What is a patent? - WIPO

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Dec 5, 2012 (4 years and 10 months ago)

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Ethical aspects and Patents in Lifescience

Peter R. Thomsen

Manager Global IP Litigation, Corporate Intellectual Property, Novartis

WIPO symposium on IP and Bioethics

Geneva, 4. Sep 2007

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Overview


Role of Patents and boundaries to ethics


Example: Human Stem Cells


Other Ethical considerations in connection with patents


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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Role of Patents

What is a patent?


A right to exclude others from doing or using
what is
claimed

in the patent


For a certain
Country,
for which patent was applied in
kept in force


For a
limited time

period (at least 20 years from Filing
Date,
TRIPs Art. 33)

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Role of Patents

What is a patent not?


A patent is not a positive right


By having a patent the patentee is not automatically
entitled to use the patented invention


Provisions of other laws may make it impossible for
patentee to use patented invention, e.g.

»

Health safety Law

»

Environmental Law

»

Restrictions of activities by Embryonic Protection Law

»
Earlier dominating Patent

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Role of Patents

What are patents good for?


Patent system gives incentive to invest in
Research and Development to promote


that more new inventions are made


that those new inventions are not kept secret but published


Reward for providing and publishing
inventions


Technical progress,
e.g. huge investments to bring a
medicament with a new active ingredient to the market

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Role of Patents

Patentability Criteria (see Art. 27.1 Art. 29 TRIPS)


For Technical inventions


Mere scientific discoveries, findings in nature, are not patentable


Novelty


Different from what is known


Inventive/Non
-
obvious


Not easily conceivable by a trained person


Industrial applicable/Useful


Enablement/ Sufficient Disclosure


Disclosed in a way that a trained person can repeat invention

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Patents and boundaries to Ethics

Role of Ethics in Patents


Ethics are about what is regarded right or wrong by a
society


Ethical norms and values may vary from culture group to
culture group, or even from country to country


Ethical norms and values may change over time


Technology may progress over time

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Patents and boundaries to Ethics

Role of Ethics in Patents


Implications for Patents?


Differentiation between
activities for which patent
protection will be sought

and the
act of patenting those
activities


Activities claimed in a patent may be ethically
problematic


However, patenting it does not add anything, because
the patent does not include the right to perform the
problematic activities

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Role of Patents and boundaries to ethics


Proposals/Conclusions



Patent system cannot be the primary tool to deal with
ethical considerations for research and commercial
activities


Other institutions necessary to solve ethical problems or to
enforce ethical norms


Since ethical standards may vary, only those inventions
should be excluded from patentability for
ordre public

or
morality reasons, for which there is a clear consensus in
overwhelming parts of society that the underlying activities
are contrary to ethical standards

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Ethics in Patent Law

International Standards


According to TRIPs, WTO
-
members may exclude from
patentability inventions in order to protect
ordre public

or
morality, provided that such exclusion is not made merely
because the exploitation is prohibited by their law
(see TRIPS,
Art. 27.2)


Illegality of an activity is not sufficient to exclude it from
patentability for
ordre public

or morality reasons

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Ethics in Patent Law

Example Biotechnological Inventions


EU
-
Directive on legal protection of biotechnological
inventions
(Dir 98/44)


Parallel provisions in the European Patent Convention

(R. 23b
-
f, EPC1973)


Patents shall not be granted for

-
Processes for cloning of human beings

-
Processes for modifying the germ cell line genetic identity of human beings

-
Uses of human embryos for industrial or commercial purposes

-
Processes for modifying the genetic identity of animals which are likely to
cause them suffering without anysubstantial medical benefit…and animals
resulting from such processes


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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Example: Human Embryonic Stem Cells (hEC)


Patents on
human stem
cells?

Patents on
human stem
cells?

Patents on
processes to
cultivate cells?

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Example: Human Embryonic stem Cells (hEC)

„Patents shall not be granted for uses of human embryos for
industrial or commercial purposes“ (EU
-
Biotech Dir 98/44)


Patents on methods to cultivate or differentiate hEC


Patents are NOT directed to uses of human embryos


Patent Offices have taken different positions:


European Patent Office
: excluded from patentability, because it was
contended that hEC are necessarily consumed in order to provide the
starting material for the claimed process; question is pending before
the Enlarged Board of Appeal (G2/06)


Patent Offices in Sweden, Great Britain and Germany
: allowed
patents, because carrying out the process as claimed does not make
use of human embryos for industrial or commercial purposes


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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Example: Human Embryonic stem Cells


Federal Patent Court in Germany

revoked part of a patent which
was directed to a process to prepare purified cells with certain
properties wherein the first step was „cultivating [human] embryonic
stemcells…“


reasoning: patents that do not claim but require as a precondition to
be carried out with human embryonic stem cells which were derived
by consuming an embryo fall under the exclusion due to „uses of
human embryos for industrial or commercial purposes “


Court did not address that human embryonic stem cells may be
legally derived from other sources, e.g. existing embryonic cell lines
and that such research is substantially funded and promoted by public
institutions (e.g. EU
-
commission or DFG)


patentee appealed and case is pending before German Federal
Supreme Court


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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Other ethical considerations in connection to patents


Patenting in Least Developed Countries (LDC)

-
Swiss Pharmaceutical Industry has decided to
voluntarily abstain from filing patent applications in
LDCs


Enforcing patents against a product of a third party

-
If a third party sells the only effective product that
infringes a patent and neither the patentee nor
somebody else could provide a substitute product

-
Serious ethical considerations how to enforce the
patent

-
Injunction may not be appropriate as this would
prevent access of patients to the product in need

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| Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

Conclusions

Ethical aspects and Patents in Lifesciences


A functioning patent system is essential for development of
new pharmaceuticals and treatments


The Patent System is not suited to enforce ethical norms


Ethical problems should be solved by other legal
instruments or institutions, e.g. Research regulations,
ethical advisory committees etc.


Since ethical standards and technology may develop over
time exclusions from patentability for ethical reasons
should be limited to clear cases with society
-
consensus
(e.g.
reproductive cloning of human beings)