Fact Sheet IP in Biotechnology
Fact Sheet IP in Biotechnology
eu
Fact Sheet
Intellectual property in Biotechnology
June 2014
1.
1.2
2.
2.2
2.3
3.
3.2
Introduction
Biotechnology is generally defined as the application of science and technology
to living organisms, as well parts, products and models thereof, to alter living or
non-living materials for the production of knowledge, goods and services1. This
definition is deliberately broad and covers all modern biotechnology but also
many other traditional or borderline activities. Taken all together, these activities
belong to what is commonly called Life Sciences.
Biotechnology is a field where technology advances rapidly but returns on
investments may be slow. For this reason, it is important for public research
organisations and enterprises to protect the innovation that they generate with
Intellectual Property Rights (IPR), which provide a basis for return on investment
in research and development, by granting monopoly rights for a certain period of
time to their owners.
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1.
Biotechnology is usually subdivided into three sectors that may overlap, namely:
1.1
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Patents
Trade marks
Registered
designs
Trade secrets
/ know-how
Plant
breeders' or
plant variety
rights
Domain
names
Web addresses
Table 1
The deployment of IPR will depend on a number of factors, including the actors
area of specialisation, structure, anticipated activities, and whether it is engaged
in commercial activity.
The table has been elaborated based on the Biotechnology Intellectual Property management
manual, Spruson & Ferguson, 2008.
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SHORT REMINDER ON IP
PATENT
A patent is a legal document, through which a right is granted for an invention, a product or a
process that provides a new way of doing something or offers a new technical solution to a
problem. A patent provide exclusive rights for a fixed period of time in exchange for public
disclosure of the invention. A patent enables the patent owner/holder to exclude unauthorised
third parties from making, using, selling, offering for sale or importing for those purposes a
product, a process, or a product obtained by a patented process for the term of the patent.
TRADE MARK
DOMAIN NAME
1.2
For a deeper analysis on the relevance of trade secrets and know-how, see the European IPR
Helpdesk fact sheet on Confidential business information, available in the library.
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In Europe, the protection lasts 20 years from the first filing of the patent application.
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The rationale behind the patent protection for biotechnology inventions is related
to the fact that:
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Methods for treatment of the human or animal body, i.e. methods for
treatment by surgery or therapy, and diagnostic methods practised
on the human or animal body. The philosophy is that medical doctors
should never be prevented from doing what their Hippocratic Oath obliges
them to do, i.e. practice medicine ethically.
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Together with the EPC, the Directive 98/44/EC on the legal aspects of
biotechnological inventions, implemented by all member states, provides the
basis for deciding on patentability of biotechnology applications at the EPO and
puts greater focus on ethical considerations.
Besides the EPC provisions, the Directive rules out:
The patenting of the entire human body in all its developmental phases;
Processes for modifying the germ line genetic identity of human beings
and the use of human embryos for industrial or commercial purposes.
Table 2 below8 summarises what can be patentable and not patentable in the
biotechnology field:
What is patentable?
Proteins
e.g.: - insulin
- erythropoietin for therapy
- cellular receptors for drug screening
Table two has been reproduced from Patents on life? European law and practice for patenting
biotechnological inventions, European Patent Office, Munich, Germany, 2009.
Enzymes
e.g.: - protease for washing powder
- cellulose-degrading enzymes for the
production of bio-fuels
Antibodies
e.g.: - for cancer treatment
- pregnancy tests
- diagnostics
Virus and virus sequences
e.g.: - hepatitis C virus
- HIV for blood testing
- development of vaccines and therapies
Cells
e.g.: - haematopoietic stem cells for the
treatment of leukaemia
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Human embryos
Micro-organisms
e.g.: - bacteria for bioremediation
- yeast for food production
Transgenic Plants
e.g.: - herbicide resistant soybean
- golden rice which accumulate provitamin A
- drought-resistant plants
- algae and genetically modified yeast for
capturing CO2 from the atmosphere
Human-animal chimera
Transgenic Animals
e.g.: - disease models for research such as the
genetically modified oncomouse
- donor animals for xenotransplantation
- dairy animals which produce
medicaments in milk
2.
Table 2
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The innovation cycle in the biotechnology sector is complex, expensive and long,
and success is uncertain. The diagram below9 summarises the key phases of this
cycle. Societal needs motivate researchers in public institutes and private
companies to come up with creative new ideas and concepts. Such research
often leads to the development of new products. In many sectors, these
products are then subjected to regulatory approval, which is itself followed by
commercialisation (either directly or indirectly by licensing agreements). These
newly commercialised products provide benefits to enterprises, researchers,
and society at large, but part of the sales revenue is ultimately reinvested into
new research.
Societal needs drive
demand: e.g. illness,
agricultural problems,
environmental challenges
or production needs
Economic returns
necessary to
reinvest to research
Benefits:
Economic returns
Tax revenues
Employment
Better products
Creative concepts
& Research:
Copyright in lab
notebooks
Know-how and trade
secrets protection
Existing inventions as
patents
Confidentiality security
IP in the
Innovation
Cycle
Commercialisation:
Packaging as designs,
trade marks and copyright
Licensing agreements
Patent claims on new
products
Copyright in product data
and patients information
Patent terms
extension is also
possible
Development:
Parental seeds lines,
plant breeding books,
field trial data as trade
secrets
Plant varieties protection
Laboratory, clinical trial
testing results confidential
as a trade secret
Devices for drugs as
patents, designs and
copyright
Regulatory approval:
Regulatory data
protected through data
protection rules and as
trade secrets
The diagram has been elaborated based on the EuropaBio brochure How intellectual property
rights promote innovation and create economic and societal value, available here.
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Considering IPR in the innovation cycle ensures that the actors (public, private
developers) are rewarded for their efforts and enable them to (re)invest in new
technology and product R&D. Therefore, it is important that the fruits of the R&D
investments are effectively protected and managed through a vigilant IP strategy
because IP is a driving force behind continued innovation.
2.2
2.3
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these matters and generate significant additional resources for new R&D
activities.
SMEs: their role cannot be underestimated. Thus, in industrial biotechnology and
in pharmaceutical sectors, SMEs are the key players in the initial development of
many innovations and, in agricultural biotechnology, collaborations with
universities allow for major innovations. Moreover SMEs are often created as
university start-ups to build on a promising innovation, which could attract the
interest of larger companies in having it licensed or even permanently assigned.
In this way access to venture capital for start-ups is facilitated in the research
phase.
Larger companies: develop their own products but collaborate also with
universities or public research institutes for the successful development of a
product. Collaborations are often set up as licensing agreements in return for
payment of royalties. In some cases, ownership of IP rights is transferred, or
SMEs are acquired.
3.
Patents are important in all technology fields but probably even more important
for new and specialised fields such as biotechnology because they can contain
information that may not be captured by other indicators. In fact, according to
the OECD, patent information is essential for small companies because it allows
them to come up with new ideas based on previous inventions and develop them
into a viable product11. For this reason, those involved in this sector should be
familiar with patent databases and how to use them.
3.1
Patents in biotechnology are available, as other patents, using two main kinds of
tools:
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These latter codes organise and index the technical content of a patent document
and, in the case of biotechnology, patents are defined as patents belonging to a
specific/defined list of patent classification codes.
The patent classification codes assigned by patent examiners during the patent
examination process help to group inventions according to technical area and so
to identify patents from a certain technological area. They are organised
hierarchically and divided in sections and subsections.
The main patent classification systems relevant to organisations wishing to
develop their technologies in the EU are: the International Patent Classification
(IPC), the European Patent Classification (ECLA) and the Cooperative Patent
Classification (CPC). Such systems provide for a hierarchical system of language
independent symbols for the classification of patents and utility models according
to the different areas of technology.
It can be noted that, in the biotechnology sector, the majority of patents are
classified in the International Patent Classification sub-classes C12M to C12S.
Note however that it is extremely difficult to capture all biotechnology patents
using only those two sub-classes.
Generally speaking, the broader the technology field, the more difficult it is to
identify the corresponding classes, as they will be spread across different higher
level categories, and possibly mixed with other technologies which are not of
interest.
Thus for instance, although the list of classes for biotechnology is concentrated in
section A, C and G of the IPC, certain patents in the biotechnology field might be
found in sections B, D and E but are mixed with other technology domains from
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which they cannot be separated (e.g. bioinformatics can be assigned to G06F but
this class includes other computer-related technologies)12.
For more information on patent searching, see the European IPR Helpdesk fact sheet on How to
search for patent information, available in the library.
13
The asterisks indicate that those IPC codes also include subgroups up to one digit. For example
in addition to the code G01N33/53, the codes G01N33/53(1), G01N33/35(2), etc., are included.
14
A framework for biotechnology statistics, cited.
13
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Indicators issued from patents can also help you to inform organisations when it
comes to take strategic decisions on key issues. Accordingly, Porter and
Cunningham15 suggest for instance five applications of patent information which
can be useful to inform any technological sector:
Technological emphasis
Technological share
Rate of technology growth
Patent quality
National profile
Citations
Patent family having most citations
Patent families having most self-citations
Forward/backward citations map
Evolution of patents citing companys
patents
15
A. L. Porter and J. Cunningham, Tech Mining: Exploiting new technologies for competitive
advantage - Generating and presenting innovation indicators, p. 249-288, New York, 2005.
14
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Legal
Main IP attorneys
Legal status of patent filings
Patent granted by patent office
Time for Company to grant US patents
Distribution of total claims per US patents
European patent opposition
Main patent reassignment
Actual or expected expiration date
Inventors
Top and last inventors
Evolution of the number of new inventors
Main inventor collaborations
Technology
Main 20 IPC codes
Evolution of top 15 IPC codes
Main patent type filed
Evolution of main patent types
Main pathologies claimed
Evolution of main pathologies claimed
Main routes of administrations claimed
Evolution of main routes of administration
Main mechanisms of action claimed
Evolution of main mechanisms of action
claimed
Formulation
Device
Table 316
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This table has been adapted from the information provided in the patent surveys 2013 Acna and
Viropharma, conducted by Knowmade and available here.
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Useful information
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GET IN TOUCH
For comments, suggestions or further information, please contact
European IPR Helpdesk
c/o infeurope S.A.
62, rue Charles Martel
L-2134, Luxembourg
Email: [email protected]
Phone: +352 25 22 33 - 333
Fax: +352 25 22 33 334
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DISCLAIMER
This Fact Sheet has been initially developed under a previous edition of the European IPR Helpdesk (20112014). At that time the European IPR Helpdesk operated under a service contract with the European
Commission.
From 2015 the European IPR Helpdesk operates as a project receiving funding from the European Unions
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Even though this Fact Sheet has been developed with the financial support of the EU, the positions expressed
are those of the authors and do not necessarily reflect the official opinion of EASME or the European
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