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PATENTABILITY IN THE LIFE SCIENCES IN EUROPE
The applicable law for the grant of a European patent via the EPO is the European Patent Convention (EPC). This includes Articles of the Convention itself, as well as the “Implementing Regulations” or Rules, which provide an indication of how the Articles are to be put into effect. For life sciences inventions the European Biotech Directive is a supplementary source of information useful for interpreting the Article and Rules.
In general, “European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application” (Art. 52(1) EPC). There are some exclusions, either for not being considered inventions or for being subject matter that is considered to be unpatentable.
Natural Products and Genetic Material
Biotechnological inventions are patentable if they concern biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature (Rule 27(a) EPC).
The simple discovery of an element of the human body, including the sequence or partial sequence of a gene, is not a patentable invention (Rule 29(1) EPC). But, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element (Rule 29(2) EPC). The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application (Rule 29(3) EPC).
Plant and Animal Varieties
European patents are not granted for plant or animal varieties or essentially biological processes for the production of plants or animals (Art. 53(b) EPC). This provision shall not apply to microbiological processes or the products thereof.
Biotechnological inventions are patentable if they concern plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety (Rule 27(b) EPC). A claim wherein specific plant varieties are not individually defined is not excluded from patentability even though it may embrace plant varieties (Enlarged Board of Appeal Decision G1/98). If the technical feasibility of an invention is confined to a particular species (or sub- species) of animal, it is excluded from patentability (Technical Board of Appeal Decision T315/03).
A process for the production of plants is “essentially biological” and, therefore, excluded from patentability, if it contains or consists of the steps of sexually crossing the whole genomes of plants (G2/07 and G1/08). A product claim to a plant or plant material resulting from an essentially biological process was previously not excluded from patentability, even if defined in product-by- process terms in which the process features define an essentially biological process (G2/12 and G2/13). However, the European Commission issued a notice in 2016, stating that was not the EU legislator’s intent for the Biotech Directive. As such, the EPO’s Administrative Council updated the implementing regulations in 2017 to exclude such products from patentability, thereby overruling G2/12 and G2/13.
One Board of Appeal decided that the regulations conflicted with the Articles of the EPC and therefore ignored this rule change, prompting a further referral to the Enlarged Board of Appeal on this question (G3/19).
The Enlarged Board of Appeal recently issued its opinion confirming that the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC also extends to products obtained by such essentially biological processes. The above exclusion does not however apply to European patents granted before 1 July 2017 nor to pending European patent applications filed before that date.
G3/19 reverses the Enlarged Board of Appeal’s previous position in Broccoli II (G2/13) and Tomato II(G2/12) which considered the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC was a process exclusion which did not extend to products (plants and plant materials) resulting from an essentially biological process.
Methods of Medical Treatment and Diagnostic Methods
European patents are not granted for methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods (Art. 53(c) EPC).
A known substance or composition is patentable for use in a therapeutic method if such use was not previously known (Art. 54(4) EPC). Such a “first medical use” may be claimed in the form “Compound X for use in therapy”. A known substance or composition is patentable for any specific use in a therapeutic method if such use was not previously known (Art. 54(5) EPC). Such a “second medical use” may be claimed in the form “Compound X for use in the treatment of disease Y”. Second medical use claims are allowable when the novelty lies in a different treatment by therapy of the same illness, for example by use of a different dosage regime (G2/08).
Methods of treatment of the human or animal body by surgery are also excluded from patentability. A claim which relates to a method in which maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded (G1/07).
Diagnostic methods practised on the human or animal body are also excluded from patentability, though the exclusion is interpreted narrowly. To qualify as an excluded diagnostic method, a claim must include all of the steps of (i) examination of a patient and collection of data; (ii) comparison of the data with standard values; (iii) identification of differences, indicative of a medical symptom; and (iv) making a diagnosis based on the identified symptoms. The steps which have a technical nature – i.e., that contribute to the novelty or inventive step of the claimed invention – must be practised on a living human or animal body (“on” need not indicate physical contact, but may be visual observation, for example). The involvement of a medical practitioner need not be required for the exclusion to apply (G1/04).
Morality and Ordre Public
European patents are not granted for inventions the commercial exploitation of which would be contrary to “ordre public” or morality (Art. 53(a) EPC). Such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.
Excluded biotechnological inventions include those which concern (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes (Rule 28 EPC).
Claims for human embryonic stem cells are not acceptable if, at the filing date, these could only be prepared exclusively by a method which necessarily involved the destruction of human embryos, even if the method is not part of the claims (G2/06). Furthermore, the EPO follows the decision of the Court of Justice of the European Union (CJEU) in the case Brüstle v Greenpeace (Case C-34/10). To be patentable in Europe, the subject matter must not have required the prior destruction of a human embryo, at any time in the past. Therefore, even inventions based on cell lines already in existence and available at the time of filing are not patentable (e.g., T2221/10)
For an invention which may cause an animal suffering, the relevant test was summarised as the need to establish (i) likely animal suffering; (ii) likely substantial medical benefit; and (iii) a correspondence between (i) and (ii) in terms of the animals in question. This assessment is to be made as if at the priority date (T315/03).
This article is for guidance only. Should you require advice on the patentability of any subject matter, please contact us.