Download The patentability of biotechnological inventions

Friday, 5th May 2006
The patentability
of biotechnological inventions:
The European Commission’s
second 16c report
Paul Van den Bulck
Partner at Ulys Law Firm (Brussels)
Lecturer at R. Schuman University Strasbourg (France)
WWW.ULYS.NET
Structure
I. Introduction
II. Content of the second 16c report
(A) latest developments occurred since the publication
of the first 16c report
(B) the scope of patents on sequences or partial
sequences of genes which have been isolated
from the human body
(C) the patentability of human stem cells and cell lines
obtained from them
I. Introduction
 Directive 98/44/EC of 6 July 1998 on the legal
protection of biotechnological inventions
 Article 16c of the Directive:
“The Commission shall send the European
Parliament and the Council […] annually as from
the date specified in Article 15(1), a report on the
development and implications of patent law in the
field of biotechnology and genetic engineering.”
 the first 16c report
(http://europa.eu.int/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf)
dealt with:
 the implementation of the Directive in Europe;
 the compatibility of the Directive with the relevant international
agreements ;
 the patentability of inventions relating to plants and animals;
 the patentability of inventions relating to elements isolated from the
human body;
 exclusion from patentability of inventions whose commercial
exploitation would be contrary to ordre public or morality.
 the second 16c report of 14 July 2005
(http://www.europa.eu.int/smartapi/cgi/sga
_doc?smartapi!celexapi!prod!CELEXnumd
oc&lg=en&numdoc=52005DC0312&model
=guichett)
 involvement of the Group of Experts and
the European Group on Ethics
II. The second 16c report
A. latest developments occurred since
the publication of the first 16c report
 the European Commission draws the state
of progress regarding the transposition of
the Directive into the national legislation of
the EC Member States: 21 Member States
have notified the Commission their legal
instruments implementing the Directive
 Setting up of a group of Experts to advise
the Commission on the preparation of 16c
reports.
 The European Commission reports that the
adoption of Council Regulation amending
Regulation 2100/94 on Community plant
variety rights in order to render Article 29 of
Regulation 2100/94 and Article 12 of the
Directive mutually compatible.
These provisions deal with cross-licenses on
patent and plant variety rights.
B. the scope of patents on (partial) sequences
of genes which have been isolated from
the human body
 The European Commission addresses the
question on whether patents on DNA sequences
should be allowed according to:
 the classical model of patent claim, i.e. the inventor
claims an invention which covers possible future uses
of that sequence; or
 the “purpose-bound protection” model, i.e. a
restriction of the patent so that only the specific use
disclosed in the patent application can be claimed?
 “purpose-bound protection” is not new:
second medical patent claims for known
medical substances (‘Swiss claims’) have
been allowed for by the EPO
(EPO Enlarged Board of Appeal, 5
December 1994, G05/83 EISAI Co Ltd.).
 Laws implementing Directive 98/44 in France
and Germany provide for purpose-bound
protection:
 France: Art. L 613-2-1, Code de la propriété
intellectuelle
 Germany: S. 1a (4), Patentgesetz
 In the second 16c report, the European
Commission does not take position on the
validity of transposition of the Directive, by the
Member States, according to the choice
between classical and limited scope of
protection for gene sequences.
C. the patentability of human stem
cells and cell lines obtained from them
 the European Commission also deals with the
patentability of human stem cells and cell lines.
 Article 5 (2) of the Directive:
“An element isolated from the human
body...including the sequence or partial sequence
of a gene, may constitute a patentable invention,
even if the structure of that element is identical to
that of a natural element.”
 Article 5 (2) of the Directive:
allows for the patentability of human stem
cells; and
allows for the patentability of human stem cell
lines
(if the invention is new, involves an inventive
step and is susceptible of industrial application)
 As regards to human embryonic stem
cells, one has to distinguish:
totipotent stem cells which are capable of
developing into a human being
pluripotent stem cells which are not so
capable, but that can be readily isolated
and grown in culture in sufficient numbers
to be useful
 Article 5 (1) of the Directive:
“The human body, at the various stages of its
formation and development, and the simple
discovery of one of its elements... cannot
constitute patentable inventions.”
 totipotent stem cells = unpatentable (since
they are capable of developing into a human
being)
 What about the patentability of pluripotent
stem cells? According to the European
Commisson: a more complex situation
Article 6 of the Directive:
1. Inventions shall be considered unpatentable
where their commercial exploitation would
be contrary to ordre public or morality;
2. ...the following, in particular, shall be
considered unpatentable:
(a) processes for cloning human beings;...
(c) uses of human embryos for industrial or
commercial purposes;...
 Article 6(2)c): does the unpatentability concerns
(i) an embryo as a whole or (ii) every invention
concerning stem cells?
No consensus within the Group of Experts.
 Importance of the interpretation of the concept
of “embryo” in the national legislation of the
Member States
 the European Commission refrains from giving
a further definition or to provide for further
harmonization in the area of Article 6(2)c)
 the European Commission concludes that
“there is no immediate answer to the question of
the patentability of embryonic pluripotent stem
cells.”
‘EDINBURGH PATENT’- case :
 Patent granted in December 1999
 patent for ‘animal transgenic stem cells’ (no human
cloning)
 EPO Opposition Proceedings (July 2002):
 amendment to exclude human embryonic stem cells
 adopted broad interpretation of Rule 23(d)(c) (6(2)c
of directive)
 does this mean that human embryonic stem cells are
unpatentable ?
 The decision of the Board of Appeal is awaited (end
2006)
TO BE CONTINUED……
Q
&A
uestions
nswers
Paul Van den Bulck
Partner at Ulys Law Firm (Brussels)
Lecturer at R. Schuman University Strasbourg (France)
WWW.ULYS.NET