Samenvatting van alle hoorcolleges van het vak Patents and innovation
- Introduction to IPR
- Aligning innovation with the patent system
- Claims and patentability criteria
- Searching exercise
- Using IPR (guest lecture)
- Start-ups
- ADx Neuroscience (guest lecture)
Contents
Introduction to intellectual property rights ........................................................................................ 9
Course objectives .......................................................................................................................... 9
What is innovation ........................................................................................................................ 9
What is innovation? ................................................................................................................... 9
Is there a need to innovate? ...................................................................................................... 9
IP rights at UA .......................................................................................................................... 10
Intellectual property .................................................................................................................... 10
General.................................................................................................................................... 10
Basic principles of intellectual property rights .......................................................................... 10
Importance of IP in drug development ..................................................................................... 11
What about access to treatment during a health crisis? ........................................................... 11
Open innovation vs traditional IP-rights ................................................................................... 13
History of intellectual property ................................................................................................ 13
What are intellectual property rights? ..................................................................................... 14
Types of IP-rights ..................................................................................................................... 14
Patents ........................................................................................................................................ 16
Why should you consider patents? .......................................................................................... 16
Publication of patents .............................................................................................................. 17
Patent systems ........................................................................................................................ 17
Patent application.................................................................................................................... 18
Claims...................................................................................................................................... 18
What can be patented? ........................................................................................................... 19
Categories of what is excluded from patent protection ............................................................ 19
Exercise ................................................................................................................................... 23
Aligning innovation with the patent system ..................................................................................... 24
Innovation ................................................................................................................................... 24
What is innovation? ................................................................................................................. 24
Different types of innovation ................................................................................................... 24
Dynamics of innovation ........................................................................................................... 24
Factors affecting dynamics....................................................................................................... 25
Conclusion for industry ............................................................................................................ 26
1
, How do non-traditional innovations occurs .............................................................................. 26
Circumstances stimulation innovation ..................................................................................... 26
Innovations can be stimulated by............................................................................................. 26
Belgian initiatives to promote innovation................................................................................. 27
Examples of innovation in Belgium .......................................................................................... 27
Problem of innovation ............................................................................................................. 27
Innovating in pharma............................................................................................................... 27
Pharma industry trends ........................................................................................................... 27
Patent system .......................................................................................................................... 28
Does the patent system align with the dynamics of innovation? .............................................. 28
Types of Claims............................................................................................................................ 29
Overview ................................................................................................................................. 29
Product claims ......................................................................................................................... 29
Process claims ......................................................................................................................... 30
Use claims ............................................................................................................................... 31
First/second medical use ......................................................................................................... 31
Questions .................................................................................................................................... 32
Patent systems ............................................................................................................................ 34
Process of obtaining patent protection .................................................................................... 34
Patenting procedure ................................................................................................................ 34
Timing decisions ...................................................................................................................... 35
Priority system......................................................................................................................... 35
PCT system .............................................................................................................................. 37
National/regional filings........................................................................................................... 39
European patent convention ................................................................................................... 40
Questions ................................................................................................................................ 41
Impact of cost on patent strategy ................................................................................................ 42
Budget often impact filing strategy .......................................................................................... 42
Patent cost .............................................................................................................................. 42
Example: cost of European patent ........................................................................................... 42
Example 2: cost of European PCT patent .................................................................................. 42
Cost non-EP patents ................................................................................................................ 42
Patent costs ............................................................................................................................. 43
Example: Bexxar ...................................................................................................................... 43
Exercise ................................................................................................................................... 44
Claims and patentability criteria ...................................................................................................... 47
2
,Criteria of patentability................................................................................................................ 47
Art 52 of the European Patent Convention (EPC) ..................................................................... 47
novelty ........................................................................................................................................ 47
Novelty (art 54 EPC) ................................................................................................................. 47
Example................................................................................................................................... 48
Exercise novelty ....................................................................................................................... 48
Relevance of how you formulate the claim .............................................................................. 49
How to define the invention .................................................................................................... 49
Exercise ................................................................................................................................... 49
Patent application as prior art (EUROPEAN PATENT OFFICE) ........................................................ 50
General.................................................................................................................................... 50
Limitations............................................................................................................................... 50
Exercise on prior rights ............................................................................................................ 51
Consequences ......................................................................................................................... 51
Other Differences EP/US .......................................................................................................... 51
Exercise ................................................................................................................................... 52
Inventive step - ............................................................................................................................ 52
General.................................................................................................................................... 52
How to determine if an invention is ‘inventive’: the ‘problem-solution approach’ .................... 53
Example 1 ................................................................................................................................ 53
Example 2 ................................................................................................................................ 54
Example 3 ................................................................................................................................ 54
Further examples of inventive step .......................................................................................... 55
Industrial application ................................................................................................................... 55
In theory .................................................................................................................................. 55
In practice................................................................................................................................ 56
Particular application for DNA sequences ................................................................................ 56
Additional criteria for patentability - enablement ........................................................................ 56
Enablement (Art 83 EPC) .......................................................................................................... 56
Enablement: Biological inventions ........................................................................................... 56
Consequences ......................................................................................................................... 57
Enablement and biological material ......................................................................................... 57
Clarity and support (Art 84 EPC) ............................................................................................... 57
Examples - support/enablement .............................................................................................. 57
Link with inventive step ........................................................................................................... 58
unity ............................................................................................................................................ 58
3
, Art 82 EPC................................................................................................................................ 58
Examples unity ........................................................................................................................ 58
Conclusion on unity ................................................................................................................. 59
Claims.......................................................................................................................................... 59
General.................................................................................................................................... 59
Examples ................................................................................................................................. 59
Claim structure ........................................................................................................................ 59
Example claim structure .......................................................................................................... 60
Exercise claim structure ........................................................................................................... 60
Claims: not set in stone ............................................................................................................ 60
Limitation for amendments: article 123(2) EPC ........................................................................ 60
You might have found a patentable invention at the UA: what to do? ...................................... 61
Drafting a patent application ................................................................................................... 61
Applicant vs inventor? ............................................................................................................. 61
Applicant/inventor? ................................................................................................................. 62
Who is the applicant? .............................................................................................................. 62
Who is successor in title? ......................................................................................................... 62
Who are not inventors? ........................................................................................................... 62
Grant of the application ........................................................................................................... 62
A granted patent… but: ............................................................................................................ 63
Exercise ................................................................................................................................... 63
Enforcement of patent rights ................................................................................................... 63
Searching exercise ........................................................................................................................... 64
Information in patent databases .................................................................................................. 64
Scientific information............................................................................................................... 64
Commercial information .......................................................................................................... 64
Legal information..................................................................................................................... 64
Scientific data in a patent application ...................................................................................... 64
Which database? ..................................................................................................................... 64
Status of patent application ..................................................................................................... 65
Status of the granted patent .................................................................................................... 66
How to search? ........................................................................................................................ 66
How? ....................................................................................................................................... 66
Exercises...................................................................................................................................... 67
Exercise 1 ................................................................................................................................ 67
Exercise 2 – DROPSTOP ............................................................................................................ 68
4
, Exercise 3 ................................................................................................................................ 68
Exercise 4 ................................................................................................................................ 69
Exercise 5 ................................................................................................................................ 70
Exercise 6 ................................................................................................................................ 71
Exercise 7 ................................................................................................................................ 71
Exercise 8 ................................................................................................................................ 72
Exercise 9 ................................................................................................................................ 72
Exercise 10............................................................................................................................... 72
Conclusions ................................................................................................................................. 73
Search for prior art (patentability analysis) .............................................................................. 73
Search for third party patent rights (freedom-to-operate) ....................................................... 73
Searching for information (landscaping analysis)...................................................................... 73
Conclusion ............................................................................................................................... 73
Remarks .................................................................................................................................. 73
Using intellectual property rights (guest lecture) ............................................................................. 74
Introduction on relevant patent litigation aspects ....................................................................... 74
Patent enforcement – ultimate weapon................................................................................... 74
Protection conferred by a patent ............................................................................................. 74
Economic rights ....................................................................................................................... 75
Patent infringement – infringing acts and exceptions .................................................................. 75
Patent infringement – infringing acts ....................................................................................... 75
Protection conferred by a patent ............................................................................................. 75
Indirect infringement ............................................................................................................... 76
Patent infringement – exceptions ............................................................................................ 76
Patent infringement – research exemption .............................................................................. 76
Patent infringement – extent of protection ................................................................................. 77
Patent infringement – extent of protection .............................................................................. 77
Examples ................................................................................................................................. 77
Patent infringement by equivalents ......................................................................................... 78
Function-way-result test in Belgium ......................................................................................... 78
Function-way-result test in Belgium ......................................................................................... 79
Overview of different proceedings............................................................................................... 80
Patent litigation – options ........................................................................................................ 80
Patent litigation – jurisdiction .................................................................................................. 80
Counterfeit seizure (beslag inzake namaak) ............................................................................. 81
Summary of proceedings ......................................................................................................... 83
5
, Accelerated proceedings on the merits .................................................................................... 83
Proceedings on the merits (bodemprocedure) ......................................................................... 83
Criminal actions ....................................................................................................................... 84
Some examples........................................................................................................................ 84
Trade secret ................................................................................................................................ 84
Some facts ............................................................................................................................... 84
Reasonable steps to keep it secret ........................................................................................... 85
Setting the scene ..................................................................................................................... 85
What is a Trade Secret? ........................................................................................................... 85
What cannot be a TS? .............................................................................................................. 86
Scope of protection under TS legislation .................................................................................. 86
Unlawful acts ........................................................................................................................... 86
Exceptions to unlawful disclosure ............................................................................................ 87
Lawful acts............................................................................................................................... 87
Remedies? ............................................................................................................................... 87
Confidentiality of TS in legal proceedings ................................................................................. 88
Limitation period – when should you initiate legal proceedings?.............................................. 88
In practice................................................................................................................................ 88
Partnering with industry: agreements and IP ................................................................................... 89
introduction ................................................................................................................................ 89
Valorisation office.................................................................................................................... 89
Partnering with industry .......................................................................................................... 89
Partnering with universities ..................................................................................................... 90
General introduction & Framework ............................................................................................. 90
What is an agreement.............................................................................................................. 90
General introduction ............................................................................................................... 90
Open innovation concept ......................................................................................................... 90
Examples ................................................................................................................................. 92
Agreements ................................................................................................................................. 92
How to partner? ...................................................................................................................... 92
Essential elements in collaboration agreements ...................................................................... 93
Confidentiality agreement = non-disclosure agreement ........................................................... 95
Material transfer agreement.................................................................................................... 96
License agreement................................................................................................................... 97
Research collaboration agreement ........................................................................................ 100
Consortium agreement .......................................................................................................... 102
6
, Exercise ................................................................................................................................. 103
Start-ups ....................................................................................................................................... 104
UAntwerpen, An enterpreneurial university .............................................................................. 104
Multidisciplinary valorisation domains ................................................................................... 104
Examples of UA spin-offs ....................................................................................................... 106
General framework of a start-up................................................................................................ 106
Three characteristics of start-ups ........................................................................................... 106
Start-ups ................................................................................................................................ 106
Profitability ............................................................................................................................ 107
Company not considered as startup anymore when............................................................... 107
Mortality rate of start-ups ..................................................................................................... 107
Fundamental ingredients ....................................................................................................... 107
Example................................................................................................................................. 108
Importance of IP for a start-up................................................................................................... 109
IP strategies ........................................................................................................................... 109
Examples of why people want IP ............................................................................................ 109
Importance of IP for a startup ................................................................................................ 109
IP due diligence defects ......................................................................................................... 109
IP management aspects ......................................................................................................... 110
Spin-off creation or license agreement .................................................................................. 110
Spin-off creation process ....................................................................................................... 111
IP transfer methodologies in startups ........................................................................................ 111
Global overview ..................................................................................................................... 111
IP commercialization in start-ups ........................................................................................... 111
Key Stakeholders of start-up ...................................................................................................... 112
Agreement between .............................................................................................................. 112
The incentive for the stakeholders ......................................................................................... 113
Types of investors .................................................................................................................. 113
Investments over time ........................................................................................................... 115
Investments in different rounds ............................................................................................. 115
Investor climate in Flanders ................................................................................................... 115
Company type (shares/stock/equity) ......................................................................................... 115
Private vs public company...................................................................................................... 115
Company costs ...................................................................................................................... 116
Company revenues ................................................................................................................ 116
Biotech model : general ......................................................................................................... 116
7
, Biotech model : drug discovery .............................................................................................. 117
Company structure ................................................................................................................ 117
Team evolution...................................................................................................................... 117
ADx Neuroscience (guest lecture) .................................................................................................. 118
ADx Business model ............................................................................................................... 118
ADx monoclonal antibodies ................................................................................................... 118
Pivotal deals .......................................................................................................................... 119
Overview of ADx .................................................................................................................... 119
Value of ADx .......................................................................................................................... 119
Scientific exposure ................................................................................................................. 120
Biomarker assay portfolio ...................................................................................................... 120
Antibody portfolio (commercial) ............................................................................................ 120
Neuro immunoassay market: blockbuster opportunity? ......................................................... 121
PET imaging and sensitive platforms are accelerating validation of fluid biomarkers .............. 121
NF-L, p-tau, and Aβ ratio are the most promising blood biomarkers....................................... 121
Sensitive platforms have accelerated blood biomarker research and studies ......................... 122
PET imaging is considered ‘standard of truth’ and are valuable surrogate for post-mortem
confirmation studies .............................................................................................................. 122
Exponential growth phase of neuro-immunoassay market is expected in 3-5 years from now122
ADx Organigram .................................................................................................................... 123
Innovation companies and employment ................................................................................ 123
8
, Introduction to intellectual property rights
- Understand what Intellectual Property Rights are and what their value is
- Understand the main requirements for obtaining patent protection
- Be able to find basic information about patents in the European patent database
- Know about the basic routes of patenting and what principles they are based on
- Understand how patents are enforced against third parties
- Understand the principles of how technology developed at the university can be transferred,
how spin-offs are set up
What is innovation?
Innovations: anything that generates new products, like services or ideas, that add values to a
company or has an impact on society. Have 3 criteria:
1. New and original products, services, ideas,..
2. Which are used in market or society
3. Add ‘value’ to a company and/or have impact on a society
Examples: oral contraceptives, television, antibiotics, vaccines, mobile phones, computers, internet,
facebook, self-driving cars, robots,…
Is there a need to innovate?
Yes, because:
- Innovation is vital to competitiveness in the global economy – it leads to wealth and comfort
o It ensures that the economy continues to run
o Research leads to improved goods and services for everyone
o Governments implement policies to support the development of innovation:
▪ To increase investment in research and development
▪ To better convert research into improved good, services or processes
▪ They realize that it is important for the well-being of the population to
promote innovation " governments stimulate innovation by funding –
- Companies that prioritize innovation, do better → these companies experience the highest
increase in turnover
- Innovation affects the lives of everyone e.g. vaccines, the internet, mobile applications
→ these can all improve the life of everyone significantly
How has (recent) innovation affected your life?
- Major importance in our life: internet and mobile applications, healthcare solution
- Smaller impact: self-scanning in supermarkets, ballpoint pens that can be erased
Innovation and economy
Study shows intellectual property is good for the European economy, balance of trade and job
creation:
- >42% of total economic activity in the EU is generated by IP-intensive industries
- 38% of all employment stems from industries that have a higher than average use of IP
rights
- IP-intensive industries account for 90% of the EU’s trade with the rest of the world
9
, IP rights at UA
- ’Knowledge-based innovations’ are not only developed within ‘industry’
- Public research organizations such as universities need to transfer their knowledge and
innovations to industry
- Industry is always looking for knowledge and technologies developed at universities (or
other companies) to develop a ‘knowledge-based economy’.
→ Industry can only do something with the research if it has some exclusivity for them (so IP
rights are necessary)
General
- What if a company keeps silent about their
innovation
o Personal gain for the inventor or
company, but not for everyone else
o More time is then needed for further
innovations, so economy slows down
o It is quite difficult to keep secrets now,
because of mobility of people
- What if a company makes the product public →
2 options:
o Protect the product with a patent
▪ Exclusivity
▪ Inventor benefit from
knowledge and earn money
▪ This money can then be used to improve invention or invent new things
→ overall: this is the best for the economy
o Don’t protect the product
▪ Competitors copy the product and sell it at a much lower cost
▪ The innovator is driven out of business because he made lots of investments
to invent the product, but he cannot earn his investments back
Basic principles of intellectual property rights
- Innovators need to be stimulated to publish their ‘innovations’ instead of keeping them
secret as this allows further innovation
- In return for publishing the invention, the innovators are given the right to inhibit others
from commercialising their ‘innovation’ without their permission
- In this way the innovators are rewarded with intellectual property rights
→ other people can benefit from the invention, but with a license (which will cost money)
- The inventors earn their investment back → this money can be used for improving the
economy further and innovate even more
10
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