Table of Contents |
| Patentability Requirements of Biotech Patents / Ulrich Storz | 1 |
1. | Introduction | 1 |
2. | Foreplay: Requirements Specific to Either the EPC or USC 35 | 2 |
2.1. | Industrial Application (Art. 57 EPC) and Exclusion of Methods of Treatment and Diagnosis (Art. 53 (c) EPC) | 2 |
2.2. | Sufficiency of Disclosure (Art. 83 EPC) | 4 |
2.3. | Enablement and Written Description Requirement (USC 35; [§] 112) | 6 |
2.4. | Best Mode (USC 35; [§] 112) | 8 |
3. | Novelty and Inventive Step/Non-Obviousness: The Moving Target | 9 |
3.1. | Novelty | 9 |
3.2. | Inventive Step/Non-Obviousness | 11 |
| References | 21 |
| Law Enforcement of Biotech Patents / Martin Quodbach | 23 |
1. | Introduction | 23 |
2. | Identifying the Infringing Object, Documentation of Evidence Against the Background of the Burden of Proof of the Patent Owner | 25 |
2.1. | Preparing the Technical Facts of the Case (If the Claimant has Access to the Infringing Article) | 25 |
2.2. | Gaining First Access to the Infringing Article | 26 |
3. | Determination of the Scope of Protection of a Patent Claim, Evaluation of Patent Features | 27 |
3.1. | General Rules of Patent Claim Interpretation | 27 |
3.2. | Literal Scope of Protection of a Patent Claim and the Doctrine of Equivalents | 29 |
3.3. | Restrictions of Disclosed Industrial Applications of Biosequences | 30 |
3.4. | The Monsanto Versus Cefetra/Toepfer Case | 31 |
4. | Determination of Jurisdiction/the Competent Court | 32 |
5. | Choosing the Adequate Litigation Procedure | 33 |
5.1. | Preliminary Injunctions Versus "Normal" Proceedings | 33 |
5.2. | Border Seizure | 35 |
6. | Procedural Problems Regarding Biotechnological Cases | 35 |
6.1. | Staying of Infringement Proceedings on Grounds of Opposition Proceedings/Nullity Actions Against the Patent | 35 |
6.2. | Dependency on Expert Opinions | 36 |
6.3. | "Italian Torpedo" | 36 |
7. | Legal Consequences of Infringing Biotechnological Patents | 37 |
7.1. | Standards Set by the IPR Enforcement Directive | 37 |
7.2. | Damages and National Case Law on Tort | 38 |
8. | Conclusion | 39 |
| Particular Aspects of US Patent Law in Biotechnologies / Matthew Parker | 41 |
1. | Priority | 42 |
1.1. | United States | 42 |
1.2. | Europe | 44 |
1.3. | The America Invents Act | 44 |
2. | Novelty | 45 |
2.1. | United States | 45 |
2.2. | Europe | 48 |
2.3. | The America Invents Act | 49 |
3. | Written Description | 50 |
3.1. | United States | 50 |
3.2. | Europe | 51 |
3.3. | The America Invents Act | 52 |
4. | Information Disclosure Statements | 52 |
4.1. | United States | 52 |
4.2. | Europe | 54 |
5. | Obviousness | 55 |
5.1. | United States: Non-Obviousness | 55 |
5.2. | Europe: Inventive Step | 57 |
6. | Best Mode | 59 |
6.1. | United States | 59 |
6.2. | Europe: No Requirement | 59 |
7. | Enablement | 60 |
7.1. | United States | 60 |
7.2. | Europe | 61 |
8. | Patent-Eligible Subject Matter | 62 |
8.1. | United States | 62 |
8.2. | Europe | 64 |
| About the Authors | 67 |