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Table of Contents |
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Chapter 1: |
Introduction to Intellectual Property |
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- § 1:1 : Introduction1
- § 1:2 : Patents3
- § 1:3 : Trade Secrets5
- § 1:4 : Other Intellectual Property8
- § 1:4.1 : Trademarks and Service Marks8
- § 1:4.2 : Trade Dress10
- § 1:4.3 : Copyrights11
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Chapter 2: |
Building a Foundation Through Technology Licensing and Development |
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- § 2:1 : Introduction16
- § 2:2 : In-Licensing16
- § 2:2.1 : Types of In-Licenses18
- § 2:2.2 : Tips for Biotechnology In-Licensing20
- § 2:2.3 : Key Components of the License23
- [A] : Background and Definition Sections23
- [B] : License Grant24
- [C] : Royalties25
- [C][1] : Industry Practice25
- [C][2] : Level Playing Field25
- [C][3] : Most Favored Licensee Status26
- [D] : License Term27
- [E] : Indemnifications and Warranties27
- [F] : Confidentiality29
- [G] : Enforcement Rights and Obligations30
- [H] : Recourse Provisions30
- [I] : Termination and Partial Termination31
- § 2:2.4 : Licenses from Academic Institutions32
- § 2:2.5 : Licensee Challenge to Validity of Licensed Patent33
- [A] : Drafting Tips for Licensors34
- [B] : Drafting Tips for Licensees36
- § 2:3 : Joint Development36
- § 2:3.1 : Understand Your Goals37
- [A] : Technology Transfer37
- [B] : Access to Capital38
- [C] : Marketing Expertise39
- [D] : Clinical Development Expertise39
- § 2:3.2 : Research Your Potential Partner39
- § 2:3.3 : Impact on Intellectual Property43
- § 2:4 : In-House Development45
- § 2:5 : Outsourcing46
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Chapter 3: |
Record Keeping, Employee Agreements, and IP Audits |
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- § 3:1 : Introduction51
- § 3:2 : Keeping Proper Laboratory Notebooks53
- § 3:3 : Formal Agreements and Written Policies and Procedures56
- § 3:4 : Intellectual Property Audits58
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Chapter 4: |
Developing Global Intellectual Property Strategies |
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- § 4:1 : Introduction63
- § 4:2 : Defining the Strategic Objectives of the Intellectual Property65
- § 4:3 : Identifying Intellectual Property Assets66
- § 4:4 : Establishing Valuable Intellectual Property Assets67
- § 4:4.1 : Developing the Patent Portfolio69
- [A] : Patent Strategy69
- [B] : Internal Company Support for the Strategy71
- § 4:5 : Implementing the Strategies72
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Chapter 5: |
Some Patent Basics for Bioscience Companies |
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- § 5:1 : Introduction77
- § 5:2 : Patentable Subject Matter80
- § 5:2.1 : Polynucleotides82
- § 5:2.2 : Polypeptides82
- § 5:2.3 : Antibodies and Hybridomas83
- § 5:2.4 : Microorganisms84
- § 5:2.5 : Plants84
- § 5:2.6 : Animals84
- § 5:3 : Statutory Requirements for a Patent85
- § 5:3.1 : Utility85
- § 5:3.2 : New Utility Requirements for Biotechnology Inventions88
- § 5:3.3 : Novelty89
- § 5:3.4 : Nonobviousness90
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Chapter 6: |
The Patent Application Process |
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- § 6:1 : Introduction96
- § 6:2 : Factors to Be Considered Before Patenting96
- § 6:2.1 : Commercial Usefulness97
- § 6:2.2 : Potential Market Size97
- § 6:2.3 : Susceptibility to Design-Around by Third Parties98
- § 6:2.4 : Anticipated Market Life98
- § 6:2.5 : Readily Available Acceptable Alternatives99
- § 6:3 : Patentability Analysis99
- § 6:4 : Determining Inventorship101
- § 6:4.1 : Conception and Reduction to Practice102
- § 6:4.2 : Joint Inventors103
- § 6:5 : Claiming the Invention108
- § 6:5.1 : Provisional Application109
- [A] : Filing a Provisional Patent Application: Some Advantages109
- [B] : Filing a Provisional Patent Application: Some Drawbacks110
- § 6:5.2 : Utility Patent Application111
- [A] : Written Description113
- [B] : Enablement and Best Mode115
- [B][1] : Enablement116
- [B][2] : Best Mode117
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Chapter 7: |
Prosecuting the Patent Application |
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- § 7:1 : Introduction121
- § 7:2 : Rejections Based on Deficiencies in the Application’s Disclosure122
- § 7:2.1 : Lack of Written Description Rejection122
- § 7:2.2 : Enablement Rejections123
- [A] : How to Make the Claimed Invention123
- [B] : How to Use the Claimed Invention124
- § 7:3 : Prior Art Rejections124
- § 7:3.1 : Anticipation (35 U.S.C. § 102)129
- § 7:3.2 : Obviousness (35 U.S.C. § 103)134
- § 7:3.3 : Obviousness-Type Double Patenting140
- § 7:3.4 : Use of Declarations142
- [A] : In re Katz Declaration143
- [B] : Rule 131 Declaration145
- § 7:4 : Timeline147
- § 7:5 : Patent Term Adjustment149
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Chapter 8: |
Positioning the Patent Portfolio |
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- § 8:1 : Introduction163
- § 8:2 : Business Considerations in Foreign Filing164
- § 8:2.1 : Where Do You File?164
- § 8:2.2 : Cost of Broadly Filed Patent Applications165
- § 8:2.3 : Tips for Selecting Countries for Filing166
- § 8:3 : Patent Infringement Demand Letter167
- § 8:3.1 : Sending a Demand Letter167
- § 8:3.2 : Responding to a Demand Letter169
- § 8:4 : Opinions of Counsel170
- § 8:4.1 : Role of Opinions in Patent Infringement Allegations170
- § 8:4.2 : Role of Opinions in Due Diligence173
- [A] : Freedom-to-Operate Opinions174
- [B] : Noninfringement Opinions176
- [C] : Validity or Invalidity Opinion178
- § 8:5 : Request for Reexamination181
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Chapter 9: |
Preserving the Marketing Life of Approved Products |
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- § 9:1 : Introduction187
- § 9:2 : Marketing Exclusivity189
- § 9:2.1 : New Chemical Entity (Five-Year Exclusivity)189
- § 9:2.2 : New Indication of a Drug (Three-Year Exclusivity)190
- § 9:2.3 : 180-Day Generic Exclusivity191
- [A] : Orange Book Listings195
- § 9:2.4 : Orphan Drug Exclusivity195
- § 9:2.5 : Pediatric Exclusivity196
- § 9:3 : Patent Term Extension (35 U.S.C. § 156)199
- § 9:3.1 : Court Interpretations202
- [A] : Patent Must Claim Either the Active Ingredient or Its Use202
- [B] : Extension Applies to the Approved Drug and Its Salts or Esters204
- [C] : In a Combination Product, One Active Ingredient Must Be New to the Marketplace206
- § 9:3.2 : The Calculation207
- § 9:3.3 : Implications for Biosciences Companies208
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Chapter 10: |
Organizing a Life Sciences Start-Up Company |
Tom Thomas ~
Paul Gibson ~ |
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- § 10:1 : Introduction212
- § 10:2 : Choosing the Type of Legal Entity212
- § 10:2.1 : Sole Proprietorship213
- § 10:2.2 : General Partnership213
- § 10:2.3 : Limited Partnership213
- § 10:2.4 : Limited Liability Company214
- § 10:2.5 : Corporation214
- § 10:3 : Jurisdiction of Incorporation215
- § 10:4 : Other Organization Issues216
- § 10:4.1 : Corporate Structure217
- § 10:4.2 : Equity Issuances to Founders218
- § 10:4.3 : Hiring and Compensating Employees219
- § 10:4.4 : Protecting Intellectual Property220
- § 10:5 : Funding for Life Sciences Start-Ups221
- § 10:5.1 : Angel Financings222
- § 10:5.2 : Venture Capital Financings223
- [A] : Dividend Preference224
- [B] : Preference on Liquidation or Sale224
- [C] : Conversion224
- [D] : Voting Rights225
- [E] : Redemption225
- [F] : Right to Maintain Proportionate Ownership226
- [G] : Right of First Refusal/Co-Sale Rights226
- [H] : Other Rights226
- § 10:6 : Impact of Securities Laws226
- § 10:6.1 : Regulation D Exemptions227
- [A] : Three Separate Exemptions228
- [B] : Accredited Investors228
- [C] : Number of Purchasers229
- [D] : Integration of Offerings229
- [E] : Information Requirements230
- [F] : Limitation on Manner of Offering231
- § 10:6.2 : Section 4(2) Exemption231
- [A] : Offeree Qualification231
- [B] : Manner of Offering232
- [C] : Availability of Information232
- [D] : Number of Offerees and Purchasers232
- [E] : Absence of Redistribution232
- § 10:6.3 : Exemption for “Offshore Transactions”233
- § 10:6.4 : Exemption for Compensatory Benefit Plans233
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Chapter 11: |
Sale or Initial Public Offering of a Life Sciences Start-Up Company |
Tom Thomas ~
Paul Gibson ~ |
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- § 11:1 : Introduction238
- § 11:2 : Sale of Company or Its Assets238
- § 11:2.1 : Basic Acquisition Structures238
- [A] : Stock Sale238
- [B] : Merger240
- [C] : Asset Sale243
- § 11:2.2 : Other Key Acquisition Considerations244
- [A] : Earn-Outs245
- [B] : Milestones246
- [C] : Indemnification247
- § 11:3 : Initial Public Offering248
- § 11:3.1 : Organization Meeting249
- § 11:3.2 : Diligence250
- § 11:3.3 : Publicity251
- [A] : The Three Periods of Registration251
- [B] : Practical Considerations252
- § 11:3.4 : Registration Statement and SEC Review253
- [A] : Cheap Stock254
- [B] : Confidential Treatment Request256
- § 11:3.5 : Corporate Governance and Policies257
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Chapter 12: |
Background and Planning for Litigation |
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- § 12:1 : Introduction262
- § 12:2 : Patent Infringement in the Life Sciences Industry263
- § 12:2.1 : What Are Patents and Why Do They Matter?263
- § 12:2.2 : What Is Infringement?264
- [A] : Direct Infringement264
- [B] : Literal Infringement265
- [C] : Doctrine of Equivalents265
- [D] : Indirect Infringement266
- [D][1] : Inducement of Infringement266
- [D][2] : Contributory Infringement268
- § 12:3 : Anticipating and Preparing for the Conflict269
- § 12:3.1 : Business Considerations270
- § 12:3.2 : Decision to Sue for Patent Infringement271
- [A] : Pre-Litigation Investigation272
- [B] : When to File Suit and Whom to Sue276
- § 12:3.3 : Good Practices as Litigation Looms278
- [A] : Attorney-Client Communications and Preserving Privilege278
- [B] : Discovery and Document Retention Policies279
- [B][1] : Background280
- [B][2] : Establishing Best Practices282
- [B][3] : Legal Hold284
- [C] : Patent Marking285
- § 12:3.4 : Negotiations to Avert the Conflict286
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Chapter 13: |
Forums for Resolving Patent Disputes |
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- § 13:1 : Introduction296
- § 13:2 : Alternative Dispute Resolution296
- § 13:2.1 : Mediation297
- § 13:2.2 : Arbitration299
- [A] : Arbitration Agreement and Its Statutory Basis299
- [B] : Advantages and Disadvantages of Arbitration304
- § 13:3 : International Trade Commission310
- § 13:3.1 : Introduction310
- § 13:3.2 : Procedure for Obtaining Relief313
- § 13:3.3 : Commission Remedies314
- § 13:3.4 : Advantages and Disadvantages of Section 337 Proceedings315
- [A] : Advantages315
- [B] : Disadvantages316
- § 13:4 : District Court Actions317
- § 13:4.1 : Introduction317
- § 13:4.2 : Where to File Suit317
- § 13:4.3 : Types of Action319
- [A] : Action for Infringement Brought by the Patent Owner319
- [B] : Action for a Declaration that a Patent Is Invalid, Unenforceable, or Not Infringed319
- § 13:4.4 : Overview of a Typical Patent Infringement Suit323
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Chapter 14: |
Proving Patent Infringement Claims |
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- § 14:1 : Introduction333
- § 14:2 : Claim Construction334
- § 14:2.1 : Hierarchy of Evidence336
- § 14:2.2 : Principles of Claim Construction339
- § 14:3 : Literal Infringement341
- § 14:3.1 : Limitations to Liability for Literal Infringement344
- § 14:3.2 : Exception for Preparing for Regulatory Approval Applications345
- § 14:3.3 : Implications for Conduct Outside the United States345
- § 14:4 : Infringement Under the Doctrine of Equivalents346
- § 14:5 : Means-Plus-Function Claims348
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Chapter 15: |
Overview of Patent Infringement Defenses |
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- § 15:1 : Introduction355
- § 15:2 : Strategic Considerations356
- § 15:3 : Defenses to a Claim of Patent Infringement359
- § 15:3.1 : Noninfringement—The Primary Defense359
- § 15:3.2 : An Overview of Defenses Particular to the Patent361
- [A] : Invalidity361
- [A][1] : Presumption of Validity361
- [A][2] : Defenses Based upon Prior Art363
- [A][3] : Formal Requirements for Validity366
- [A][4] : Patentable Subject Matter369
- [B] : Unenforceability370
- § 15:3.3 : Overview of Defenses Particular to the Parties371
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Chapter 16: |
The Anticipation Defense |
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- § 16:1 : Introduction375
- § 16:2 : Section 102(a) Anticipation: Public Knowledge377
- § 16:2.1 : Sufficient to Disclose to One Skilled in the Art378
- § 16:2.2 : Inherency381
- § 16:3 : Section 102(b) Anticipation: On-Sale Bar and Public Use Bar382
- § 16:3.1 : On-Sale Bar383
- [A] : Commercial Offer to Sell383
- [B] : Ready for Patenting385
- § 16:3.2 : Public Use Bar386
- § 16:4 : Strategic Considerations389
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Chapter 17: |
The Obviousness Defense and Defenses Under Section 112, First Paragraph |
Richard L. Blaylock ~ |
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- § 17:1 : Introduction397
- § 17:2 : Section 103: Obviousness398
- § 17:2.1 : Scope and Content of Prior Art400
- § 17:2.2 : Differences Between Prior Art and Claimed Invention401
- § 17:2.3 : Level of Ordinary Skill in the Art401
- § 17:2.4 : Objective Evidence of Nonobviousness402
- § 17:3 : Section 112, First Paragraph405
- § 17:3.1 : Enablement406
- § 17:3.2 : Written Description410
- § 17:3.3 : Best Mode414
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Chapter 18: |
The Unenforceability Defense |
Richard L. Blaylock ~
Colin T. Kemp ~ |
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- § 18:1 : Introduction421
- § 18:2 : Inequitable Conduct422
- § 18:2.1 : Overview of Test422
- § 18:2.2 : Materiality425
- § 18:2.3 : Intent431
- § 18:2.4 : Balancing Materiality and Intent434
- § 18:3 : Patent Misuse435
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Chapter 19: |
Infringement Defenses Particular to the Parties |
Richard L. Blaylock ~
Colin T. Kemp ~ |
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- § 19:1 : Introduction445
- § 19:2 : Time Limit on Recovery of Damages (Section 286)446
- § 19:3 : Laches446
- § 19:3.1 : Delay447
- § 19:3.2 : Prejudice449
- § 19:3.3 : Ultimate Determination by Court450
- § 19:4 : Equitable Estoppel451
- § 19:5 : License Defenses453
- § 19:5.1 : Express License454
- § 19:5.2 : Implied License455
- [A] : First Sale Doctrine456
- [B] : Other Implied License Defenses459
- § 19:6 : Plaintiff Lacks Title to Patent461
- § 19:7 : Section 271(e)(1) Experimental Use Exception462
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Chapter 20: |
Resolution of Litigation |
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- § 20:1 : Introduction473
- § 20:2 : Settlement474
- § 20:2.1 : Releases and Covenants Not to Sue475
- § 20:2.2 : Licenses476
- § 20:2.3 : Agreements Not to Use Patented Technology478
- § 20:2.4 : Acquisition479
- § 20:3 : Surrender479
- § 20:4 : Intermediate Events481
- § 20:4.1 : Temporary Restraining Orders and Preliminary Injunctions481
- § 20:4.2 : Dispositive Claim Construction Rulings482
- § 20:5 : Final Adjudication483
- § 20:5.1 : Summary Judgment484
- § 20:5.2 : Judgment on a Motion to Dismiss486
- § 20:5.3 : Trial486
- § 20:5.4 : Post-Trial Proceedings487
- § 20:5.5 : Appeal488
- § 20:6 : Reexamination of Patents489
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Chapter 21: |
Compensatory Damages |
Richard L. Blaylock ~
Colin T. Kemp ~ |
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- § 21:1 : Introduction493
- § 21:2 : Lost Profits494
- § 21:2.1 : Panduit Test494
- § 21:2.2 : “Market Share” Test498
- § 21:3 : Reasonable Royalties501
- § 21:4 : Damages for Lost Sales of Products Not Covered by the Patent506
- § 21:5 : Damages for Unpatented and Ancillary Components508
- § 21:6 : Notice and the Patent Marking Requirement509
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Chapter 22: |
Other Monetary Relief |
Richard L. Blaylock ~
Colin T. Kemp ~ |
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- § 22:1 : Introduction517
- § 22:2 : Extraordinary Damages517
- § 22:2.1 : Treble Damages for Willful Infringement518
- [A] : Willfulness518
- [B] : Enhancement524
- [C] : Note About Investigating Freedom to Operate526
- § 22:2.2 : Attorneys’ Fees in Exceptional Cases527
- § 22:3 : Interest and Costs532
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Chapter 23: |
Nonmonetary Relief |
Richard L. Blaylock ~
Colin T. Kemp ~ |
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- § 23:1 : Introduction543
- § 23:2 : Preliminary Injunctions544
- § 23:2.1 : Four-Factor Test545
- [A] : Likelihood of Success on the Merits546
- [B] : Irreparable Harm548
- [C] : Balance of the Hardships551
- [D] : Public Interest553
- § 23:2.2 : Bond Requirement554
- § 23:2.3 : Temporary Restraining Orders554
- § 23:2.4 : Practical Considerations556
- § 23:3 : Permanent Injunctions558
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Chapter 24: |
What Is a Trade Secret? |
Kirke M. Hasson ~ |
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- § 24:1 : Introduction567
- § 24:2 : Uniform Trade Secrets Act Definition570
- § 24:2.1 : Application of the Definition to Particular Kinds of Information571
- § 24:2.2 : Novelty Is Not Required573
- § 24:2.3 : “Negative” Information May Be Protected577
- § 24:2.4 : Reasonable Efforts to Maintain Secrecy579
- § 24:3 : “Readily Ascertainable” Information579
- § 24:3.1 : Judicial Approach580
- § 24:3.2 : California’s Legislative Approach582
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Chapter 25: |
Trade Secret Misappropriation |
Kirke M. Hasson ~ |
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- § 25:1 : Introduction587
- § 25:2 : Uniform Trade Secrets Act Definition588
- § 25:3 : Application of the Definition589
- § 25:3.1 : Theft May Be Inferred from Circumstantial Evidence589
- § 25:3.2 : “Improper Means” Not Limited to Criminal Acts590
- § 25:3.3 : Implied Duties Not to Use or Disclose590
- § 25:3.4 : Acquisition by Mistake591
- § 25:4 : Derivative Products, Methods, and Processes591
- § 25:5 : Remedies592
- § 25:5.1 : Damages593
- § 25:5.2 : Injunctions596
- § 25:5.3 : Enhanced Damages597
- § 25:5.4 : Attorneys’ Fees597
- § 25:5.5 : Interest598
- § 25:6 : Criminal Liability598
- § 25:6.1 : Federal Criminal Laws598
- § 25:6.2 : State Criminal Laws600
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Chapter 26: |
Patent Protection Versus Trade Secrets Protection |
Kirke M. Hasson ~ |
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- § 26:1 : Introduction606
- § 26:2 : Subject Matter Differences606
- § 26:3 : Underlying Principles606
- § 26:4 : Patent Disclosures Generally Are Inconsistent with Trade Secret Protection607
- § 26:4.1 : Invention Must Be Fully Disclosed in a Patent Application607
- § 26:4.2 : “Best Mode” Must Be Disclosed in a Patent Application608
- § 26:4.3 : Patent Specification Becomes Public If the Patent Issues, and Sometimes Earlier608
- § 26:4.4 : Patent Applicant May Be Required to Deposit Organisms in a Public Repository609
- § 26:5 : Trade Secret Use May Preclude Later Patent Protection609
- § 26:6 : Proof of Infringement Differs from Proof of Misappropriation610
- § 26:7 : Use of Patented Invention for Research Reasonably Related to Seeking FDA Approval610
- § 26:8 : Protecting Basic Pharmaceutical Information Such As Composition611
- § 26:9 : Speed for Obtaining Protection613
- § 26:10 : Procedures to Obtain Protection; Costs613
- § 26:11 : Duration of Protection614
- § 26:12 : Competitor’s Ability to Evade Protections615
- § 26:13 : Reverse Engineering615
- § 26:14 : Environments Where Publication Is Important616
- § 26:15 : Employee Mobility617
- § 26:15.1 : Noncompetition Agreements617
- § 26:15.2 : “Inevitable Disclosure” Doctrine617
- § 26:16 : Licensing618
- § 26:17 : Enforcement Procedures and Available Relief618
- § 26:18 : Remedies620
- § 26:18.1 : Exemplary Damages620
- § 26:18.2 : Attorneys’ Fees621
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Index |
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