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Title page 1

Contents 4

Acknowledgments 6

Summary 7

1. What is biotechnology? 8

Brief history of biotechnology 8

Main categories 10

2. How is biotechnology in the life sciences used today? 12

3. The life sciences innovation ecosystem: from bench to market 14

Early-stage development 14

Jurisdictional divergences 15

Marketing authorization 16

Patent application licensing 17

Supplementary protection certificates (SPCs) 17

Exclusive licenses 18

Nonexclusive licenses 18

Research exemption 18

Reasons for patenting early research results 19

Attracting financing 21

Regulatory considerations for products of medical biotechnology 21

Financing to complete regulatory review 22

4. Market considerations for biotechnology products and the role of governments 26

Regulatory approval 26

Confidential information and data 26

Access to medicines 27

Additional governmental incentives 27

5. Role of intellectual property in biotechnology commercialization 29

Biotechnology patents 30

Intellectual property and financing biotech products 30

6. Academic institutions and the biotechnology industry 32

7. Technology transfer in biotechnology (continuum of agreements) 36

IP ownership 36

Technology transfer legislation 36

Role of the Technology Transfer Office (TTO) 36

Technology transfer agreements 37

Material transfer agreements (MTAs) 37

Industry-sponsored research agreement (ISRAs) 37

Continuum of agreements related to technology transfer 37

Nondisclosure agreement/confidentiality agreement 38

Material transfer and evaluation agreements/material and data transfer agreements (from institution to company) 39

Collaboration agreement/cooperation agreement 40

Short-term option/letter of intent 40

Exclusive option agreement 41

Exclusive license agreement 41

Nonexclusive license agreements 45

Research agreements with industry and nonprofit foundations 45

Consulting agreements 46

Licensing know-how and data/information ("nonpatentable information") 46

Financial research support from foundations and nonprofits 50

8. Biotechnology in the time of COVID-19 52

The need for developed innovation ecosystems 52

Limited nonexclusive royalty-free license 53

Licensing pools and patent pools to facilitate access to a suite of patented technologies 53

9. Cross-border collaborations: challenges and opportunities 57

Considerations applying to cross-border collaborations and jointly owned IP 58

Cross-border collaborations between academic institutions and for profit entities 59

Impact of international regulations on cross-border collaboration 59

10. Utilizing genetic resources for economic growth 61

11. Humanitarian goals versus for-profit activities 63

Conclusion 64

Technology transfer 64

Complexity and risk 64

Capital intensiveness 65

Tables 29

Table 5.1. The costs of drug development by stage 29

Figures 20

Figure 3.1. The drug discovery, development and approval process 20

Figure 3.2. Simplified overview of the development of a pharmaceutical product in the European Union 20

Figure 3.3. Schematic illustration of the drug discovery and development pathway 22

Figure 6.1. Timeline of the development of Taxol 34

Figure 7.1. The continuum of agreements in the technology transfer process 38

Boxes 17

Box 3.1. Bench to market - early stages 17

Box 3.2. The phases of clinical trials 24

Box 5.1. Intellectual property and financing 30

Box 6.1. The platform for mRNA COVID-19 vaccines created at Penn 32

Box 6.2. Oxford University/AstraZeneca rapid development of a COVID-19 vaccine 33

Box 6.3. The development of Xtandi for the treatment of advanced prostate cancer 34

Box 6.4. University of Pennsylvania/Novartis alliance yields first approved gene therapy for cancer 35

Box 7.1. Key provisions to include in material transfer agreements and evaluation agreements 39

Box 7.2. Advantages of a short-term no-practice option from the perspectives of both parties 40

Box 7.3. Elements of an exclusive license agreement 42

Box 7.4. Key financial terms included in ELAs 44

Box 7.5. Parameters and caveats for consulting agreements 46

Box 7.6. Ways of protecting nonpatentable information 47

Box 8.1. The Medicines Patent Pool 54

Box 8.2. The COVID-19 Technology Access Pool 55

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