In line with Article 53(b) of the European Patent Convention, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has changed its stand through conclusive pronouncement on the patentability of plants (and animals) formed through essentially biological processes many times during the last decade (EPC). Due to the EPO's more recent practise of requiring applicants to expressly disclaim plants obtained by such processes from claims directed at plants obtained by technical processes, the decisions have not created the desired legal certainty, but rather a gap in patent protection for biotechnological inventions. Article 53(b) was originally designed to exclude plant varieties and essentially biological processes of plant breeding from patentability in order to avoid duplication with existing national, regional, and international protection of plant varieties. This would enable plant breeders to continue employing time-honored biological techniques of breeding and crossing without worrying about patent protection.
Companies looking to safeguard plant innovation in Europe should take this most recent development into mind. Importantly, it is still feasible to protect plants and plant products with a European patent if a technological step introduces or modifies a novel feature. Nonetheless, it is no longer feasible to protect plants and plant products if the novel characteristic is the result of conventional crossing and selection alone, without any extra technological step. (As stated before, Pepper has no retrospective impact prior to July 1, 2017).
Many naturally occurring mutations may also be created experimentally, and many manufactured mutations might have happened naturally. Current EPO guideline states that protection may still be acquired if a disclaimer restricts the claimed subject matter to technically manufactured products13. Therefore, applicants should evaluate carefully if their innovations are actually excluded.
It was not obvious if plant products, which are created from basically biological processes, were likewise precluded from patentability until the recent EBA judgment G 3/19 (Pepper). Plants generated from fundamentally biological processes were originally approved for patenting by the EBA in G 2/12 and G 2/13 (Broccoli and Tomato II). Plants having technologically induced genomic alterations were not meant to be affected by the amended interpretation of Article 53(b) of the EPC in G 3/19. This includes not just plants with a transgene, but also plants with mutations generated by technologies based on random mutagenesis (such as UV radiation or chemical treatment) or targeted genome editing, like the Nobel Prize–winning CRISPR-Cas technology.
The EBA decided that the breadth of the exclusions to patentability set out in Article 53(b) of the EPC might be understood in many ways, allowing for a dynamic, time-dependent construction of the law. When coming to this flexible approach, the EBA considered the fact that ten of the 38 contracting states had previously made it illegal to patent plant (or animal) goods derived solely via fundamentally biological processes. The EBA voted to adopt Rule 28 and its interpretation of Article 53(b) (2). This line of decisions, as well as the process by which they came about, has raised concerns about the EBA's autonomy from the EPO president and the Administrative Council in the eyes of many experts in the law, patent practice, and concerned sectors. Not only should one debate the far-reaching and intimidating practical repercussions of G 3/19 for patenting plant-based innovations in Europe, but also the complaint against the procedural complexities of the current judgment. Despite its optimistic and goal-oriented presentation, G 3/19 has contributed significantly to the existing legal ambiguity. Until it is settled by the courts, the EU, or the EPC legislature, it will hinder the research and development environment for green biotechnology advancements in the European agriculture business.
There is no indication about the need for a disclaimer anywhere in G 3/19. Similarly, there is no legal precedent requiring a disclaimer for plants cultivated using mostly biological methods. In G 1/98, the European Patent Office (EPO) determined that claims to transgenic plants are patentable, notwithstanding the fact that the claim scope covers multiple plant kinds that were previously barred in the case of the exclusion of plant varieties. There is no mention of a mandatory disclaimer in any of the documents that led to the creation of EPC Rule 28(2). The use of double standards is unacceptable. Claims that comprise non-patentable subject matter but do not expressly allege such subject matter should not be rejected for patentability according to the G 1/98 decision. In light of this, applicants should not be asked to sign a disclaimer that excludes claims based exclusively on information obtained by essentially biological techniques.
To prevent the necessity for a disclaimer during prosecution before the EPO, the best practice for developing new patent applications should involve the formation of positive claim features that indicate the requirement for a technical (e.g., genome editing) step. In addition, rather than leaving its interpretation to the courts, it is appropriate to put relevant disclaimer language with definitions into new patent applications. Breeding (i.e., crossing and selection) for plant propagation, combination with other traits, or introduction into other genetic backgrounds should be explicitly excluded from the disclaimer.
For instance, Article 53(b) argues that only plant species that are forbidden. Claiming a plant with a trait or mutation makes the invention patentable and enables its application in several plant species. A patent for an unique and inventive allele, haplotype, changed protein, or DNA sequence will cover plants having such material, even if they were generated through essentially biological processes. Consequently, plant breeders continue to risk infringing upon existing patent rights, as is the case in any innovative area of research and development, notwithstanding the exemption to patentability offered by Article 53. (b). It is fair to assume that, in order to participate in cutting-edge research and development, plant breeders will have to accept this at least partly.
Without redress, G 3/19 and the EPO's disclaimer practice will certainly freeze green and agricultural biotechnology research across Europe. It will be essential to clarify and strengthen patentability and patent enforceability in the field of genome-edited plants by making clear, through European and/or EPC legislation, that plants produced by reproducible technical means remain patentable and the obtained patents are enforceable, if the aim is to maintain and encourage further innovation and research funding.