A lengthy back-and-forth about the patentability of plants, plant materials and animals derived from essentially biological processes appears to have reached its denouement with the Enlarged Board of Appeal’s (“EBA”) opinion in G 0003/19 last week (here).

Legal background

G 0003/19, better known as Pepper, concerns the patentability of a pepper plant as claimed in Sygenta’s EP2753168 application, and is the sixth case relating to the interpretation of Art. 53(b) EPC to reach the EBA. Art. 53(b) provides an exclusion from patentability under the EPC, stating that European patents shall not be granted in respect of “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”.

The main question in respect of Art. 53(b) has long been whether its wording excludes from patentability not only essentially biological processes (i.e. process claims), but also the products of essentially biological processes (i.e. product and product-by-process claims). This is a matter of considerable importance to the European agritech industry, which has relied upon the narrower interpretation of the exclusion to enable it to patent the products it produces, even if the processes themselves are excluded from patentability.

Within the EU, the extent to which biotechnological inventions are patentable is set out in Directive 98/44/EC (“Biotech Directive”), which has subsequently been implemented into national law by the Member States, and which led to the introduction of Art. 53(b) EPC. The Biotech Directive states at Art. 4(1) that “[t]he following shall not be patentable: […] essentially biological processes for the production of plants or animals”, hence the language of Art. 53(b) EPC.

Previous case law

The seminal opinion on Art. 53(b) prior to Pepper was issued in the consolidated G 2/12 and G 2/13 cases, also known as Tomatoes II and Broccoli II. In Tomatoes/Broccoli II the EBA conducted a thorough interpretative review and held that the correct interpretation of Art. 53(b) in light of all the appropriate considerations, including the Biotech Directive, was that the term “essentially biological processes for the production of plants” could not be read so as to include the products defined or obtained by such processes.

Recent legislative developments

However, in 2017 at a meeting of the Administrative Council[1] of the EPO, a new Implementing Regulation to the EPC was introduced by the Council.  The vote to introduce the Rule passed by a substantial margin with 35 of the 38 representatives in favour, 1 in opposition, 1 in abstention and 1 absentee. The new Rule 28(2) states that “[u]nder Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”  The Implementing Regulations are a body of secondary legislation designed to aid in the interpretation of the EPC. This amendment was made in consequence of the European Commission’s position paper on the Biotech Directive, which was produced following the Tomatoes/Broccoli II decision. The EC paper concluded that the purpose of the Biotech Directive was to exclude both essentially biological processes and products derived from such processes from patentability, in contrast to the then position of the EBA in Tomatoes/Broccoli II.

Pepper

Rule 28(2) therefore created a clear tension between the case law of the EPC as decided by the EBA and the secondary legislation to the EPC. When Pepper reached the Technical Board of Appeal (“TBA”) as T 1063/18 shortly after the implementation of Rule 28(2), the TBA held in its decision that Rule 28(2) was void as a consequence of its incompatibility with Art. 53(b) as interpreted by the prior case law of the EBA. The TBA declined to refer its decision to the EBA. Following the demurral of the TBA, the President of the EPO promptly stepped in to refer two questions to the EBA relating to the decision in T 1063/18 himself.  The President asked:

1. Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?
2. If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes not explicitly allows said subject-matter?

The EPO President may make a referral to the EBA under Art. 112 EPC. In order to make a referral, two conditions must be satisfied. First, there must be two conflicting decisions on a question of law from the Boards of Appeal. Second, an answer from the EBA is required to ensure the uniform application of the law, or a point of law of fundamental importance is in issue. As the decision in T 1063/18 directly followed the reasoning of Tomatoes/Broccoli II, and there was no conflicting decision subsequent to Tomatoes/Broccoli II, it was widely considered in the patent community that the EBA would find the referral to be inadmissible. The issue was slightly confused by the fact that only one Board of Appeal deals with patents in this sector, and so in effect the TBA would need to disagree with itself in order for a referral to be made by the President.

As a first point of order, the EBA considered the President’s questions to be too leading and too broad. It noted that if it allowed the premise of the first question, it would have the effect of accepting that the Administrative Council could effectively overrule any EBA decision it did not agree with by creating an Implementing Rule making the relevant EBA decision untenable. To avoid having to make such a statement, the EBA rephrased the President’s questions as follows:

Taking into account developments that occurred after a decision by the Enlarged Board of Appeal giving an interpretation of the scope of the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC, could this exception have a negative effect on the allowability of product claims or product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process feature define an essentially biological process.

Admissibility

The Board considered that the issues underlying the referral concerned a point of law of fundamental importance requiring a uniform application of the law. It arrived at this conclusion on the basis that the approach of the EPO in light of Tomatoes/Broccoli II was not harmonised with the legal developments within the contracting states to the EPC and within the EU. Further, this is an issue for a significant number of pending and future cases at the EPO.

More surprisingly, the EBA also found that the President’s referral concerned a point of law on which two different Boards of Appeal had given differing decisions. As the TBA’s decision in Pepper followed the Tomatoes/Broccoli II  case law, the EBA did not consider there was a divergence in the case law on the question of whether products of essentially biological processes could be patented. However, the EBA found that by disregarding Rule 28(2), the TBA in Pepper had created a divergence in case law with other decisions which considered the impact of Implementing Regulations on the interpretation of the EPC. This was because prior cases had acknowledged that an Implementing Regulation could affect the interpretation of a provision of the EPC, even where that provision had been previously interpreted by a Board of Appeal. The TBA’s dismissal of Rule 28(2) as void due to its conflict with Tomatoes/Broccoli II therefore provided basis for the President’s referral under Art. 112.

Decision

The EBA acknowledged that the meaning of Art. 53(b) was open to questions of interpretation, as this was the basis of Tomatoes/Broccoli II. Although it endorsed the decision reached in that case, the EBA went on to note that the interpretation of the EPC is dynamic, and therefore subject to change over time in light of developments to the legal and factual situation underpinning the act of interpretation.

The EBA considered that although Art. 53(b) had in the past been properly construed as excluding only essentially biological processes from patentability, Art. 53(b) is written in such a way that it is possible to read it as also excluding products of essentially biological processes from patentability. It was clear to the EBA that by implementing Rule 28(2) it was the intention of the contracting states to the EPC that Art. 53(b) should be read as excluding products of essentially biological processes, and because Rule 28(2) was not fundamentally incompatible with Art. 53(b) the EBA concluded that it must abandon the interpretation arrived at in Tomatoes/Broccoli II, and adopt the new broader interpretation which aligns with Rule 28(2) and the EC position paper on the meaning of the Biotech Directive.

What next?

The opinion of the EBA will only affect patent applications with a priority or application date on or after 1 July 2017, the date on which Rule 28(2) came into force. Patent applications for products derived from essentially biological processes with priority or application dates prior to 1 July 2017 will continue to be approved by the EPO, as they are in accordance with the law as it stood following the Tomatoes/Broccoli II opinion.

Pending further legislative changes, it seems that the debate at the EPO about the patenting of biological processes and their products is settled for now, and not in the favour of industry.

[1] The Administrative Council is the supervisory body of the EPO, and is comprised of representatives of each of the contracting states of the EPC.