The European Patent Organisation (EPO) has signed a validation agreement with Cambodia. This means it will be possible to validate a granted European patent in Cambodia, for the first time extending the protection conferred by European patents into Asia. This builds on existing validation agreements with Morocco and Moldova and extension agreements with Bosnia & Herzegovina and Montenegro (as well as a planned validation agreement with Tunisia), increasing the total number of countries in which protection may be obtained through a European patent to 43, now spanning three continents and covering markets of more than 650 million inhabitants. The agreement is due to enter force once adopted into Cambodian law, which should occur around July 2017.
Notably, the Cambodian government has chosen to use a World Trade Organization (WTO) waiver regarding pharmaceutical products which will be excluded from the agreement during a transitional period. This waiver exempts Least Developed Countries (LDCs) from having to implement certain provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding the protection of pharmaceutical patents and clinical trial data. The waiver permits LDCs such as Cambodia to develop fledgling pharmaceutical manufacturing industries and to continue to import generic medicines from abroad without regard to patents. At present, the waiver transitional period is due to end in 2033, although it may be extended by agreement of the WTO TRIPS Council.
As of December 2016, the European Patent Office (EPO) has stayed all examination and opposition proceedings relating to patents and patent applications in which the decision depends on the patentability of a plant or animal obtained by an essentially biological process. This measure has been taken following the release of a Notice by the European Commission stating that plants and animals derived from essentially biological processes should not, in its view, be considered patentable.
At present, Article 53(b) of the European Patent Convention (EPC), which is the law under which the EPO grants European patents, a patent shall not be granted for plant or animal varieties or essentially biological processes for the production of plants or animals (although this provision does not apply to microbiological processes or the products thereof). The purpose of excluding patent protection for plant varieties in particular is to avoid overlap with plant breeders’ rights available under other national and international laws.
The Implementing Regulations to the EPC also contain a number of rules relating to plant and animal varieties. In particular, biotechnological inventions are patentable if they concern plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety (Rule 27(b) EPC) or if they concern a microbiological process or other technical process, or a product obtained by means of such a process other than a plant or animal variety (Rule 27(c) EPC). The regulations clarify that a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection, and that a microbiological process is any process involving or performed upon or resulting in microbiological material.
The Implementing Regulations were previously amended to take into account a European Union Directive (Directive 98/44/EC, otherwise known as the Biopatent Directive) issued by the European Commission. The Biopatent Directive regulates many different categories of biological materials, including elements isolated from the human body, plants and animals, and genetically modified organisms. The European Patent Organisation is a not an EU body and is not subject to EU law. Nevertheless, the EPO member states (many of whom are currently EU members) chose to amend the Implementing Regulations to comply with the Directive and ensure harmonisation in patent law across Europe.
Since the Implementing Regulations were amended, the EPO and its Boards of Appeal have taken the Biopatent Directive, as well as judgments of the Court of Justice of the European Union relating to the interpretation of the Directive, into account when assessing biotechnological cases. However, the EPO has consistently interpreted Article 53(b) EPC narrowly in the sense that while essentially biological processes for the production of plants or animals are clearly not patentable, plants or animals produced as a result of such essentially biological processes are treated as being patentable. This is because Article 53(b) does not specifically exclude from patentability the products of such essentially biological processes; it merely excludes the processes themselves.
In two high-profile cases decided in 2013, referred to as Broccoli II (G2/13) and Tomato II (G3/12), the Enlarged Board of Appeal found that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC “did not have a negative effect on the allowability of a product claim directed to plants or plant material such as a fruit”. The Enlarged Board also found that the fact that the only method available for generating the claimed subject-matter at the filing date of the application was an essentially biological process for the production of plants did not render a claim directed to plants or plant material other than a plant variety unallowable. These decisions have been controversial as they were seen to favour the rights of large biotechnological companies.
In contrast, the Notice issued by the European Commission in November states that the European legislator’s intention was to exclude products obtained by means of essentially biological processes, contradicting the established case law at the EPO. It is for this reason that the EPO has stayed all proceedings relating to such products until such time as the EPO member states confirm how the EPO should proceed. If the EPO member states choose to follow the new interpretation provided by the European Commission Notice, the EPO has confirmed that it will implement their decision.