Exclusions to patentability Flashcards
*** Chiron v Murex Diagnostics [1996
Industrial application includes “any kind of industry” in its widest sense (whether or not for profit)
Needs a “useful purpose”
Key terms: Industrial application
- Paez’s Application
Inventions alleged to operate in a manner which is clearly contrary to well-established physical laws, such as perpetual motion machines, are regarded as not having industrial application.
Key terms: Industrial application
Paris Convention, Article 4quater
“The grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the sale of the patented product or of a product obtained by means of a patented process is subject to restrictions or limitations resulting from the domestic law.”
Key terms: ordre public
TRIPS Article 27(2)
Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordrepublic or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
Key terms: ordre public
Patents Act 1977, s 1(3)-(4)
(3) A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality.
(4) For the purposes of subsection (3) above exploitation shall not be regarded as contrary to public policy or morality only because it is prohibited by any law in force in the United Kingdom or any part of it.
Key terms: ordre public
EPC, Article 53(a)
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
Key terms: ordre public
- T 315/03 Transgenic animals/HARVARD [2006
Whether it is contrary to morality is judged at the priority date
Key terms: ordre public
- T 19/90 Oncomouse/HARVARD [1990]
The exclusion should reflect the current views of society in relation to morality and technology
“a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other.” = BALANCING TEST
Animal varieties cannot be patented, but “animal varieties” does not extent to “animals” per se, but limited to sub-species of animals.
As the technical feasibility of invention is not confined to a particular animal variety, transgenic animals do not fall within the exclusion.
Key terms: ordre public, balancing test, animal varieties
- G 1/07 Treatment by surgery/MEDI-PHYSICS [2011]
Each exception must be considered for its purpose to determine whether it should be narrowly interpreted.
Key terms: how to read exclusions
- Aerotel Ltd v Telco Holdings Ltd [2006]
All exceptions should be narrowly construed
Key terms: how to read exclusions
- T 356/93 Plant cells/PLANT GENETIC SYSTEMS [1995] OJ EPO 545
“It is generally accepted that the concept of ‘ordre public’ covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment. Accordingly…inventions the exploitation of which is likely to breach public peace or social order (for example, through acts of terrorism) or the seriously prejudice the environment are to be excluded from patentability as being contrary to ‘ordre public’.
The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deep routed in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation. Accordingly…inventions the exploitation of which is not in conformity with conventionally accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality.”
Key terms: ordre public EPO
- Relaxin [1995]
“[whether] human genes should be patented is a controversial issue on which many persons have strong opinions…the EPO is not the right institution to decide on fundamental ethical questions.” AVOIDING ONCOMOUSE TEST
Key terms: avoidance of the balancing test
- Phillip Grubb et al, Patents for Chemicals, Pharmaceuticals and Biotechnology (suitability of patent officers to decide on morality)
“Patent Officers are, in this respect, simply members of the public, with no special aptitude or training. As long as the criteria for applying EPC, Article 53(a) are as stated in the Guidelines, namely ‘whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable’ then examiners, as members of the public in general, are as well fitted to judge this as anyone else. But if, as they are required to by the Board of Appeal in the Oncomouse case and by the BPD, examiners are supposed to carry out sophisticated balancing of subjective moral values as part of the examination procedure, then they are wholly incapable of such a task. Are EPO examiners to have courses in moral philosophy or theology? And if so, what variety?”
Key terms: view point on balancing test
- G 2/06 Use of embryos/WARF [2009]
“The EPC forbids the patenting of claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, even if the said method is not part of the claims.”
Key terms: stem cells
- C-34/10 Greenpeace v Brustle [2012]
1.Article 6(2)(c) means that:
–any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;
–it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
- The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
- Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
Key terms: stem cells
- C-364/13 International Stem Cell Corp
“Article6(2)(c) of Directive must be interpreted as meaning that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.”
Key terms: stem cells
- G 1/98 Transgenic plant/NOVARTIS II [2000]
Enlarged Board held that patent protection ends where the protection under the UPOV Convention (or under the Community Plant Variety Regulation) begins (and the converse)
Where a plant variety is individually claimed it cannot be patented irrespective of how it was made.
This means that a variety is excluded where it was produced by selective breeding or by genetic engineering. But where a transgenic plant is claimed, but no variety identified, then it can be patented even if the claim covers plant varieties.
Key terms: protection of plant varieties
- G 2/07 Broccoli/PLANT BIOSCIENCE [2012]
It must be concluded that the legislator’s intention was to exclude from patentability the kind of plant breeding processes which were the conventional methods for the breeding of plant varieties of that time. These conventional methods included in particular those (relevant for the present referrals) based on the sexual crossing of plants (i.e. of their whole genomes) deemed suitable for the purpose pursued and on the subsequent selection of the plants having the desired trait(s). The application of technical means or other forms of human intervention in such processes which helped to perform them was already common.
Key terms Essentially biological processes
- G 1/04 Diagnostic methods [2006] (‘defining diagnosis’)
“‘the exclusion from patentability of [medical] methods… seems actually to be based on socio-ethical and public health considerations. Medical and veterinary practitioners should be free to take the actions they consider suited to diagnose illnesses by means of investigative methods. Consequently, the policy appears to be aimed at ensuring that those who carry out diagnostic methods as part of the medical treatment of humans or veterinary treatment of animals are not inhibited by patents.”
Diagnostic methods likewise do not cover all methods related to diagnosis. To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c), it must first be established whether all of the necessary phases are included in the claim.
The claim must include method steps relating to all of the following phases:
(i) the examination phase, involving the collection of data,
(ii) the comparison of these data with standard values,
(iii) the finding of any significant deviation, i.e. a symptom, during the comparison,
(iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis for curative purposes stricto sensu).
…each of the preceding technical method steps relating to phases (i) to (iii) must be performed on a human or animal body.
Key terms: industrial application, diagnostic methods
- G 1/07 Treatment by surgery/MEDI-PHYSICS [2011] (defining ‘surgery’)
This includes that the requirement medical expertise and the health risk involved may not be the only criteria which may be used to determine that a claimed method actually is a “treatment by surgery” within the meaning of Article 53(c) EPC. The referring decision and the President have mentioned the degree of invasiveness or the complexity of the operation performed…Although it appears likely that interventions involving a high degree of complexity and/or high degree of invasiveness would normally also be such as to require professional medical expertise and entail health risks even when carried out with the required care and expertise, the Enlarged Board does not wish to rule from the outset that, depending on circumstances of the individual case under consideration, other criteria could not also determine that a physical intervention on the human or animal body is a “treatment by surgery
Key terms: Surgery
- T 266/07 Magnetic resonance/WARF
Injecting a contrast agent (not surgical) - into the HEART would be though
Key terms: Surgery
- T 992/03 Treatment by surgery/MEDI-PHYSICS
Administering an anaesthetic gas (not surgical)
Key terms: Surgery
- T 1605/07 Blood flow measurement/TRANSONIC
Using a device that removes blood from the body and then puts it back (surgical)
Key terms: Surgery
* T 290/86 Cleaning plaque/ICI [1992] Unilever Limited (Davies’s) Application (1983) RPC 219
“Therapy” not limited to curative medical treatment as opposed to prophylactic medical treatment of disease, which may be preventive or curative.”
Something which has an excepted use which is dissociable from a permitted use will fall into the exclusion.
Key terms: Therapy
