T 1199/08 – Quod Licet Bovi Non Licet Homini

In the present case, both the patent proprietor and the opponent filed an appeal against the maintenance of the patent in amended form. 
Claim 1 of the main request before the Board read:

1. A method for the cryopreservation of sex-selected bovine sperm comprising:

(a) obtaining a bovine sperm sample;

(b) adding an initial extender and sex-selecting sperm by flow cytometry;

(c) cooling said selected sperm sample;

(d) isolating by centrifugation sperm from said selected cool sperm to produce isolated cool sperm;

(e) adding final extender to said cool isolated sperm to produce a cool suspension of sperm, wherein the final extender comprises a cryoprotectant and Tris[hydroxymethyl]aminomethane; and

(f) freezing said suspension of sperm.

Claims 2 to 13 were dependent on claim 1. Claim 14 was another independent claim:

14. A frozen sex-selected bovine sperm sample comprising a portion of the sperm present in a source sample and an extender, said portion of sperm being stained with a fluorescent dye and sex-selected by flow cytometry, and said extender comprising a cryoprotectant and Tris[hydroxymethyl]aminomethane, wherein thawing yields sperm that can be used in artificial insemination and achieves pregnancy.

Claim 15 was dependent on claim 14.

Claim 16 was directed to the use of the sperm sample of claim 14 or 15 for the manufacture of a formulation for artificial insemination. Claim 17 was dependent on claim 16.

The question arose whether this claim complied with the requirements of A 53(b), which, as you certainly know, excludes essentially biological processes for the production of animals from patentability.

[16] A 53(b) provides that:

“European patents shall not be granted in respect of:

(a) [...]

(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.”(emphasis added by the Board).

[17] [Opponent 3] considers that claim 1 contravenes this provision, insofar as the prohibition applies to essentially biological processes for the production of animals and argues that this objection extends to the other claims, including the product claims 14 to 15 and the use claims 16 to 17. In support of her objection, [opponent 3] has referred to decisions G 2/06 and G 1/08, the proceedings of which were consolidated with those of decision G 2/07, as well as the Oliver Brüstle v. Greenpeace decision of 18 October 2011 of the Court of Justice of the European Union (CJEU decision C-34-10). As only an abridged version of decision G 1/08 was published, reference will be made hereinafter to decision G 2/07 which was published in its entirety.

[18] [Opponent 3] argues that, in accordance with the “whole content approach” developed by the Enlarged Board of Appeal (EBA) in decision G 2/06 [22], not the explicit wording of claim 1 but the technical teaching of the patent as a whole should be taken into consideration for a correct assessment of whether claim 1 falls under the prohibition of A 53(b). [Opponent 3] contends that, following this approach which is reflected by the CJEU decision C-34-10, it becomes obvious that the only purpose of the claimed method is the production of an animal.

[19] [Opponent 3] considers further that, in the method of claim 1, the step of sex-selecting sperm by flow cytometry is a selection step which, together with the other technical steps, serves the only purpose of assisting in the crossing step and leads subsequently and inevitably to the breeding of an animal. Consequently, drawing a parallel with the reasoning made in decision G 1/08 regarding a process for the production of plants, the claimed method should be regarded as an essentially biological process for the production of animals.

[20] In decision G 2/06, the EBA has answered inter alia the question of whether R 28(c) forbids the patenting of claims directed to products (in the referring decision: human embryonic stem cell cultures) which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products were derived, if the said method is not part of the claims. Regarding R 28(c) which provides that, under A 53(a), European patents should not be granted in respect of biotechnological inventions which, in particular, concern uses of embryos for industrial or commercial purposes, the EBA has noted that said rule does not mention claims, but refers to “invention” in the context of its exploitation and has indicated that “[W]hat needs to be looked at is not just the explicit wording of the claims but the technical teaching of the application as a whole as to how the invention is to be performed” (emphasis added by the Board). This defines the “whole content approach” as referred to by [opponent 3]. The EBA has noted further that “[T]o restrict the application of R 28(c) (formerly R 23d(c)) to what an applicant chooses explicitly to put in his claim would have the undesirable consequence of making avoidance of the patenting prohibition merely a matter of clever and skilful drafting of such claims” (see point [22] of the Reasons).

[21] The present Board does not see any reason to apply this approach of decision G 2/06 to the situation underlying present claim 1. Said approach has been developed in the context of a particular exception to patentability governed by A 53(a) in view of R 28(c) which focuses on the patentability of inventions related specifically to the ethical concerns associated with the destruction of a human embryo, whereas for present claim 1 the context to be considered is the one of another exception to patentability which is governed by A 53(b). Present claim 1 is indeed directed to a method for the preparation of sex-selected bovine sperm resulting in a product with properties allowing its long term storage.

[22] In the case underlying the CJEU decision C-34-10, the invention was concerned with neural precursor cells obtainable from human embryonic stem cells. The Court had to answer inter alia the question of whether technical teaching is to be considered unpatentable pursuant to Article 6(2)(c) of the Directive 98/44/EC (R 28(c)) even if the use of human embryos does not form part of the technical teaching claimed by the patent, but is a necessary precondition for the application of that teaching. In paragraph 50 of the Decision, the Court noted that “Not to include in the scope of the exclusion from patentability set out in Article 6(2)(c) of the Directive technical teaching claimed, on the ground that if does not refer to the use, implying their prior destruction, of human embryos would make the provision concerned redundant by allowing a patent applicant to avoid its application by skilful drafting of the claim” (emphasis added by the Board). Thus, for the very same reason given at point [21] supra, the Board sees no reason to apply the approach of CJEU decision C-34-10 to the situation underlying present claim 1.

[23] In the case underlying decision G 2/07, the referring Board had to decide on the patentability of a process for the production of Brassica oleracea, which as claimed comprised in succession steps of a) crossing wild Brassica oleracea species with broccoli double haploid breeding lines, b) selecting hybrids, c) backcrossing and selecting plants with a the genetic combination encoding the expression of elevated levels of given compounds and d) selecting a broccoli line with elevated levels of said compounds. This was a non-microbiological process for the production of plants which contained a step of sexually crossing the whole genome of plants and of subsequently selecting plants, i.e. a traditional method of breeding new plant varieties

[24] The EBA came to the conclusion that

“[S]uch a process does not escape the exclusion of A 53(b) 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 or plants or of subsequently selecting plants” (see decision G 2/07 [order 2]).

[25] Regarding additional technical steps performed either before or after the process of crossing and selection per se decision G 2/07 indicates:

“For the previous or subsequent steps per se patent protection is available” (G 2/07 [page 70, lines 4 to 5])

and

“[H]owever, in such case the claims should not, explicitly or implicitly, include the sexual crossing and selection process.” (G 2/07 [page 70, lines 10 to 12]).

[26] The process of claim 1 does not comprise a step of breeding an animal and none of its steps involves any crossing. Furthermore, it is an obvious fact, in an attempt to draw a parallel between a method for the production of plants and a method for the production of animals, that a selection step equivalent to a selection step in a traditional method of breeding new plant varieties which takes place after a crossing step between pre-existing varieties is not present in claim 1.

[27] Therefore, [opponent 3]’s argument that it was only skilful claim drafting that avoided in the present case the application of the prohibition of A 53(b), regarding processes for the production of animals, is not convincing.

[28] From the analysis made at points [20] to [27] supra, the Board concludes that claim 1 is directed to a method which allows for the long term preservation of sex-selected sperm. This method does not qualify as an essentially biological process for the production of animals, and, therefore, in line with the parallel reasoning developed in decision G 2/07 regarding processes for the production of plants, it does not fall under the prohibition of A 53(b). Thus, claim 1 meets the requirements of A 53(b). The same conclusion applies to dependent claims 2 to 13.

[29] Claim 14 and dependent claim 15 are directed to a frozen sex-selected bovine sperm sample, a product which is not mentioned in A 53(b). In view of the fact that, according to established case law, any exception to patentability must be construed narrowly, A 53(b) provides an exhaustive list of possible exclusions from patentability. Therefore, the frozen sex-selected bovine sperm sample according to claim 14 or claim 15 does not fall under the prohibition of A 53(b).

[30] Claim 16 and dependent claim 17 are directed to the use of a sperm sample according to claim 14 or claim 15 for the manufacture of a formulation for artificial insemination. Such a use is also not mentioned in A 53(b). Therefore, the use of frozen sex-selected bovine sperm sample according to claim 16 or claim 17 does not fall under the prohibition of A 53(b).

[31] In view of these remarks, the Board concludes that the main request as a whole complies with the requirements of A 53(b). The Board regards it as relevant to note that, in the course of the oral proceedings of 24 November 2011, as clearly reflected in the minutes thereof which were not contested by the parties, [opponent 3] withdrew her request to refer questions of law with respect to this issue. Therefore, the attempt made by [opponent 3] in her letter of 31 March 2012 to re-open the debates in this respect was unsuccessful. When formulating her final requests, [opponent 3] did not include such a request.

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