T 2796/18 - Rule 28(2) after all

Key points

•  The AC decided, under the former President, that Rule 28(2) was to apply also retroactively to applications already pending on 01.07.2017. The present decision concerns an appeal against the refusal of such an application on the sole ground that "the subject-matter of claim 1 was therefore excluded from patentability pursuant to Article 53(b) EPC and Rule 28(2) EPC"  because the claimed plants were exclusively obtained by means of an essentially biological process, which was not disputed.
• The Enlarged Board in G 3/19 did not opine on the validity of Rule 28(2) at all. Rather, the Enlarged Board changed their interpretation of Article 53(b) EPC. That new interpretation does not apply to applications already pending on 01.07.2017, the Enlarged Board held. This leaves open to some extent whether Rule 28(2) and Article 3 of that AC decision (OJ 2017 A56) is valid. 
• The Technical Board of Appeal in the present decision: "as the present application was filed before 1 July 2017, and is still pending (see section I), the new interpretation of Article 53(b) EPC adopted in opinion G 3/19 (supra), does not apply. Furthermore, Article 53(b) EPC, as interpreted by decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal (supra), does not exclude the subject-matter of the main request from patentability. In view of the above considerations, the board concurs with the appellant that the subject-matter of the claims is not excluded from patentability pursuant to Article 53(b) EPC in conjunction with Rule 28(2) EPC." 

EPO T 2796/18 - 

Link to the decision after the jump, as well as an extract of the decision text.

T 2796/18 - Rule 28(2) not to be applied to applications filed before 01.07.2017

 Key points

•  " The sole reason given by the examining division for rejecting the main request was that the claimed plants were exclusively obtained by means of an essentially biological process and that the subject-matter of claim 1 was therefore excluded from patentability pursuant to Article 53(b) EPC and Rule 28(2) EPC." 
• The Board: " as the present application was filed before 1 July 2017, and is still pending [], the new interpretation of Article 53(b) EPC adopted in opinion G 3/19 (supra), does not apply." 
• " Furthermore, Article 53(b) EPC, as interpreted by decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal (supra), does not exclude the subject-matter of the main request from patentability.  In view of the above considerations, the board concurs with the appellant that the subject-matter of the claims is not excluded from patentability pursuant to Article 53(b) EPC in conjunction with Rule 28(2) EPC."
• As a comment, the Administrative Council decided that Rule 28(2) EPC “shall apply to European patent applications filed on or after this date [01.07.2017], as well as to European patent applications and European patents pending at that time”, Article 3 of the Decision of the Administrative Council 29.06.2017, OJ 2017 A56; i.e. also to applications filed before 1 July 2017 and still pending on 1 July 2017.

T 2796/18 - 

https://www.epo.org/law-practice/case-law-appeals/recent/t182796eu1.html

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is admissible.

Main request

Exceptions to patentability (Article 53(b) EPC)

2. The sole reason given by the examining division for rejecting the main request was that the claimed plants were exclusively obtained by means of an essentially biological process and that the subject-matter of claim 1 was therefore excluded from patentability pursuant to Article 53(b) EPC and Rule 28(2) EPC.

T 0420/19 - Art.53(b) and (not) Rule 28(2)

 Key points

• In this opposition appeal, claim 6 is directed to “ A barley plant, or part thereof, wherein the barley plant carries a mutation in the gene encoding methionine-S-methyltransferase(MMT) that causes a total loss of MMT function".” The opponent is a public interest group.
• The opponent submitted that “the claimed barley plants fell under the exception to patentability defined in Article 53(b) EPC because they were the direct product of an essentially biological process.” The filing date is in 2009.
• The Board notes that in G 3/19, the EBA further decided that "the new interpretation of Article 53(b) EPC given in this opinion has no retroactive effect on European patents containing such claims which were granted before 1 July 2017, when Rule 28(2) EPC entered into force, or on pending European patent applications seeking protection for such claims which were filed before that date".
• The Board, after some further remarks on this legal issue, notes that: “Since the patent was granted before 1 July 2017 (see section III above), the subject-matter of claim 6 (and dependent claims 7 to 9 and 16) is not excepted from patentability in view of Article 53(b) EPC as interpreted by the decisions of the EBA G 2/12 and G 3/12.”
•  As a comment, the Board does not comment on Rule 28(2) as the legal basis for the revocation. The Administrative Council decided that Rule 28(2) EPC “shall apply to European patent applications filed on or after this date [01.07.2017], as well as to European patent applications and European patents pending at that time”, Article 3 of the Decision  of the Administrative Council 29.06.2017, OJ 2017 A56.
•  The Enlarged Board in G 3/19 has not said expressly that Rule 28(2) is invalid, neither that said Article 3 of the AC Decision is invalid. However, from the present decision, it seems clear that at least said Article 3 is vacated. The present decision does not discuss Rule 28(2) as such. 
•  See also here.
•    Further on sufficiency: “The opposition division considered that the only methods given in the patent to obtain the claimed mutants was mutagenesis and subsequent screening, thus relying on identification of a chance event. In view of the number of plants that would have to be screened to arrive at the claimed invention, it was undue burden to identify further mutants in addition to those deposited pursuant to Rule 31(1)(a) EPC, been identified by this method”
•  “The board considers that the mere fact that mutagenesis is a random process and that large numbers of mutant barley plants might have to be screened does not, in the present case, represent an undue burden the skilled person. The board therefore does not agree with the opposition division that the fact that mutagenesis, due to reliance on mutations at "random" locations in the genome, necessarily represents an undue burden for the skilled person. …  In the present case, the invention is reproducible without undue burden because there is evidence that the chance event can be identified frequently enough to guarantee success.”
• As to inventive step: “ In the absence of a readily available library of insertional mutants of barley it would have been necessary to use a screening procedure for detecting mutant barley grains lacking MMT activity. No such assay is disclosed in either document D1 or D2. The need to develop such an assay would have dissuaded the skilled person from arbitrarily choosing barley when attempting to solve the technical problem.”

T 1045/16 - Budapest Treaty deposit

Key points

• The patent a melon plant “comprising an introgression from a plant of melon accession PI313970”. The patentee argues that these melons plants were publicly available and “ould be ordered directly from the website of the US National Plant Germplasm System”. The Board considers the invention to be insufficiently disclosed. 
• Rule 31 EPC specifies that “If an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Article 83 if: [a valid deposit under the Budapest Treaty was made of a sample of the biological material”.
• The patentee does not dispute that the deposit with the US National Plant Germplasm System is not a deposit under the Budapest treaty as it is not a recognized institute. The patentee argues that the deposit makes the material available to the public in the sense of Rule 31 EPC.
• The Board does not accept this argument. “To be considered "available to the public" in the sense of Rule 31(1) EPC, a biological material must therefore be available in a manner that allows the skilled person to be certain that they can obtain it at least over the term of the patent. By way of illustration, examples of such biological material are brewers yeast and Escherichia coli in general, or indeed melon plants in general. Non-examples are specific, non-generic strains of microorganism or indeed accessions of plants only available from a non-Budapest Treaty institution.”
• I add from the decision that “It was common ground that, to carry out the invention in the sense of Article 83 EPC, the person skilled in the art required access to propagating material (e.g. seeds) containing the CYSDV-resistance-conferring QTL and marker, identical to or derived from melon accession PI313970 (the "relevant biological material"), see Section X., above. It was further not in dispute that there was no deposit of such material with a recognised depositary institution as set out in Rule 31(1)(a) EPC.”
  
  
• As a comment, I note that one opponent had submitted that PI313970 “originates from India ... the patent is a misappropriation of genetic material as provided by seed banks and originally stemming from India” (https://register.epo.org/application?documentId=ESSUE2GM3432900&number=EP06835672&lng=en&npl=false, p. 7, bottom). 
• The OD decision states, p.11, that PI313970 was originally isolated in India in 1961.
• 
  

T 1045/16 

https://www.epo.org/law-practice/case-law-appeals/recent/t161045eu1.html

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is admissible.

Admissibility of the opposition of opponent 2

2. In the board's view, the opponents comprised in the joint opposition are the legal and natural persons indicated in bold in the notice of opposition of opponent 2, dated 3 February 2012, at pages 1 to 2. It is apparent that Christoph Then, whose name is indicated in bold in the notice of opposition, is one of the joint opponents and, at the same time, the common representative of them. Therefore, the Board agrees with the assessment of the opposition division that the identity of the persons participating in the joint opposition is clear, and the opposition is admissible.

Main request - claim 1

Disclosure of the invention (Article 83 EPC/Rule 31 EPC)

3. The requirements of Article 83 EPC are met if the European patent discloses the claimed invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Special provision is made in Rule 31 EPC for inventions which involve the use of or concern biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art. In such cases, Rule 31(a) EPC provides that the invention is regarded as being disclosed as prescribed in Article 83 EPC only if a sample of the biological material has been deposited with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977 not later than the date of filing of the application.

T 1854/19 - Implicitly overruling the Administrative Council

 Key points

• This is a follow-up case to G 3/19 (Pepper). In pepper, the Enlarged Board gave a new interpretation of Article 53(b) EPC which corresponds to Rule 28(2) EPC in excluding ‘essentially biological plants’ from patentability (but in fact appears to exclude more from patentability than Rule 28(2) EPC). The Enlarged Board said in G 3/19 that “this negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending”; the ‘negative effect’ is that of Article 53(b) EPC for the types of plant-related subject-matter recited in G 3/19 hn.1. 
• However, the Administrative Council decided that Rule 28(2) EPC “shall apply to European patent applications filed on or after this date [01.07.2017], as well as to European patent applications and European patents pending at that time”, Article 3 of the Decision Administrative Council 29.06.20147 OJ 2017 A56.
• The Enlarged Board in G 3/19 has not said (or at least not explicitly) that Rule 28(2) is invalid, neither that said Article 3 of the AC Decision is invalid.
• Therefore, G3/19 strictly speaking leaves open the question of whether Rule 28(2) is to be applied to applications filed before 01.07.2020
• The present Board: “In view of the provisions set out by the Enlarged Board of Appeal for European patent applications pending before 1 July 2017, the new interpretation of Article 53(b) EPC - announced in opinion G 3/19 [...]- has no retroactive negative effect on the subject-matter of the main request (see opinion G 3/19, points XXVIII and XXIX). This implies that the opinion does not acknowledge the retroactive effect, as provided for in Article 3 of the Decision of the Administrative Council of 29 June 2017 [OJ 2017 A56] that introduced Rule 28(2) EPC.”
• This Board finds that “the subject-matter of the set of claims of the main request is not excluded from patentability” because of the filing date of the present application and because " Article 53(b) EPC, as interpreted by decisions G 2/12 and G 2/13 is applicable to the present application”. Strictly speaking, the present Board still does not say that Rule 28(2) is not applicable to this application but this is unambiguously implied by finding that the subject-matter is not excluded from patentability. 
• So this Board finds that the Enlarged Board implicitly overruled the Administrative Council in G3/19.
• I note that said Article 3 of said Decision of the AC is not strictly speaking a provision of the Implementing Regulation, so it is not clear if Article 164(2) applies. 

EPO T 1854/19 - - link

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is therefore admissible.

Main request - claims 1 to 14

Exceptions to patentability (Article 53(b) EPC)

2. In view of the provisions set out by the Enlarged Board of Appeal for European patent applications pending before 1 July 2017, the new interpretation of Article 53(b) EPC - announced in opinion G 3/19 of 14 May 2020 and being consequential to the introduction of Rule 28(2) EPC on 1 July 2017 - has no retroactive negative effect on the subject-matter of the main request (see opinion G 3/19, points XXVIII and XXIX). This implies that the opinion does not acknowledge the retroactive effect, as provided for in Article 3 of the Decision of the Administrative Council of 29 June 2017 that introduced Rule 28(2) EPC.

3. Thus, Article 53(b) EPC, as interpreted by decisions G 2/12 and G 2/13 (OJ EPO, 2016, A27 and A28) is applicable to the present application and the subject-matter of the set of claims of the main request is not excluded from patentability.

4. The board thus considers the appeal allowable.

T 1032/16 - Onion is obviouss

 Key points

• G 3/19 decided basically that plants which are not genetically modified, are unpatentable (plants obtained with an essentially biological process) but only for applications having a priority date after 01.07.2017. Hence, the Board turns to inventive step in this case.
• “Claim 1, a product-by-process claim, is directed to a long-day onion plant producing bulbs which combine the properties "pyruvate of less than 5.5 µMol/g FW" and "SSC of at least 7.5%" at harvest, wherein the onion plant "is obtained by crossing a plant of which seeds were deposited under Accession No. PTA-9053, PTA-9054 or PTA-5 9055 with another onion plant"”
• “In the board's view, the feature that the claimed plants are obtainable by crossing a deposited onion plant with another onion plant is not a limitation to the immediate progeny of such a cross, but includes all plants having such a cross in their ancestry. Thus, the process feature is not construed as imparting any particular genotype to the claimed plants. Lower pungency upon storage is thus not a feature of the claimed onion plants. The board concludes that no additional identifiable phenotypic or genotypic characteristics are conferred on the long-day onion plant by the process of claim 1.”
• D1 discloses a long-day onion plant producing bulbs which combine the properties "pyruvate of less than 5.5 µMol/g FW" and "SSC of at least 7.5%" at harvest”. 
• " It was however uncontested that the genetics of the claimed onion plant differs from that of the hybrid onion plant of document D1, albeit in an unknown manner, see point 5." 
• There is some case law that unclear features can not be used to provide novelty, but that case law is not applied here.
• " the board agrees with the appellant that the problem to be solved by the claimed subject-matter can be formulated as the provision of a further long-day onion plant producing bulbs having low pungency and high SSC." 
• " Document D1 [] already establishes that combining traits of long-day onion plants (bulb formation after 14 hours of light, high storability, high SSC) with the low pungency trait of short-day onion plants in a single onion plant/bulb requires no more than standard plant breeding techniques" 
• Hence the claim is obvious.

T 1032/16 -  link

Inventive step (Article 56 EPC) - claim 1


Closest prior art

7. In the decision under appeal, document D1 was taken as representing the closest prior art for the claimed onion plants. This view was maintained by the appellant in the appeal and was not contested by the respondent. The board sees no reason to differ.

8. Document D1 discloses onion (Allium cepa) plants requiring 14 or more contiguous hours of daylight to initiate bulb formation, i.e. long-day onions, which produce bulbs having a pyruvic acid development (PAD) measurement of less than 5.5 myMol/g FW at harvest and whose bulbs can be stored without an increase of PAD measurements of more than 15% compared to the PAD measurement at the time of harvest (see paragraphs [0021], [0022], [0023] and [0053]). It is undisputed that document D1 does not explicitly disclose any SSC values.

9. However, document D1 does disclose hybrid plants whose parents were the long day onion plants WYL 77-5128B and WYL 77-5168B (see paragraph [0081]). WYL 77-5128B and WYL 77-5168 are long-day Spanish onion breeding lines, combining all the desired features of typical long-day Spanish onions with the additional feature of low pungency (see paragraphs [0087] and [0089]). Seeds of these inbred lines were deposited in accordance with the Budapest Treaty (see paragraphs [0088], [0089] and [00168] of document D1). The board concludes that the hybrid plants disclosed in paragraph [0081] are made available by document D1. The person skilled in the field of plant breeding is furthermore aware that a cross between these two inbred lines of document D1 always yields the same hybrid plant (see also document D10, paragraph bridging pages 1 and 2).

G 0003/19 - Unpatentable plants (Pepper)

Key points

• “The Enlarged Board [] abandons the interpretation of Article 53(b) EPC given in decision G 2/12 [sic, G 2/13 is not mentioned]  and, in the light of Rule 28(2) EPC, holds that the term “essentially biological processes for the production of plants or animals” in Article 53(b) EPC is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process” (r.26.8). Therefore, such products are not patentable under Article 53(b) EPC (see below for transitional provisions). 
• This leads to the headnote:
• “Taking into account developments after decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal, 
• the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC has a negative effect on the allowability of 
• product claims and product-by-process claims directed to 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.”
• “This negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending.”
• I note that the alternative ground of exclusion from patentability due to process features (recited in a product-by-process claim)  defining an essentially biological process is not expressly specified in R.28(2) and reverses G 2/13 hn.2(a). The (only public) underlying document for R.28(2), CA/56/17 appears to be silent about process features. 
• The Enlarged Board also extends the prohibition to "plant material" in the headnote, unlike R.28(2) (see the comparison below). The interested reader is referred to CA/56/17, paras. 48, 50 and 64 for the reason why R.28(2) does not mention 'plant material'. The Enlarged Board does not mention that (not patentable) 'plant material' is restricted to propagation material. So perhaps the exception extends to claims directed to a harvested tomato and to tomato paste and tomato juice. Plant material 'such as fruit' is mentioned in G2/12 hn.1.
• Before arriving at its decision to overturn  G2/12 (and G2/13), “the Enlarged Board concludes that, in view of the clear legislative intent of the Contracting States as represented in the Administrative Council and having regard to Article 31(4) Vienna Convention ["a special meaning shall be given to a term if it is established that the parties so intended"], the introduction of Rule 28(2) EPC allows and indeed calls for a dynamic interpretation of Article 53(b) EPC.”
• The Enlarged Board, however, begins its analysis by rephrasing the questions referred by the President of the Office. The first question is rephrased because the “wording of question 1 is too general and unspecific in that it broaches an institutional topic which reaches well beyond the ultimate object of the referral”.
• The Enlarged Board considers the rephrased question to be admissible: “there are different decisions of two Boards of Appeal on the question whether an amendment to the Implementing Regulations can have an impact on the interpretation of an Article of the EPC” (namely, T 1063/18 implying that such amendment can't have such an impact and T 315/03, r.7.3 stating that “that Article 53(a) EPC contains nothing which precludes or limits its own subsequent interpretation [] by (secondary) legislation”). 
• The Enlarged Board decision has the advantage that it avoids a clash with the Contracting States (wisely, in my view). At the same time, the Enlarged Board appears to leave open the question of whether Rule 28(2) EPC is binding on the Enlarged Board. 
• “[A]lthough neither the Contracting States, in accordance with Article 172 EPC, nor the Administrative Council, in accordance with Article 33(1)(b) EPC, has formally amended Article 53(b) EPC to extend the scope of the process exclusion to animals, plants and plant material obtained by essentially biological processes, when now interpreting Article 53(b) EPC, the Enlarged Board cannot ignore the Administrative Council’s decision to introduce a new paragraph 2 in Rule 28 EPC”. The phrase ‘cannot ignore’ seems to have a different meaning than ‘is bound by’. Indeed the headnote shows that R.28(2) does not preclude the Enlarged Board from declaring more subject-matter non-patentable. 
• “As the content of Rule 28(2) EPC does not stand in contradiction to the new interpretation of Article 53(b) EPC given in this opinion, there is no conflict between these provisions.” (emphasis added)
• As to the transitional provision: “For applications, the relevant date is their date of filing or, if priority has been claimed, their priority date.”
• Also interesting is the statement that “[i]rrespective of [the legal status of the Commission's Notice under EU law], as an independent international organisation with its own autonomous legal order, the EPOrg is not directly bound by Union law. It is therefore all the more true that a legally non-binding Notice on the interpretation of the EU Biotech Directive issued by the EU Commission in reaction to decisions of the Enlarged Board on the interpretation of a provision of the EPC, i.e. Article 53(b) EPC, does not form part of EPC law.”

• On the general question of whether exceptions are to be interpreted in a narrow or a broad way: “the Enlarged Board also confirms [...] that the object and purpose of the exception to patentability under Article 53(b) EPC is not sufficiently obvious to answer the question whether or not the clause is to be construed in a narrow or broad way.”

• One Board member of the panel in G3/19 was also a member of the (combined) panel in G 2/12 and G2/13. This member was interestingly enough also the rapporteur in all three cases  (link). 

• The decision recites  “the claimed process features”, but I think that features are not strictly speaking claimed. Subject-matter is claimed, features are recited in a claim. Possibly the headnote should be read as “if the process features of the product-by-process claim define an essentially biological process” (cf. G2/13, hn.2(a)).
• The decision recites “or if the claimed process feature define” (sic) in r.3.3, 'features' in the plural in the headnote and "the claimed process feature defines" r.26.8 but I don't think this any relevance for the substance of the holding.

EPO Headnote
Taking into account developments after decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal, the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC has a negative effect on the allowability of product claims and product-by-process claims directed to 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.
This negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending.

Comparison G 3/19 vs. Rule 28(2)

Headnote: "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"

Rule 28(2): "plants or animals exclusively obtained by means of an essentially biological process"

Addendum 20.07.2020
The Supreme Court has stated: “The principle that statutes operate only prospectively, while judicial decisions operate retrospectively, is familiar to every law student.” Rivers v. Roadway Express, Inc., 511 U.S. 298, 311-12 (1994).  link (with further references and discussion)

EPO G 0003/19 - link
G 3/19 G3/19


SUMMARY OF THE PROCEEDINGS
The referred questions

I. By letter dated 4 April and received on 8 April 2019, the President of the European Patent Office (hereinafter the EPO President) referred the following questions to the Enlarged Board of Appeal (hereinafter the Enlarged Board) under Article 112(1)(b) EPC:

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?

REASONS FOR THE OPINION

The relevant legal provisions

I. Specific reference will be made to the following:

Article 112(1)(b) EPC Decision or opinion of the Enlarged Board of Appeal;
Article 53(b) EPC Exceptions to patentability;
Rule 26(1) and (5) EPC General and definitions, corresponding to Rule 23b(1) and (5) EPC 1973, which was inserted in the Implementing Regulations by decision of the Administrative Council of 16 June 1999 and entered into force on 1 September 1999 (OJ EPO 1999, 437);
Rule 27(b) EPC Patentable biotechnological inventions, as amended by decision of the Administrative Council CA/D 6/17 of 29 June 2017 (OJ EPO 2017, A56) and in force from 1 July 2017;
Rule 28(2) EPC – Exceptions to patentability, introduced by decision of the Administrative Council CA/D 6/17 of 29 June 2017 (OJ EPO 2017, A56) and in force from 1 July 2017;
Articles 31 and 32 Vienna Convention on the Law of Treaties of 23 May 1969 (Vienna Convention);

Articles 1 to 4 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (EU Biotech Directive, OJ EU 1998 L 213/13; OJ EPO 1999, 101).

[Article 31  General rule of interpretation

1. A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

2. The context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes:
(a) any agreement relating to the treaty which was made between all the parties in connexion with the conclusion of the treaty; (b) any instrument which was made by one or more parties in connexion with the conclusion of the treaty and accepted by the other parties as an instrument related to the treaty.

3. There shall be taken into account, together with the context:
(a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions; (b) any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation; (c) any relevant rules of international law applicable in the relations between the parties.


4. A special meaning shall be given to a term if it is established that the parties so intended.

Article 32 Supplementary means of interpretation

Recourse may be had to supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion, in order to confirm the meaning resulting from the application of article 31, or to determine the meaning when the interpretation according to article 31:

(a) leaves the meaning ambiguous or obscure; or (b) leads to a result which is manifestly absurd or unreasonable.]

Scope and focus of the referral

II. As an initial matter, before the admissibility and substantive issues of the referral are addressed, it is necessary to analyse the scope and focus of the referred questions and the supporting reasoning. Formally speaking, the present referral addresses two issues: first, the scope of the Administrative Council’s power to adopt or amend Rules of the Implementing Regulations to give effect to an interpretation of an Article of the EPC which differs from that given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal (question 1); secondly, the proper interpretation of Article 53(b) EPC following the adoption of Rule 28(2) EPC, which excludes from patentability plants and animals exclusively obtained by means of an essentially biological process (question 2).

G 3/19 - Plants by biological process not patentable

" The Enlarged Board of Appeal of the European Patent Office adopted a dynamic interpretation of the exception to patentability under Article 53(b) of the European Patent Convention (EPC) and held that the non-patentability of essentially biological processes for the production of plants or animals also extends to plant or animal products that are exclusively obtained by means of an essentially biological process." 

" In order to ensure legal certainty and to protect the legitimate interests of patent proprietors and applicants, the Enlarged Board ruled that the new interpretation of Article 53(b) EPC given in G 3/19 had no retroactive effect on European patents containing such claims which were granted before 1 July 2017, or on pending European patent applications seeking protection for such claims which were filed before that date." 

EPO - News item

Decision:
https://www.epo.org/law-practice/case-law-appeals/recent/g190003ex1.html




The EPO President has now also reacted: ‘I strongly welcome the opinion of the Enlarged Board of Appeal. It will bring greater legal certainty for patent applicants, and the general public, on what is a sensitive and complex issue that has legal, societal and economic implications.'

"The Office will act in accordance with the clarifications provided in the Enlarged Board's opinion and implement them in its examination practice in close consultation with stakeholders."
https://www.epo.org/news-events/news/2020/20200514a.html

T 1849/12 - Appeal without appealable decision

Key points

• With the "staying of proceedings" being in place for referral G3/19 (Pepper) (link), some patent applications for plants may face the third "staying" (with the first and second staying being for Broccoli / Tomato I and II). Hence this decision (already from 19.03.2013) might be of renewed interest. 
• The translation below is from the (former) K's Law Blog (post).
• In this examination appeal, the search report was positive. The applicant then requested an early grant and auxiliary an appealable decision. The Examining Division then sent a Communication explaining that there was no legal basis for an appealable decision. The applicant then filed an appeal, hence before a decision to refuse the application.
• The Board held that the appeal was admissible. The Communication is "a final and legally binding statement on the request of the appellant, which, as to its content, has the nature of a decision within the meaning of A 106(1).". The decision is an interlocutory decision which was not made separately appealable by the ED. "The EPC does not contain an explicit provision [that allows to determine] in which cases a separate appeal against so-called interlocutory decisions has to be allowed.  Rather, the legislator has given the deciding department discretion to decide [on that matter]". The Board reviews this exercise of discretion and concludes that "that the ED, when refusing the request that an appealable decision be issued has insufficiently taken account of an essential aspect and has exercised its discretion in an erroneous way. Therefore, the communication of the ED is to be considered to be separately appealable." 
• However, the Board does not allow the appeal because the need for a top-up search would prevent grant of a patent before 18  months from the priority date. 

EPO T 1849/12 - link


Translation
[2.1.3] However, the Board shares the opinion of the appellant that its request for a Rule 71(3) communication being issued immediately has been dealt with conclusively in the impugned communication and has been refused in a final manner by the ED. This is because, within the framework of the examining proceedings, the ED has made a final and legally binding statement on the request of the appellant, which, as to its content, has the nature of a decision within the meaning of A 106(1).


As this decision has resulted in the refusal of the request of the appellant to have the patent and the rights under A 64 related to it granted soon, [the appellant] is also adversely affected.

Admission of the separate appeal

[2.2.1] Pursuant to A 106(2), a decision which does not terminate proceedings as regards one of the parties can only be appealed together with the final decision, unless the decision allows a separate appeal.

The EPC does not contain an explicit provision [that allows to determine] in which cases a separate appeal against so-called interlocutory decisions has to be allowed.  Rather, the legislator has given the deciding department discretion to decide [on that matter], according to its duties (Travaux préparatoires to the EPC 1973, Report on the second session of the Coordination Committee, May 15-19, 1972, document BR/209/72, point 67).

It is undisputed that a first instance department which, in application of the EPC, has to take discretionary decisions has a margin of discretion which the Board of appeal has to respect. The Board may only should only overrule the way in which a first instance department has exercised its discretion if it comes to the conclusion either that the first instance department in its decision has not exercised its discretion in accordance with the right principles, or that it has exercised its discretion in an unreasonable way, and has thus exceeded the proper limits of its discretion cf. G 7/93 [2.5-6]).

[2.2.2] The impugned communication of the ED, which is to be qualified as a decision, does not terminate the examination proceedings with respect to the appellant. The ED has expressly refused the auxiliary request of the appellant for an appealable decision and has justified this by referring to the lack of an appropriate legal basis.

When doing so, it apparently has not sufficiently taken account of the fact that the request of the appellant, to allow the patent to be granted soon, by immediately issuing a R 71(3) communication, could not have been granted in a meaningful way in case a successful appeal had been filed after the final decision on the grant. Thereby it has adversely affected [the appellant] by issuing its communication, in a way that cannot be remedied by means of an appeal after the final decision.

[2.2.3] Nor could the appellant avail itself of another legal remedy provided by the EPC against the impugned communication. Under these circumstances, the ED should have allowed a separate appeal because only an appeal could offer the appellant an opportunity to remedy the adverse effect within the framework of a judicial examination of the refusal of its request. This is all the more so because the EPC does not provide for an appeal against inaction of the EPO (cf. J 26/87).

[2.2.4] Thus the Board comes to the conclusion that the ED, when refusing the request that an appealable decision be issued has insufficiently taken account of an essential aspect and has exercised its discretion in an erroneous way. Therefore, the communication of the ED is to be considered to be separately appealable.

[2.3] As the appeal satisfies all the other requirements of A 106 to A 108 and R 97 and R 99, it is admissible.

G 3/19 - Referral - Pepper

Referred point of law:
Under Article 112(1)(b) EPC the President of the European Patent Office refers the following points of law to the Enlarged Board of Appeal:

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?

Analysis admissibility

• The President submits that there are "different decisions" for question 1. In particular, T1063/18 would conflict with earlier decisions which would "acknowledge" that the AC is competent to give an authentic interpretation of an Article of the EPC in the Implementing Regulations "without being limited in this regard by an interpretation of the Article set forth in earlier case law". These decisions are T315/03 (r. 7.3) T272/95 (r.4), G2/07 (r.2.4). In para. 49 ff. the President further points to G2/06 (r.13), J 20/84 r.5 (about filing with fax) and T991/04 r.6). I note that none of these decisions appears to deal specifically with the issue of whether a decision of the Enlard Board has a limiting effect on subsequent changes of the Rules. 
• The President submits that "On this basis question 2 is also admissible, since it is directly related to the different application of Article 164(2) EPC as exemplified in the specific case of Rule 28(2) EPC. In the alternative, question 2 should be considered admissible based on an analogous application of Article 112(1)(b) EPC". The President submits that application of Article 112(1)(b) by analogy is not excluded and that "[t]he effect of decision T 1063/18 is comparable to the situation where two Boards have given different decisions".
• The President also submits as an auxiliary reason for admissibility of Question 2 that "question 1 is clearly admissible. Question 2 should be considered admissible too on the same basis." 
• The President curiously enough cites G 2301/16 as support for the sentence that “the Enlarged Board of Appeal is ‘the highest judicial authority of the EPO’.” (para. 31 of the referral, footnote 29).  

EPO G 3/19 - G0003/19 - G 0003/19

https://www.epo.org/law-practice/case-law-appeals/eba/pending.html 


link to PDF: http://documents.epo.org/projects/babylon/eponet.nsf/0/7C42BAE688EAD1F1C12583D70036374E/$File/Referral%20T%201063%2018_for%20President_2%20April_edited_clean%20approved.hyperlinks.ohnebeck%20(2).pdf 



A. Admissibility of the referral


[...]
I. Different decisions of two Boards of Appeal
4. Decision T 1063/18 differs from earlier case law with regard to the way in which an EPC Rule which clarifies the meaning and scope of Article 53 EPC is assessed under Article 164(2) EPC.
8. This approach differs from other decisions, namely the case law relating to the implementation of Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (hereafter referred to as "EU Biotechnology Directive") into the EPC.


9. In decision T 315/03 (relating to what has become Rule 28(1)(d) EPC) the Board fully acknowledged the Administrative Council’s competence to interpret Article 53(a) EPC by amendment to the Implementing Regulations based on Article 33(1)(c) EPC without being limited in this regard by an interpretation of the Article set forth in earlier case law.

[...]
11. In decision T 272/95 (relating to what has become Rule 29(1) EPC) the Board, too, fully acknowledged the Administrative Council’s competence to give "a more detailed interpretation of the meaning of Article 53 EPC".4

12. In decision G 2/077 the Enlarged Board of Appeal also followed an approach under Article 164(2) EPC which differs from the one underlying decision T 1063/18 as well as decision T 39/93 on which the Technical Board of Appeal relied for its conclusion. Namely, the Enlarged Board of Appeal did not endorse the reasoning underlying decision T 39/93 that under Article 164(2) EPC a previous interpretation of Article 53 EPC by the Enlarged Board of Appeal would a priori preclude its clarification by means of a newly drafted Rule of the Implementing Regulations.


13. The Enlarged Board held in point 2.4 of the Reasons for the Decision that: "[b]ased on the assumptions that the approach to the interpretation of Article 53(b) EPC adopted by the boards of appeal prior to the introduction of Rule 23b(5) EPC 1973 reflected the true meaning of that Article, and that Rule 23b(5) EPC 1973 was aimed at a very narrow construction of Article 53(b) EPC 1973, and one which was hardly to be reconciled with the previous interpretation of that Article, the referring Board considers that Rule 23b(5) EPC 1973 is in conflict with Article 53(b) EPC 1973, contrary to Article 164(2) EPC.
Reference is made by the referring Board to decision T 39/93 (OJ EPO 1997, 134, point 2.3 of the Reasons), in which it was held that, in view of Article 164(2) EPC, the meaning of an Article of the EPC on its true interpretation as established - in that case - by a ruling of the Enlarged Board of Appeal cannot be overturned by a newly drafted rule of the Implementing Regulations. As will be set out below, this reasoning is based on assumptions which are not endorsed by the Enlarged Board, so that a problem of conflict between Rule 26(5) EPC and Article 53(b) EPC in the sense described by the referring Board does not arise. (emphasis added)." [emphasis in referral document]

T 2435/13 - Crossing of plants

Key points

• This examination appeal is about a method "for producing a B. oleracea plant " comprising a step of "crossing said B. rapa plant with a B. oleracea plant", i.e. crossing between different species. The applicant submits that this method is not excluded from patentability under Article 53(b) EPC because in claim 1 "only partial homologous recombination on limited portions of the respective genomes took place". Therefore, "the claimed method was not directed to a process for the production of plants involving sexually crossing the whole genomes of plants" as specified in G2/07 and G1/08. G2/07 and G1/08 referred to conventional method "based on the sexual crossing of plants (i.e. of their whole genomes)" as being excluded. The present Board has to interpret the "i.e." phrase.
• "The board considers that, in fact, it can rather be inferred from [G2/07 and G1/08] that the EBA considered all methods containing or consisting of steps of sexually crossing the whole genome of plants and the subsequent selection of plants, regardless of those plants being sexually incompatible or not, to be excluded from patentability. In the board's view this is so since it was decisive for the EBA that in such processes, in contrast to other processes to change the genome of plants, such as e.g. irradiation [...], the genetic make-up of the plants resulting from the cross is determined by the result of the meiosis in the parent plants." 

T 2435/13 - link

Claim 1 of the main request read:
"1. A method for producing a B. oleracea plant comprising a monogenic and dominant resistance to clubroot comprising the steps of:
a) obtaining a B. rapa plant resistant to clubroot comprising a monogenic and dominant resistance to clubroot;
b) crossing said B. rapa plant with a B. oleracea plant,
c) rescuing embryos resulting from the cross of step b);
d) regenerating a plant from a embryo of step c);
e) selecting a plant of step d) that is resistant to clubroot comprising a monogenic and dominant resistance to clubroot;
f) back-crossing a plant resulting from step e) with a B. oleracea plant;
g) rescuing embryos resulting from the back-cross of step f); and
h) selecting a plant of step g) that is resistant to clubroot comprising a monogenic and dominant resistance to clubroot."

Reasons for the Decision

1. The appeal is admissible.

Introduction - The invention described in the application

2. Disclosed in the application (see e.g. page 2, lines 6 to 15, page 10, line 5 to page 11, line 2, example 1) is the transfer of a monogenic dominant resistance to clubroot from Chinese cabbage (Brassica rapa) to initially broccoli (B. oleracea) and then further to other B. oleracea cole-crop forms such as white cabbage, cauliflower and Brussels sprouts.

3. The resistance to clubroot was transferred from B. rapa to B. oleracea by means of an interspecific cross (hybridisation) followed by embryo rescue of the hybrid F1 progeny. Clubroot-resistant F1 progeny plants were then used for repeated backcrossing to B. oleracea and disease tests in all backcross generations. Plants resulting from the first backcross (BC1 progeny) were also recovered by embryo rescuing.

4. Embryo rescue - which techniques as such were known in the art - to obtain the F1 (and BC1) progeny after the interspecific cross is necessary in order to overcome the sexual incompatibility between B. rapa and B. oleracea due to the different number of chromosomes (n=10 or 9, respectively) in the two species. Embryo rescue in fact allows the problems of the non-viability of the embryo due to degradation of the endosperm in the seeds comprising the F1 embryos (10 + 9 chromosomes) to be overcome.

T 1063/18 - Plants and Rule 28 (Pepper)

Key points

• The written decision in the Pepper case is now available. The Technical Board decided that recently added Rule 28(2) EPC is in conflict with Article 53(b) EPC as interpreted by the Enlarged Board of Appeal in decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II). The Technical Board decided that "in accordance with Article 164(2) EPC, the provisions of the Convention prevail".
• "In the decision under appeal, the examining division reasoned that Rule 28(2) EPC constitutes a "clarification of the scope of Article 53(b) EPC". The board however cannot deduce from decisions G 2/12 and G 2/13 any other interpretation of Article 53(b) EPC than that plants are not excluded from patentability, even if they can only be obtained by an essentially biological process. Since [new] Rule 28(2) EPC excludes plants or animals exclusively obtained by means of an essentially biological process from patentability, its meaning is in conflict with the meaning of Article 53(b) EPC as interpreted by the EBA."
• "In the present case, Rule 28(2) EPC in fact reverses the meaning of Article 53(b) EPC, as interpreted by the EBA. In view of this direct contradiction, interpreting Rule 28(2) EPC in such a way that no contradiction exists is not possible."
• "The board agrees with the finding in decision T 39/93 (see Reasons, point 3.2) that "the meaning of an Article of the EPC (...), on its true interpretation as established by a ruling of the Enlarged Board of Appeal cannot, (...), be overturned by a newly drafted Rule of the Implementing Regulations, the effect of which is to conflict with this interpretation". The board concludes that it must apply decisions G 2/12 and G 2/13 unless it has reasons to refer the same question underlying these decisions for reconsideration by the EBA."
• The Board sees no reasons for a new referral to the EBA. The Boards observes that the Notice of the Commission of the EU of 8 November 2016 "has no legal authority." In particular, within the legal framework of the EU, binding interpretations of the Biotech Directive are to be given by the CJEU. Accordingly, also the argument that new Rule 28(2) EPC served to ensure consistency between the Biotech Directive and the EPC fails because the presumption that the Biotech Directive has to be interpreted as set out in the Notice is not valid.
• "If the adoption of Rule 28(2) EPC by the Administrative Council [...] were to be considered a subsequent agreement in the sense of the Vienna Convention and used for the interpretation of Article 53(b) EPC, this would reverse the meaning of Article 53(b) EPC as interpreted by the EBA (see point 24 above), i.e. it would represent an amendment of an Article of the Convention." However, the AC is not competent to amend Article 53(b) EPC. - 20.02.2019: here I originally omitted a key phrase from the decision: "However, the Administrative Council is not, in the light of Articles 33(1)(b)and 35(3) EPC, competent to amend the Convention, here Article 53(b) EPC, by amendment of the Implementing Regulations, here Rule 28(2) EPC."   
• As a comment, T 39/93 was (in relevant part) about what is now Rule 116 for which G 6/95 found that Rule 116 does not apply to the Boards. G6/95 was about whether the Boards are required to issue a preliminary opinion, T 39/93 is (in the relevant part, namely headnote I) about whether Rule 116 affects the rules for admitting documents in appeal. I note that T 39/93 is more frequently cited for its headnote II about the "subjective" technical problem, or for its headnote III about the skilled person does not have any inventive capability. Its headnote I is that Rule 116 " should not be construed as an invitation to file new evidence or other material departing from the legal and factual framework of issues and grounds pleaded and evidenced throughout the proceedings prior to the hearing of the appeal". The present decision refers to point 3.2 of T 39/93 where the Board "for the sake of completeness" reasoned that "the Board cannot accept the Appellant's legal proposition that an amendment to a procedural rule [of Rule 116] is capable of overriding those well-established legal principles, laid down in the points of law above referred to, that define the nature and function of appeals, and in particular the scope and effect of Article 114(1) EPC in relation to that function." (which is followed by the sentence quoted above).

EPO Headnote

Rule 28(2) EPC is in conflict with Article 53(b) EPC, as interpreted by the Enlarged Board of Appeal in decisions G 2/12 and G 2/13. In accordance with Article 164(2) EPC, the provisions of the Convention prevail.

EPO T 1063/18 - T1063/18 - link

Reasons for the Decision

1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is therefore admissible.

Main request

Exception to patentability under Article 53(b) EPC in conjunction with Rule 28(2) EPC

2. Exception to patentability under Article 53(b) EPC in conjunction with Rule 28(2) EPC of the subject-matter of claims 1 and 2 was the sole reason given in the decision under appeal for refusing the application.

3. Article 53(b) EPC excludes from patentability "plant or animal varieties or essentially biological processes for the production of plants or animals".

Decisions G 2/12 and G 2/13

4. Decisions G 2/12 (OJ EPO 2016, A27; Tomato II) and G 2/13 (OJ EPO 2016, A28; Broccoli II) of the Enlarged Board of Appeal (EBA) concern the patentability of plants directly obtained by and/or defined by an essentially biological process, the meaning of "essentially biological process for the production of plants" having already been defined in decisions G 2/07 (OJ EPO 2012, 130; Broccoli I) and G 1/08 (OJ EPO 2012, 206; Tomato I). The EBA considered that what remained to be determined was: whether or not the exclusion from patentability of essentially biological process for the production of plants "is limited to method or process claims or whether it also encompasses a patent claim for a product that is directly obtained and/or defined by an 'essentially biological process'." The EBA gave an interpretation of the meaning of this aspect of Article 53(b) EPC, considering its wording, the legislator's intention and taking into account the aspect of subsequent agreement and practice within the meaning of Article 31(3) Vienna Convention on the law of treaties, concluded at Vienna on 23 May 1969 (further referred to as: the Vienna Convention), as well as a systematic and historical interpretation (see Reasons, point VII.).

5. The EBA stated that applying the various methodical lines of interpretation to Article 53(b) EPC pointed towards not extending the scope of the process exclusion pursuant to Article 53(b) EPC "directly to a product claim or a product-by-process claim directed to plants or plant material such as a fruit, or to plant parts other than a plant variety" (see Reasons, points VII.6.(2) and (3)).

T 1957/14 - QTL's unclear

Key points

• In what appears to be an important decision for patents relating to plants and seeds, the Board decides that the claim at issue is unclear because it relies on QTL's (quantitative trait locus).
• The claim is directed to a maize plant having at least 14 QTL's, each QTL is defined by a pair or markers and by a position on a chromosome, each marker is essentially a DNA sequence which is given in the claim (SEQ ID), but the markers are not themselves the genes giving the advantageous properties (if I understand the technology correctly). More importantly is that QTL's are the most commonly used way to define conventionally bred plants in patent claims.
• "In the board's view, the skilled person may well understand the terms used in the claim and how to use the technology related to these terms in practice. Yet this understanding and these practical skills do not, in the present case, convey to the skilled person the structural features necessary to unambiguously characterise the alleles referred to in the claim."
•  "The alleles are moreover defined in claim 1 by further definitions in relation to the QTLs, i.e. the QTLs' supposed location on a chromosome, the QTLs' linkage to marker loci which in turn are defined by PCR primers identified by their sequence and the size of the amplification product " (as I tried to summarize above).
•  "In the board's opinion it is evident that none of these definitions provides the skilled person with any information about the structural features of the alleles themselves. Thus, the sequence of an allele is neither derivable from the QTL's supposed location on the chromosome nor from a characterisation of the markers linked to it, regardless of how extensive that characterisation is."
•  'Hence, the physical parameters of the alleles (see point 4 above), their structures, are not defined by the definitions in the claim. Consequently, the essential features characterising the claimed plant, the alleles (see point 3 above), are also not defined by the claim. For the above reasons, the board concludes that claim 1 lacks clarity."
• Added: The particular QTL's at issue were also defined by a reference to a deposited material. "in the board's opinion, the reliance on deposited inbred line material for the definition of the essential features of the invention and by requiring it to be analysed in order to identify the relevant alleles is at odds with the principle that, generally, the meaning of a claim, including its essential features, should be clear, for the person skilled in the art, from the wording of the claim alone "
• The  oral decision was given on 17 January 2018 so the written decision has taken some time to issue (on 30.11.2018). The claims in case T 1063/18 for which oral proceedings are publicly announced for 5 December 2018 also rely on QTL features. See here for a 2016 paper on patent claims and QTL's. See in particular pages 21 and 23 and in particular page 31. 

EPO T 1957/14 - link




Claim 1 of the main request reads:
"1. A maize plant characterized by a set of at least
14 QTLs each of which contributes to the phenotypic trait of grain yield as measured by quintals per hectare, wherein each of said QTLs is characterized by the presence of an allele of that QTL that contributes in a positive way to the phenotypic trait of grain yield, wherein each QTL is genetically linked to at least one marker locus selected from the group of loci characterized by at least one pair of linked markers each of which can be identified by a pair of PCR oligonucleotide primers consisting of a forward primer and a reverse primer exhibiting a nucleotide sequence as given in
(1) SEQ ID NO: 59/60 with an amplification product in a PCR reaction having a molecular weight of 120 bp and SEQ ID NO: 77/78 with an amplification product in a PCR reaction having a molecular weight of 85 bp, respectively, identifying a marker pair linked to QTLl, wherein QTL1 is located on chromosome 1 at a supposed position at 115.6 cM and is obtained from inbred line M3047/2 (NCIMB 41460); ...

Reasons for the Decision

Introduction and explanation of terms

1. The present invention relates to a maize plant "with a genome comprising a unique allele profile associated with the corresponding QTLs [quantitative trait loci] contributing to the expression of a variety of phenotypic traits of economic interest selected from the group of grain yield (...)" (see application, page 1, first paragraph). "The term "quantitative trait" has been used to describe a phenotype that exhibits continuous variability in expression and is the net result of multiple genetic loci presumably interacting with each other and/or the environment" (see application, page 1, fourth paragraph). The term "quantitative trait locus" (QTL) refers "to an association between a genetic marker and a chromosomal region and/or gene that affects the phenotype of a trait of interest" (see application, page 4, first full paragraph). A "genetic marker" is a "feature of an individual's genome (e.g., a nucleotide or a polynucleotide sequence that is present in an individual's genome) that is associated with one or more loci of interest" (see application page 4, lines 24 to 26). An "allele is understood, within the scope of the invention, to refer to alternative forms of various genetic units associated with different forms of a gene or of any kind of identifiable genetic element" and "an allele associated with a quantitative trait may comprise a single gene or multiple genes or even a gene encoding a genetic factor contributing to the phenotype represented by said QTL" (see application, page 2, fifth and sixth paragraph).

Main request

Clarity (Article 84 EPC) - claim 1

2. Article 84 EPC provides that the claims shall define the matter for which protection is sought and that they shall be clear and concise and be supported by the description. Rule 43(1) EPC further requires that the claims shall define the matter for which protection is sought in terms of the technical features of the invention.

The technical features of the invention are the physical features which are essential to it. The technical features of a claim to a physical entity are the physical parameters of the entity. In appropriate cases technical features may be defined functionally (see G 2/88, OJ EPO 1990, 93, Reasons, point 2.5).

The meaning of the technical features essential to the invention ("essential features") should be clear for the person skilled in the art from the wording of the claim alone (see decision G 1/04, OJ EPO 2006, 334, Reasons, point 6.2).

3. Claim 1 is directed to a maize plant (see section VI for the complete wording of the claim). The plant is characterised by "a set of at least 14 QTLs" and each QTL is characterised by "the presence of an allele of that QTL that contributes in a positive way to the phenotypic trait of grain yield".

Thus, the technical features essential for the invention are the alleles present in the QTLs because they are ultimately responsible for the phenotypic trait of grain yield.

T 1208/12 - Excluded plant variety

Key points

• The date of the decision at the oral proceedings is 07.02.2017, the decision was published more than a year later on 27.02.2018. 
• The Board decides that a claim for a hybrid plant seed produced by a cross of two types of Brassica plants, is directed to an excluded plant variety.
• The present Board: " For analysing the ruling in decision G 1/98, the board considers it however relevant to emphasise a guiding initial principle established by the Enlarged Board of Appeal in point 3.1 of the reasons for the decision, namely that: "Clearly, it is not the wording but the substance of a claim which is decisive in assessing the subject-matter to which the claim is directed. However, it does not follow that the subject-matter of a claim may be equated with the scope of a claim. In assessing the subject-matter of a claim, the underlying invention has to be identified. In this respect, it is relevant how generic or specific the claimed invention is" 

EPO T 1208/12 - link

Reasons for the Decision

1. The appeal is admissible.

The invention as claimed

2. The claimed invention (see section III) is a hybrid Brassica seed, and a plant grown therefrom, comprising a particular inheritable fertility restorer gene. The hybrid seed is further defined as resulting from a cross between a male parent plant and a female (male-sterile) parent plant.

[Claim 1 of the main request read:
"1. A hybrid seed comprising an inheritable and stable fertility restorer gene for ogura cytoplasmic male sterility, or hybrid plant thereof, produced by a cross between a plant obtained from seed deposited as Brassica napus olifiera 97SN-1650, 97SN-1651, 96FNW-1792-03 or 96FNW-1822-07 having the respective ATCC accession numbers 97838, 97839, 209001 or 209002 as a male parent and a second Brassica plant as a female parent, wherein the second Brassica plant has a glucosinolate level that is sufficiently low to ensure that the hybrid plant yields oilseeds having a total glucosinolate content of less than 30 mymol per gram dry weight."]

3. The male parent plant is defined as being obtained from seed from either of four particular (and deposited) Brassica napus olifiera varieties. The female parent plant is defined as being a Brassica plant having a glucosinolate level which is functionally defined, i.e. such a level that is sufficiently low to ensure that the hybrid plant yields oilseeds which have a total glucosinolate content of less than a certain defined (low) value (this value depending on the request under consideration, see section III).

T 2323/11 - Essentially biological process

Key points

• Claim 1 is directed to a method of producing a transgenic plant, by crossing two transgenic plants. The first plant has the gene of interest introduced, as well as an introduced marker gene. The second plant has a gene introduced that removes, upon crossing with the first plant, the marker gene. This removal step occurs after the zygote is formed.
• The question raises whether this method is "essentially biological" and hence excluded under Articel 53(b) EPC.
• The Board finds the method to be excluded.  " The board considers therefore that the trait of the excision of the target gene is the result of the crossing of the parent plants and is determined by the underlying natural phenomenon of meiosis, as the latter determines the genetic make-up of the plants produced. [] The board thus concludes that the claimed method is a method as held to be excluded from patentability by virtue of Article 53(b) EPC "

EPO T 2323/11 -  link

Reasons for the Decision

1. The appeal is admissible.

Main request and 1st auxiliary request - claim 1

The invention described in the application

2. Genetic engineering of plants by transformation typically involves the introduction of a gene of interest ("trait gene") and a marker gene (e.g. a selectable marker such as an antibiotic or herbicide resistance gene) into the genome of the plant. The marker sequence allows identification and selection of desired plant cells during the transformation process, but typically lacks any function after the transformation was successful. However, their presence in the genome of the resulting organisms influences the acceptance of such plants as food products among consumers (see application as published page 1, lines 9 to 20).

3. The present invention concerns the removal of unwanted sequences, e.g. such marker sequences, from the genome of transgenic plants which comprise an introduced gene for an agronomically valuable trait. The claimed method concerns the sexual crossing of two distinct transgenic parent plants. The first transgenic parent plant contains, besides sequences of interest conferring a particular trait on the plant, an undesired gene sequence in its genome ("target gene"). The second transgenic parent plant comprises a transgene encoding a particular sequence-specific DNA endonuclease which, when expressed in a cell which comprises the "target gene" in its genome, irreversibly excises this target gene from the genome. From such crosses, descending plants can be isolated which lack the marker sequences in their genome.