This reader presents an introduction on the use of know-how and
intellectual
properties
(IP) and its
benefits for students in science, engineering, medical and business
courses. The basic concepts and definitions of
IP will be
treated and also their use and purpose will be described.
The different topics of IP are explained with an example relevant to
your background.
Those interested will find additional information in the appendix links by following the
links.
1.2 Every day IP
Chances are that you are using products or services appropriated by a
variety of
intellectual
property rights
(IPR) on
a daily basis, eg. brands, designs, patents, copyrights.
Many of the products that you will buy or use daily are from a
certain brand. Such a brand makes you recognize the product and the
manufacturer. For example the brand Coca-Cola for cola. On the other
hand manufacturers and organisations use their brands to market their
products and services.
Next to brands, organisations have their tradenames registered at the
Chamber of Commerce.
The book you are reading or the music you are listening to are works
made by an author or musician. These makers would like to be rewarded
for the efforts put into the making of their work. You are therefore not
allowed to copy this work without their permission since it is
copyrighted.
In the development and production of bicycles and cars there are many
proprietary technologies. Manufacturers of these product would like to
earn back their investments in research and development by using
patents.
When you are already developing products yourself now or in the
future and when involved as entrepreneur or manager you will have to
work with different kinds of IP. As a student it is therefore useful to
acquire sufficient knowledge of IP for your future career. Even during
studies you it can be worthwhile to use them for many reasons, for
example for design assignments.
1.3 Why do
IP rights
exist?
Several hundred years ago the use of intellectual property rights was
hardly known. At the beginning of the book printing technology it became
possible to copy and disseminate works of literature far more easily.
From that moment authors and publishers started to feel the need to
appropriate the rights for the production and distribution of these
works. With new technologies during the Industrial Revolution mass
production in large quantities became feasible for products and devices.
This gave rise to a growing interest by manufacturing companies to
appropriate trademarks, logos and patents for their products and
inventions.
The
modern patent in Venice
During the fifteenth century, Venice was a rich and flourishing city.
One of the reasons for this prosperity was the stained glass produced on
the island of Murano.
This was a rare and expensive product that became an important
economical asset for the city.
However, the formula for making coloured glass was known only to a
few people: the glassmakers of Murano.
The Senate of Venice began to worry about the possibility that the
glassmakers might die or flee to other countries, thus losing this
precious secret.
To avoid such hypothesis, Venice offered the glassmakers to train
some apprentices sent by the city. However, the glassmakers refused
because accepting the offer would have meant that they loose their
monopoly and create potential competitors.
Understanding Murano’s concern, Venice offered, in exchange for the
secret, an exclusive right for a limited time to guarantee the
glassmakers monopoly. The document granting this right was called a
“patent”, from the Latin verb “patere”, meaning to make known.
Thanks to this, the craftsmen accepted the offer and Venice managed
to keep the secret, so that we can still enjoy the beautiful coloured
glass of Murano today.
In 1474, Venice published the first patent statue in history, to
regulate the matter. See figure 1.
Figure 1: The Venetian Patent Statute,
enacted by the Senate of Venice in 1474, is widely accepted to be the
basis for the earliest patent system in the world.
The general concept behind the use of intellectual property rights is
that the creator or manufacturer can apply for a temporary exclusive
right hence appropriating their (often intangible) assets and stopping
competitors. By doing so the IP owner acquires the possibility to
exploit the production of these assets which are otherwise easily copied
or manufactured by competitors. So, on the one hand intellectual
property rights incentivize persons and innovators who invested both
time and money to develop a new product. While on the other hand
competitors cannot copy the product and sell it at a cheaper prices
without making such investments.
Consumers of those products which have been appropriated with
intellectual property rights may have to pay a higher price. Without
these intellectual property rights competitors would have been able to
sell the products at a lower price. For society at large the
introduction of
IPR is
not only to have all products available at the lowest prices, but to
have access to new products and innovations. While using
IPR
innovative companies are temporarily in a position to charge higher
prices thus enabling a return on (earlier made) investments. This is
shown in figure 2.
Figure 2: Use for business and
society
1.4 Well known
IP
Companies, entrepreneurs, authors, engineers, developers, scientists
and inventors can use a variety of
IPRs
like copyrights, trademarks, patents, trade names, logos, designs,
databases, plant breeders, integrated circuit layout and trade
secrets.
Some of the well known IP rights are:
Copyright
Will give the creator (author) at the end of the creation
automatically global protection for original works like text, music and
images. Copyrights limit free distribution of the work.
Trademarks
After registration, the trademark owner receives the exclusive right
to use the trademark for certain goods and services. A trademark right
can be used to take action against competitors who want to exploit the
same or similar trademark in the same market.
Patents
After the application, registration and examination of a
patent,
others can be excluded from the commercial exploitation of the patented
invention.
Tradenames
Trade and company names are used to make a company known to customers
in the market and ensure a reputation and thus customer loyalty. Another
company may not cause confusion with its trade name by using a trade
name that is too similar to a previously registered trade name.
Designs
After registration, the design holder receives the exclusive right to
use the design. A design right can be used to take legal action against
competitors who wish to exploit a similar design.
1.5 Frequently used IP for
innovations
This document will not describe the legal aspects of IP. See the
links to several articles of different laws in Parts of Patent law. We will
describe how to use IP, and more specifically for innovations. An
overview of the importance of the different IP rights for innovations
can be seen in the following table.
Effectiveness of appropriability mechanisms for product
innovations; % product innovations for which deemed effective.
Source: Cohen, Nelson,
and Walsh (2000), table 1. Note: Each number is a
mean response, representing the percentage of product innovations in the
row category for which the type of protection in the column is deemed
“effective”. The response categories are <10%, 10%–40%, 41%–60%,
61%–90%, >90%.
In general we can see that secrecy (including what we call know-how)
is one of the most frequently used appropriability mechanisms. At the
same time patents are important in the sectors drugs and medical
equipment.
Other IPRs (for example trademarks or designs) are less frequently
used for innovations, but are of course very important for sales and
marketing.
1.6 An example
In this section we introduce the example which will be elaborated in
next chapters.
Here, the main example is the research into and subsequent
development and commercialisation of the PER.C6 technology. This
research is about a vector to produce adenovirusses and a cell line to
encapsidate the virus. In the years between 1992 and 1996 scientific
research at Leiden University lead to the development of this technology
for future use in gene therapy. Already in 1984, prof. Dinko Valerio
started scientific experiments into this technology as part of his work
as PhD student at Leiden University. He was one of the pioneers in the
Netherlands and after his return from the USA he incorporated Introgene
plc. together with prof. van Bekkum. Next, the company started a series
of research cooperation projects with prof. Van der Eb and dr. Hoeben at
Leiden University focussing on the development of cell lines with
improved features. During the experiments they showed that several
virusses, eg. adenovirusses, can be used for genetherapy as well as for
a production platform of multiple vaccines ands medicines. Formerly it
was known that adenovirusses can be used for gene therapy however their
research enables certain improvements. PhD student Frits Fallaux and dr.
Bram Bout were involved as scientists and inventors in a number of those
experiments.
The invention concerns the production of adenovirusses which can be
used as vectors and a cell line to package the virus. The idea behind
the invention is to solve problems of existing production processes of
adenovirusses as a vector. See figure 3 for the functioning of the
Adenovirus as a vector. In 1996 Leiden University applied for a patent
(WO 97/00326) for this invention.
Figure 3: Gene therapy using an
adenovirus vector
Various studies from the World Health Organisation WHO show that some
four percent of the global population suffer from gene related diseases.
As such, the PER.C6 technology developed at Leiden can offer an
interesting possibility to help solving this serious unmet societal need
and health related problem. On the other hand it is widely acknowledged
that the pathway from research, development, clinical trials, market
authorisation for a therapy or the manufacturing of novel vaccines and
medicines is extremely expensive and seldomly executed by one company
only. Therefore, in last decades it has been become common practice that
scientists at universities and medical centres cooperate with
pharmaceutical and spinoff companies for the development of such medical
services and materials. The example of Introgene plc. can be considered
as an interesting case by itself. Next we see that IP and clear
instructions on IP ownership and management often play an important role
in the process and development of novel drugs, vaccines and therapies.
And in particular patents and trademarks.
The most important patent application for the PER.C6 technology can
be found and read as WO 9700326.
This patent application will be used for further explanation about the
use of patents in Patents.
The idea to use adenovirusses for gene therapy has been published
earlier. But the new celline of the research group of Valerion has
several advantages compared with existing technologies:
The chance that competent virusses for homologous recombination will
grow is reduced considerably by not having overlapping sequences between
vector and adenovirus sequence in the cell line,
There can be 38 kb pairs of strange DNA induced into adenovirusses.
Previously it was limited to 7 kb.
The use of a adenovirus is not limited to one host by host range
mutation,
The expression of the toxic adenovirus protein E2 is controlled by
mutation which restricts that proteïne E2 to bind to DNA within
certain temperatures only
induced promoter
expression of viral proteins in transduced cels, avoiding
inflammations in cells.
Viral replication proteins E1A and E1B only appear in packaging
cells PER.C6 (PGK-E1-Retinoblasts) and not in the adenovirus
construct.
The adenovirus only consists of a minimal set of parts:
encapsualtion signal, inverted terminal repeat, mutant E2 protein and
target DNA.
Cohen, Wesley M, Richard R Nelson, and John P Walsh. 2000.
“Protecting Their Intellectual Assets: Appropriability Conditions
and Why u.s. Manufacturing Firms Patent (or Not).” Working Paper
7552. Working Paper Series. National Bureau of Economic Research. https://doi.org/10.3386/w7552.
