Decisions on consolidated referrals G2/12 and G2/13 have now issued from the Enlarged Board of Appeal answering the question of whether products (plants or parts thereof) obtainable by essentially biological processes are patentable at the EPO.  The very brief answer is yes, which is good news for companies trying to protect inventions in this area.

History of Tomatoes

European patent No. 1211926 as granted concerned a method for breeding tomatoes having a reduced water content (comprising several steps of crossing, the collection of hybrid seeds and screening for reduced fruit water content) and a tomato product capable of natural dehydration.  This patent was opposed and was maintained in amended form by the Opposition Division.  This decision was appealed by both the patent proprietor and the opponent (appeal T 1242/06) and a first referral (G 1/08) was made to the Enlarged Board of Appeal from this case, relating to the circumstances under which processes for the production of plants fall within the “essentially biological” exclusion of Article 53(b) EPC.  The opponent withdrew their appeal during the first referral.

In view of the Enlarged Board decision (G1/08) in the first referral, the patent proprietor amended the claim requests on file to delete the process claims which would likely be considered as being directed to unpatentable essentially biological processes.  The patent claims on file at this stage were thus only directed to tomato fruits or tomato fruit products.  Although the Appeal Board indicated that such products would not be excluded as plant varieties under Article 53(b) EPC, they were concerned that allowing these claims may render the exclusion to essentially biological processes ineffective, since these products would effectively need to be produced by such a method.  The following questions were therefore referred to the Enlarged Board:

1. Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit?

2. In particular, is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject matter is an essentially biological process for the production of plants disclosed in the patent application?

3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC?

History of Broccoli

European patent No. 1069819 as granted concerned a method for the selective increase of anticarcinogenic glucosinolates in Brassica species, where the method comprised a step of crossing particular Brassica species and the selection of hybrids with increased levels of the compounds of interest.  A Brassica plant or a part or a seed thereof were also claimed, where the plant was produced according to the method or by a hybrid crossing.  The appeal proceedings (T83/05) arose from appeals filed by two opponents, who were party to an opposition filed against the patent, against the decision of the Opposition Division to maintain the patent in amended form (containing method, product and product-by-process claims).  

The first referral from this case to the Enlarged Board of Appeal related to the interpretation of the exclusion for essentially biological processes in Article 53(b) EPC.  G2/07 issued from the Enlarged Board in this regard, and the proprietor amended the claims in view of this decision by filing requests restricted to product and product-by-process claims.   These amendments then led to the following questions being referred to the Enlarged Board of Appeal:

1. Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts?

2. In particular: (a) Is a product-by-process claim directed to plants or plant material other than a plant variety allowable if its process features define an essentially biological process for the production of plants? (b) Is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application?

3. Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC?

4. If a claim directed to plants or plant material other than a plant variety is considered not allowable because the plant product claim encompasses the generation of the claimed product by means of a process excluded from patentability under Article 53(b) EPC, is it possible to waive the protection for such generation by “disclaiming” the excluded process?

The referral was made in addition to the referral on the Tomato case since clarification regarding the patentability of product-by-process claims where the process is an essentially biological process was specifically required, along with a decision on the allowability of disclaiming such a process from the claims.  Further, the Broccoli patent concerned plants and plant parts rather than fruit as in the Tomato case.  

The referral

In consolidated proceedings, the Enlarged Board invited comments from the patent proprietors, from the opponents of the Broccoli case and from the President of the EPO on the referral.  

The proprietor of the Tomato patent indicated that the referral should be deemed as inadmissible in view of G1/98, which determined that only product claims directed to plant varieties are excluded from patentability under Article 53(b) EPC.  Further it was indicated that if the referral is admissible then G2/07 and G 1/08 (the first referral decisions) should be reviewed to exclude only processes which result directly in a plant variety.  The proprietor of the Broccoli patent indicated that the first question of the referral should be answered in the negative and that G2/07 and G 1/08 should be reviewed as they have led to a second referral and the exclusions should be narrow.  Further, it was submitted that those decisions should not be extended to product claims which are clearly distinguished from process claims in Article 53(b).  

The Broccoli opponent commented that questions 1, 3 and 4 should be answered in the negative and question 2 in principle in the affirmative and argued that to exclude plants which are obtainable by an essentially biological process would result in nothing being patentable in the plant world.  

Finally, the President concluded that Article 53(b) EPC did not have a negative effect on the allowability of product claims to plants.  He commented that there is no indication that the exclusion of essentially biological processes should be extended to products.

Decision

Firstly, it was decided that the referrals were admissible.  The Board concluded that G 1/98 did not comment on the extension of the exclusion to essentially biological processes to products and that G 1/98 only concerned the plant variety exclusion.  The referrals were indicated as necessary to provide a uniform application of the law.

The Board further indicated that there was no need to review G1/98, G 2/07 or G 1/08, as the referring questions do not relate to the plant variety exclusion or to the patentability of essentially biological processes.

The exclusion of Article 53(b) EPC was then examined to determine whether a narrow or broad interpretation should be given to the language.  Various different lines of interpretation were examined (including grammatical, systematic, teleological, subsequent agreement and historical) and the intermediate conclusion of the Board was that there is no evidence that the term “essentially biological processes for the production of plants” should extend beyond processes to products defined or obtained by such processes.  The Board then considered whether the legal impact of this understanding of Article 53(b) EPC necessitates the broadening of the scope of the process exclusion (if the interpretation is at odds with the legislator’s intention), where it was concluded that extension of the restriction is not required.  The Board commented that extending the exclusion to cover plants or plant materials would introduce an inconsistency to the EPC as such products are generally eligible for patent protection (other than plant varieties).  Further, the Board commented that although product or product-by-process claims may encompass and provide protection for not only the product but for the use of a product and production of the product, the relevant point of law is whether subject matter is excluded from patentability, not the protection conferred by such a claim.  

The Board therefore concluded that claims directed to plants or plant material such as a fruit or plant parts, other than a plant variety, are not excluded from being patented under the “essentially biological process” exclusion of Article 53(b) EPC.  Thus in the case of G2/12, the first and third questions were answered in the negative and the second question was answered in the affirmative, using a double negation and in the case of G 2/13, the first and third questions were answered in the negative and the second question was answered in the affirmative, using a double negation.  The Board indicated that the fourth question did not require an answer.