Products of Essentially Biological Processes – patentable again at the EPO?
The issue of the patentability of plants and animals obtained from “essentially biological processes” has been in a state of flux in recent years at the EPO. Reports are out suggesting that a decision of the EPO Technical Board of Appeal on 5th December 2018 is an exciting development for those interested in seeking protection in this technology area. The Board found that the recently amended Rule 28(2) EPC is in conflict with Art. 53(b) EPC. In this article we shall review how we got here, where we stand today, and note what is currently patentable at the EPO under EPC law.
Rules 27 and 28 EPC relate to the interpretation of Article 53 EPC, [this article] covers exclusions from patentability under Europe Patent law. To refresh your memories, Rules 27 and 28 EPC have clauses relating to the protection of plants and animals and the products of essentially biological processes. The relevant sections (as of December 2018) are as follows:
Rule 27: Patentable biotechnological inventions
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; […]
Rule 28: Exceptions to patentability
[…] (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.
Article 53: Exceptions to patentability
European patents shall not be granted in respect of:
[…] (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; […].
A Brief History and Interpretation of the Law
Plant and animal “varieties” and “essentially biological processes” for the production of plants and animals have long been excluded from patent protection under Article 53 EPC, as laid down in the 1998 Directive of the European Parliament and of the Council (98/44/EC) “The Biotech Directive”.
As such, method-type claims involving any steps of “classical” plant or animal breeding (e.g. selection and crossing) are not allowable, as these are considered “essentially biological”. Conversely, claims directed to “biotechnological” (e.g. transgenic processes) methods are allowable, as these are not essentially biological. Whether the products (e.g. plants or animals) resulting from such methods can be protected has been legally uncertain for some time now.
It is worth noting at this point that plant varieties have been protectable in Europe since the 1960s through the Plant Breeder’s Rights (PBR) or Plant Variety Rights (PVR). This protection is separate and different to the protections granted by patent protection.
Following years of debate about the interpretation of the above mentioned Articles, Rules and the Biotech Directive, the ruling in the landmark ‘Broccoli II’ and ‘Tomato II’ (G2/12 and G2/13) cases was that protection can be granted to protect plants and animals resulting from both non-essentially biological (e.g. transgenic) methods and classical methods, as long as the resulting products comply with the standard patentability requirements (mainly novelty, inventive step, reproducibility etc.). These decisions ruled that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of such products.
These decisions, despite intending to provide some legal certainty after years of referrals and indecision as to the interpretation of the law, did not go down well everywhere, particularly with plant breeders. As a result of lobbying and following a European Parliament resolution, the European Commission issued a Commission Notice finding that “the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes”. This is contrary to the ‘Broccoli II’ and ‘Tomato II’ (G2/12 and G2/13) cases. The Commission found these decisions were in conflict with the Biotech Directive and Rules 27(b) and 28(2) EPC, and thus sought to overturn the finding of these decisions.
As a result of this Commission Notice, in July 2017, the EPO released Decision (CA/D 6/17), amending Rules 27(b) and 28(2) EPC to be in line with the Notice. The amended Rule 28 made it clear no patent shall be granted for claims directed to plants or animals exclusively obtained by means of an essentially biological process (as produced above). This was welcomed in some fields, as this essentially removed any overlap between rights granted by patents and the aforementioned Plant Breeder’s Rights or Plant Variety Rights. However, amendments to the law which renders once patentable products as unpatentable, will always be met with disappointment by some parties. These reduced protection rights in this field, inevitably has adverse effects on the Ag-Bio industry, which produce plants and animals (such as the Tomato and Broccoli strains at the heart of the ‘Broccoli II’ and ‘Tomato II’ cases).
However, noted by observers was that these changes directly conflicted with the decisions of the Enlarged Board of Appeal in ‘Broccoli II’ and ‘Tomato II’ (G2/12 and G2/13) cases. Article 122 EPC makes it clear that decisions of the Enlarged Board of Appeal are legally binding, so as of July 2017 there was evidently legal conflict.
The Recent Decision
This conflict was highlighted and addressed in the recent decision of The Board of Appeal in T 1063/18, a ruling on Syngenta’s EP application EP2753168, where claims directed to a pepper plant produced by an essentially biological process were rejected. The Board ruled that the newly amended (July 2017) Rules 27 and 28 were in direct conflict with the interpretation of Article 53(b) EPC in the ‘Broccoli II’ and ‘Tomato II’ (G2/12 and G2/13) cases. Here, the Board of Appeal found that Rule 28(2) is unenforceable, and that the ‘Broccoli II’ and ‘Tomato II’ case decisions still stand. This particular patent application has gone back to the Examination Division and the Rule 28 rejection is expected to be dropped as a result of this. This decision essentially renders the amended R.28(2) EPC null and void.
This will likely be well received by many companies and organisations in the sector, with hope for patent protection of products from essentially biological processes in the future.
However, Rule 28(2) still exists under the EPC, and Examiners may still be applying this during examination of pending European patents. As such, future rulings on the interpretation of the new Rules 27 and 28 will be followed closely by the industry, and will set the precedent. It is likely that the EPO will once again suspend examination of such applications, and we could see a referral to the Enlarged Board in an attempt to settle the matter.
What is protection available for today?
As it stands today, patent protection can be sought in Europe for the following:
- Transgenically or mutagenically produced plants or animals, along with the methods of producing them (providing the methods do not include any steps pertaining to essentially biological processes), for example plants that have been purposefully altered to carry new traits, such as pest or drought resistance; and
- Plants or animals produced by essentially biological processes, such as classical breeding techniques, but not the methods themselves;
Also patentable, and related to these, are:
- Plant products that are not propagation material in themselves, such as flour, sugars or fatty acids; and
- Microorganisms, such as in vitro cultures of cells (plant or animal), e.g. yeast cultures that may be utilised in food production techniques.
However, it is important to note that national courts of individual countries, which would deal with enforcement and litigation of such granted patents, will have their own opinion on the patentability of such claims. In theory such courts will be bound by the Biotech Directive, and as such could find such claims to actually be unenforceable.
We at TLIP will be among those closely following developments. We are on hand to advise on the patentability of such subject matter, and if you have any questions relating to any of the above please do not hesitate to contact us at email@example.com.