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Summary business management (2020) part 2
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I wrote this summary, based on the lectures of Business management. it helped me to study for the exam, which I passed by an 7,5.
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Lecture 1: IntroductionMaking a business plan is the main object of this course.
Final grade:
Business plan: 50%
IP seminars: 20% of the grade
EXAM: 30% (2x digital MC questions)
All grades must be >5,5
Start-up and/or personal BP plans:
- What is our ultimate dream (Job, position in society, start-up plan)
- For discussing concept versions of BP we are going to plan Q&A sessions online and
peer groups (see CANVAS)
- Uploaded Friday 11th December!
- Handed in as a hard copy at the VU – Monday 14th December!
IP seminars: 17 November & 24 November!
- 13:30-17:15
- Practical use of patent databases and search tools. Obligatory classes!
Personal BP:
- The entrepreneur, idea, mission and strategy,
external factors and liability, IP, patents, trade
secrets, marketing plan, production plan, personnel
plan, management, financial plan
- How do we look in 10 years, customers, competitors,
products (costs of good, price, value), outreach,
reaching your goal, what do you need to do that
Lecture 2: Business patents
Medicine development
Lack of innovation or efficiency decrease:
- Expenditures are growing
- Costs are valuable
- Efficiency in which we develop medicine is
decreasing (factor 5/6/7)
- 12 years today is the average developing time of a
new medicine from the patent to the patient (bench
to bedside) – in history it was 4 years
- Because the time is rising, costs are rising as well
Public support: strong support by national governments
and authorities with creating a favorable regulatory and
funding environment.
1
,As an industry, you have to spent huge amount of money to a new medicine. You have to be
sure that you will get the money back (the medicine is effective and will be bought).
Time of developing is getting longer
Cost to develop new medicine is getting higher
Intellectual property: Intellectual property (IP) is a category of property that includes
intangible creations of the human intellect. There are many types of intellectual property,
and some countries recognize more than others. The most well-known types are copyrights,
patents, trademarks, and trade secrets.
Industrial rights (registration!): Patent law, Brands, Drawings and model rights
Other rights (no registration!): Copyright, Databases, Trade Secrets
Trade secrets:
- Coca Cola (not a single person knows the
complete recipe)
- You cannot trade secret in drugs (you have to
be fully transparent), everything needs to be
disclosed, which hinders trade secret
protection.
Examples of trade secrets into a pharmaceutical
regulatory filling:
- Manufacturing processes or techniques
- Product formulas
- Ingredients and recipes
- Assays
- Names of vendors and suppliers
- Unique combinations of generally known concepts
Industrial Law (you have to pay for it):
- Patent Law
- Brands
- Drawing and model rights
Other rights (you don’t have to pay for that):
- Copyright (DO COPY RIGHT your business plan !!! do a confidentially clause)
o They protect your intellectual property
- Databases
- Trade secrets
Sue them when they cannot go back! Waiting is a must! When they can go back, they pay
you a 100 dollar, and when they cannot go back anymore you might get 100.000,-
Copy right can exist next to portrait right!
2
, - The right of publicity, often called personality rights, is the right of an individual to
control the commercial use of his or her name, image, likeness, or other unequivocal
aspects of one’s identity.
- The intellectual property rights on photographs are protected in different
jurisdictions by the laws governing copyright and moral rights. In some cases
photography may be restricted by civil or criminal law. Publishing certain
photographs can be restricted by privacy or other laws. Photography can be generally
restricted in the interests of public morality and the protection of children.
Copy left: is the practice of offering people the right to freely distribute copies and modified
versions of a work with the stipulation that the same rights be preserved in derivative works
down the line. Copyleft software licenses are considered protective or reciprocal, as
contrasted with permissive free software licenses.
Software has been published for free, you can develop further with that software. Then
you can never sell that software because that was free.
Industrial rights: registration with government! However, there is not a police! You have to
police yourself, you can go to civil court.
- Brands are not the same as a trade mark.
- McDonalds is the brand. The in-n-out Burger is very similar as McDonalds. Products
are better than McDonalds. They try to get the clients from McDonalds to their better
products.
- Brands can be most value.
Anti-Jet lag drug: original patent on bp. Viagra is very well known. It is a pharmaceutical
disfound. Cialis is the best selled drug. You have to choose another color for an erectile
dysfunctioning drug. Is that important? Tests with blue and shape placebo pills gave 24%
improvement (Fake Viagra). In Europe there is no patient marketing.
Patent procedure:
- Filing date is day 1.
- There is a priority year (12 months) > you can
add data or inventers
- The patent office they start investing in your
patent (18 months) secret between you and the
patent office > not public knowledge until 18
months.
- After publishment it will be examined (you have
to make your investment). Will it be granted??
(6/7/8 years)
- You might get extended patent (20-25 years from file to end)
Patent in medicine:
20 years patent? you only have 8 years in the
market (12 year production). There is fast
deterioration. Every delay is a bummer.
3
, Your branding is important in your personal plan.
The curve will look different if you are branded.
Predetermined patent life:
- In a small ‘blockbuster’ market of 1 billiion annual sales a delay of one day has a huge
impact
- Gross turnover loss almost 3 million daily!
- At royalty rate (of 3%): 82.00 per day for licensor.
- 100 M market 8200
- 10 M market 820 day for 24.600 per month!
-
Brand extension / copy right, the decline does not have to
decline very steep. It could be less steep. Creating a
second/third patent (you can file patents on production /
proliferation / adjustments). You can delay the selling period
very long!
10 to 11 times higher revenues than expenditures. That is
because of 9 or 10 drugs also fail! This graph is better and
might be drawed. However, it will not go back to zero!!!
Drugs compounds have to be:
- Safe (in 2 animal models)
- Efficient!
Clinical trials (human trials):
Phase 1: human healthy volunteers (safety) –
60% of drugs survives
Phase 2: exploratory (short term safety, mainly
effectiveness) – 30% of drugs survives
Phase 3: confirmatory (safety, dosage,
effectiveness) – 60% of drugs survives
From 10 drugs in the phase tests there needs to
be 33.000 discoveries in the labs. most products do not
reach the market
Lecture 3: Intellectual property
4
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