AL: News

Further developments in patentability of products obtained from essentially biological processes

Wednesday 27 February 2019

After years of controversy, the Technical Board of Appeal (TBA) of the EPO has recently decided that products obtained by essentially biological processes can be patent protected (T1063/18). We published a summary of this case earlier in the year prior to the publication of the written decision by the TBA. The TBA has now published their decision and we provide a summary of their reasoning.

Pending application EP2753168 in the name of Syngenta with claims to cultivated pepper plants was refused by the EPO’s Examining Division in April 2018, as failing to comply with the requirements of Article 53 (b) EPC and Rule 28 (2) EPC. Thus, the application was refused for the sole reason that the claimed subject-matter falls within the exception to patentability. This decision was subsequently appealed by the Applicant and oral proceedings were held on the 5th December 2018.

The applicant submitted various lines of argumentation, including that the Rule 28 (2) EPC (as recently amended by the Administrative Council of the EPO) was in contradiction to Article 53(b) EPC as interpreted in landmark decisions G2/12 and G2/13. Five further third parties filed arguments, four of which were in support of Syngenta’s argumentation.

The Board agreed with the Applicant and found that the recently amended Rule 28(2) EPC was in direct conflict with Article 53 (b) EPC. Also, as emphasised by the Board, under Article 164 (2) EPC, the provisions of the convention prevail in case of conflict with the Implementing Regulations. The Board was of the view that the European Commission’s position set out its notice in 2016 was not legally binding as only the Court of Justice of the European Union (CJEU) is competent to issue a legally binding interpretation of the Biotech Directive.

With this in mind, the Board did not see any reasons to deviate from the original interpretation of Article 53(b) EPC as set out by the Enlarged Board of Appeal (EBA) in G2/12 and G2/13.

The Board concluded by remitting the case to the examination division for further prosecution to resolve objections for clarity and inventive step.

Further Developments

On the 20th February 2019, a meeting was held between the Committee on Patent Law, the European Patent Office and the representatives of the 38 EPO Contracting States, with the European Commission acting as an observer, to decide on possible next steps following this decision.

The Committee recognised the requirement for legal certainty in the interest of the users of the European patent system and the general public.

This decision T1063/18 is good news for many innovators in the agritech industry, but it seems that we may not have heard the final word. Applicants are advised to watch for further legal developments and it will be interesting to see if further Decisions will issue on this question of patentability.

Background

To obtain a European Patent, inventions must satisfy the requirements of patentability set forth by the articles and rules of the European Patent Convention (EPC). Unique to biotechnological inventions, Rule 27 stipulates what constitutes a patentable biotechnological invention, whilst Article 53 and Rule 28(2) set out exclusions from patentability. Particularly, Article 53(b) and Rule 28(2) specify that plant or animal varieties or essentially biological processes for the production of plants or animals are excluded from patentability. Rule 26(5) further defines that the production of plants or animals is essentially biological if it consists entirely of natural phenomena, e.g. cross breeding or selection of organisms based on favourable characteristics. Additionally, the Directive 98/44/EC provides a supplementary means of interpretation when considering the EPO's rules regarding biological inventions (for further information on the Biotechnology Directive, see here).

Tomatoes and broccoli

The interpretation of the rules governing the patentability of biotechnological inventions in Europe has been controversial, in particular the rules relating to biological processes and products obtained from such processes.

In the key decisions G2/13 and G2/12 of March 2015, the EPO’s Enlarged Board of Appeal held that claims to products derived from an essentially biological process are allowable as long as the other criteria for patentability are fulfilled. This was the case even if the process used to obtain the products (i.e. selecting and crossing the plants) is essentially biological and thus in itself not patentable. The main rationale for the decision was that exclusions from the general principle of patentability have to be narrowly interpreted in law. Therefore, the exclusion of claims directed to an essentially biological process for the production of plants did not extend to products derived therefrom.

However, this ruling was seen by the European Parliament as in potential conflict with the legal protection provided to plant varieties under EU plant variety right legislation. In December 2015, the European Parliament asked the European Commission to look into the patentability of products derived from essentially biological processes.

In November 2016, the European Commission concluded that the EU legislator's intention when adopting the Biotechnology 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 EPO’s Enlarged Board of Appeal to allow claims to products obtained from an essentially biological process went contrary to the intentions of the Biotechnology Directive.

The EPO concluded that plants and animals exclusively obtained by essentially biological processes are excluded from patentability. Rules 27 and 28 EPC were amended to state that “under 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 amended Rules entered into force on 1 July 2017.

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