Essentially biological processes for the production of plants and animals – EPO Enlarged Appeal Board decisions G2/07 and G1/08 – Essentially Biological Processes

From Paul Cole

Opinions were handed down on 9th December in the above two cases concerning the scope of the exclusion of a.53(b) EPC 1973. That article is further defined in r.23b(5) EPC 1973, now r.26(5) EPC 2000 which specifies that such a process is essentially biological if it consists essentially of natural phenomena such as crossing or selection.

Case G2/87 arose from a referral of Technical Board of Appeal 3.3.04 in case T83/05 PLANT BIOSCIENCE/Broccoli and related to a method of producing broccoli (Brassica oleracea) with elevated levels of glucosinolates which are believed to be chemoprotective agents. The patent in issue claimed:

“A method for the production of Brassica oleracea with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinolates, or both, which comprises:

          (a) crossing wild Brassica oleracea species selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines;

          (b) selecting hybrids with levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines;

          (c) backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and

          (d) selecting a broccoli line with elevated levels of 4- methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinlates [sic], or both, capable of causing a strong induction of phase II enzymes,

          wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes.”

The patentees averred that the wild Brassica strains mentioned in step (a) grew in remote geographical locations and were not likely to hybridise with broccoli breeding lines unless specifically brought into contact with them by human intervention. Furthermore step (a) involved the use of a non-natural starting material, i.e. a double haploid strain, which was made by technical steps described by the patentees. Additionally the use of molecular markers in steps (b) and (c) of the claimed process was a technical step requiring removal and in vitro analysis of plant tissues.

Case G1/08 arose from a referral by the same Technical Board in case T1242/06  STATE OF ISRAEL/Tomatoes, where the patent in issue claimed:

“A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of:

          crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed;

                   collecting the first generation of hybrid seeds;

                   growing plants from the first generation of hybrid seeds;

                   pollinating the plants of the most recent hybrid generation;

                   collecting the seeds produced by the most recent hybrid generation;

                   growing plants from the seeds of the most recent hybrid generation;

       allowing fruit to remain on the vine past the point of normal ripening; and screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.”

The patentees argued firstly that interspecies crossing between L. esculentum and a wild tomato species required special intervention in order to reach a reliably fertile offspring and would not take place in nature since generally individuals belonging to separate species are not capable of interbreeding, and secondly selection for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin would not occur in nature.

A preliminary issue arose as to whether the Implementing Regulations under the EPC could establish substantive law. The Enlarged Board held that observations in previous appeal board decisions that the Implementing Regulations could deal only with procedural questions and not with matters of substantive law was incorrect, and the only limitation on the law-making powers of the Administrative Council, which is empowered to amend the Implementing Regulations, was that if there was conflict between the Implementing Regulations and the EPC, then the latter should prevail.

The Board noted that r.26(5) EPC 2000 adopted the language of a.2(2) of the Biotechnology Directive (98/44/EC, 6th July 1998), but after lengthy consideration of the legislative history of that Directive concluded that even though the wording of the texts as finally enacted is unclear and contradictory 

“it is nonetheless evident that the objective meaning of the definition given in Article 2(2) Biotech Directive corresponds neither to the amendments voted for by the European Parliament nor to the substance of the earlier drafts, but rather is definitely something different”

As a result the legislative history did not assist in determining what the legislator intended to say. Accordingly r.26(5) EPC did not give any useful guidance as to how to interpret a.53(b) EPC, and the Enlarged Board had to do so on its own authority.

The Enlarged Board held that the purpose of the exclusion was to avoid the patenting of breeding processes in which technical measures or devices were used only as means to bring about processes for the production of plants that were otherwise based on biological forces. Although breeding processes by their nature involve human intervention the conclusion to be drawn is that a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC. However, if a process of sexual crossing and selection includes within it 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 that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC and qualifies as a potentially patentable technical teaching.

The answers to the questions of law referred to the Enlarged Board were accordingly that:

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.

In the outcome it seems that processes for the production of plants will henceforth be difficult to patent unless exogenous genetic material is introduced by recombinant DNA techniques. Neither the broccoli nor the tomato patent appears likely to survive in its present form, although decisions will not become final until the two cases have returned to Appeal Board 3.3.04 whose role is to interpret and apply the ruling from the Enlarged Board.

Comment

         In addition to the finding about plant breeding inventions, the Enlarged Board made observations relevant to problem/solution analysis as carried out by the EPO.

         According to the EPO Examination Guidelines at  C IV 11.5.2  in assessing inventive step, the distinguishing features are identified between the claimed invention and the closest prior art and the technical effect that results from those features is identified:

“In the context of the problem-and-solution approach, the technical problem means the aim and task of modifying or adapting the closest prior art to provide the technical effects that the invention provides over the closest prior art.”

         This approach to the definition of “the objective technical problem” by reconstruction from the technical effect achieved is reinforced by observations of the Enlarged Board with reference to earlier decisions of the German courts:

“Human intervention, to bring about a result by using the forces of nature, pertains to the core of what an invention is understood to be. Like national laws, the EPC does not define the term “invention” but the definition that was given many years ago in the “Red Dove” (“Rote Taube“) decision of the German Federal Court of Justice (“Bundesgerichtshof”), BGH 27.3.1069, X ZB 15/67 set a standard which still holds good today and can be said to be in conformity with the concept of “invention” within the meaning of the EPC.

In that decision, in the version of the translation into English published in 1 IIC (1970), 136, the German Federal Court of Justice defined the term “invention” as requiring a technical teaching. The term technical teaching was characterised as “a teaching to methodically utilize controllable natural forces to achieve a causal, perceivable result” (point 3 of the Reasons)…

The above quote is strikingly reminiscent of a passage in the Preliminary Observations in a book by George Ticknor Curtis, a 19th century attorney whose clients included Samuel Morse, Charles Goodyear and Cyrus McCormick. In his book “A Treatise on the Law of Patents for Useful Inventions”, Charles C Little and James Brown, Boston, 1849 (downloadable from the Antique Rare IP Library of IP Mall) George Curtis said:

“It is evident, therefore, that the whole of the act of invention, in the department of useful arts, embraces more than the new arrangement of particles of matter in new relations. The purpose of such new arrangements is to produce some new effect or result, by calling into activity some latent law, or force, or property, by means of which, in a new application, the new effect or result may be accomplished. In every form in which matter is used, in every production of the ingenuity of man, he relies on the laws of nature and the properties of matter, and seeks for new effects and results through their agency and aid.”

It will be noted that knowledge of the significance of new effect or result ante-dated the decision of the Supreme Court in Hotchkiss v Greenwood (1850), ante-dated the first German patent act (1877) and ante-dated the establishment of the EPO (1978) by at least 130 years.

EPO practice is firstly to require the alleged technical effect (or solution to the alleged technical problem) to be present, illustrated or at least credible over the whole area claimed and secondly in order to avoid arbitrary selections to require a causal link between the purported effect and the distinguishing features. That practice is now seen to be in accordance with the decision in Red Dove. The importance of identifying new results and effects and mentioning them in specifications intended to be filed at the EPO either directly or via the PCR route needs no further elaboration.

In the present case, basis for the decision was that meiosis was an inherently random process which determined whether or not a plant was produced having the desired combination of genes and the application of technical means (e.g. radiation or a special greenhouse) does not change the underlying natural process of meiosis. In order for a process to be patentable there must be human intervention such that the result is not the mere mixing of the genes of the plants selected for sexual crossing, e.g. by involvement of a genetic engineering technique such that a relevant human intervention can be seen to have taken place.

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