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 0420/19 -

https://www.epo.org/law-practice/case-law-appeals/recent/t190420eu1.html

4. The board notes however that the EBA has, in Opinion G 3/19, already dealt with the considerations raised by Appellant II. In that opinion, the EBA abandoned the interpretation of Article 53(b) EPC given in decisions G 2/12 and G 2/13 and, in the light of Rule 28(2) EPC, held that the term "essentially biological processes for the production of plants or animals" in Article 53(b) EPC was 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 (see Reasons, XXVI.8).

5. However, in order to ensure legal certainty and to protect the legitimate interests of patent proprietors and applicants, 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".

6. The EBA explicitly dealt with the question of whether the EPC legislator, by adopting Rule 26(1) EPC, intended to align the EPC with the EU Biotech Directive and hence intended Article 53(b) EPC to be interpreted as excluding from patentability products (plants and animals) exclusively obtained by essentially biological processes.

7. In response to arguments in the referral by the President of the EPO, the EBA concluded that "the Directive itself does not directly lead to the conclusion, drawn by the EPO President, that the EPC legislator intended Article 53(b) EPC to be interpreted as excluding from patentability products (plants and animals) exclusively obtained by essentially biological processes" and "...neither Rule 26 EPC as such nor the very wording of the EU Biotech Directive, to which Rule 26(1) EPC refers, lead directly to an interpretation of Article 53(b) EPC which would expand the process exclusion to the products of such processes" (see Reasons, VX.1.2 and 1.3).

8. The EBA also considered whether or not the Notice on the interpretation of the EU Biotech Directive issued by the EU Commission in 2016, in which it took the view that the EU legislator's intention in adopting the EU Biotech Directive was to exclude from patentability products (plants/animals and plant/animal parts) obtained by means of essentially biological processes, was to be taken into account under Article 31(3)(a) and (b) Vienna Convention (see Reasons, XV.2.1 to XV.2.4). It concluded that the EU Commission's Notice was not legally binding, and that the legally effective and binding interpretation of Union law lay within the exclusive competence of the Court of Justice of the European Union (CJEU), which has the interpretative supremacy with respect to Union law (Article 19(3)(b) of the Treaty on EU (TEU), consolidated version 2016, in combination with Article 267 TFEU).

9. On the date of the Opinion of the EBA and on the date of the present decision, no decision concerning the exception to patentability in respect of animals, plants or plant materials obtained by an essentially biological process and the interpretation of Article 4 EU Biotech Directive has been handed down by the CJEU.

10. Moreover, the EPOrg was not directly bound by Union law and especially not by a legally non-binding Notice on the interpretation of the EU Biotech Directive issued by the EU Commission (see Reasons XV.2.4).

11. 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.

Inventive step -(Article 56 EPC)

12. With regard to the claim request considered allowable by the opposition division, appellant II submitted that the subject-matter of claim 6 (corresponding to claim 6 of present auxiliary request 8 with an amended proviso) lacked an inventive step in view of the disclosure in document D1 alone or in combination with common general knowledge. This reasoning applies equally to claim 6 of the main request, of which the above subject-matter is an embodiment.