목차
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
