Title: PATENTING HUMAN STEM CELLS: an URGENT NEED for a CLARIFICATION
1PATENTING HUMAN STEM CELLS an URGENT NEED for a
CLARIFICATION
- Judge Christian BYK, Court of appeal, Paris,
Secr.Gl International association of law, ethics
and science, Member French Committee for UNESCO.
2Introduction
- Patenting human stem cells has become one of the
most controversial issues of the bioethics field
at the beginning of the XXI st century, at least
in industrial countries. A series of good
reasons may explain the importance of this on
going controversy. - First, we may note that most of the issues
related to patenting biotechnology have found a
solution - Secondly, patenting human stem cells raised again
the issue of their embryonic origin - Third, it concentrates the critics made against
using the human body and parts of it as an
essential tool of the new biology, with a
particular attention on the commercialisation of
the human body
3Introduction
- This confusion certainly finds some grounds in
the very broad scope covered by the expression
patenting human stem cells. - What kinds of cells does it include? What kinds
of patents are concerned? - The margin of discretion left to the national
laws by the European legislator has also
effective consequences on the European
harmonization - Finally who has interest in supporting an on
going confused discussion? And who may
efficiently help to clarify it?
4What are we speaking about?
5What are the stem cells concerned?
- A stem cell can be defined as an
undifferentiated somatic cell that is capable of
either division to give rise to daughter stem
cells, or differentiating into specialized cell
type given the appropriate signals. - We may consider 3 types of distinctions
regarding human stem cells
6The first distinction
- considers the sources from which the stem cells
are originated adult, foetus or embryo. This
distinction raises important questions may the
patentability of stem cells be affected by their
origin and are the consequences different
regarding the various sources of human stem cells?
7The second distinction
- lies on the functionalities of human stem cells
totipotent, pluripotent and multipotent stem
cells - A totipotent cell is a cell that has an unlimited
capability to create an entire new organism. - A pluripotent stem cell can give rise to any
foetal or adult cell type but it cannot develop
into an entire foetus. - A multipotent cell (a haematopoietic cell for
example) can give rise to several other cell
types but those types are limited in number. This
distinction is extremely important when we have
to distribute in legal categories the cells
concerned. What is patentable is relying on this
legal categorisation.
8The third distinction
- applies to the fact that the human stem cells may
be modified or not. some analysts use this
distinction for its legal consequences in the
field of patent regarding biotechnological
material.
9Appreciating the ethical issues regarding the
different kinds of patents
- A first classification is based on the 3 existing
kinds of inventions products, processes,
applications - A product is a determined material object with
specific characteristics which makes it different
from any other existing object. - A process is a mode of treatment which produce a
given result (immaterial) or product (material). - An application refers to the application of a
known process combined with the production of a
product or a result and the novelty of the
application The global question is to know if and
how far stem cells can be covered by these
different types of inventions and if such
inventions can be protected under patent law.
10Appreciating the ethical issues regarding the
different kinds of patents
- A second type of classification based on patents
national and European patents - National patents are delivered by national patent
offices according to national patent laws. In
European Union countries, those laws have to be
in conformity with directive 98/44/EC of 6th July
1998. - European patents are delivered by the European
Patent Office (Munich) according to the European
Patent Convention the main question is how the
issue of patenting human stem cells may be
affected by the existence of this dual system?
11The dual system of norms a threat to a
consistent European policy
12European Union Patent Law legal uncertainty and
policy inaction
The interpretation of the exclusion clause
- It is globally left to the margin of appreciation
of Member States. the legal framework may be sum
up as follows the 1998 directive on patenting
biotechnology does not include specific
provisions on stem cells but does include such
provisions on the human body at its various
stages. - The rules applying to the human body consists in
one technical principle and one ethical
principle.
13The interpretation of the exclusion clause
- The technical principle (art.5) draws a
distinction between the unpatentability of the
human body in natural state as against elements
isolated from the human body which could
constitute a patentable invention, providing they
satisfy the patenting criteria of novelty,
inventive step and industrial application. - The ethical principle (art.6) states that
inventions shall be unpatentable where their
commercial exploitation would be contrary to
ordre public and morality and provides a
non-exhaustive list of unethical inventions that
would be excluded from patentability.
14The interpretation of the exclusion clause
- Are human stem cell inventions subject to the
technical distinction which allows patents on
elements isolated from the human body? If so, do
such inventions, or some of them, nevertheless
fall in the ethical exception of art.6? - Although the directive intended to harmonise
patent law in the field of biotechnological
inventions, its wording has left uncertain the
precise legal scope in regard to human stem cells
and acute differences have emerged in the
interpretation of the exclusion clause by Member
States.
15The fragmented legal landscape
- If the majority of the EU Member States follow
the exact wording of article 6 in their national
laws, some have changed the wording of art.6.2.c - Concerning the practice of national patent
offices, opposed views have been adopted. - While the legislations may open broad
interpretations of the exclusion clause, the
practice of the national patent office seems to
favour a narrow interpretation of this clause.
16The wait and see policy of the European Union
- This confused situation is reinforced by the
views expressed by some European institutions,
leaving the European Commission with an uneasy
approach. - On one hand, some European institutions have
called for a strict restrictive interpretation on
the patentability of human stem cells. - On the other hand, the analysis of the
jurisprudence of the European Court of Justice
points in a direction of greater sensitivity to
national perceptions of ethics and morality ,
even in the field of protection of fundamental
rights. - The ECJ will preserve national differences as
part of the broad margin of appreciation of
Member States within a common Community framework
of fundamental rights.
17The wait and see policy of the European Union
- As a consequence, the European Commission adopted
in its 2005 report on the implementation of the
directive a very careful attitude. - the Commission concluded that in the light of
its analysis totipotent stem cells should not be
patentable, on grounds of human dignity but, on
the other hand, it expressed the view that there
is no immediate answer to the question of
patentability of embryonic pluripotent stem cells - This is an implicit recognition that the
leadership of the EU policy in the issue of
patenting human stem cells is greatly challenged
by other existing European norms
18The challenge rose by other European norms
The European Patent Convention
- The European Patent Office voluntarily
transposed the wording of the provisions of the
directive in the form of amendments to the
European Patent Convention Implementing
Regulations on 16th June 1999. But the ECJ has no
authority in examining these regulations and
consequently the interpretation of the exclusion
clause is totally left to the organs of the EPO.
Two cases are of specific interest concerning the
issue of patenting human stem cells.
19The European Patent Convention
- The Edinburgh decision (31 July 2003) deals with
methods of isolating and/or enriching and /or
selectively propagating animal stem cells and
with genetically modified animal cells for use in
the methods. - The Opposition Division concluded that not only
is the use of a human embryos exclude from
patentability, but also the human embryonic stem
cells retrieved therefrom by destruction of the
human embryos
20The European Patent Convention
- The Warf referral relates to cell cultures
comprising primate embryonic stem cells. the
Examining Division was of the opinion that Rule
23d ( c) should be interpreted broadly and
therefore refused the application on the basis
that the invention involved the direct and
unavoidable use of human embryos. - On appeal, the Technical Board of Appeal referred
(21st April 2006) the matter to the Enlarged
Board of Appeal
21The European Patent Convention
- The four questions raised are as follows
- Does Rule 23d (c ) EPC apply to an application
filed before the entry into force of the rule? - Does Rule 23d(c ) EPC forbid the patenting of
claims directed to products (here human
embryonic stem cells cultures) which as
described in the application- at the filing date
could be prepared exclusively by a method which
necessarily involved the destruction of the human
embryos from which the said products are derived
, if the said method is not part of the claims? - Does Art. 53 (a) EPC forbid patenting such
claims? - In the context of questions 2 and 3, is it of
relevance that after the filing date the same
products could be obtained without having to a
method necessarily involving the destruction of
human embryos ( here e.g derivation from human
embryonic stem lines) ?
22The European Patent Convention
- The current approach of the EPO is still unclear
because on one hand, the decision of the
Opposition Division is not binding on the other
first instance divisions and, on the other hand,
the referral to the Enlarged Board of Appeal is
still pending.
23The European Human Rights Conventions
- It is essential, as recital 43 of the directive
to refer to the legal obligations of the Member
States as arising from European conventions on
human rights, the European Convention on Human
Rights (1950), the European Convention on
Biomedicine (1997) and its Protocol on Human
Cloning (1998). - The European Convention on Human Rights
clarifies what are the rights of the embryo in
Europe. - the European Court of Human Rights has
consistently held that the question whether the
human embryo has a right to life comes with the
margin of appreciation of Member States. - In the 2006 Evans v.U.K case, the court extended
this approach to the human embryo in vitro. - The conclusion is easy under the European
Convention on Human Rights, there is no legal
basis to establish a uniform norm of
interpretation in this area that may be used in
the perspective of applying article 6 of the
directive
24The European Human Rights Conventions
- The biomedicine convention has limited effect on
the status of the human embryo. - Although art.18.1 states that where the law
allows research on embryos in vitro, it shall
ensure adequate protection of the embryo, the
expression adequate protection is vague and its
implementation is anyway a matter of national
law. - Regarding art.18.2, which states that the
creation of human embryos for research purposes
is prohibited, we can remark that none of the
States which allow such creation have ratified
the convention - Furthermore, in a July 2003 report the working
party on the human embryo concluded that a
consensus could not be reached on a protocol on
the human embryo in vitro. - May art.21 which stipulates that the human body
and its parts shall not, as such, give rise to
financial gain , imply a ban on the
commercialisation of the human embryo the
explanatory memorandum gives a negative reply to
this question
25The European Human Rights Conventions
- The 1998 Protocol to the Biomedicine Convention
prohibits human reproductive cloning. - Both the intention of the Member States and the
wording of art.1 of the Protocol make it
unambiguous that the text does not concern human
embryos and therapeutic cloning.
26Conclusion
- The present legal situation the implementation
of the EU directive does not encourage a
harmonising process regarding the exclusion
clause of article 6. - The EPC system creates an obligation for the
European Patent Office to decide what is
patentable or not but the process can not rely on
common European view.
27Conclusion
What could be then the solutions to this issue?
- One would be to modify the directive and
consequently the EPC Implementing Regulations to
introduce the appropriate provisions regarding
human stem cells. - A second solution would be that the EPO takes
into consideration the fact that only toti-potent
stem cells may develop into human embryos and
accepts granting patents for pluri- and
multi-potent embryonic stem cells - A third solution would invite the EPO to operate
a distinction between inventions involving stem
cells which were retrieved by destruction of the
embryos from cells obtained by other means - As the Enlarged Board of Appeal could not wait
for the modifications of the European norms, its
coming decision will certainly be inspired by one
of the last two solutions