Impact on the European Patent System - Sofia Moratti

mutebabiesΒιοτεχνολογία

6 Δεκ 2012 (πριν από 5 χρόνια και 1 μήνα)

206 εμφανίσεις

International Max Planck Research School

for Competition and Innovation

Interdisciplinary Ph.D. Programme

Research Fellowships

International Research

Industry Cooperation

International Max Planck Research School

for Competition and Innovation

Impact of Brüstle vs. Greenpeace on the
biotechnological sector


first indications

Max Weber Multidisciplinary Workshop, EUI



Florence, October 10
th
, 2012

Agnieszka Kupzok, LL.M. IP

October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

3

Overview




Context



Impact on the European patent system



Importance of patenting in the biotechnological sector



Impact on the biotechnological sector



Further considerations


October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

4

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 Br
üstle judgement of the CJEU was used as a

convincing argument.

October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

5

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.”



October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

6

Impact on the European Patent System (II)





Br
üstle v.
Greenpeace

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

CJEU’s
judgements
have an
impact on
the EU 27.

EPO Member States =
EU 27 + 11 States

October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

7

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


October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

8

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.


October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

9

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.


October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

10

Impact of Br
üstle 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.

October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

11

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


October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

12

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.



October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

13

Thank you for you attention!

agnieszka.kupzok@yahoo.com

October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

14

European Parliament



October 10
th
, 2012

Agnieszka Kupzok Impact of “Br
ü
stle“ on the Biotech sector

15

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
]