In a surprising decision, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) recently found that the products of essentially biological processes are not patentable, reversing its earlier opinion.
The decision, which can be found here surprised many observers. It was triggered by a referral from EPO president António Campinos in April 2019, and is the latest development in a saga that has now been running for more than 20 years.
In 1999 the EPO implemented the ‘Biotech’ Directive (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions), with the purpose of harmonising national law on the patentability of inventions relating to biological material.
As a result of the Biotech Directive, essentially biological processes for producing plants and animals were excluded from patentability and this is implemented by Article 53(b) EPC. A process for the production of plants and animals is considered to be essentially biological if it consists entirely of natural phenomena such as crossing or selection. However, biotechnological methods of producing transgenic plants and tools, such as genetic markers for use in such methods, can be patented.
The exclusions to patentability provided by the Biotech Directive have been confirmed by numerous decisions of the EPO Boards of Appeal, for example, in the related cases Broccoli II (G2/13) and Tomato II (G2/12). In G2/12 and G2/13 it was found that Article 53(b) EPC should be interpreted narrowly and should not prevent the grant of patent claims directed to plants or plant products produced by essentially biological processes.
However, these decisions of the EBA were not received favourably by some groups, especially plant breeders’ associations. Having come under pressure from such lobbying groups and certain national governments to limit the extent of patent protection available in this area, in December 2015, the European Parliament adopted a resolution asking the European Commission to review the patentability of products of essentially biological processes.
The European Commission concluded that the EU legislator’s intention when adopting the Biotech Directive was to exclude from patentability products that are obtained by means of essentially biological processes.
Thus, the rulings in G2/13 and G2/12 by the EBA to allow claims to products obtained from an essentially biological process were considered by the EU Commission to be contrary to the intentions of the Biotech Directive.The Commission’s Notice was highly controversial and although it was not binding on the EPO, Decision (CA/D 6/17) was issued by the EPO’s Administrative Council to amend Rules 27(b) and 28(2) EPC in light of the Notice. Rule 28(2) EPC was thus amended to state that European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. The Decision to amend Rule 28(2) EPC was unprecedented because it was in direct contradiction to the previous decisions of the EBA (in G2/12 and G2/13).
The amendment to R28(2) EPC was tested before a Technical Board of Appeal in December 2018, in T1063/18. In the decision, the Board of Appeal found that the amendment to Rule 28(2) EPC reverses the meaning of Article 53(b) EPC, as interpreted by the EBA, and it is not possible to interpret Rule 28(2) EPC in such a way that no contradiction exists. According to Article 164(2) EPC, in case of conflict the Articles prevail, thus rendering the amendment to Rule 28(2) EPC void.
The Board also found that it was not necessary to deviate from the interpretation of Article 53(b) EPC given by the EBA in decisions G2/12 and G2/13 and in addition, a referral to the EBA was also unnecessary. Nevertheless, the EPO President referred T1063/18 to the EBA, arguing that the referral was necessary to restore legal certainty. However, the referral was highly controversial. Various parties, including CIPA (the professional body for patent attorneys in the United Kingdom), questioned the admissibility of the referral in the absence of conflicting decisions from EPO Appeal Boards on the interpretation of Article 53(b) EPC. Nevertheless, in G3/19, the EBA has now found that “the exception to patentability … in Article 53(b) EPC has a negative effect on the allowability of product claims … directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process”.
The decision of the EBA in G3/19 is remarkable for a number of reasons. Firstly, it surprised many observers that the EBA was able to give a decision and did not find the referral to be inadmissible in view of a possible lack of conflicting case law that a presidential referral requires. Several referrals have been deemed inadmissible for this reason previously. Secondly, the EBA took the rare step of reversing its own earlier decisions in G2/13 and G2/12. The EBA explained that the reason for the divergence is that the exception to patentability under Article 53(b) EPC required a “dynamic interpretation”.
As explained in the EPO’s press communiqué, “On the merits of the referral, the Enlarged Board endorsed its earlier findings on the scope of Article 53(b) EPC, which were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time. This meant that decisions G2/12 and G 2/13 did not settle the meaning of Article 53(b) EPC once and for all. Taking account of the Administrative Council’s decision to introduce Rule 28(2) EPC, the preparatory work on this provision and the circumstances of its adoption, as well as legislative developments in the EPC contracting states, the Enlarged Board concluded that new Rule 28(2) EPC allowed and indeed called for a dynamic interpretation of Article 53(b) EPC”. Thirdly, the decision of the EBA is effective only as of a particular date rather than fully retrospectively.
The EBA stated that the new interpretation of Article 53(b) EPC given in G3/19 does not apply to patents granted before 1 July 2017, when the amended Rule 28(2) EPC was introduced, or pending applications filed before that date. The EPO President António Campinos welcomed the EBA decision: “It will bring greater legal certainty for patent applicants, and the general public, on what is a sensitive and complex issue that has legal, societal and economic implications”.
As a result of the decision in G3/19, product and product-by-process claims directed to plants, plant material, or animals, are excluded from patentability if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.
At first glance this decision would appear to come as a blow to the European Agritech industry. In practical terms, however, very little has actually changed for patent applicants in this field. The enforcement of European patent claims to plants produced by crossing and selection was already limited in this area and in a number of countries national legislation already excluded patent protection for the products of essentially biological processes and means to rely more on plant variety rights for protecting innovations in this area.
It is also worth emphasising that plants and plant material obtained by a technical process are unquestionably patentable. It is also still possible to obtain patent protection for plant or animal derived products that are not propagation material and in vitro plant or animal cell populations which are treated as microorganisms.