International Max Planck Research School for Competition and Innovation
Interdisciplinary Ph.D. Programme
International Research
Research Fellowships
Industry Cooperation
International Max Planck Research School for Competition and Innovation
Agnieszka Kupzok, LL.M. IP
Impact of Brüstle vs. Greenpeace on the
biotechnological sector – first indications
Max Weber Multidisciplinary Workshop, EUI
Florence, October 10th, 2012
Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Overview
• Context
• Impact on the European patent system
• Importance of patenting in the biotechnological sector
• Impact on the biotechnological sector
• Further considerations
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Context
• Highly politicized topic
• September 18, 2012
• Legal Affairs Committee of the European Parliament
voted to exclude research funding for hESC from
Horizon 2020 Framework Program for Research and
Innovation.
• The Brüstle judgement of the CJEU was used as a
convincing argument.
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Impact on the European Patent System (I)
• CJEU opined on the wording of the Biotech Directive
• EPO adopted the wording of the Biotech Directive in its
Implementing Regulations, in 1999.
• Due to Article 53 EPC, issues affecting “ordre public” are
included in the patentability inquiry of the EPO.
• Combined with Rule 28c of the Implementing Regulations,
which implements Art. 6(2)(c) of the Biotech Directive, the
interpretation of ECJ influences the patentability in all EPO
Member States
• EPO President 2011: “If the judges rule in favour of a
restrictive interpretation of biotech patentability
provisions, the EPO will immediately implement it.”
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Impact on the European Patent System (II)
EPO Member States =
EU 27 + 11 States
Brüstle v.
Greenpeace
CJEU’s
judgements
have an
impact on
the EU 27.
Interpretation of
Directive
98/44/EC Art.
6(2)(c)
Art. 6(2)(c)
included in EPO
Implementation
Regulations, Rule
28; Together w/Art.
53 (a) EPC
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
EPO Scenarios for the Future – analytical tool
• 4 Scenarios to approach the changing circumstances:
–
–
–
–
Market Rules – Predominance of Business
Who’s World – Predominance of Geopolitics
Trees of Knowledge – Predominance of Society
Blue Skies – Predominance of Technology
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
The biotechnological sector
• Very innovative, dynamic, and characterized by a
large amount of SMEs
• European Commission estimated in 2011 that the
sector contributed 1,55% of gross value added in the
EU.
• Biotechnology is the driving force in innovation
processes in several industries (pharmaceuticals,
agrochemical, energy, environment)
• Biotechnology is one of the most research-intensive
sectors
• Protection of research results, especially due to the
high portions of revenue invested in R&D plays an
important role.
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Patenting in the biotechnological sector
• Allows to secure rights in this sector characterized by
long development trajectories.
• Especially significant, as R&D is characterized by
high costs of development and relatively low cost of
imitation
• Is an essential component, when SMEs are
established in the sector as spin-offs.
• Provide a contracting basis between “basic” research
in the biotech sector and development of specific
products and treatments by pharmaceutical
companies.
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Impact of Brüstle v. Greenpeace on the biotechnological
sector
• Due to the investment intensive R&D in the
biotechnological sector, inability to patent is expected to l
lead to lower financing, especially seed financing and
venture capital
• Lack of financing may function as a barrier to entry.
• Lack of proprietary rights may shift the structure of the
sector toward “in-house” R&D by big pharmaceutical
companies
• The guarantee to the investors that patents provide comes
at a social cost of the society faced with higher prices
charged by the company having exclusivity. Lack of
patents in the hESC may lead to cheaper medication.
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
However…
• Patenting is neither a guarantee nor a bar to market success
• There are alternatives to patenting in securing benefits from
investment: strategic business behavior, lead time.
• Territorial nature of patent law limits the bar on hESC to the EU
+ other EPO Member States.
• Territoriality implies that foreign firms will not obtain patents on
hESC-related inventions in the EU, either.
• Territoriality of patent law also implies that researchers in Europe
can apply for patents elsewhere, notably in the United States.
• Nature of innovation focuses on finding alternatives:
– Induced Pluripotent Stem Cells (iPSCs) (Nobel Prize 2012)
– Progenitors
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Conclusions
• Straightforward securing of investment through
patenting is not possible for hESC-based research.
• Morality and “ordre public” considerations led to a
limitation of rules governing technological progress.
• Alternative perspective could be to observe that EU
polity is willing to sacrifice future economic gains in
order to protect the dignity of human life.
• The CJEU judgment affects the biotechnological
sector disproportionately strongly, due to the sector’s
characteristics and reliance on the patent system.
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Thank you for you attention!
[email protected]
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
European Parliament
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Agnieszka Kupzok Impact of “Brüstle“ on the Biotech sector
October 10th, 2012
Bruestle
Brüstle v Greenpeace eV (CJEU, 2011)
26. [‘Human embryo’] must be regarded … as designating an autonomous concept of
European Union law…
29. [U]nlike Article 6(1) of the Directive, which allows the … Member States a wide
discretion in applying the [public ordre/morality] exclusion from patentability … Article
6(2) allows the Member States no discretion with regard to the unpatentability of the
processes and uses which it sets out, since [its] purpose is to delimit [Article 6(1)]…
34. The … European Union legislature intended to exclude any possibility of
patentability where respect for human dignity could thereby be affected. It follows that
the concept of ‘human embryo’ … must be understood in a wide sense.
45. That interpretation is … identical to that adopted by the Enlarged Board of Appeal of
the European Patent Office [in Warf]…
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The biotechnological sector - Sofia Moratti European University