WHY SHOULD YOUR CLIENT BE THINKING ABOUT PATENTS?
§ 3.2.1 Risks and Prevention of Infringement
§ 3.2.2 Securing a Unique Advantage in the Market
§ 3.3 PATENTS VERSUS OTHER TYPES OF INTELLECTUAL PROPERTY
§ 3.3.1 Advantages and Disadvantages of Obtaining Patents
§ 3.4 WHAT IS PATENTABLE?
§ 3.4.1 The America Invents Act
§ 3.4.2 Subject Matter Considerations
(a) The Four Enumerated Categories
(b) Utility
(c) Judicially Created Exceptions to Eligibility
§ 3.4.3 Design and Plant Patents
§ 3.4.4 Novelty
§ 3.4.5 Public Use
§ 3.4.6 Sales and Offers for Sale
§ 3.4.7 Experimental Use Exception
§ 3.4.8 Publication
§ 3.4.9 Secret Prior Art
§ 3.4.10 Obviousness
§ 3.5 ELEMENTS OF A PATENT APPLICATION
§ 3.5.1 Disclosure
§ 3.5.2 Claims
§ 3.5.3 Oath
§ 3.5.4 Fees
§ 3.5.5 Provisional Application
§ 3.5.6 Continuation-in-Part Applications
§ 3.6 THE PROCESS OF OBTAINING AND ENFORCING A PATENT
§ 3.6.1 Patent Prosecution
§ 3.6.2 Preissuance and Postissuance Procedures
(a) Procedures Available to a Patent Owner to Correct an Issued Patent
(b) Adversarial Procedures to Determine Ownership of Claimed Subject Matter
Proceedings Available to Third Parties to Correct the Scope of Claims
§ 3.7 LITIGATION
§ 3.7.1 Enforcement and Defense
§ 3.7.2 Major Litigation Issues
§ 3.7.3 Clearance Opinions
§ 3.7.4 Precomplaint Considerations
§ 3.7.5 Injunction and Damages Remedies
§ 3.7.6 Additional Prefiling Considerations
(a) Multiple Defendants
(b) Staffing
Company Staffing
(c) How Shall the Claim of Infringement Be Asserted?
§ 3.7.7 Claim Interpretation
§ 3.7.8 Markman Hearing
EXHIBIT 3A—Timing and Costs for Patent Protection
EXHIBIT 3B—Patent Infringement Complaint
EXHIBIT 3C—Patent Infringement Answer and Counterclaim
EXHIBIT 3D—Reply to Counterclaim
EXHIBIT 3E—Patent Infringement Demand Letter
Chapter 4
Trade Secret Law
§ 4.1 INTRODUCTION
§ 4.2 STATUTORY AND COMMON LAW BASES
§ 4.2.1 State Law
(a) Statutory Basis
Civil Statute
Criminal Statute
(b) Restatement (First) of Torts
Trade Secret Defined
Proscribed Conduct
Harm
(c) Uniform Trade Secrets Act
Section 1—Definitions of Improper Means, Misappropriation, Person, and Trade Secret
Section 2—Injunctive Relief
Section 3—Damages
Section 4—Attorney Fees
Remaining Sections
(d) Restatement (Third) of Unfair Competition
Trade Secret Defined
Proscribed Conduct
Harm
(e) Common Law
Trade Secrets Defined
The Cause of Action
Harm/Remedies
Inevitable Disclosure Doctrine
(f) Related State Law Claims
§ 4.2.2 Federal Law
(a) Possible Private Right of Action Under the Economic Espionage Act
(b) Scope of the Computer Fraud and Abuse Act
(c) Recent Use of the International Trade Commission for Foreign Trade Secret Misappropriation
§ 4.2.3 International Law
§ 4.3 ESTABLISHING A TRADE SECRET PROTECTION PROGRAM
§ 4.3.1 Trade Secret Audit
(a) Catalog
(b) Review
(c) Analyze
§ 4.3.2 Trade Secret Protection Program
(a) Identification and Disclosure of Trade Secrets
(b) Standards Applicable to Injunctive Relief
§ 4.3.3 Special Contexts of Trade Secret Issues
(a) Mobile Devices
(b) Government Procurement
(c) Federal and State Regulatory Submissions
(d) Preemption by and of Related Laws
Patent Laws
Copyright Laws
UTSA Preemption of Other State Law Claims
Chapter 5
Noncompetition Agreements and Related Restrictive Covenants
§ 5.1 INTRODUCTION
§ 5.2 THE LAW OF NONCOMPETITION AGREEMENTS
§ 5.2.1 Reasonableness
(a) Test for Reasonableness
Noncompetition Agreements Arising from Employment
Noncompetition Agreements Arising from Independent Contractor Relationships
Noncompetition Agreements Arising from the Sale of a Business
Other Issues of Reasonableness
(b) Modification of Unreasonable Restrictions/Reformation
§ 5.2.2 Duration
§ 5.2.3 Geographic Reach
§ 5.2.4 Scope of Proscribed Activities
§ 5.2.5 Legitimate Business Interests
(a) Recognized Legitimate Business Interests
Goodwill
Trade Secrets and Confidential Information
Special Skills
Training
(b) Business Interests That Are Not Recognized as Legitimate
§ 5.2.6 Public Policy Considerations
§ 5.2.7 Statutory and Rule-Based Industry Exemptions
(a) Statutory Exemptions
Physicians
Nurses, Psychiatrists, Social Workers
Broadcasters
(b) Rule-Based Exemptions
Lawyers
Financial Service Providers
§ 5.3 NEGOTIATING AND DRAFTING NONCOMPETITION AGREEMENTS
§ 5.3.1 Requirement of a Writing
§ 5.3.2 Required Elements: Duration, Geographic Reach, Scope of Prohibited Activities
§ 5.3.3 Identification of the Legitimate Business Interests
§ 5.3.4 Preparation to Compete
§ 5.3.5 Extension/Scaling Back of the Term
§ 5.3.6 Acknowledgment of Consideration, Legitimate Interests and Their Reasonableness, and Irreparable Harm
§ 5.3.7 Assignment/Successors in Interest
§ 5.3.8 Change of Position/Responsibilities
§ 5.3.9 Specification of Remedies
§ 5.3.10 Disclosure Obligations
§ 5.3.11 Return of Company Property and Information
§ 5.3.12 Other Terms
§ 5.3.13 Additional and Alternative Restrictive Covenants
(a) Garden Leave Clause/Notice Requirement
(b) Forfeiture-for-Competition/Compensation-for-Competition Clauses
(c) Nonsolicitation Agreements
(d) No-Raid/Nonraiding/Antiraiding/Antipiracy Agreements
(e) No-Hire and No-Poach Agreements
(f) Nondisclosure/Confidentiality Agreement (NDA)
(g) Invention Assignment Agreements
§ 5.4 ENFORCING AND DEFENDING AGAINST NONCOMPETITION AGREEMENTS
§ 5.4.1 Applicable Standards
§ 5.4.2 Injunctive Relief Is Not an Entitlement
§ 5.4.3 Initial Considerations
§ 5.4.4 Satisfying the Irreparable Harm Requirement
§ 5.4.5 Special Considerations
(a) Loss of Trade Secrets and Confidential Information as Irreparable Harm
(b) Loss of Goodwill as Irreparable Harm
(c) The Developing Impact of Social Media
§ 5.4.6 Enforcing a Noncompetition Agreement
(a) Before the Lawsuit Is Even Contemplated
(b) Investigate
(c) Conduct an Exit Interview
(d) Determine Whom to Sue
(e) Send a Cease and Desist Letter
(f) Act Quickly
(g) Credible Evidence—Percipient Witnesses, Expert Witnesses, and Expedited Discovery
(h) Bond
§ 5.4.7 Defending Against a Noncompetition Agreement
(a) Initial Considerations
Former Employee’s Initial Steps
New Employer’s Initial Steps
Impact of the New Position on the Former Employer
Sue or Wait to Be Sued?
Joint or Individual Representation?
Indemnification of Employee?
(b) Possible Defenses
Basic Requirements
Consideration
Lack of Irreparable Injury
Balancing of Harms
Competitors and Competition
Scope of Restriction
Delay/Mootness
Equity and Fairness
Employer’s Breach
Employer’s Changes: Successors and Assigns
Ambiguity
Waiver, Amendment, and Other Mitigating Conduct
Novation
Antitrust
EXHIBIT 5A—Web Logs Addressing Trade Secrets and Noncompetes
Chapter 6
Trademarks: Law, Practice, and Current Issues
§ 6.1 INTRODUCTION
§ 6.2 WHY SHOULD CLIENTS CONSIDER PROTECTING TRADEMARKS?
§ 6.3 BASIC PRINCIPLES OF TRADEMARK LAW
§ 6.3.1 What Is a Trademark?
§ 6.3.2 Goals of Trademark Protection
§ 6.3.3 Legal Bases for Trademark Rights (Statutory and Common Law)
§ 6.3.4 Acquisition of Rights
§ 6.3.5 Fundamental Concepts of Trademark Law
(a) Distinctiveness of Marks and Acquisition of Secondary Meaning
(b) Likelihood of Confusion
(c) Fame and Principles of Dilution
Definition of “Fame”
Dilution by Tarnishment or Blurring
§ 6.3.6 Trademark Rights Can Be Abandoned
§ 6.3.7 Joint Ownership of Trademarks Can Create Issues
§ 6.3.8 Trademarks Conceived by Employees or Partners
§ 6.3.9 Trademarks Used by Third Parties, Distributors
§ 6.4 TRADEMARK CLEARANCE SEARCH AND ANALYSIS
§ 6.4.1 Avoiding Likelihood of Confusion
§ 6.4.2 Assessing a Mark’s Distinctiveness
§ 6.4.3 Trademark and Trade Name Searching
(a) A Word of Caution About Searches
(b) Is There Ever a Time When Searching Is Unnecessary?
§ 6.5 TRADEMARK REGISTRATION PRACTICE
§ 6.5.1 Federal Registration Practice
§ 6.5.2 Federal Trademark Applications
(a) Obtaining a Filing Date
Name of Applicant
Correspondent Address
Clear Drawing of the Mark
Listing of Goods and Services with Which the Mark Will Be Used
Filing Fees
(b) Completing the Application and Getting to Registration
§ 6.5.3 Types of Federal Applications
(a) Use-Based Applications and Use in Commerce
Use in Commerce
(b) Intent-to-Use Applications
(c) Sections 44 and 66 Applications
§ 6.5.4 Examination of Applications—Bases for Refusal
(a) Lack of Distinctiveness
(b) Likelihood of Confusion
Overcoming Likelihood of Confusion Refusals
§ 6.5.5 Responding to Office Actions
§ 6.5.6 Postexamination Issues
(a) Publication
(b) Notice of Allowance and Statement of Use
(c) Declaration of Use
(d) Specimens
(e) Registration Timeline
§ 6.6 TRADEMARK REGISTRATION MAINTENANCE
§ 6.6.1 Section 9 Renewal
§ 6.6.2 Section 8 Affidavit of Use
§ 6.6.3 Section 15 Incontestability
§ 6.7 TRADEMARK ENFORCEMENT AND DEFENSES
§ 6.7.1 Proper Trademark Usage
(a) Trademarks Are Adjectives
(b) Forms of Notice
§ 6.7.2 Policing Trademark Rights Through Watch Services
§ 6.7.3 Taking Action Against Potential Infringers
(a) Demands to Cease and Desist
(b) Trademark Trial and Appeal Board Proceedings
(c) Civil Action
§ 6.7.4 Bringing a Trademark Claim in Federal Court
(a) Note on Internet Presence and Jurisdiction
(b) Trademark Infringement Claims
Similarity of Marks
Similarity of Goods or Services
Channels of Trade
Advertising
Class of Purchasers
Actual Confusion in Marketplace
Bad Intent of Defendant
Strength of Mark
(c) False Advertising/Designation of Origin
(d) Dilution
State Antidilution Provisions
(e) Counterfeiting
(f) Counterfeiting—Criminal Enforcement
Federal Criminal Law
State Criminal Law
Defenses to Criminal Counterfeiting
(g) Counterfeiting—Criminal Penalties
(h) Customs and Border Patrol—Seizures
(i) International Trade Commission
(j) Counterfeiting—Civil Enforcement
(k) Other State Law Civil Claims
§ 6.7.5 Defenses to Trademark Infringement or Related Claims
(a) Laches
(b) Acquiescence
(c) Unclean Hands
(d) Fair Use
(e) License
§ 6.7.6 Relief
(a) Injunctions
Likelihood of Success on the Merits
Irreparable Harm
Balancing Harm to Defendant
Public Interest
(b) Destruction and Seizure Orders
(c) Monetary Damages
§ 6.8 TTAB OPPOSITION AND CANCELLATION PROCEEDINGS
§ 6.8.1 Applicable Procedure and Governing Law
§ 6.8.2 Standing to Bring a TTAB Action
§ 6.8.3 Opposition Proceedings
§ 6.8.4 Cancellation Proceedings
§ 6.8.5 Matters Specific to TTAB Proceedings
(a) Form of Complaint
(b) Answer
(c) Defenses
§ 6.8.6 Issue Preclusion and the Impact of TTAB Proceedings on Subsequent Litigation
§ 6.9 TRADE DRESS
§ 6.9.1 Packaging Versus Configuration: Two Standards
§ 6.10 TRADEMARKS IN TRANSACTIONS
§ 6.10.1 Licensing and Franchise Agreements
§ 6.10.2 Trademark Assignments
(a) Valid Trademark Assignments Versus Assignments in Gross
(b) Recording a Trademark Assignment
(c) Trademarks and Security Interests
§ 6.11 SPECIAL ISSUES RELATING TO TRADEMARKS: THE INTERNET, NEW TECHNOLOGIES, AND DEVELOPMENTS IN THE INTERSECTION OF THE LANHAM ACT, PRODUCT LABELING, AND DECEPTIVE ADVERTISING
§ 6.11.1 Domain Names
(a) The Anticybersquatting Consumer Protection Act
(b) Domain Name Dispute Resolution Proceedings
§ 6.11.2 New Generic Top-Level Domains and New Domain Name Rights Enforcement Mechanisms
(a) Sunrise Registration Period
(b) Trademark Claims Service
(c) Uniform Rapid Suspension System
§ 6.11.3 Keywords, Online Advertising, and Search Engine Optimization
§ 6.11.4 Social Networking and Media
§ 6.11.5 3D Printing and Trademarks
§ 6.11.6 The Lanham Act, Unfair Competition, and Intersections with Product Labeling and Promotion After the Supreme Court’s 2014 Term
§ 6.12 INTERNATIONAL TRADEMARK PROTECTION
§ 6.12.1 The Paris Convention and “Convention Priority”
§ 6.12.2 Madrid Protocol and Madrid Agreement
(a) Advantages
(b) Disadvantages
§ 6.12.3 Community Trade Mark
(a) Advantages
(b) Disadvantages
EXHIBIT 6A—Glossary of Trademark-Related Concepts
EXHIBIT 6B—Trademark-Related Resources
EXHIBIT 6C—Trademark Request Form (Internal/Corporate)
EXHIBIT 6D—New Trademark Application Filing Checklist
Chapter 7
Copyright Law
§ 7.1 INTRODUCTION: OVERVIEW OF COPYRIGHT LAW
§ 7.1.1 Copyright Protection
§ 7.1.2 The Copyright Owner
§ 7.1.3 When Does Copyright Protection Begin?
§ 7.1.4 When Does Copyright Protection End?
§ 7.1.5 Rights of a Copyright Owner
§ 7.1.6 What May Be Copyrighted?
§ 7.1.7 The Purpose of Copyright Law
§ 7.1.8 Sources of Copyright Law
§ 7.1.9 Federal Preemption of State Law
(a) “Equivalent” Rights and the “Extra Element” in Preemption Cases
§ 7.1.10 International Copyright Treaties
(a) National Treatment
§ 7.2 COPYRIGHTABLE VERSUS NONCOPYRIGHTABLE SUBJECT MATTER
§ 7.2.1 What Is Copyrightable?
(a) Originality: A Low Threshold
What Is Original?
(b) Fixation
What Is Fixation?
Copyright Law Protects Expression, But Does Not Protect Ideas
(c) Which Types of Works Are Entitled to Copyright Protection?
Importance of the Right Copyright Pigeonhole
Literary Works
Pictorial, Graphic, and Sculptural Works
Photographic Expression
(d) Compilation and Collective Works
Extent of Compilation Protection
(e) Derivative Works
Original Work and Derivative Work Have Separate Copyrights
§ 7.2.2 What Is Not Copyrightable?
(a) Names, Titles, Slogans, and Short Phrases
(b) Useful Articles
(c) Systems and Methods of Operation
Lotus: Massachusetts Software Case
Contrast with Altai Analysis
Interoperability Is a Favored Public Policy
Systems Are Not Protectable
(d) Facts
§ 7.3 WHO OWNS THE COPYRIGHT?
§ 7.3.1 General Rule: The Creative Party Owns the Copyright
§ 7.3.2 Works Made for Hire
(a) Who Is an “Employee”?
(b) Commissioned Works
(c) The Relevance of Classifying a Work as Made for Hire
§ 7.3.3 Joint Authors
(a) Key Factors for a Joint Work
(b) All Joint Authors Share Equally
(c) Limitations on Joint Authors
§ 7.3.4 Government-Authored Works
§ 7.4 DURATION OF COPYRIGHT
§ 7.4.1 Works Created on or After January 1, 1978
§ 7.4.2 Works Made for Hire
§ 7.4.3 Anonymous or Pseudonymous Works
§ 7.4.4 Works Created Before January 1, 1978
(a) Works Created Before 1978 but Published in 1978 or Later
(b) Works Created and Published Before 1978
§ 7.4.5 December 31 Rule
§ 7.4.6 Public Domain at Expiration of Copyright Period
§ 7.4.7 Exception for Foreign Works
§ 7.4.8 Summary of Above
§ 7.5 OBTAINING A COPYRIGHT; REGISTRATION AND NOTICE
§ 7.5.1 Copyright Is Automatic
§ 7.5.2 The Advantages of Federal Registration
§ 7.5.3 Mechanics of Registration
(a) Effective Date of Registration
§ 7.5.4 Mandatory Deposit
§ 7.5.5 Copyright Notice
(a) Notice Still Advisable
§ 7.5.6 Form of Notice
(a) Notice on Phonorecords
(b) Where Should the Notice Be Placed?
§ 7.6 RIGHTS OF A COPYRIGHT OWNER
§ 7.6.1 Exclusive Rights and Their Limitations
§ 7.6.2 Reproduction Right
(a) Limitations on the Reproduction Right
Libraries and Archives
Musical Works: “Mechanical” Compulsory License
Certain Software Copying Permitted
Broadcasters’ Ephemeral Recordings
Organizations Serving Blind and Disabled
§ 7.6.3 Derivative Work Right
§ 7.6.4 Distribution Right
(a) Right to Distribute or Not Distribute
(b) Preventing Importation
(c) Limitations on the Distribution Right: The “First Sale” Doctrine
First Sale Right Does Not Permit Rental of Phonorecords and Computer Programs
§ 7.6.5 Public Performance Right
(a) Exclusive Right Relates to Public Performances Only
Public Defined
Performing Rights Societies
(b) Limitations on the Owner’s Performance Right
Face-to-Face Instruction
Transmissions to Classrooms and Limited Distance Education
Religious Services
Nonprofit Performances
Sound Recordings
§ 7.6.6 Public Display Right
(a) Framing and Inline Linking Are Not Infringing Public Displays
(b) Limitations on the Public Display Right
Viewers in the Same Place
Similar Limitations to Public Performance Right
§ 7.6.7 “Moral Rights” for Works of Visual Art
(a) Moral Rights Are Noneconomic Rights
(b) The Visual Artists Rights Act
What Is a “Work of Visual Art”?
Three Rights of Attribution
Right of Integrity
Rights of Attribution and Integrity Are Separate from Copyright Rights
Rights Are Personal and Not Transferable
Rights Waivable
§ 7.7 TRANSFERRING A COPYRIGHT AND TERMINATING THE TRANSFER
§ 7.7.1 Rights Transferable in Whole or in Part
§ 7.7.2 What Is a Transfer?
§ 7.7.3 How May Copyrights Be Transferred?
(a) No Writing Necessary for Nonexclusive Licenses
(b) Contributions to Collective Works Such as Periodicals
(c) Does the Written Instrument Transferring Copyright Need to Meet Any Specific Requirements?
(d) Can Cashing a Check from the Proposed Assignee Constitute a Valid Assignment?
(e) Duration
(f) Should Copyright Transfers Be Recorded in the Copyright Office?
(g) Mechanics for Recording a Copyright Transfer
(h) Conflicts Between Transferees
(i) New Media
(j) Assignments and Licenses of Copyright May Be Terminated as a Matter of Law, Regardless of Contract
What About Derivative Works Prior to Termination?
Formalities of Termination Notice
Can a Licensor Waive the Right to Terminate?
Works Made for Hire Are Not Subject to the Termination Right
Effect of Termination
§ 7.8 LITIGATION OF COPYRIGHT INFRINGEMENT AND CLAIMS UNDER OTHER LAWS
§ 7.8.1 Where to Sue? Subject Matter Jurisdiction
(a) Federal Courts . . . Usually
(b) Diversity Jurisdiction
§ 7.8.2 Federal Jurisdiction: Copyright Infringement
§ 7.8.3 Federal Jurisdiction: Interpretation of the Copyright Act
§ 7.8.4 Personal Jurisdiction
§ 7.8.5 Venue
§ 7.8.6 Suits Against the Government
§ 7.8.7 State Government Immunity from Suit
§ 7.8.8 International Issues
(a) Governing Law
(b) The Yellow Submarine Case: Authorization to Infringe Overseas Not a Violation of the U.S. Copyright Act
§ 7.8.9 Who May Sue?
(a) Copyright Owner and Exclusive Licensee
(b) Assignment and Prior Infringement Claims
§ 7.8.10 Statute of Limitations
(a) When Does the Claim Accrue?
(b) Each Infringement Is a Distinct Injury
§ 7.8.11 Civil Copyright Infringement Complaint
§ 7.9 CIVIL COPYRIGHT INFRINGEMENT: DIRECT, CONTRIBUTORY, AND VICARIOUS INFRINGERS
§ 7.9.1 Who Is Liable?
§ 7.9.2 Direct Infringers
§ 7.9.3 Liability for the Infringement of Others—Vicarious Infringement and Contributory Infringement
§ 7.9.4 Elements of Contributory Infringement
(a) Knowledge: Actual or Constructive
(b) Material Contribution to the Infringement
§ 7.9.5 Limit on Contributory Infringement: The “Staple Article of Commerce” Theory
(a) The Betamax Case
Inducement Liability Under Grokster
(b) Requirement of Direct Infringement
§ 7.9.6 Elements of Vicarious Infringement
(a) Supervision
(b) Financial Interest
(c) Personal Liability of Corporate Officers
§ 7.10 WHAT IS COPYRIGHT INFRINGEMENT?
§ 7.10.1 Elements of an Infringement Claim
(a) Plagiarism Is Not the Same as Infringement
§ 7.10.2 Ownership: The First Element of Infringement
§ 7.10.3 Copying: The Second Element of Infringement
(a) How Does a Plaintiff Show Copying?
(b) First Element of Copying: Opportunity to Access Plaintiff’s Work
Example of Successful Wide Dissemination Argument
What if the Work Is Not Widely Disseminated?
Striking Similarity
(c) Second Element: Copying of Copyrightable Elements
Merger Doctrine and “Scenes a Faire”
(d) Substantial Similarity
Copying the Overall Pattern of a Work
Copying Individual Segments of a Work
The Ordinary Observer Test
Total Concept and Feel
Abstraction-Filtration-Comparison in Software Cases
§ 7.11 DEFENSES TO COPYRIGHT INFRINGEMENT
§ 7.11.1 Fair Use
(a) History of Fair Use
(b) Purpose of the Doctrine
(c) Fair Use as Codified
(d) Fair Use Factors Not Exclusive . . . Supposedly
(e) No Single Fair Use Factor Is Decisive
(f) Fair Use Is an Affirmative Defense
The Oh Pretty Woman Case: Example of Defendant Bearing the Burden of Proof
(g) Case-by-Case
(h) The First Fair Use Factor: The Purpose and Character of the Use
“Good Faith” Is Relevant to the Character of Use
“Transformative” Use
“Incidental Use”?
Classroom Use . . . Brevity and Spontaneity
Reverse Engineering
“Temporary” and “Intermediate” Use
(i) The Second Fair Use Factor: Nature of the Copyrighted Work
Fair Use of Unpublished Works
(j) Third Fair Use Factor: Amount and Substantiality of the Portion Used
Gerald Ford Biography: Important Qualitative Taking
The Importance of the Material Used to the Defendant’s Work May Also Be Relevant
(k) The Fourth Fair Use Factor: Effect on the Potential Market for, or the Value of the Copyrighted Work
Example of Use’s Negative Impact on Market for the Original
The Market Test Is Focused on the Particular Work
But Not Necessarily on the Particular Use
§ 7.11.2 Copyright Misuse
(a) Misuse Is Not Limited to Antitrust Violations
(b) Examples of Copyright Misuse
Plaintiff’s Software License Forbids Development of Potentially Competing Products
Plaintiff’s License Implicitly Forbids Development of Products That Compete with the Copyrighted Product
Plaintiff Prevents Customer from Using a Competing Product
§ 7.11.3 Fraud on the Copyright Office
§ 7.12 PLAINTIFF’S REMEDIES FOR INFRINGEMENT
§ 7.12.1 Monetary Damages
(a) No Double Counting
(b) Statutory Damages
(c) Increase for Willfulness
(d) Decrease for Innocent Infringement
(e) Statutory Damages Only Permitted for Timely Registered Works
§ 7.12.2 Injunctions
(a) Permanent Injunctions
(b) Relief in Claims Against Federal Entities
§ 7.12.3 Impoundment, Recall Orders, and Destruction
(a) Impoundment
(b) Recall Orders
(c) Destruction or Other Disposition of Infringing Articles and Means of Production
§ 7.12.4 Attorney Fees
§ 7.13 PROTECTING COPYRIGHT MANAGEMENT SYSTEMS: ANTICIRCUMVENTION
§ 7.13.1 Summary of Anticircumvention Provisions
§ 7.13.2 What Are Technological Measures?
(a) Example of Encryption
(b) The Streambox “Secret Handshake” Case: Example of Equipment that Facilitates Circumvention
§ 7.13.3 Permitted Circumvention
§ 7.13.4 Classes of Exempted Works
§ 7.13.5 Copyright Management Information
§ 7.14 LIABILITY FOR ONLINE COPYRIGHT INFRINGEMENT
§ 7.14.1 Background
§ 7.14.2 Summary of Section 512 Safe Harbor
(a) Who Is an ISP?
(b) What Steps Must an ISP Take to Benefit from the Safe Harbor?
What Kind of Notice Must the Copyright Owner Give?
What Must an ISP Do When It Receives a Notice of Alleged Infringement?
A Party Sending a Takedown Notice Must Act in Good Faith and Consider Fair Use
ISPs Must Register Their Copyright Compliance Agents with the Copyright Office
(c) Safe Harbor for Linking to Infringing Sites
§ 7.14.3 Special Consideration for Nonprofit Universities
§ 7.15 CRIMINAL COPYRIGHT INFRINGEMENT
§ 7.15.1 Elements of Criminal Copyright Infringement
§ 7.15.2 Willfulness
§ 7.15.3 Only Two Exclusive Rights May Form Basis of Felony
§ 7.15.4 Tampering with Copyright Notices
(a) Penalties
§ 7.16 BUILDING A COPYRIGHT PROTECTION PLAN
EXHIBIT 7A—Online Resources for Copyright Law
EXHIBIT 7B—U.S. Copyright Office Information Circulars and Form Letters
EXHIBIT 7C—Assignment of Copyrights
Chapter 8
FDA Approval and Licensing as Intellectual Property
§ 8.1 BIOSIMILARS
§ 8.1.1 Affordable Care Act
§ 8.1.2 Biosimilar Approval
§ 8.1.3 Why Are Biosimilars Important?
§ 8.1.4 How Biosimilars Differ
§ 8.1.5 Biosimilars Landscape
§ 8.1.6 Data Exclusivity
§ 8.1.7 Actual Approval of Biosimilars (Zarxio)
§ 8.1.8 Additional FDA Guidance Documents
(a) FDA Draft Guidance for Clinical Evaluations
(b) Comparative Safety and Effectiveness Data
(c) FDA Draft Guidance for Patient Population
(d) Extrapolation
(e) FDA Draft Guidance for Industry
§ 8.1.9 Patent Issues
§ 8.2 HATCH-WAXMAN
§ 8.2.1 Drug Price Competition and Patent Term Restoration Act
§ 8.2.2 Branded Drug Approval
§ 8.2.3 Generic Drug Approval
§ 8.2.4 Types of Applications
(a) ANDA
(b) Paper NDA Section 505(b)(2) Application
§ 8.2.5 New Drug Exclusivity
(a) Nonpatent Exclusivities
§ 8.2.6 Patent Exclusivity and the Orange Book
§ 8.2.7 Challenging Patent Exclusivity
(a) Patent Certification
§ 8.2.8 Paragraph IV Certification
§ 8.2.9 ANDA Exclusivity
(a) Exclusivity Forfeiture
§ 8.2.10 Patent Term Extension
§ 8.2.11 Commencing Litigation and Approval Stays
§ 8.2.12 Potential Litigation Claims and Defenses
§ 8.2.13 Proof of Infringement
§ 8.2.14 Safe Harbor
§ 8.2.15 Final Remedies
§ 8.2.16 Settlement and Unfair Competition Challenges
§ 8.2.17 Periods of Exclusivity in Foreign Countries
§ 8.2.18 Conclusion
§ 8.3 U.S. MEDICAL DEVICE LAW
§ 8.3.1 Premarket Notification/510(k)
§ 8.3.2 Premarket Approval
§ 8.3.3 Investigational Device Exemptions
§ 8.4 INFORMATION COLLECTED BY FDA AND ACCESS THERETO
§ 8.5 PROTECTING THE INVESTMENT/FDA COMPLIANCE
§ 8.5.1 Relationships Between Manufacturers and Researchers
§ 8.5.2 Postmarketing Requirements
§ 8.6 TENSIONS BETWEEN U.S. DEVICE AND PATENT LAW
§ 8.7 HATCH-WAXMAN FOR MEDICAL DEVICES
§ 8.7.1 Patent Term Extension for Medical Devices
§ 8.7.2 Research Exemptions for Medical Devices
§ 8.8 TRANSFERS OF 510(k)s AND PMAs
EXHIBIT 8A—8+2(+1) Exclusivity Formula
Chapter 9
Ethics Issues in Intellectual Property
§ 9.1 INTRODUCTION
§ 9.2 ADMISSION TO PRACTICE AND GOVERNING RULES
§ 9.3 CANDOR
§ 9.4 COMPETENCE
§ 9.5 CONFLICT
§ 9.6 PRIVILEGE AND CONFIDENTIALITY
§ 9.7 DECORUM AND PROPER ADVOCACY
Table of Cases
Table of Statutes Rules and References
FEDERAL
MASSACHUSETTS
OTHER STATES
ADDITIONAL REFERENCES AND RESOURCES
Index