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“Although a patent can be refused on the grounds of Ordre public or…

- - - - provided that a patent 'shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or antisocial behaviour'
      - Section 1(4) PA 1977 specified that behaviour would not be offensive, immoral, or antisocial simply because it is illegal in the UK.
        
        Intended to give effect to a comparable exemption in Art 53(a) EPC
    - - Section 1 PA 1977 amended to be consistent with Art 6 of the Biotech Directive
        
        Section 1(3): A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality.
  - - - Art 6(2) of the directive is now Rule 28 of the Implementing Regulations
  - - - Art 6(1): 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.
      - Art 6(2): illustrative list of inventions which are deemed unpatentable under Art 6(1)
        
        processes for cloning human beings
        
        processes for modifying the germ line genetic identity of human beings
        
        uses of human embryos for industrial or commercial purposes
        
        processes for modifying the genetic identity of animals which is likely to cause them suffering
      - Soon after the Council accepted the revised directive, an action was raised by the Netherlands to annul the directive
        
        Ground: Art 6 gave national authorities too much discretion in applying concepts expressed in general and ambiguous terms
        
        Rejected by the ECJ: Art 6 gave national authorities a wide scope for manoeuvre in applying the exclusion, this was necessary in order to take into account the particular difficulties that may arise from a patent in the social and cultural context of the member states.
- - - - Q2: dues Rule 28 prohibit claims directed to products which at the filing date could only be prepared by a method that necessarily involved the destruction of human embryos?
      - Q4: Was it relevant that after the filing date, the same products could be obtained without having to use a method that involved the destruction of a human embryo?
      - EBoA: Neither the EU legislator, nor the EPC legislator has chosen to define the term embryo. Given the purpose to protect human dignity and prevent the commercialisation of human embryos, the enlarged board can only presume the term ;embryo' was not to be given any restrictive meaning.
        
        Rule 28 and the corresponding provisions in the Directive does not mention claims but refers to the invention in the context of exploitation, Therefore, not just the explicit wording of the claims, but technical teaching of the application as a whole must be considered.
        
        someone having a patent application with a claim directed to a product has on grant the right to exclude others from making the product. Therefore, even when the intention is to use that product for further research, the invention is being exploited on a commercial or industrial level.
  - - - Questions referred by the German Federal Supreme Court
        
        Interpretation of the term 'embryo'?
        
        CJEU did not define 'embryo' but held that it was an autonomous concept in the EU.
        
        para 53: any human ovum, once fertilised must be regarded as a human embryo
        
        para 37: also states that the products of SCNT and parthenogenesis which are capable of commencing the process of development must also be classed as human embryos
        
        think he has made a minstake here!
        
        Does 'use of human embryos for commercial or industrial purposes' include use for scientific research?
        
        grant of a patent implies, in principle, industrial or commercial exploitation
        
        ability to prohinit from exploitation
        
        Would an invention be patentable if use of the human embryo did not form part of the teaching, but was a necessary pre-condition?
        
        the fact that destruction may occur at a stage long before the implementation of the invention is irrelevant
  - - - Are unfertilised human ova whose division and further development may be stimulated by parthenogenesis and which, in contrast with fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term 'human embryo'?
      - Partly unclear due to para 35 to 37 of the Brustle decision
  - - - the inventions usefulness to mankind was undoubted: likely to involve fewer animals , animal testing was indispensible to cancer research, and the invention did not pose risks to the envirnment.
    - - Rule 23(d)(d) superseded the balancing approach in the first oncomouse decision.
  - - - transgenic plants and plant cells resistant to herbicide
        
        Technical Board of Appeal articulated the scope of the concepts of ordre public and morality under Art 53(a)
        
        Covers the protection of public security, the physical integrity of individuals as part of a society and the protection of the environment.
        
        The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong
- - - - Hybrid plants/Lubrizol concerned the interpretation of the exclusion of essentially biological processes under Article 53(b) EPC and merely set out that ‘[l]ike any exception to a general rule of this kind the exclusion of “essentially biological” processes for the production of plants (or animals) has to be narrowly construed.
        
        The exception as it applies to Article 53(a) EPC was adopted from the treatment of Article 53(b) EPC in Harvard Oncomouse.
        
        subsequently cited as an accepted principle on remittance to the Examining Division31 and in the latter decision of the Technical Board of Appeal in Plant Genetic Systems.
      - In Harvard Oncomouse, the Technical Board of Appeal attempted to justify a general principle of narrow interpretation for exclusions by reference to the positive wording of Article 52(1) EPC which sets out the basic principle of patentability: ‘patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step’
        
        emphasized the phrase ‘shall be granted’ in support of this contention, as opposed to presumably a wording akin to ‘shall not be granted unless’.
        
        reasoning of the Technical Board of Appeal and the consequent limitation of the Article 53(a) EPC analysis in the Examining Division was criticised by Beyleveld and Brownsword in their 1993 analysis of the Harvard Onco- mouse decision.
        
        Article 52(1) EPC had not been expressly classified as a su- perior provision, and therefore there was no reason why an overall negative approach to patent grants could not be implied from the inherent ‘negative’ wording of the Article 53(a) EPC exception, ie, a patent shall not be granted
      - In Plant Genetic Systems, the Technical Board of Appeal adopted a broader approach
        
        referred to the travaux preparatoires of the EPC where it was set out that ‘the concept of patentability in the European patent law must be as wide as possible’.
        
        thus concluded that ‘the exceptions to patentability have been narrowly construed...[T]his approach applies equally in respect of the provisions of Article 53(a) EPC.
  - - - However, could be argued, in line with Beyleveld and Brownsword’s opinion, that the fact that the patent regime is subject to regulation under the EPC, requiring certain conditions to be met for a patent grant, requires a restrictive interpretation of patentability under the EPC
      - Beyleveld and Brownsword suggest that it would only be possible to infer a narrow interpretation from a long-established practice of narrow interpretation of the exceptions in the EPC.56 There is, however, no evi- dence of such a practice in the history of the EPO prior to the assertion of its application in Hybrid plants/ Lubrizol
      - Vienna Convention does not seem to allow for such an inference where it is not evident from the treaty or an agreement between the parties to the treaty.
- - - - European Commission produced a revised version in 1995
        
        Adopted by the council in June 1998
- - - - Compare to the more moderate ‘unacceptability’ standard, such as Harvard Oncomouse and Plant Genetic Systems, which seem to require a level of conclusive evidence which renders the exclusion impotent.