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Summary lectures exam 2 Business Management in Health and Life Sciences (AM_470584)
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This is a summary of all lectures that were given for exam 2 of BM, including all guest lectures.
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Seminar A - 22/11/2022 - Strategic IP management to develop yourbusiness (Peter van Dongen & Marco de Beurs)
Netherlands Patent Office = registration and grant of patents → dissemination of info about IP
→ Netherlands Enterprise Agency (RVO): granting patents, trademark, designs, info/education IP
awareness, independent → patent
agents + attorneys: (write) patent
applications, help with infringement,
FTO (Freedom to Operate) searching.
Innovations and IPR rights: including
patents → starts with basic research
(by universities), leads to patent
application -> applied research ->
development testing (by SMEs,
startups) -> investment (patent is
granted or a second patent
application before bringing something to the market, because problem will probably change
before it reaches the market, content of first patent can be
the same, but clinical structure will be different) ->
purchasing power.
IP rights: picture right → 5 rights: (1) patents, (2) copyright
(software/alogirthms), (3) trademarks (Apple logo), (4)
registered designs (design of mobile phone), (5) trade secrets.
→ IPRs as incentives for innovators: with the absence of
approbriability (ownership) for products, processes or
service, it is highly unlikely that entrepreneurs will invest →
because then (a) no exclusivity or temporary monopoly, (b)
no price premium (raising price of the products, so higher margin to recoup into investments
into R&D), (c) no profit and incentive for R&D (companies will not invest in product development)
→ needs to be attractive to invest in new products in marketplace → National Innovation Policy.
IP as intangible asset → multiple IPRs → FEX. Tesla has a patent, design patent (registered
design), trademark over their logo, copyright for their software.
- Trademark: €240 - €1000 for 10 years Benelux - EU → sign that distinguishes your
products/services from those of your competitors (FEX. logo’s, brandnames, shapes,
colours, sounds, etc) → should be distinctive, registration per country/community/
region/10 years → Nice classification system → search registered marks: TM view.
- Design rights: €150 - €750 for 5 years Benelux - EU → aesthetic characteristics of a
design, not determined by tech (colour, shape, material, etc) → should be new →
registration per country, per 5 years with a max of 25 years → registration at Benelux
office of intellectual property or EU-IPO → Locarno (Vienna) classification system •
search registered designs: Design View.
- Copyright: 0 euros → copyright protection concerns original works of literature, science
and art, software → 70 years after decease of creator → no formal registration required,
but rights to creator or to employer (work related) → make agreements.
- Patents: starting from a few thousand euros → new, innovative and applicable technical
inventions (products/proces) → max 20 years exclusivity for commercialisation →
, registration per country, via international procedures → international or centralised
patent classification (IPC/CPC) system → patent search, Espacenet.
How to appropriate IPR? → picture left → if you file
a patent there is a tradeoff; sole owner of product,
but you have to show the purpose of the
application (becomes public knowledge).
Patent procedure: filing, search report, granting,
taxes → per country; FEX. Netherlands Patent
Office -> European; 1 application for 42 countries,
European Patent Office (EPO) -> international; 1
application for appr. 152 countries, World Intellectual Property Organisation (WIPO).
Patents and patent databases benefits: (a) protection of inventions, (b) huge collection of solutions
→ if you get a monopoly, you have to disclose it (tradeoff) → half a million patents are applied by
producers of a car → patent = property right to invention (technical) -> copyright (art), design
(shape), trademark (sign, symbol).
→ market opportunity aspects from the view of patents: (1) existing patent rights (limit
production and sales, expired rights can be used) -> (2) potential competitors and partners
(busuiness strategy depends on potential competitors and partners).
Worldwide patent does not exist → you have local laws → there is a worldwide patent application
procedure, but you always end up with the different countries.
→ others are not allowed to commercially produce, use, sell, stock the invention → maximum 20
years, regional (country) → requirements patents: disclose invention (cannot have secret
inventions), novel, inventive, able to carry out (by a person skilled in the art), industrial applicable
→ is important up until the filing date → prior art = everything made accessable or available to
the public → everything up to filing date.
Example: Endoscope invention → problem; need to be able to work around organ or instrument,
solution = bending tip → development to make it better → an idea is effective and transformed
into a real device → application; description (how it works), claims (determine what you want to
have protected, scope of protection), figures (for further explanation).
- Start of procedure: filing - search (about nine months) - search report (after nine months)
- prior art documents (containing simpler solutions) - check claim - priority year
(strategy: costs and benefits -> is the possible patent still usefull? Which countries?) -
costs (fees: application -> grant, yearly fees → patent attorney → translations → FEX. NL
application ≈ 2.000 – 10.000 euros -> yearly fee NL: 4 th year 40 euros -> 20th year 1.400
euros -> EP application (6 countries) ≈ 30.000 euros).
- PCT (Patent Cooperation Treaty): within 12 months → do another search report →
publication at 18 months → examination up to 30 months → thereafter EP in Europe and
other countries.
- After grant: infringement, warning, negotiations, court, keep patent alive (fees) → can
become invalid (by third party) → EP: 9 months opposition period → infringement will
stop your product: sales, production, damages → avoiding infringement: different
solution, licenses, invalidate patent.
- Validity check = patent not relevant (claims) -> patent application not granted (or not yet)
-> patent validity in a country (patent register) → focus on patent documentation and
non-patent literature before priority date.
, Types of search: starts with landscaping (overview of existing solutions, possibilities/restrictions)
→ before product development: freedom to operate (know the rights of others) → protection of
invention by patent: prior art search (good patent requires knowledge of prior art).
Patent database: patent publications in Google patents, Espacenet (EPO), Patentscope (Wipo),
Depatisnet (Germany) → also info on internet and in library → find info about technical overview,
names of inventors, names of companies, time in history.
- Make a first selection → go from 130 million to a 100-1000 documents → second
selection; only relevant documents (10-30 documents) → find closest and relevant prior
art (close to invention and interesting solutions).
- Demo searching = how to find all endoscopes with a flexible shaft?
→ in past: search through a heap of patents with a certain
classification code → classification = goal: group similar documents
(same technology) - origin: searching with paper, performed by
persons (examiners) - aspects: application, function, characteristics
- objective: state of the art for search reports → International Patent
Classification (IPC).
- Most used classification systems: (a) based on IPC with further subdivisions: Cooperative
Patent Classification (CPC) (Europe, USA), Deutsche Patentklassifikation (Dekla), File
Index (FI) (Japan) -> (b) Old US classification -> (c) F-term: deep indexing (Japan).
- Finding classification codes: look through classification list → find some documents by
text search and check classification codes (use statistics) → search in classification
search (Espacenet).
- Tips: use classification (CPC) to search → classification is not perfect → combine
classification with searching with words → combine classifications → look at cited and
citing documents.
13 - 25/11/2022 - Insight in the
Pharmaceutical industry (IQVIA)
IQVIA = Partner of Pharma & Healthcare.
Pharmaceutical industry: discovery, development and
manufacture of drugs and medications → top 10 of total
revenue of global pharmaceutical companies in 2020
(picture left).
From molecule to market: R&D - product development -
manufacturing and distribution - approval and market
access - commercial → 5 things about the drug approval process:
1. Discovery and screening: new drugs are tested on animals before people, multiple
species are used to gather info on safety.
2. Submit IND application: Investigational New Drug application for FDA (based on results
of initial testing) → includes drug composition and details of manufacturing → plan for
testing drugs on humans (reviewed by FDA to approve clinical trials).
3. Clinical trials: 3 phases with humans → I: emphasises safety and includes 20-80 healthy
volunteers -> II: emphasises effectiveness and includes hundreds of patients with a
certain disease or condition -> III: more info on safety and efficacy and includes
thousands of patients, using different populations and different doses.
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