European Patent Office:Patent Claims on Plants (and Animals) are not excluded

In a landmark decision the Enlarged Board of Appeal of the European Patent Office (EPO) has accepted claims drawn to plants as such as being patentable. This decision (G 1/98 "Transgenic Plant/NOVARTIS II") turned down the jurisdiction according to the decision T 356/93 "Plant Cells/PLANT GENETIC SYSTEMS", which said that claims to plants per se are not acceptable according to the European Patent Convention (EPC). Now, G 1/98 returned to the EPO practice before the "PLANT GENETIC SYSTEMS" decision. Under this "old" practice – now revived by the present G 1/98 – claims to plants or animals per se have been regarded as being patentable, if these claims are new, inventive, industrially applicable and – due to the exclusion of plant and animal varieties from patentability (according to Art. 53 b EPC) – not limited to a single plant or animal variety. This is the case for most inventions which involve genetic manipulation of plants or animals. Examples for these "old" practice are given in the decisions T 320/87 "Hybrid Plants/LUBRIZOL" and T 19/90 "Oncomouse/HARVARD".

In the "PLANT GENETIC SYSTEMS" decision this jurisdiction was held to be contrary to the EPC. In "PLANT GENETIC SYSTEMS" the Technical Board of Appeal (BoA) argued that a claim, if drawn to plants as such, always includes plants which belong to a specific plant variety. In analogy to the requirement of novelty, according to which a claim is only accepted as novel, if the whole claim is novel, the BoA said that claims which comprise subject matter which is excluded from patentability cannot be granted.

With the present decision of the Enlarged Board of Appeal the EPO not only returned to its former practice, but also complies with the EU directive for the legal protection of biotechnological inventions (EU-directive 98/44/EC). In the present decision it was clearly stated that the exclusion of plant varieties from patentability only relates to claims drawn to plant varieties as such, but does not to claims with a larger scope. Therefore, examination of this aspect was seen as not being comparable to the examination of novelty (as held in "PLANT GENETIC SYSTEMS"), but being similar to the examination concerning Art. 53 a EPC, according to which a patent shall not be granted if the exploitation of an invention would be contrary to "ordre public" or morality. Such an exclusion is applicable for inventions which the public (as a whole) would regard as so abhorrent that the grant of patent rights would be inconceivable (e.g. inventions likely to induce a riot or public disorder, or lead to criminal or other generally offensive behaviour (e.g. a letter bomb)). A prohibition by law or regulation in one or all of the EPC contracting states, however, is not sufficient for such an exclusion. Also an invention which has both an offensive (i.e. nonpatentable) and a nonoffensive character is not excluded from patentability. This examination standard should also apply to plants, the present "Transgenic Plant/NOVARTIS II" says.

In the present decision G 1/98 "Transgenic Plant/NOVARTIS II", the Enlarged Board of Appeal also stressed and confirmed the fact that claims to specific plant varieties are not patentable, even if these varieties are produced by microbiological processes (cf. Art. 53 b, wherein it is stated that the exclusion of plant and animal varieties and essentially biological processes from patentability does not apply to microbiological processes or the products thereof). Indeed, the Enlarged Board of Appeal outlined that processes of genetic engineering are not identical with microbiological processes. The term "microbiological processes" as mentioned in the EPC was defined as being synonymous with processes using micro-organisms and that such micro-organisms are different from the parts of living beings used for the genetic modification of plants.

The impact of the present "Transgenic Plant/NOVARTIS II" decision for the daily practice lies in the fact that for showing patentability of inventions relating to genetic altering of plants (and claiming plants per se) proof has to be provided that the invention is not restricted to a specific plant variety. It is therefore advisable to include examples for at least two different plant varieties in the patent application or   at the latest   file such examples during examination proceedings with the EPO. Although "Transgenic Plant/NOVARTIS II" relates to claims to plants only, it is also applicable to claims to animals. With respect to animals, however, one additional aspect has to be taken into account: during examination of such claims it has to be determined whether animals will suffer pain in the course of the exploitation of this invention and – if they suffer pain – whether this pain might be acceptable in view of the medical benefit for mankind (see: Art. 6(2)d of the EU directive 98/44/EC).