Ethical aspects and Patents in Lifescience

1
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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Overview

• Role of Patents and boundaries to ethics
• Example Human Stem Cells
• Other Ethical considerations in connection with
  patents

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Role of PatentsWhat 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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Role of PatentsWhat 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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Role of PatentsWhat 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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Role of PatentsPatentability 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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Patents and boundaries to EthicsRole 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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Patents and boundaries to EthicsRole 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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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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Ethics in Patent LawInternational 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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Ethics in Patent LawExample 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 benefitand
  animals resulting from such processes

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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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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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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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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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ConclusionsEthical 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)