THE TECHNOLOGY TRANSFER LAW HANDBOOK

Transcription

1 THE TECHNOLOGY TRANSFER LAW HANDBOOK E ditors Elizabeth Rodriguez and Sean Solberg M M J ll S c itiiu : of M I Intellectual Property Law AMERICAN BAR ASSOCIATION

2 Contents P reface xiii About the Authors xv Acknow ledgm ents xxi Chapter 1 Changes to the P atent Laws l Richard Brandon and Sean D. Solberg I. Filing Patent Applications Naming University Assignees as the Applicant 2 A. Summary 2 B. Declarations and Assignee-Applicants before the AIA 2 C. AIA: Inventor Declarations Are Still Required 3 D. Other Procedural Differences Relating to Declarations under the AIA 5 E. Summary of AIA Declaration Changes 6 F. Broadened A bility under AIA for Assignee Filing as Applicant 6 G. Advantages of Filing as an Assignee-Applicant 7 FI. Traps for the Unwary University 8 II. USPTO Fee Savings for Universities Filing under Micro Entity Status Created by AIA 9 A. Summary 9 B. Small Entity Status 10 C. Qualifying for Micro Entity Status 10 D. Fee Savings over the Course of Prosecution Can Be Significant 11 v

3 vi C o n t e n t s E. Micro Entity Status Requires Continual Review of Whether Small Entity Status Remains 12 F. Traps for the Unwary University 12 III. Effects of AIA on Joint Development Involving Universities and Third Parties 13 A. Summary 14 B. CREATE before AIA 14 C. AIA Eliminated the Offending Provisions but Introduced Another Issue 15 D. Disadvantages of AlA s CREATE-Like Exemption 17 E. Traps for the Unwary University 18 IV. Derivation 20 A. Summary 20 B. Pre-AIA Interference Proceeding 20 C. Derivation Proceeding under the AIA 21 D. Comparison of Derivation and Interference Proceedings 23 E. Advice for Universities 24 V. New Grace Period 25 A. Summary 25 B. Pre-AIA Grace Period 26 C. New Limited Grace Period 26 D. Protection against Intervening Third-Party Disclosures 28 E. Im plications for Universities 30 F. Advice for Universities 31 VI. Conclusion 32 C hapter 2 M anaging P atent Prosecution 33 John R itter and Sean D. Solberg I. Worldwide Strategy: Generally 34 A. Survey Results 36 B. Advice for Universities 38 II. Worldwide Strategy: Patent Prosecution Highway 38 A. Survey Results 39 B. Summary 39 C. Original PPH 40 D. PPH E. PCT-PPH 43 F. Global PPH and IP5 PPH 47

4 C o n t e n t s v ii G. Advice for Universities 48 III. U.S. Strategy: Provisional versus Non-Provisional 50 A. Survey Results 53 B. Advice for Universities 54 IV. U.S. Strategy: Continuations and Continuation-in-Part Applications (and Requests for Continuing Examination) 54 V. U.S. Strategy: Accelerated Examination 61 VI. Conclusion 64 Chapter 3 P o st-grant Proceedings under AIA 65 Jason T. N ickla and E m ily Harris I. New Review Proceedings 66 A. Post-grant Review 66 B. Inter Partes Review 67 C. Transitional Program for Covered Business Method Patents 69 D. Supplemental Examination 70 II. Timeline and Processes for Post-issuance Proceedings 71 A. Discovery 71 B. Claim Amendments 72 C. Claim Construction 72 D. Sanctions 72 E. Burden 72 F. Resolution 72 G. Appeal 73 H. Estoppel 73 III. Insights for University TTOs 74 IV. Conclusion 79 Chapter 4 Patenting Diagnostic Tests Post-Myriad and Post-Prometheus 81 Warren D. Woessner and Robin A. C hadwick I. Prometheus and Classen-. Their Importance and Analysis 83 A. Prometheus Laboratories, Inc. v. Mayo Collaborative Services 83 B. Classen Immunotherapies, Inc. v. Biogen Idee 85 II. Myriad Decision: Its Importance and Analysis 86 A. Association for Molecular Pathology v. U.S. Patent and Trademark Office 86

5 v i i i C o n t e n t s III. Myriad and Prometheus Rulings Applied: PerkinElmer, Inc. v. Interna, Ltd. IV. USPTO Guidelines V. Conclusion Chapter 5 Patenting Softw are Eric W. G uttag I. Early Cases II. The Important Takeaways from the Supreme Court Decision in Bilski III. Federal Circuit Views in the Post-Bilski to Pre-CLS Bank International En Banc Period IV. What Do the Opinions in the CLS Bank International En Banc Decision Mean, and Do the Ultramercial Remand Decision and the Accenture Global Services Decision Provide Any Clarification? V. What Rules of Thumb Can Now Be Gleaned for Patenting Software? Chapter 6 Stanford v. Roche, the CREATE Act, and the AIA Gregory C. Brown I. University Assertion of Ownership II. AIA Execution of Assignments III. CREATE Act, Joint Inventorship, and Assignments IV. Conclusion C hapter 7 M axim izing Value of Joint Inventions through M anagem ent A greem ents, P atent Pooling, and Bundling Strategies Stephanie Adam any I. Management of Joint Inventions II. A. U.S. Patent Law Governing Patent Ownership and Joint Inventions B. Planning for and Managing Joint Inventions Optimizing Management of Inventions through Patent Pooling and Bundling

6 C o n te n ts ix A. A Brief History of Patent Pools and Anticom petitive Considerations 149 B. Recent History of Patent Pools and the U.S. Department of Justice 151 C. Licensing to Third-Party Licensing Organizations 152 D. Other Options for Combining Patents to Increase Commercialization through Licensing 154 III. Conclusion 155 C hapter 8 University P atent Enforcem ent 157 Jacob H. Rooksby I. Background on Patent Litigation 157 II. Common Issues for Universities Involving Patent Infringement Disputes 161 A. Avoiding Invoking Declaratory Judgment Jurisdiction 161 B. Standing to Sue and the All Substantial Rights Inquiry 163 C. The Role of Faculty Inventors 166 D. Agreements with Licensees Regarding Litigation 167 E. The Opportunities and Costs for Universities Pursuing Patent Enforcement as a Technology Transfer Strategy 168 III. Planning for the Future: What University Technology Managers and Their Counsel Can Do 171 IV. Conclusion 173 C hapter 9 Essential Aspects fo r Licensing of Federally Supported Subject Inventions 175 Paul Elihu Stern and Elizabeth D. Rodriguez I. Scope 177 A. License Grant 178 B. Exclusive or Nonexclusive 178 C. Affiliates 179 D. Field and Territory 179 E. Additional Licensed Rights 180 F. Sublicense Rights 181 G. Diligence Obligations 182 H. License Fees 184 I. Retained Rights 187 J. Improvements 187

7 X C o n t e n t s II. Indem nification, Insurance, and Disclaimers 189 A. Patent Prosecution and Enforcement 191 B. Template Agreements I 95 III. Conclusion 196 C hapter 10 Biotech Licensing 197 Robert M acw right I. Components of Licensed Technologies 198 A. Licensed Know-How 1 " B. Biological Materials 200 C. Derived Products 201 D. Licensed Services 201 II. Sublicenses 204 A. Supporting Rights 204 B. Sublicense Defined 206 C. Premium on Equity 208 D. Noncash Revenues 208 E. Sublicensing Revenue 209 F. S liding Scale for Sharing Sublicensing Revenues 209 III. Termination of License 211 A. Access to Regulatory Filings and Supporting Rights 212 B. Effect of Termination on Sublicenses 213 C. Performance Milestone Anxiety 214 D. Managing Patent Validity Challenges by Performing Licensees 215 IV. A nticipating Common Misadventures 217 A. Royalty Stacking 217 B. Undeveloped Indications 217 C. Patent Term Extension 219 V. Conclusion 220 C hapter 11 The Other In tellectu al Property 221 Charles C. Valauskas I. Rationale for Emphasis on Patents 221 II. Trade Secrets/Know-how 222 III. Copyright 225 IV. Trademark 227

8 C o n t e n t s x i V. Right of Publicity 231 VI. Commercialization 232 VII. Conclusion 234 Chapter 12 Approaches to Managing Patent Filing Costs Anne Craig and Wesley D. Blakeslee I. Models for Fee Arrangements for Patent Filings 235 A. Assessing Current Law Firm Service Profile 236 B. Some Questions to Ask S cientific Expertise Patent Experience Level of Team Custom er Service C om m itm ent to Managing Costs A dm inistrative Ease C. Getting Your Own Flouse in Order 238 D. Setting the Stage for Performance Standards 239 E. Engaging Only Excellent Firms 240 F. Alternative Fee Arrangements 240 G. The Classic Billable Flour 241 FI. Discounted Fee Structures 241 I. Fixed-Fee and Flat-Rate B illing 241 J. Using Small Law Firms 242 K. Becoming the Dominant Client of a Firm 242 L. Summary 243 II. Building an Internal Patent Counsel Office 243 A. Things to Consider 243 B. Creating an Internal Patent Counsel Group to Reduce Overall Patent Costs 245 C. Determining Cases to Be Hand led by the Internal Patent Counsel Group 246 D. B illing for the Work of Internal Counsel 246 E. Flow Much to Charge 247 F. Calculating Direct Savings 248 III. Conclusion 248

9 xii C o n t e n t s C hapter 13 The University as a Venture Investor 249 C hristopher F. W right and Louis P. Berneman I. Equity License Transactions 252 A. Ramifications of Entity Choice 253 B. Warrants 254 C. A ntidilution 255 D. Participation (Preemptive) Rights 255 E. Redemption Rights 256 F. Assignment Rights 256 G. Tag-Along and Drag-Along Rights 256 H. Registration Rights 257 I. Information Rights and Right to Transfer Equity 257 J. Expectation Management and Conflict of Interest 258 K. Private Equity Documentation 259 L. Unrelated Business Income Tax 259 M. Insider Trading 259 II. Direct Cash Investing Approaches and Challenges 260 III. Partnering Investment Approaches and Challenges 263 IV. Conclusion 264 Index 267