Ethical aspects and Patents in Lifescience Peter R. Thomsen Manager Global IP Litigation, Corporate...

Ethical aspects and Patents in LifesciencePeter R. Thomsen

Manager Global IP Litigation, Corporate Intellectual Property, Novartis

WIPO symposium on IP and BioethicsGeneva, 4. Sep 2007

2 | 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


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)


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


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


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


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


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


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


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


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 benefit…and animals resulting from such processes


Example: Human Embryonic Stem Cells (hEC)

Patents on human stem cells?

Patents on human stem cells?

Patents on processes to cultivate cells?


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


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


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


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)

Ethical aspects and Patents in Lifescience Peter R. Thomsen Manager Global IP Litigation, Corporate...

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