wipo life science symposium on ip and bioethics - felix addorseptember 4, 20071 dr. felix addor...
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WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 1
Dr. Felix Addor
Deputy Director General, Swiss Federal Institute of Intellectual Property
Lecturer on International Intellectual Property Law, World Trade Institute and University of St.Gallen
WIPO Life Science Symposium on IP and BioethicsGeneva, September 4, 2007
Adressing bioethics issues :A Swiss – EC Perspective
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 2
„Considering the exclusive right to invention as given for the benefit of society, I know well the difficulty of drawing a line between the things which are worth to the public the embarrassment of an exclusive patent, and those which are not.“(Thomas Jefferson, 1813)
“As the value that society places
on intellectual property has increased,
that line has become murkier.”(The Economist, 2004)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 3
Patenting of life forms:
Patent examiners playing God?
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 4
Misconceptions about patents
A patent is not a permission to use an invention (not a
marketing authorization).
A patent is not an approval of an invention or of the possible
exploitation of an invention.
The patent system is not a tool to guide the research
and technical development or to prevent abuses of new
technologies!
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 5
What can be protected by a patent?
1. Inventionproduct or process
that offers a new technical solution to a problem
3. Novelty not comprised in the state of the art = unavailable to the public
4. Inventive stepnot obvious for the person skilled in the art
5. Industrial applicationcommercially exploitable
2. No exclusion
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 6
What is an invention in the biotech field?
Discovery
= Description of something
existing
= Extension of human knowledge
Invention
= Instruction how to solve a problem
with technical means
= Extension of human abilities
Penicillin
Penicillium notatum
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 7
The human body = patentable subject matter?
“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.”
(Article 5(1) EU-Directive)
“The human body as such, at all
phases of his formation and
development, including the embryo, is
not patentable.”
(Article 1a(1) new Swiss Patent Law)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 8
Elements of the human body: patentable subject matter?
“An element isolated from the human
body or otherwise produced by means
of a technical process, […], may
constitute a patentable invention,
even if the structure of that element is
identical to that of a natural element.”
(Article 5(2) EU-Directive)
“Elements of the human body in their
natural surrounding are not patentable.
Such elements are patentable as
invention if they are produced by means
of a technical process, if a technical
utility is indicated and if the other criteria
of article 1 (novelty, inventive step,
industrial applicability) are fulfilled.”
(Article 1a(2) new Swiss Patent Law)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 9
Gene sequences = patentable subject matter?
“… a mere DNA sequence without
indication of function does not contain
any technical information [teaching]
and is therefore not a patentable
invention.”
(Recital 23 EU-Directive)
“A naturally occurring sequence or
partial sequence of a gene as such is
not patentable.”
(Article 1b(1) new Swiss Patent Law)
Isolated genes
=
as a tiger in a cage!
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 10
Gene sequences = patentable subject matter?
“An element isolated from the human
body or otherwise produced by means
of a technical process, 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) EU-Directive)
“Sequences deriving from a naturally
occurring sequence or partial sequence
of a gene are patentable as inventions,
if they are produced by means of a
technical process, if their function is
concretely disclosed and if the other
criteria of article 1 (novelty, inventive
step, industrial applicability) are
fulfilled.”
(Article 1b(2) new Swiss Patent Law)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 11
1 2 3 4 5
Dependency on previous patents (crow ded art) (n = 29)
Dif f iculties to enter a technological f ield because of too many patents (n = 29)
Patents, blocking access to technologies (n = 28)
Conf licting and overlapping patents (n = 29)
Unaw areness of research staf f about patenting (n = 29)
Patents, impeding further R&D (n = 28)
Submarine patents in the f ield (n = 24)
Over-complex patent licensing negotiations (n = 29)
Individual royalties are too high (n = 28)
Accumulation of too many royalties for too many dif ferent patent holders (n = 27)
Patents hampering research co-operations (n = 29)
Break dow n of patent rights negotiations (n = 28)
Proliferation of legal patenting disputes (n = 28)
Ethical problems (n = 27)
Main problems with gene patents (acc. to participants of CH empirical survey)
CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 34 (1=never, 5=very often) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 12
Possible remedies
0 5 10 15 20 25 30 35 40 45 50
Consortia
Introduction of provisionalapplications
Maximum royalty fees
Introduction of a graceperiod
Cross licensing
Patent pools
Protection limited to concretedisclosure functions of DNA
Broad research exemption
CH Survey: 8.2 Remedies, Fig. 35 (named as many times as effectively to ...) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 13
Assessment of a protection limited to the concrete disclosed functions of DNA?
1 2 3 4 5
The absolute protection of DNApatents is hampering researchand further development (n=25)
A concrete disclosure of thefunction enables the restriction
of patent claims (n=24)
Limited protection of DNApatents is for our purpose more
important than absoluteprotection (n=23)
A limitation of the scope ofprotection should be providedfor in patent legislation (n=22)
CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 39 (1=no agreement, 5=total agreement) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 14
Gene
F
Uses
B
A
C
D
E
ProteinsDerivedSequences
Reasoning: Is the absolute protection a too generous reward for the patent owner ?
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 15
Gene
F
Uses
B
A
C
D
E
ProteinsDerivedSequences
Alternative: Purpose-limited product claims ?
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 16
Gene
F
Uses
B
A
C
D
E
ProteinsDerivedSequences
The approach of the new Swiss Patent Law
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 17
The approach of the new Swiss Patent Law (2):
Absolute product claims on restricted sequences
Article 8c new Swiss Patent Law :
(DNA sequences: Scope of protection)
The protection of a claim, containing a nucleotide sequence, which is derived from a naturally occurring sequence or partial sequence of a gene, is restricted to those parts of the sequence, which is performing the concretely described function.
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 18
Ethical limits to patentability:Inventions contrary to ordre public or morality
Some subject matter is excluded from patentability even
if it constitutes an invention:
Inventions shall be considered unpatentable where their
commercial exploitation would be contrary to ordre
public or morality; however, exploitation shall not be
deemed to be so contrary merely because it is
prohibited by law or regulation.
(Article 6(1) EU-Directive / Article 2(1) new Swiss Patent Law)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 19
How to deal with the human embryo?
Ethical controversy
Source: University of Wisconsin-Madison
The issue of human stem-cells
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 20
Ethical limits to patentability:Human embryonic stem-cells Adult, foetal and embryonic human stem-cells are elements
of the human body Adult and foetal human stem-cells are patentable in
principle no specific ethical issues But: Embryonic human stem-cells are obtained from an
human embryo that has to be destroyed controversial situation in Europe
Decisions by EPO: Edinburgh patent (EP 0 695 351) partly revoked Thomson patent (EP 0 770 125) refused (appeals are pending in both cases)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 21
Ethical limits to human embryonic stem-cells
Subject matter EPO EGE CH
Unmodified ES Excluded from patentability
Rule 23 d (c) EPC
Excluded from patentability
Excluded from patentability
Art. 2(1)(e) PatG
Modified ES Excluded from patentability (?)Rule 23 d (c) EPC
Patentable Patentable
Procedures to obtain ES
Excluded from patentability (?)
Rule 23 d (c) EPC
Patentable Patentable
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 22
AssessmentArt. 5(1) EU-Directive
Art. 1a(1) new Swiss Patent Law
Art. 6(2)(a) EU-Directive
Art. 2(1)(a) new Swiss Patent Law
(incl. the clones thus obtained)
Recital 38 EU-Directive (transgenic
animals?)
Art. 2(1)(b) new Swiss Patent Law
(transgenic animals not excluded)
Invention concernshuman body/human genome
(reproductive and therapeutic)
cloning of human beings
processes for producing chimeras
or hybrids
Ethical limits to patentability
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 23
AssessmentEU-Directive unclearArt. 2(1)(c) new Swiss Patent Law
Art. 6(2)(b) EU-DirectiveArt. 2(1)(d) new Swiss Patent Law (incl. germ line cells thus obtained. Somatic gene therapy not excluded)
EU-Directive unclearArt. 2(1)(d) new Swiss Patent Law (only non modified ESC)
Art. 6(2)(c) EU-Directive (for industrial or commercial uses)Art. 2(1)(f) new Swiss Patent Law (for non medical uses)
Invention concernsprocesses for human parthenogenesis
germ line therapy
human embryonic stem- cells
use of human embryos
?
?
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 24
Assessmentnot contrary to ordre public/morality
not contrary to ordre public/morality
not contrary to ordre public/morality
not contrary to ordre public/morality
Art. 6(2)(d) EU-DirectiveArt. 2(1)(g) new Swiss Patent Law
Invention concernsdiagnostic processes involving genes
organs
somatic cells
genes
processes for genetic modification of animals likely to cause unjustified suffering
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 25
Assessing the ‚morality‘ of claimed inventions
Post grant opposition procedure (Art. 59c new Swiss Patent Law)
Any person may file an opposition against a granted patent if the ethical limits
seem not to be respected, in particular with regard to patents: of the human body of elements of the human body in their natural surrounding of naturally occurring sequence / partial sequence of a gene as such of inventions where their exploitation would violate human dignity, or would
disregard the dignity of plants and animals of inventions where their commercial exploitation would be contrary to
ordre public or morality
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 26
Biotechnology Patents – Access and Benefit Sharing
What role can patent system play?
Focus of international discussions: New disclosure requirements
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 27
Approach of the new Swiss Patent Law
Requirement to declare the source
of genetic resources and traditional knowledge
in the patent application (Art. 49a)
Sanctions for wrongful declaration (Art. 81a):
fines up to CHF 100,000
publication of ruling
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 28
Research/experimental use exemption (Art. 9.1b new Swiss Patent Law) When do you need a license to use patented inventions for research purposes?
All research (commercial or not) = free – if aimed at gaining new knowledge about subject matter of the invention
Introduction of “bolar exemption”: Use of the invention to obtain the authorisation of a pharmaceutical product = free use of invention e.g. through
Clinical trials = possible
Even production of specimens = possible
BUT
Production of the new drug only after expiration of
the patent (= no stockpiling)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 29
Limits of research exemption: The issue of research tools
Research exemption: the used invention must be the object and not the instrument of research:
Problem: no free use of „research tools“, (such as polymerase chain reaction)
if instrument = license needed
Solution: Access guaranteed through legal licence (Art. 40b new Swiss Patent Law):
= right to use the research tool for everybody
+ obligation to pay licence fee
no agreement = fee fixed by a court
no “reach through” licence fees
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 30
Compulsory licence for diagnostic testing
Access to reliable diagnostic methods may be hampered if
disease caused by specific gene sequence or single nucleotide polymorphisms (SNPs),
and
diagnostic method based on the relevant nucleotide sequence patented
Art. 40c new Swiss Patent Law provides for a compulsory licence
in case of Anticompetitive behaviour = breach of antitrust law/abuse of dominant
position/agreement restricting competition/abusive behaviour (e.g.
BRCA1- breast cancer gene)
WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 31
Transparency
Knowledge
Research & Private Use Exemption
PublicPatent Owner
Innovation
Exclusive Right
Incentive
Protection of Investments
Goal = Balancing of Interests