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Title page 1

Contents 4

Acknowledgments 5

Introduction 6

Trends within innovation in life sciences 7

The effects of COVID-19 on life sciences 12

1. Patenting in life sciences: general aspects 13

1.1. Patent-eligible subject matter 14

1.2. Novelty 16

1.3. Inventive step or non-obviousness 17

1.4. Sufficiency of disclosure or enablement 18

1.5. Usefulness or industrial applicability 19

1.6. Patent law vs. know-how or trade secret 19

1.7. Impact of key patenting requirements on patent strength 22

1.8. The role and sources of experimental data 22

1.8.1. Main data sources 22

1.8.2. Support of claims and patentability 24

2. Patent application filing and prosecution 27

2.1. Common procedural elements 27

2.1.1. Application filing: what you need to know 28

2.1.2. Prosecution: what you need to know 29

2.2. Life sciences and the international patent system 30

2.2.1. PCT 30

2.2.2. TRIPS 30

2.2.3. Budapest Treaty 31

2.2.4. Biotechnology Directive 31

2.2.5. Aspects of regional and national patent law divergences in life sciences 32

2.3. Typical claim structures 33

2.3.1. Products 33

2.3.2. Methods of treatment 35

2.3.3. Claims including ranges 36

2.3.4. Diagnostics claims 36

2.3.5. Defensibility strength of claim types 37

3. Main application fields 38

3.1. Vaccines 38

3.1.1. Patentable elements: case study 38

3.2. Diagnostics 40

3.2.1. Japan 40

3.2.2. United States of America 40

3.2.3. Europe 41

3.2.4. Patentable elements: case study 43

3.3. Therapeutics 44

3.3.1. Biologics 44

3.3.2. Small molecules 46

3.3.3. Patentable elements: case study 46

4. Patent strategy 48

4.1. Filing strategy 48

4.2. Commercial strategy 48

4.3. Improved communication approaches 49

4.3.1. Researchers and inventors 50

4.3.2. Patent attorneys 50

Conclusion 51

List of acronyms 52

Tables 33

Table 1. Gene patenting divergence 33

Figures 16

Figure 1. Could you please rate the following elements based on their importance for thestrength of the patent (post-grant) in the life sciences field? 16

Figure 2. Could you please rate the importance of the following elements for the strength/defensibility of a patent application in the life sciences sector? 22

Figure 3. The key milestones of the most common patent filing strategy 28

Figure 4. Different objections that the life sciences patent attorneys who participated in our survey reported receiving either frequently or very frequently 30

Figure 5. Ranking of patentability factors in view of jurisdiction divergences according to life sciences patent attorneys who participated in our survey 32

Figure 6. Defensibility strength of claim types as viewed by the life sciences patent attorneys who participated in our survey 37

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