HC’s – Business management
HC’s Business management
HC 1 – Introduction
Final business plan + executive summary deadline: 23/12/21 16:59 @ Canvas. Also hand in hard copy
and separate executive summary @VU.
IP seminars are mandatory! 23/11 and 30/11 13:30-17:15! The assignment deadline is 01/12/21
16:59.
Final grade (everything >5,5):
- Business plan = 50%
- IP seminar assignment = 20%
- Exam 1 + Exam 2 = 30%
The business plan must consist of: The entrepreneur, Idea, Mission, Strategy, External factors and
Liability, IP, Patents, Trade secrets, Marketing plan, Production plan, Personnel plan, Management,
Financial plan. How do we look in 1, 3, 5 or 10 years? Who are the customers? Who are the
competitors? What are the products (product market combination (PMC), turnover, cost of goods
(COG), price, value, etc.)? Why would the customer buy with us? What do you do when you’ve
reached my goals (define)? What do you need to do to accomplish this (people, knowledge, facilities,
money, etc.)?
HC 2 – Business plan
New chemical entity (NCE) = a completely new medicine/pharmaceutical compound. E.g. a cure for a
cancer form, before this invention no cure for this form of cancer existed. So not a new medicine of
something that already existed (already a safe and used pharmaceutical compound). It is only is NCE
if it is completely new in chemical/molecular structure. Almost 60% of all registrations of new drugs
are me-too drugs; drugs that already have another safe and efficient drug on the market for the
same purpose (e.g. a new lower blood pressure drug, when safe and efficient drugs that exist for this
cause already exist).
We all use pharmaceutical compounds, and we need to try to keep refreshing the reservoir of
compounds we use/prescribe. In the world on prescription, around 40.000 compounds exist today.
The replacement rate is really bad (about 30 NCE at 30.000 new compounds). The price it costs to
develop a new chemical entity has risen a lot in the last 100 years (about 150 billion total, so about 5
billion per NCE)!! Its very expensive, even when you take into account the inflation. Also it takes a lot
longer from idea to the patient (looking at the regulatory aspects); 4 years in the old times, and on
average 12 years nowadays to develop a drug (12 years on average, so can take longer/shorter).
Since investing in a drug costs about 1,4 billion, and about 12 years, this does not sound very
appealing to investors; you wont get money back soon (12 years). If you invest all this money, and
you have to wait such a long time for your investment to come back at you, it is very important that
this investment is protected. This protection is the Intellectual property rights (IPR) = the rights you
have on your created intellectual property. First aspect of IPR is to keep your mouth shut! Don’t tell
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anyone the secrets. It is not possible that you have your new drug going through the regulatory
authority without telling them about the working compound; ‘it is based on strawberry’s, and the
rest is a trade secret’. But you cannot have a secret about which compound/molecule is working in
your entity (so explain what the compound does to cure the disease); otherwise people would not
believe it is save, or if it works. In pharmaceutical development, trade secrets need to be used in
another type; some ingredients, manufacturing processes or techniques, product formulas, assays,
names of suppliers, unique combinations of generally known concepts; things that have no direct
relation to the safety and if it is working.
IPR
IPR are very important in any business plan (BP). IPR that do not need registration with the
authorities are: copyright, databases, and trade secrets. Because you don’t need to register with the
authorities it is easier/quicker, and you don’t have to pay. Copyright law = the right you have on all
your creative property; everything you make. So add ©year after your last name! It is yours; the
paper/thing you made, and no one can use it without permission. PUT THIS ON YOUR BUSINESSPLAN
AND CV. If someone has used your copyright document without permission; wait with notifying
them!! When you wait, their product comes on the market, and they can never go back! So they owe
you more money. Portrait right: if you make a picture of some people without a famous person, you
can sell or publish the picture (it’s the property of the photographer). But if you have a famous
person somewhere hidden in between, you cannot sell/publish the picture without their permission
(that person has portrait right).
Copyleft; joke against ©; you can use it for free, but if you improve it, you need to give it back for
free to society. So you can use it, but don’t ask money for it later on.
Industrial rights are rights that you can only do with registration in the government: patent law,
brands and trademarks (e.g. yellow arches of McDonalds + colour scheme; people know it and
recognize it; very important in growing your brand/organisation/business), and drawings and model
rights (e.g. the model of Ferrari car). These cost money.
Patent law
Patents are a formal way of protecting your knowledge. You cannot patent something that is already
existing; you need to show that it is new or better. You can patent an improvement; show that pink
beanbags are better/cheaper → patent pink beanbags (instead of the blue ones that already exist).
You can patent something once, and after 20-25 years, the patent is done and is the bases of new
interventions/improvements (better/cheaper).
It starts at the filing date/priority date;
the moment you file your patent. At
this moment, the clock starts ticking for
20-25 years. The 1 year after that you
can change your patent, and add data:
priority year. You cannot change your
molecule; that is a new patent. But you
can add studies, inventors,
improvements, data, etc. You can
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change the patent, without changing the priority. We usually file patents before we know what is
going on (you find out what it exactly is in the priority year)! So you are the first with the economic
benefit. The most important part is the publication of the patent (at 18 months). In the first 18
months, your patent is the big secret! You tell no one that you’ve filed the patent. After 18 months,
you introduce your patent. After a couple years (how much differs), you know if the patent is
granted. If it is granted in a very long time, e.g. 6 years (this is often the case), you get these 6 years
back in the duration of your patent. So your patent is existing 6 years longer (but in total its always
around 20-25 years).
So when you file a patent, you know it will expire in about 20-25 years. And for the first years it will
just cost you a lot of money. So you just have a short time to gain profit in the market.
HC 3 – Intellectual property in all its forms
A patent attorney protects the patents of clients, makes use of the IPR system, and makes sure that
the patent of the client does not conflict with other patents.
The only things that prevents copying products are Intellectual Property Rights (IPRs). This is easier
nowadays because everything is digital, and transportation has become a lot easier. The importance
of IPR has grown a lot! This is because the world has become more digital and competitive; you can
easily see what your competitor is doing, and create a me-too product (copy it). The only way to
prevent this is by IPR. About 84% of a big company (e.g. Google) is intellectual property. So recent
years we see a big rise in the importance of IPRs. But IPRs are not just for big companies; it is of big
value for start-up companies (very small) as well. Without IP protection, it will be more important for
a company to be able to win at marketing, distribution, manufacturing, than to come up with a big
innovation. Without IP, the way to success is not to invest money into the development of a new
product; it will be copied very quickly. IP makes it possible to recoup long and expensive
development processes. By filing an IP, you have to publish your invention; stimulating technological
progress: sharing knowledge through mandatory publication in the patent database (or IP-database),
in exchange for a temporary monopoly. There is a lot of useful information in this database! About
patents that have expired, or that are just in the USA for example.
IP-landscape in COVID-19 vaccines; complex
3 main parts in the RNA-based vaccines: mRNA code (IPR from University of Pennsylvania), lipid layer
(IPR from Arcturus), and protein stabilizer (spike protein) (IPR from NIH). So a lot of actors have
invented a part of the vaccine. The IP landscape of these vaccines is very complex. All the IP-actors
are compensated for their inventions/actions. You are awarded for your contribution.
Patents are basically just words; words that describe your invention. But you need to include all
essential elements! All the details.. Strong patent claims are broad! And difficult to circumvent, but
comply with patentability requirements (must describe details, novelty (new) requirements,
inventive steps). Strong patent claims create value and attract investors / partners, and can be
licensed to others.
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