The Novartis Case in the EPO

TITLE: The Novartis Case in the EPO AUTHOR: Robin Nott PUBLICATION: European Intellectual Property Review, London, Volume 21, Issue 1, pp 33-36 DATE: January 1999 SOURCE: Sweet & Maxwell Ltd URL:
http://www.smlawpub.co.uk

COMMENTS

Robin Nott

On February 21, 1995 the Technical Board of Appeal of the European Patent Office (EPO) gave its decision in the Plant Genetic Systems (PGS) case (T356/93),[1] stating that claims in a patent which referred to plants (generally and without any reference to varieties) were invalid on the grounds that such claims fell within the exclusion of plant ... varieties under Article 53 (b) EPC. Notwithstanding that decision, claims to the transformed gene, which equally encompassed plants into which the gene had been inserted, were allowed. An appeal to the Enlarged Board of Appeal was dismissed.

For some time it has been reported that if another case based on similar facts were to come before the Technical Board of Appeal again, the decision would be reversed. That other case is the Novartis case.

Background

Novartis had developed a transgenic plant and had filed the following claims, all of which were refused by the Examining Division of the EPO.

19. A transgenic plant and the seed thereof comprising recombinant DNA sequences encoding (a) one or more lytic peptides, which is not lysozyme, in combination with; (b) one or more chitinases; and/or (c) one or more beta1, 3glucanases in a synergistically effective amount.

23. A method of preparing a transgenic plant which is able to synthesize one or more lytic peptides together with one or more chitinases; and/or one or more beta1, 3glucanases in a synergistically effective amount, said method comprising the steps of preparing a transgenic plant comprising recombinant DNA sequences encoding one or more lytic peptides, which is not lysozyme together with one or more chitinases; and/or one or more beta1, 3glucanases.

24. A method of preparing a transgenic plant which is able to synthesize one or more lytic peptides which is not lysozyme together with one or more chitinases; and/or one or more beta1,3glucanases in a synergistically effective amount; said method comprising the steps of preparing two or more transgenic plants comprising recombinant DNA sequences encoding one or more lytic peptides together with one or more chitinases; and/or one or more beta 1,3glucanases, and crossing said plants using conventional breeding techniques.

In summary, Claim 19 is to a transgenic plant and its seed; Claim 23 to a method of producing that plant, details of the method being unspecified; and Claim 24 a method of preparing the transgenic plant by preparing two or more transgenic plants encoding the relevant sequences by an unspecified method and crossing them using conventional breeding techniques.

It was accepted by Novartis that some of the embodiments within the claims would be plant varieties.

The EPO Questions to the Enlarged Board of Appeal

Novartis put to the Technical Board of Appeal the questions set out in the Appendix to this comment for referral to the Enlarged Board of Appeal. The Board rephrased those questions for the Enlarged Board in the following terms and set out their views on the questions which they referred. The questions referred were as follows:

1. To what extent should the instances of the EPO examine an application in respect of whether the claims are allowable in view of the provision of Article 53 (b) EPC that patents shall not be granted in respect of plant varieties or essentially biological processes for the production of plants, which provision does not apply to microbiological processes or the products thereof, and how should a claim be interpreted for this purpose?

2. Does a claim which relates to plants but wherein specific plant varieties are not individually claimed ipso facto avoid the prohibition on patenting in Article 53 (b) EPC even though it embraces plant varieties?

3. Should the provisions of Article 64 (2) EPC be taken into account when considering what claims are allowable?

4. Does a plant variety, in which each individual plant of that variety contains at least one specific gene introduced into an ancestral plant by recombinant gene technology, fall outside the provision of Article 53 (b) EPC that patents shall not be granted in respect of plant varieties or essentially biological processes for the production of plants, which provision does not apply to microbiological processes or the products thereof?

The Board's views were as follows:

Question 1

Plant varieties In dealing with questions as to plant varieties one approach considered was whether a formal approach should be adopted in assessing whether or not product claims covered plant varieties by checking whether the words plant variety appeared in the claim. The Board, sensibly it would seem, rejected that approach and adopted the same approach as would be adopted in considering novelty or inventive step, that is whether or not the embodiments within the claim would include a plant variety.

Essentially biological process In relation to the final portion of Claim 24, the question as to whether or not essentially biological processes for the production of plants were involved, the Board suggested three ways in which the question could be approached:

(1) that the process should contain no essentially biological steps but should only comprise clearly identified nonbiological process steps;

(2) to adopt the approach taken in Decision T320/87 [2]Â where it was held that whether or not a process is to be considered as essentially biological has to be judged on the basis of the essence of the invention, taking into account the totality of human intervention and its impact on the result achieved. The consequences of such an approach would be that a process for the production of plants comprising at least one essential technical step, which cannot be carried out without human intervention and which has a decisive impact on the final result does not fall under the exceptions to patentability under Article 53 (b) EPC first half sentence. The Board felt that the outcome of such an approach would be relatively uncertain;

(3) another approach suggested, the most favourable to the applicants, was to regard the presence of one clearly identified nonbiological process step as sufficient to escape the exclusion of Article 53. The comment was made that this was not the approach so far adopted by the Boards of Appeal.

The Technical Board has done no more than comment on the three proposals, but appears to have concluded that, whichever route was adopted, the Novartis invention would still be unpatentable. That conclusion is surprising. While the Technical Board's decision gives no indication of the processes used to produce the transgenic plant, presumably a transgenic plant has been modified by processes which include substantial human intervention, potentially more than in the Lubrizol Genetics case, and so are not essentially biological on that test.

Microbiological processes and their products The Board also considered microbiological processes and their products and considered that the question to be decided when considering if a genetically engineered plant variety could also be considered a product of a microbiological process was whether or not the genetically engineered variety is closer to the original concept of a plant variety or closer to the original concept of a product of a microbiological process. The Board concluded that the genetically engineered plant varieties of the invention bore no relation to what was originally meant by the product of a microbiological process, but that they were virtually indistinguishable from conventionally produced plant varieties. This led the Board to the conclusion that genetically engineered varieties are covered by the prohibition in Article 53 (b) EPC even if they should in some sense be considered the product of a microbiological process. This appears to be totally contrary to the provisions of Article 53 (b). If a microbiological process is used, why should it matter for the benefit of the microbiological processes exclusion to be available whether the product looks like a clear liquid (such as ethyl alcohol) or anything else, or like a plant?

The Board considered that part of Novartis' question 1 relating to the Board's obligation to take account of subsequent practice in relation to international conventions, rejected it, and, inexplicably, refused to refer that part of the Novartis question to the Enlarged Board. The Board had doubts as to whether it would be practicable or desirable for arguments relating to subsequent practice to be gone into on each patent application by the EPO and suggested that the question of subsequent practice should either be acknowledged in the Guidelines for Examination (which, as the Boards acknowledged, are not binding on the Board of Appeal, and thus open to challenge in appeal proceedings), or for the subsequent practice to be argued for in the course of appeal proceedings before the Boards or the Enlarged Board of Appeal such as the present. Their refusal to refer that question in the light of their comments is inexplicable. In particular, the Enlarged Board should be given the chance to review whether the Board had been wrong in their approach to subsequent practice. The Enlarged Board's decision would influence, and frequently, if not always, bind subsequent examiners.

The answers proposed by the Board, if adopted, sound the death knell of all but a very limited number of patents encompassing plant varieties in their claims.

Question 2

Novartis argued that the claims should be allowable:

(a) because the claims covered more than one plant variety; and (b) because the claims covered plants which were not plant varietiesfor example plants that were not distinct, uniform and stable as required by the plant variety rights legislation. (This approach was described as the more than a single variety approach.)

The Board recognised that the literature proposed that the invention, being a broad technical contribution capable of being embodied in all sorts of plants, should be entitled to patent protection, and indeed needed broad patent protection if any worthwhile protection was to be available. However, the Board also pointed out that method claims, and product claims relating to the gene expressing the desired feature and to the vector by which the transformation of the plant cells is carried out, can be protected, none of which fall under the exclusion from patentability of Article 53 (b). They thus took the view that the refusal of the Board to grant claims to plants would not deprive the applicant of all protection.

However, the protection given by method claims is generally accepted as being unsatisfactory. The long, now successful, battle by the pharmaceutical industry to get product protection everywhere bears witness to that. The claims to the gene itself in relation to an invention involving the transformation of plant cells would cover plants themselves if they incorporated the gene, and a claim to the gene would equally be a claim covering plant varieties; and so in logic equally void under Article 53 (b), a point made by the applicants. However, the Board did allow claims to the gene (as it did in the PGS case).

However, the Board pointed out that it was obliged to apply the law, that Article 53 (b) EPC states that patents shall not be granted for plant varietiesin the plural and rejected the more than a single variety approach. The Board also pointed out that the more than a single variety argument had not been raised in the Oncomouse decision (T19/90) [3] where claims to animals had been allowed. They also pointed out the anomaly that if the more than a single variety approach was allowed, claims encompassing a number of plant varieties would be allowable, while claims to a single plant variety, the ultimate embodiment of the invention, would not, a notion quite alien to patent law in general. The Board suggested that this approach would leave a fundamental anomaly at the heart of patent law as it relates to plants.

The Board was also asked to address the similarities and differences between Articles 52 (2), (3) and (4) EPC (exclusions from patentability of discoveries, etc., and the as such limit to that exclusion (2) and (3); and exclusion of methods of treatment of the human or animal body from patentability (4)), found no help in them and saw no reason to depart from what they saw as the clear meaning of Article 53 (b).

Question 3

The Board reviewed the law, including a Swiss decision, and came to the conclusion that method claims for the manufacture of plants were patentable under Article 64 (2) EPC; and that such patents would give protection for plants produced by the method as long as they were the direct products of the method claimed. The Board did not address a question as to whether or not progeny of the plants would also infringe. The disadvantages to inventors of being forced to rely on productbyprocess claims has been addressed above.

Question 4

This question is based on a comment in the Oncomouse case: This would also presuppose that Article 53 (b) EPC applied at all in respect of animals [plants] which are genetically manipulated, given that neither the drafters of the Strasbourg Convention nor those of the EPC could envisage this possibility.

The Board felt that there was no reason why the mere fact of being derived by genetic engineering should give the producers of such plant varieties a privileged position relative to breeders of plant varieties which meet all the requirements of Article 52 (1) EPC but have not been arrived at by genetic engineering.

The Board does not appear to recognise two salient differences: first, that the products of genetic engineering can usually be applied to a whole range of plant varieties; and secondly that while conventional plant breeding will produce new varieties, these are not generally reproducible by repeating the crossing process, and that patents for new material produced by conventional breeding techniques have been rejected for lack of reproducibility (for example the Red Dove [4] case in Germany). In contrast, the application of biotechnology will normally achieve the same result and the same transformation of properties, even if the particular transformed gene will not always be inserted at the same point in the plant genome.

In further reviewing question 4, the Board addressed the Biotechnology Directive. Commentators on the drafting process have always understood that the Directive was to allow plant and animal varieties to be protected (for example Recital 32 and Art. 4.2). However the Board suggested that Article 4.2 of the Directive could be satisfied by permitting process claims alone and thereby giving protection to the direct and indirect results of this process.

This approach will strike horror into all those who have supported the Biotechnology Directive over the years and been involved in its gestation and birth. The difficulties which the pharmaceutical industry has faced because, for many years and in many countries, pharmaceutical product patents were banned, and protection could only be obtained through processes and productbyprocess claims, is well known. Efforts to remedy that have gone on for many years, and now under TRIPs the right to patent pharmaceutical products is established. The prospect of having the same limitations on biotechnological patents and facing the same limitation beggars belief.

The writer cannot conceive that the legislators of the Directive ever contemplated that biotechnological inventions would only be allowed to have productbyprocess protection.

If this approach were to be adopted it would undo at a stroke all that the Biotechnology Directive was thought to have achieved in allowing the patenting of plants and animals, notwithstanding the exclusion of Article 53 (b) EPC and the corresponding exclusion in Article 2.2. The writer regards the Board's view on the Directive as plainly wrong. On the Board's approach both under the EPC and the Directive only process claims and productbyprocess claims would be allowed. Article 2.2 would be redundant.

That cannot have been the European Parliament's intention. The Board must be wrong.

Conclusion

Apart from his comments above, the writer is surprised at the Board's decision. He has always understood that the reasoning behind Article 53 (b) was the idea that, because a plant variety could be protected using plant variety rights and the UPOV Convention, it was not thought proper to give individual plant varieties the double protection of plant variety rights and patents. (Even the ban on double protection has been removed from the latest UPOV Convention.) He also understood that plants (and animals) were unpatentable because plant breeding was not reproducible (see Red Dove above). Hence the introduction of Article 53 (b).

With the advent of genetic engineering, where the same invention can be applied to a range of plants and is reproducible, the objections to patenting fall away and patents encompassing a range of plant and animal varieties should and would be allowed. (This result was most certainly in the minds of those responsible for and involved in the developing and enactment of the Biotechnology Directive.)

The writer awaits the decision of the Enlarged Board of Appeal. He is very concerned that the Enlarged Board will support the Technical Board and ban claims under the EPC which include in their scope plant and animal varieties. If that is the result, it seems inevitable that claims of any sort, including genes, to any invention, which can be applied to plant varieties, and so bring plant varieties within their scope will be invalid under Article 53 (b) - unless they can some how escape with the benefit of the microbiological processes exemption, which seems to be being squeezed itself.

One can only speculate how much damage such a conclusion will do to the European biotechnology industry. Possibly the only consolation is that many of the older patents will only be revocable in national proceedings - and given that even the English House of Lords has said that one should follow the EPO, even that may be no consolation.

And one other thought: if the Biotechnology Directive does allow inventions covering a range of plants and animals to be patentable - not yet clear -the effort will have been worthwhile! Unless even that protection is cut down following the first review by the Ethical Committee!

Observations to the Enlarged Board can be filed until February 5, 1999. It is now reported that the Enlarged Board will give its decision later that year. The writer hopes that it will be favourable.

The Novartis Questions

1. What duties do the instances of the EPO have regarding examining an application in respect of whether the claims are allowable in view of the provision of Article 53 (b) that patents shall not be granted in respect of plant varieties or essentially biological processes for the production of plants, which provision does not apply to microbiological processes or the products thereof; in particular, are the instances of the EPO obliged to take into account relevant provisions of international conventions on which EPC Contracting States have agreed such as the TRIPs Agreement, E. U. directives, the Agreement on Community Patent, the UPOV Convention, etc., in the sense of subsequent practice of Article 31 (3) of the Vienna Convention on the Law of Treaties and the necessity to pay attention to questions of harmonisation of national and international rules of law as stated by the Enlarged Board of Appeal in G05183?*

2. Does a claim which is based on a technical contribution the application of which is not confined to a single or particular plant variety and relates to plants but wherein specific plant varieties are not individually claimed, ipso facto avoid the prohibition on patenting in Article 53 (b) EPC even though it embraces plant varieties?

3. Should the provisions of Article 64 (2) EPC be taken into account when considering what claims are allowable?

4. Does the provision of Article 53 (b) EPC that patents shall not be granted in respect of plant varieties or essentially biological processes for the production of plants, which provision does not apply to microbiological processes or the products thereof, apply to a claim for a plant grouping in which each individual plant of that grouping contains at least one specific gene introduced into an ancestral plant by recombinant gene technology?

ROBIN NOTT Partner, Cameron McKenna

[1] PLANT GENETIC SYSTEMS/Glutamine Synthetase inhibitors [1995] E.P.O.R. 357. [2] LUBRIZOL/Hybrid plants [1990] E.P.O.R. 173. [3] HARVARD/Oncomouse [1990] E.P.O.R. 501. [4] BGH GRUR 1969. 672Rote Taube. * Note: that part of question 1 in italics was not referred to the Enlarged Board on the ground that it was too vague.