Significant points in the new rules include the following:
1) The term "plant variety" is defined in the identical way as in Article 1(vi) of the 1991 text of the International Convention for the Protection of New Varieties of Plants (UPOV - See Information Letter N.S. 190), namely "a plant grouping within a single botanical taxon of the lowest known rank which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be:
Since the issue of what is meant by "plant variety" is currently before the Enlarged Board of Appeals in the Novartis case, it is not clear what the effect of this definition will be if the Enlarged Board of Appeals decides that what is meant in the EPC is something different from this.
2) The term "essentially biological" which appears in the prohibition of the grant of patents for plants or animals produced by an "essentially biological process" is defined as consisting of "entirely natural phenomena such as crossing or selection". This is a very narrow definition which is apparently intended to make it clear that genetic modification at any stage in the production of a plant or animal will take the process outside the prohibition.
3) The regulation goes on to state the impact of these definitions on the prohibitions on patentability in the EPC in the following terms:
a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes;
b) distinguished from any other plant grouping by the expression of at least one of the said characteristics; and
c) considered as a unit with regard to its suitability for being propagated unchanged".
b) distinguished from any other plant grouping by the expression of at least one of the said characteristics; and
c) considered as a unit with regard to its suitability for being propagated unchanged".
Since the issue of what is meant by "plant variety" is currently before the Enlarged Board of Appeals in the Novartis case, it is not clear what the effect of this definition will be if the Enlarged Board of Appeals decides that what is meant in the EPC is something different from this.
2) The term "essentially biological" which appears in the prohibition of the grant of patents for plants or animals produced by an "essentially biological process" is defined as consisting of "entirely natural phenomena such as crossing or selection". This is a very narrow definition which is apparently intended to make it clear that genetic modification at any stage in the production of a plant or animal will take the process outside the prohibition.
3) The regulation goes on to state the impact of these definitions on the prohibitions on patentability in the EPC in the following terms:
Biotechnological inventions shall also be patentable if they concern:
4) The Regulation addresses the question of what is unpatentable under the provisions of the EPC as being inventions whose publication or exploitation would be contrary to ordre public or morality and so unpatentable as including:
5) Finally, without relating the provisions back to the EPC, the regulation addresses the question of the patentability of other matters relating to the human body and its elements and in particular the requirements for patentability of DNA sequences by pronouncing that simple discoveries of elements of the body such as genes, "including the sequence or partial sequence of a gene, cannot constitute patentable inventions". However, if produced by a "technical process, such elements may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. In any case, the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent".
a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;
b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;
c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
4) The Regulation addresses the question of what is unpatentable under the provisions of the EPC as being inventions whose publication or exploitation would be contrary to ordre public or morality and so unpatentable as including:
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; and
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.
b) processes for modifying the germ line genetic identity of human beings;
c) uses of human embryos for industrial or commercial purposes; and
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.
5) Finally, without relating the provisions back to the EPC, the regulation addresses the question of the patentability of other matters relating to the human body and its elements and in particular the requirements for patentability of DNA sequences by pronouncing that simple discoveries of elements of the body such as genes, "including the sequence or partial sequence of a gene, cannot constitute patentable inventions". However, if produced by a "technical process, such elements may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. In any case, the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent".
August 1999 Index