Crucial Rule Changes for the Patentability of Plants and Animals at the European Patent Office
Starting with immediate effect from the 1st July 2017, plants and animals obtained from essentially biological processes will no longer be patentable before the European Patent Office (EPO).
Following a meeting of the Administrative Council, the Decision (CA/D 6/17) was taken to amend Rules 27(b) and 28(2) EPC. These rules form part of the EPC Implementing Regulations and therefore affect the interpretation of Article 53 EPC which determines the exclusions from patentability in Europe. The decision comes after years of controversy around the patentability firstly of biological processes for the production of plants and animals and secondly of the plants and animals that they produce.
The new rules will read as follows:
Biotechnological inventions shall also be patentable if they concern:
…(b) without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety….
(1) Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
.... (2) 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.
For some time at the EPO plant varieties and “essentially biological processes” for the production of plants and animals have been excluded from patent protection under Article 53 EPC. These exclusions to patentability are derived originally from Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (The “Biotech” Directive).
However, obtaining patent claims to methods including steps of “classical” plant or animal breeding (i.e. crossing and selection) is not possible, whilst claims to biotechnological methods (e.g. transformation and regeneration) of producing transgenic plants or animals and to tools such as markers for use in methods of breeding can be allowable. Separate protection for specific plant varieties has been available since the 1960s via the plant variety rights system; International Convention For The Protection Of New Varieties Of Plants of December 2, 1961, as revised at Geneva on November 10, 1972, and on October 23, 1978, and on March 19, 1991.
Until now, it has in principle been possible to obtain patent claims to plants and animals resulting from both transgenic methods and those resulting from crossing and selection (providing that the resulting plant material is new, inventive and can be reproduced reliably). As mentioned above, although such claims have been controversial in recent years, their patentability has been confirmed on several occasions including by the highest decision-making authority at the EPO; the Enlarged Board of Appeal in the famous ‘Broccoli’ and ‘Tomato’ cases.
However, these decisions were not received favourably by some groups, especially plant breeders associations who have argued that allowing plants resulting from crossing and selection to be patented is an unfair intrusion into the territory of plant variety rights. Having come under pressure from such lobbying groups to limit the extent of patent protection available in this area , in November of last year, the European Commission issued a Notice which stated that the scope of the exclusion to “essentially biological processes” for the production of plants and animals should be interpreted to mean that plants and animals resulting from classical breeding and selection are not patentable in Europe .
While the Notice was not binding on the EPO, a decision was taken in light of it to stay prosecution of all such cases until a way could be found to reconcile the practice of the Commission’s comments with the EPC. This has now been achieved by the changes to Rules 27(b) and 28(2) EPC. While this may seem a relatively simple yet legally binding option to exclude plants and animals exclusively obtained by an essentially biological breeding process from patentability, this decision is unprecedented as it stands in direct contradiction to the previous decisions of the EPO’s Enlarged Board of Appeal ( ‘Broccoli’ and ‘Tomato’ cases).
Importantly for AgBio research in Europe, transgenic plants and animals and biotechnological methods of producing them remain patentable. However, a consequence of the EPO decision is that plants and animals obtained by methods which include classical breeding steps (i.e. those which only result in a mixing of genes of the parental lines) are not patentable before the EPO.
The change in position by the EPO will come as a disappointment to patent applicants in the agricultural sector with significant European markets, and those who may have acted to file applications based on the recent EPO Enlarged Board of Appeal decisions G2/12 and G2/13. One unfortunate consequence of the decision might be that researchers are discouraged from developing new plants or animals, and plant or animal material which could be of great commercial or humanitarian value. However, it could be argued that in practical terms, little has changed for patent applicants as the enforcement of European patent claims to plants produced by crossing and selection was already limited in this area. Prior to the Commission’s Notice, the countries with the largest plant breeding sectors in Europe; the Netherlands, Germany and France had all previously enacted legislation which specifically excluded patent protection for plants produced by crossing and selection, a position with which the EPO Decision CA/D 6/17 is now in alignment. Therefore granted claims to such plants could not be enforced in these major jurisdictions anyway. However, the situation in the UK is not clear at present. The UKIPO has not yet issued any statement regarding the EPO Rules changes, but typically, the UKIPO tends to follow European precedence on such issues, however it remains to be seen how this relationship may be affected once Brexit occurs.
In contrast, the decision will surely be well received by plant breeders. Under the previous legislation, plant breeders had to acquire a licence from any relevant patent holder in order to use plants and plant varieties encompassed by such patent claims in a breeding programme. Now that patent claims to plants obtained by classical breeding are deemed not patentable, this is no longer the case.
The new EPO provisions will apply with immediate effect (as from 1st July 2017) and are expected to be included in the 2017 EPO Guidelines revision with further clarification in the 2018 edition. Proceedings in examination and opposition cases concerning plants obtained by classical breeding techniques that have been stayed since November 2016 following the Commission's Notice will now resume and are subject to the new legislation.
In view of the decision, patent applicants in this area would be wise to consider the following points of advice when deciding their strategy for patent applications directed towards plant or animal breeding in Europe:
- It is still possible to obtain patent protection for transgenic plants or animals, plants or animals obtained by mutagenesis, and/or biotechnological methods of producing them, providing other patentability criteria are fulfilled;
- It is 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;
- If protection of plants produced by classical breeding techniques is of importance, then consider filing plant variety right applications covering key plant products;
- Claims in patent applications directed to plants or animals produced by classical breeding techniques should be avoided in Europe;
- The possibility of obtaining granted claims to plants or animals produced by classical breeding techniques may remain in other jurisdictions, and may develop in others, therefore retaining this subject matter at least in the description of an application is advisable.
HGF can help you determine the best strategy for your patent application and plant variety right protection. Please contact us for further information and advice. Our team of plant and animal specialists include Dr Richard Williams, Douglas Drysdale, Ellie Purnell, and Dr Ben Tolley.