Related SectorsLife Sciences Plant Science
Related ServicesPatents Plant Variety Rights
Related PeopleMeeta Mistry
Plant Sciences Patents – an Update
In this update we consider recent developments in the plant field. We look at Enlarged Board of Appeal (EBA) decision, G3/19, and at the subject matter that remains patentable or otherwise protectable following this decision. We also take a brief look at a CJEU decision, C-176/18, and extent of protection afforded by plant variety rights pre- and post-grant.
In May this year, the Enlarged Board of Appeal (EBA) issued its opinion in G3/19 finding that plants produced by essentially biological processes are no longer patentable in Europe. This effectively reversed its previous decision in “Broccoli II” (G2/13) and “Tomatoes II” (G2/12) in which it had confirmed that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC was a process exclusion which did not extend to products obtained by the excluded process.
According to Article 53(b) EPC, “European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals”.
Article 53 EPC: Exceptions to Patentability
European patents shall not be granted in respect of:
(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(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;
(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
A Brief Timeline: How we arrived at G1/93
EBA decision, G1/98, decided that a claim where specific plant varieties are not individually claimed, is not excluded from patentability, even though it may embrace plant varieties.
2. G 2/07 (Broccoli I) & G 1/08 (Tomatoes I)
In Broccoli I and Tomato I, a referral to the EBA by the Technical Boards of Appeal sought to gain clarity on what may be regarded as an “essentially biological process”, and therefore excluded from patentability, and in particular on whether plant breeding processes containing the steps of crossing and selection could avoid the exclusion from patentability simply by including any other feature of a technical nature.
The EBA concluded that a non‑microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes and of subsequently selecting plants is “essentially biological” within the meaning of Art. 53(b) EPC and therefore excluded from patentability. Such a process does not escape the exception to patentability merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
This means that the mere use of molecular markers does not make an essentially biological process patentable, but that technical devices or means, such as molecular markers, may themselves be patentable.
To fall outside the exclusion of Article 53(b), and therefore to be patentable, an additional step of a technical nature is needed, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of mixing of the genes of the plant chosen for sexual crossing. The process then falls outside the realm of plant breeding, which is what the legislator wanted to exclude from patentability.
This outcome was largely based on the legislator’s intention, which had not been to exclude from patentability a whole class of inventions, i.e. horticultural or agricultural (agronomic) processes, but to exclude from patentability those plant breeding processes which were the conventional methods of plant-variety breeding at the time. These conventional methods included those based on the sexual crossing of plants (i.e. of their whole genomes) and subsequent selection of the plants having the desired trait(s). It could also be gathered from the legislative history that the mere use of a technical device in a breeding process was not to be considered sufficient to lend the process itself a technical character.
3. G 2/13 (Broccoli II) & G 2/12 (Tomatoes II)
What was not decided in Broccoli I / Tomatoes I was the patentability of products resulting from processes excluded as being essentially biological under Article 53(b) EPC. To seek clarification on the patentability of such products, there was a second referral to the EBA (Broccoli II and Tomatoes). In Broccoli II and Tomatoes II, the EBA confirmed that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC is a process exclusion which does not extend to products obtained by the excluded process, meaning that plants and plant materials resulting from an essentially biological process are considered patentable subject matter.
4. European Parliament’s referral to the EU Commission
The exclusion to patentability, both in the Biotech Directive (Directive 98/44/EC) and in Article 53(b) EPC, expressly excludes from patentability essentially biological processes for the production of plants and animals, but neither mentions the patentability or otherwise of the products derived from such processes.
Subsequent to the Broccoli II / Tomatoes II EBA decision, the European Parliament asked the EU Commission to consider the abovementioned patentability exclusions and whether the finding of the EBA would also have been reached in the EU context.
The EU Commission however concluded the opposite to the EBA in Broccoli II / Tomatoes II in stating “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” (see Commission Notice 2016/C 411/03).
Although the Commission Notice was not legally binding on the EPO and was mentioned as “intended to assist in the application of the [Biotech] Directive” and confirmed that “only the Court of Justice of the European Union [CJEU] is competent to interpret Union law”, the EPO’s Administrative Council (AC) nevertheless controversially amended Rules 27b and 28(2) EPC to specifically exclude from patentability plants (and animals) exclusively obtained by means of an essentially biological process. The amended Rules came into force on 1 July 2017.
Rule 27 EPC: Patentable biotechnological inventions
Biotechnological inventions shall also be patentable if they concern:
(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;
(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;
(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
Rule 28 EPC: Exception to Patentability
(1) Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
(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.
The EPO’s reasoning for introducing the Rule amendment was to safeguard uniformity and given the Biotech Directive’s incorporation into the EPC. This however resulted in the EU Commission’s position being in direct conflict with the EBA in Broccoli II / Tomatoes II, but being in line with the patent laws of a few member states, such as Austria, Germany, France, The Netherlands and Portugal, who have specific provisions in their national law excluding from patentability plants and plant parts obtained by an essentially biological process.
5. T1063/18: Extreme dark green, blocky peppers
The amendment to Rule 28(2) EPC was tested in appeal case, T1063/18, against a decision by the Examining Division to refuse European patent application number 12 756 468.0, relating to “extreme dark green, blocky peppers”, for the sole reason that it considered the claimed subject-matter to be plants exclusively obtained by means of an essentially biological process which fell within the exception to patentability according to Article 53(b) and Rule 28(2) EPC.
The Technical Board of Appeal (TBA) in T1063/18, in an enlarged composition consisting of three technically and two legally qualified members, decided that Rule 28(2) EPC was in conflict with Article 53(b) EPC as interpreted by the EBA in decisions G 2/12 and G 2/13 (Broccoli II and Tomatoes II). Article 164(2) EPC states that in case of conflict between the Articles and Rules of the EPC, the Articles shall prevail. The TBA decided that new Rule 28(2) EPC had no impact on the interpretation of Article 53(b) EPC, and followed the Enlarged Board’s earlier decisions G 2/12 and G 2/13.
Article 164: Implementing Regulations and Protocols
(1) The Implementing Regulations, the Protocol on Recognition, the Protocol on Privileges and Immunities, the Protocol on Centralisation, the Protocol on the Interpretation of Article 69 and the Protocol on Staff Complement shall be integral parts of this Convention.
(2) In case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail.
Following the Technical Board of Appeal’s written decision in T1063/18, issued on 5 February 2019, the EPO issued a statement particularly supporting measures to obtain an opinion from the EBA on this matter.
The President of the EPO may under Article 112(1)(b) EPC refer a point of law to the EBA where two Boards of Appeal have given different decisions on that question. There have been no such contradicting Board of Appeal decisions and questions were therefore raised by different parties, including by CIPA (The Chartered Institute of Patent Attorneys), as to whether any such referral by the President would be admissible.
Nevertheless, on 5 April 2019, the President of the EPO submitted questions to the EBA to clarify the applicable legal framework in reaction to concerns expressed by the Contracting States, the user community and representatives of civil society worried about legal uncertainty resulting from decision T 1063/18. The President of the EPO stated that the referral to the EBA was an important step on the way to restore legal certainty in the interest of the users of the European patent system and the general public.
Various commentators however argued that the legal situation was made clear by the EBA in Broccoli II and Tomatoes II in deciding that plants produced by essentially biological processes were patentable and that it was the AC who introduced legal uncertainty by introducing amended Rule 28(2) EPC in direct contradiction of the EBA’s decision. The President, in referring questions to the EBA, was criticised by some for adding to the uncertainty in asking the EBA to consider a question they have already considered.
The questions referred to the EBA by the President of the EPO were as follows:
1. Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?
2. If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?
6. G3/19: Pepper
The EBA issued its opinion, G3/19, in May this year. It was a surprise to many that the President’s referral was found admissible, given the lack of divergent case law, and that the referral was found admissible only after the President’s question had been rephrased.
The conclusion reached on the exclusion from patentability of plants and animals obtained from essentially biological processes, effectively reversing the EBA’s previous position in Broccoli II and Tomatoes II, was also surprising.
G1/93 does not apply to European patents granted before 1 July 2017 and European patent applications filed before that date and that are still pending, 1 July 2017 being the date amended Rules 27b and 28(2) EPC came into force. This means that for such applications, claims directed to plants produced by essentially biological processes will be considered patentable subject matter. It may well be though that such claims will not survive a challenge under the national law of those countries with specific provisions excluding from patentability plants and plant parts obtained by an essentially biological process.
In an accompanying press release, the EPO explained that the EBA adopted a “dynamic interpretation of the exception to patentability under Article 53(b) EPC”, taking account of the Administrative Council’s decision to introduce Rule 28(2) EPC, the preparatory work on this provision and the circumstances of its adoption, as well as legislative developments in the EPC contracting states. In adopting this dynamic interpretation, the EBA abandoned its earlier interpretation of Article 53(b) EPC in Broccoli II and Tomatoes II.
The EBA endorsed its earlier findings on the scope of Article 53(b) EPC, which it said were based on the classical (i.e. the grammatical, systematic, teleological and historical) methods of interpretation. However, the Enlarged Board found that a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time. This meant that decisions in Broccoli II and Tomatoes II did not settle the meaning of Article 53(b) EPC once and for all.
The EBA held that, after the introduction of new Rule 28(2) EPC, Article 53(b) EPC was to be interpreted to exclude from patentability plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.
To some it may seem that the rephrasing of the President’s question and the reversal of the previous decisions in Broccoli II and Tomatoes II may have been done to arrive at the same viewpoint as the Commission. This has raised questions on the true independence of the EBA and its susceptibility to pressure from the President and AC.
Furthermore, could the EBA’s opinion that “a particular interpretation which has been given to a legal provision can never be taken as carved in stone, because the meaning of the provision may change or evolve over time” potentially open the door for parties before the EPO, especially those with deep enough pockets, to challenge established interpretations of other legal provisions.
The other area of potential concern relates to the EPO’s requirement to introduce a disclaimer if the claims read onto an essentially biological process – see the EPO’s Guidelines for Examination, Part G, Chapter II, 5.4 (https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_5_4.htm). The Guidelines state that:
“If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, might be the result of either a technical intervention (e.g. directed mutagenesis) or an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product in order to comply with the requirements of Art. 53(b) and Rule 28(2). Otherwise the application is considered to relate to excluded subject-matter and is to be refused on the basis of Art. 53(b) in conjunction with Rule 28(2). A disclaimer is required in all cases and, in particular, even if the description only mentions a technical method of production and is silent on the use of an essentially biological process”.
This raises questions on infringement and enforceability. For example, could a third party use the knowledge of the patent and reproduce the same using an essentially biological process and thereby avoid infringement?
There may well be legitimate reasons to commercialise the invention using an essentially biological process rather than the technical means described in the patent. As a case in point, in July 2018, the Court of Justice of the European Union (CJEU) ruled that organisms created using gene-editing techniques such as transgenic plants had to be classified as genetically modified organisms (GMOs). At the same time, other less precise and conventional mutation breeding techniques (mutagenesis) are exempt from the EU GMO legislation. Consequently, plants with a single mutation produced by using genetic scissors are classified as genetically modified organisms, while conventionally obtained mutants – which can have hundreds or thousands of mutations – are not subject to the strict regulation of genetically modified organisms. Ag-biotech companies may therefore need to find a breeding method ‘workaround’ to their own inventions simply to avoid regulatory hurdles. However, by doing so, they may struggle to enforce their patents containing disclaimers to products obtained by essentially biological processes.
On the other hand, plant breeders and various seed organisations have welcomed the decision in G3/19, which has provided them with some much-needed certainty.
Protection of Plant-Related Inventions After G3/19
The following is a brief reminder of some of the available avenues for the protection of plant-related inventions following G3/19.
- Processes which are not essentially biological remain patentable. What is deemed to be an essentially biological process is set out in Broccoli I and Tomatoes I and is discussed above briefly.
- Plants and animals also remain patentable, except for plant and animal varieties. See G1/98.
- Microbiological processes and their products remain patentable. Claims to In vitro plant (or animal cells) are treated as claims to microorganisms.
- Processes for producing plants by inserting or modifying a trait in the genome using genetic engineering do not rely on sexual crossing and may therefore be patentable. In such cases, the sexual crossing and selection steps should not be in the claims.
- Claims to methods of identifying plants with a desired trait using tools, such as molecular markers, should be patentable.
- Genetic engineering techniques involving the transfer or modification of one or more genes or traits, but which do not include the transfer of a whole genome, should be patentable.
- The molecular markers or other tools used in the crossing and selection steps of a breeding process may also be patentable.
- Plant Variety Protection (PVP) protection is still available for plant varieties. There is no corresponding Sui Generis right for the protection of animal varieties, although some countries do allow protection under their national law for the protection of animal breeds.
- Bag tag licences, which are similar to shrink wrap licences used on software products, may become more widely used, for example, for the protection of seeds, and especially where no other protection is possible. The enforceability of such licences however remains a weak point.
- Keeping the breeding lines trade secret.
Turning now to plant varieties. A recent CJEU decision, C‑176/18, concerned the interpretation of Article 13 of Council Regulation (EC) 2100/94 on Community plant variety rights.
The case related to Club de Variedades Vegetales Protegidas (‘CVVP’), holder of Community plant variety rights in respect of the mandarin tree variety ‘Nadorcott’, and exploitation of that variety by Mr Adolfo Juan Martínez Sanchís.
The application for Community plant variety protection was lodged by Nadorcott Protection SARL on 22 August 1995 and granted on 15 February 2006. Between 22 August 1995 and 15 February 2006, Mr Martínez Sanchís purchased, from a nursery that was open to the public, plants of the Nadorcott variety, some of which were planted in the spring of 2005 and others in the spring of 2006. After 15 February 2006, he replaced a number of plants of that variety with new plants that he purchased.
CVVP brought infringement proceedings, on the one hand in respect of the acts undertaken by Mr Martínez Sanchís prior to the grant on 15 February 2006 of the Community plant variety right (during the ‘provisional protection’ period), and on the other hand for infringement in respect of acts undertaken after that date.
Article 5(3) of Regulation No 2100/94, entitled ‘Object of Community plant variety rights’, provides as follows:
‘A plant grouping consists of entire plants or parts of plants as far as such parts are capable of producing entire plants, both referred to hereinafter as “variety constituents”.’
Article 13 of that Regulation, entitled ‘Rights of the holder of a Community plant variety right and prohibited acts’, provides:
‘1. A Community plant variety right shall have the effect that the holder or holders of the Community plant variety right, hereinafter referred to as “the holder”, shall be entitled to effect the acts set out in paragraph 2.
2. Without prejudice to the provisions of Articles 15 and 16, the following acts in respect of variety constituents, or harvested material of the protected variety, both referred to hereinafter as “material”, shall require the authorisation of the holder:
(a) production or reproduction (multiplication);
(b) conditioning for the purpose of propagation;
(c) offering for sale;
(d) selling or other marketing;
(e) exporting from the Community;
(f) importing to the Community;
(g) stocking for any of the purposes mentioned in (a) to (f).
The holder may make his authorisation subject to conditions and limitations.
3. The provisions of paragraph 2 shall apply in respect of harvested material only if this was obtained through the unauthorised use of variety constituents of the protected variety, and unless the holder has had reasonable opportunity to exercise his right in relation to the said variety constituents.
Article 95 of that regulation is worded as follows:
‘The holder may require reasonable compensation from any person who has, in the time between publication of the application for a Community plant variety right and grant thereof, effected an act that he would be prohibited from performing subsequent thereto.’
The litigation ended up at the Spanish Tribunal Supremo (Supreme Court) who sought a preliminary ruling by the CJEU on the interpretation of Article 13 of Regulation No 2100/94.
The CJEU decided as follows:
1. Article 13(2)(a) and (3) of Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights must be interpreted as meaning that the activity of planting a protected variety and harvesting the fruit thereof, which is not likely to be used as propagating material, requires the authorisation of the holder of the Community plant variety right relating to that plant variety where the conditions laid down in Article 13(3) of that regulation are fulfilled.
2. Article 13(3) of Regulation No 2100/94 must be interpreted as meaning that the fruit of a plant variety, which is not likely to be used as propagating material, may not be regarded as having been obtained through the ‘unauthorised use of variety constituents’ of that plant variety, within the meaning of that provision, where those variety constituents were propagated and sold to a farmer by a nursery in the period between the publication of the application for a Community plant variety right in relation to that plant variety and the grant thereof.
3. Where, after such protection has been granted, those variety constituents were propagated and sold without the authorisation of the right holder, the latter may assert his or her right under Article 13(2)(a) and (3) of that regulation in respect of that fruit, unless he or she had reasonable opportunity to exercise his or her right in relation to those variety constituents.
The full decision may be found here. This decision clarifies that fruit obtained from plants planted during the provisional period may not be regarded as having been obtained through unauthorised use within the meaning of Article 13(3), even if harvested after the Community plant variety right was granted. The holder of a plant variety right cannot enforce any rights for acts carried out during the provisional period, however, Article 95 of the Regulation provides for ‘reasonable compensation’. The decision will no doubt provide welcome guidance on freedom to operate for parties wishing to use Community plant variety rights pre- and post grant, but especially pre-grant, as well as to the holders of Community plant variety rights wishing to assert their rights.
This article is for guidance only and should not be taken as legal advice. If you require advice on the protection of plants, or similar inventions, please contact our life sciences team.