Last month, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) reached their decision in case G3/19 (“Pepper”). The EBA have taken a “dynamic approach” in interpreting Article 53(b) EPC and concluded that claims directed to plant or animals obtained exclusively by means of an ‘essentially biological process’ are not patent eligible. However, this exclusion to patentability does not apply to any pending or granted patent applications before 1 July 2017.
Thus, the EBA have made a U-turn on the previous ruling in decisions G2/12 and G2/13 (“Tomatoes II” and “Broccoli II” of 2013). The new G3/19 decision represents the latest twist in a long running legal and political saga surrounding the patentability of plants or animals produced by conventional breeding methods in Europe.
Article 53(b) EPC states:
“European patents shall not be granted in respect of 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.”
Despite being only a single sentence long, what may fall within this exception to patentability has been unsettled at the EPO for over 20 years. Indeed, the interpretation of Article 53(b) EPC has now been the subject of six referrals to the EBA - the highest judicial authority under the EPC.
In G1/98 of 1999, the question arose whether Article 53(b) EPC acts to exclude transgenic plants. The Enlarged Board of Appeal considered that Article 53(b) EPC is intended to define a borderline between patent protection and plant variety protection. The first part of Article 53(b) EPC excludes claims directed to any specific plant varieties, as plant variety rights (PVRs) are instead available to protect this type of IP. However, patent rights are available for any broader technical teaching that may be implemented in an indefinite number of plant varieties. Hence, a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53(b) EPC, even though it may embrace plant varieties. Claims directed to genetically modified or gene-edited plants are therefore in principle patentable, so long as they are drafted more broadly to any species, genus or higher.
In consolidated decisions G1/08 and G2/07 (the first so called “Tomato” and “Broccoli” decisions of 2010), the question arose whether Article 53(b) EPC acts to exclude marker-assisted breeding of plants. The Enlarged Board of Appeal considered that any method does not escape the exclusion of the second part of Article 53(b) EPC merely because it contains any further step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants. However, the Enlarged Board of Appeal concluded (somewhat obscurely) that any technical step leading to the introduction or modification of a trait that is not the result of the mixing of the genes of the plants may qualify as a potential patentable teaching.
Whether or not a method for producing plants or animals may be “essentially biological” therefore remained an open question. For example, in decision T1729/06, the technical Board of Appeal examined a process for producing seedless watermelons involving the pollination of sterile female flowers of a triploid plant (unable to carry out successful meiosis) with pollen of a diploid pollinator plant. Since the method did not concern sexually crossing two whole genomes of plants (i.e., resulting in successful meiosis and fertilisation), the Board concluded it did not constitute an essentially biological process so was allowable under Article 53(b) EPC.
In consolidated decisions G2/12 and G2/13 (the so called “Tomato II” and Broccoli II” decisions of 2013), the question arose whether Article 53(b) EPC also excludes plants obtained by any essentially biological process. The EBA adopted the principle that exclusions from general principles of patentability should be narrowly interpreted in law. As such, the EBA found that although Article 53(b) EPC excludes essentially biological methods for producing plants or animals, this exclusion does not apply to plants or animals themselves produced by such methods (so long as they were not directed to any single plant variety).
Intervention by the European Commission
The G2/12 and G2/13 decisions therefore seemingly provided legal certainty to the agricultural industry. However, some argued these decisions led to a discordant framework of exceptions to patentability in Europe, wherein claims directed to products produced by essentially biological steps were allowable yet claims directed to the processes by which such products were obtained were not allowable. In addition, the G2/12 and G2/13 decisions were in conflict with national patent law of major EPC states such as Germany and the Netherlands. In such countries, legislation explicitly excludes products produced by essentially biological processes (as well as the processes themselves).
Following G2/12 and G2/13, the European Commission reviewed the “Biotech Directive” 98/44/EC and issued an “Interpretive Notice” in 2016. The European Commission took the view that the EU legislator’s intention when adopting the Biotech Directive was to exclude from patentability plants exclusively obtained by essentially biological processes.
The Biotech Directive is an EU instrument, so is not directly applicable at the EPC. However, Rules 26 to 29 EPC were inserted into the EPC in 1999 to implement the EU Biotech Directive. For example, under Rule 26(1) EPC, the EU Biotech Directive is used as a supplementary means of interpreting the relevant provisions of the EPC. Following the intervention by the European Commission in 2016, the Administrative Council of the EPO introduced new Rule 28(2) EPC on 1 July 2017 that states:
“Under Article 53(b) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. [emphasis added]”
Rule 28(2) EPC is therefore intentionally in direct conflict with the interpretation of Article 53(b) EPC reached by the Enlarged Board of Appeal in G2/12 and G2/13. Instead, Rule 28(2) EPC seeks to harmonize the EPC with the European Commission’s interpretation of the EU Biotech Directive.
Under Article 164(2) EPC, the provisions of the European Patent Convention (e.g. “Articles”) should prevail over the Implementing Regulations (e.g. “Rules”). The Technical Board of Appeal therefore found in decision T 1063/18 (the first instance "Pepper" decision) that Article 53(b) EPC (as interpreted in G2/12 and G2/13) prevails over new Rule 28(2) EPC. Thus, the Technical Board of Appeal found that plants exclusively obtained by essentially biological processes are in principle patentable at the EPO.
Intervention by the EPO president
The EPO’s committee on patent law (including representatives of the 38 EPC Contracting States and observers from the European Commission) supported measures to obtain an opinion from the Enlarged Board of Appeal following decision T1063/18. Despite some controversy and question marks being raised over the legal validity of this approach, the EPO President referred in April 2019 the following points of law to the Enlarged Board of Appeal:
The EBA deemed the referral admissible, but side-stepped some of the broader issues surrounding the first question in reaching the latest decision in G3/19. In re-formulating the second question, the EBA have taken account of the developments after G2/12 and G/13 and have placed greater weight on the EU Biotech Directive. Consequently, the EBA have taken a more “dynamic approach” and ruled that Article 53(b) should be interpreted as excluding from patentability, animals or plants exclusively obtained by an essentially biological process.
Notably, the decision will not apply retrospectively to European patents granted before 1st July 2017 when Rule 28(2) EPC was introduced, and applications filed before that date that are still pending. However, there is a question mark as to the extent such claims may be enforceable across Europe under national law of the EPC member states.
So where does this all leave innovative breeding companies in Europe?
It is clear that patent claims may still be granted to transgenic or genome-edited plants. Thus, the European patent system provides an incentive to innovate in GM crops and gene-editing. Indeed, most patent applications regarding plants concern GM-related inventions.
However, the commercialization of transgenic crops (or even gene-edited crops) is subject to strict (and lengthy) regulatory requirements in Europe. In the UK, a new Agricultural Bill is being considered to relax the regulatory restrictions around gene-editing of crops. This may provide a more favorable environment for small and medium enterprises to develop new or improved crops in the UK through gene-editing techniques such as CRISPR.
Marker-assisted breeding may also help to avoid regulatory issues raised by genetic engineering. For example, DNA markers are an important innovation over the last 20 years and have increased the efficiency on introducing new traits. However, complex trait introgressions, particularly from wild species, may also demand large investment.
It is recognized that IP protection through patents may encourage investment aimed at developing improved crops through marker-assisted breeding. This may be important to start-ups in this area, to help protect their position when they have not yet developed any marketable varieties. Yet, the European patent system excludes from patentability any claim encompassing the sexual crossing of plants, even if they contain technical steps to assist such crossing steps. In view of G3/19, it is now further clear that plants obtained through such processes cannot be patented.
It may still be possible to achieve grant of claims directed to genetic molecular markers themselves, so long as the other requirements for patentability (e.g. novelty, inventive step and sufficiency of disclosure) are met. The latest EPO guidelines also confirm that processes for selecting plants or animals using genetic molecular markers without crossing the plants or animals are not excluded from patentability. For example, the following claim may in principle still be allowable:
“Method for selecting a plant having phenotype Y by screening for the presence of a marker having the sequence shown in SEQ ID NO: X”
Under Article 64(2) EPC, the protection conferred by a process patent may be extended to the products obtained directly by the process even if the products are not patentable per se (see G1/98). However, in the absence of any crossing steps, the direct product of such a selection method may be information (e.g. regarding the marker) rather than the plant itself. As a consequence, method of selection claims may not necessarily extend patent protection to the plant product itself.
For quality traits introduced through marker-assisted breeding (e.g. fatty acid, secondary metabolite or protein levels), it may still be possible to broadly claim non-propagatable material from the plants (e.g. flour, sugars or oil) even if they are derived from plants obtained by an essentially biological process. However, it would likely need to be established that the compositions themselves are novel and inventive based on their chemical properties alone (e.g. regardless of how they may have been produced). In practice establishing absolute novelty is likely to be difficult, and may also not be practical for other traits such as disease resistance or heat tolerance which may instead relate to changes in the physiology of the plant itself (rather than any quantifiable difference in the food derived from the plant).
Where effective patent protection may not be available, plant variety rights (PVRs) may represent a better option to protect any specific marketable varieties. Ultimately, the choice for a company between patents or plant variety rights may depend on what provides the best balance between investment and revenue.
If you would like further information please contact Charlotte Watkins or Huw Jenkins at email@example.com.
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