Methods of selective breeding of plants and animals allowable in New Zealand
A recent European Enlarged Board of Appeal decision has brought into contrast the differences in patentable subject matter with regard to plants, animals and methods of their generation between New Zealand and Europe. Under New Zealand law it would appear that a plant or animal variety is patentable as it meets the definition of an invention under the Patents Act 1953. Furthermore a selective breeding method has also been held to be an “invention”.
New Zealand - Seminis Vegetable Seeds Inc and Cornel Research Foundation Inc
The New Zealand position with regards to methods of selective breeding was considered by Assistant Commissioner Hazlewood in P16/2007. In particular claim 10 of the patent in question is of interest:
10. A method of producing a Botrytis resistant Lycopersicon esculentum plant, the method comprising the steps of:
a. crossing a Botrytis resistant donor Lycopersicon hirsutum plant with a recipient Lycopersicon esculentum plant;
b. planting seed obtained from the cross in step a and growing into plants;
c. selfing the plants of step b;
d. planting seed obtained from the selfing in step c and growing into plants;
e. isolating genetic material from the plants of step d and performing marker assisted selection with one or more molecular markers from chromosome 10; and
f. selecting those Lycopersicon esculentum plants containing DNA introgressed from said donor plant, wherein said introgressed DNA contains at least one gene that encodes for Botrytis resistance and wherein said introgressed DNA is further identifiable by at least one molecular marker selected from the group consisting of: TG313, CT234, TG408, CT20, CT57, TG241, TG233, and CD32B.
Note that this consists primarily of marker assisted selective breeding.
AC Hazlewood applied the test set down in National Research Development Corp v Commissioner of Patents (1959) 102 CLR 252 (NRDC) and came to the conclusion that a method of selective breeding was an “artificially created state of affairs of economic significance” since it would not happen in nature.
AC Hazlewood also considered the older UK decisions of Rau GmbH’s Application 52 RPC 362and RHF’s Application 61 RPC 49and in particular at the apparent approval of RHF’s Application in NRDC. This apparent approval was noted in the 1974 UK Patent Office manual and was given as a reason for plants and methods of selective breeding not being patentable inventions. The Assistant Commissioner accepted the Applicant’s view that NRDC did not approve that notion that fruit and growing crops are not patentable, only that altering the conditions of growth may not be patentable as part of a general discussion of the non-definitive nature of the “vendible product test”.
Rau GmbH’s Application 52 RPC 362appears to be the most on point as it refused a method of selective cultivation of lupin seeds. However, NRDC considered the case ran together the questions of novelty and “manufacture”. Therefore it was not found persuasive by NRDC of the Assistant Commissioner.
Clearly, methods of selective breeding and their results (i.e. plants and animals) are at present patentable subject matter in New Zealand. It is also worth noting that a similar position applies in Australia as the legislative provisions for an “invention” are similar. As New Zealand also has plant variety right legislation, this effectively means that at present dual protection for plants under both systems is available.
This anomaly is addressed by the new Patents Bill excluding Plant Variety rights from patentability. At present this exclusion does not apply to methods of selectively breeding plants, or to animals.
Europe - Decision of the Enlarged board of Appeal G 001/08
In contrast to the New Zealand law, the EPC contains a specific provision excluding plant or animal varieties, article 53(b) EPC reads:
European patents shall not be granted in respect of:
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
There is clearly little scope for disagreement that a plant or animal variety is not capable of being the subject of a plant or animal variety. However, how much intervention results in the process no longer being “essentially biological”? The Enlarged Board decision focused on two cases directed to selective breeding of broccoli and tomato plants. The broccoli was selectively bred with the assistance of molecular markers to identify the specific traits, while the tomatoes were allowed to remain on the vine past the point of “normal ripening”. In both cases it was argued that (a) selective breeding inevitably involved a step of human intervention, and hence the process was not “essentially biological” or (b) the use of molecular markers, and/or altered conditions of ripening was a technical step which took the methods beyond what was “essentially biological”.
The board decided in the following way:
“1. A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC.
2. Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
3. If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC.
4. In the context of examining whether such a process is excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a
fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.”
Thus unlike New Zealand law, both plant and animal varieties and methods of selective breeding are excluded from patentability before the EPO provided that the point under 3 above is not met.
If you require any further information regarding patenting a plant or animal variety, a method of selective breeding, or obtaining a plant variety right, please contact us.
David Nowak - February 2011.
