Tuesday, 12 July 2016

R 2/14 - Is there an undue burden?

Undue burden?

This is a successful petition for review.  

Claim 1 as granted refers to an amino acid sequence "SEQ ID NO:4". Unfortunately, the sequence contains an error and does not provide the required desaturase activity. The opposition division revoked the patent as not complying to Art. 83 EPC. In the appeal, the proprietor countered that the skilled person could nevertheless prepare a protein having the desired activity. 

In the appeal decision, the board rejects this argument. The relevant part of the decision is the following:



"30. Since the skilled person relying on the patent application was not informed that the protein defined by SEQ ID NO:4 was inactive, and since the patent application neither disclosed any active sequence variants having at least 60% sequence identity nor which positions of SEQ ID NO:4 had to be modified in order to obtain a functional desaturase, it had to go back to E. gracilis and redone the desaturase in order to put the claimed invention into practice. Even though each of the steps necessary for recloning could be performed by a person skilled in the art,- it is the combination of all the necessary steps (isolation of total mRNA, PCR amplification and selection of a group of amplification products with homology to known desaturases, completion of the 5' and 3' ends by RACE amplification, cloning and expression of the full length sequence to assess its function) which creates an undue burden on the skilled person trying to perform the invention. The same applies to the two alternative approaches mentioned by the appellant.

31. Thus, contrary to the requirements of Article 83 EPC, the skilled person would not have been in a position to perform the claimed invention readily and without undue burden across essentially the entire scope of claim 1."

The proprietor raised two complaints against the decision, the second of which is that the board based its decision on facts and arguments in respect of which the parties were not heard and did not reason its conclusions about the objection under Articles 100(b) and 83 EPC.





Reasons for the Decision

Admissibility

1. The petitioner is adversely affected by the decision under review.

2. The petition was filed in accordance with the formal requirements pursuant to Article 112a(4) EPC and Rule 107 EPC.

3. As to the respondent's objection to the admissibility of the petition (point VII.3.2 above), it is to be noted that the deficiencies relied upon by the petitioner concern only alleged deficiencies in the written reasons given by the board for its decision under review. Thus, the petitioner could not have raised the required objections under Rule 106 EPC.


4. Consequently, the petition is admissible.

Allowability

5. The petitioner essentially invokes the ground of petition according to Articles 112a(2)(c) and 113(1) EPC.

6. The right to be heard according to Article 113(1) EP is an important procedural right intended to ensure that no party is caught unaware by grounds and evidence in a decision turning down his request on which that party has not had the opportunity to comment (see R 3/10 of 29 September 2011, Reasons, point 2.10; J 7/82, OJ EPO 1982, 391, Headnote II and Reasons, point 6). This requirement includes the party's right to have the relevant submissions and arguments considered and fully taken into account in the written decision in a manner that enables it to understand, on an objective basis, the reasons for the decision (see R 19/10, supra, Reasons, points 6.2 and 6.3; R 23/10, supra, Reasons, point 2; R 8/11 of 29 November 2011, Reasons, point 1.2.9; R 17/11 of 19 March 2012, Reasons, point 4; R 15/12 of 11 March 2013, Reasons, point 5 b); R 13/12 of 14 November 2012, Reasons, point 2.2; R 19/12 of 12 April 2016, Reasons, points 6.1 and 6.2).

7. Before investigating the petitioner's arguments, it is to be noted that the examination whether or not a European patent application or patent meets the requirements of Article 83 EPC is a matter of substantive law. In view of this, it has to be borne in mind that review proceedings based on Article 112a(2) (c) EPC are confined to procedural defects so fundamental as to be intolerable. It follows from the essential interest of legal certainty that appeal proceedings leading to a final decision shall be re-opened only if one of the grounds provided for in Article 112a EPC applies. It is by no means the objective of petition for review proceedings to review the correct application of substantive law (consistent case law since R 1/08 of 15 July 2008, citing the travaux preparatoires, and R 2/08 of 11 September 2008).

8. The issue of sufficiency of disclosure of the claimed invention was dealt with by the board in the decision under review in the summary of facts and submission in points XI. and XII., and in the reasons for the main request in points 22 to 32 and for the auxiliary request in points 33 to 35. In particular, point 29 of the reasons explicitly referred to submissions of the petitioner, and points 30 and 31 contained the board's conclusions that it disagreed with the petitioner.

9. The first complaint
(…)

10. The second complaint

10.1 Regarding the second complaint, the petitioner argued

(a) that, insofar comparable to the situation underlying decision R 16/13 (supra), the board had based the decision under review on a ground that it introduced into the written reasons ex officio and without prior discussion with the parties and

(b) that the reasoning of the board was restricted to a mere statement of legal conclusions rather than a discussion of facts previously discussed by and/or with the parties, i.e. that the board failed to reason its conclusion that the person skilled in the art might have performed each of the steps necessary for recloning but that the combination of all the necessary steps would create an undue burden on the skilled person trying to perform the invention.

10.2 In respect of the first argument (a), the Enlarged Board notes the following:

10.2.1 According to decision R 16/13 (supra, headnote and Reasons, point 6), the Enlarged Board held that the right to be heard under Article 113(1) EPC is violated if a board of appeal relies for its decision ex officio on grounds that had not been put forward by the parties, without having given the losing party an opportunity to comment on these grounds and, if the patent proprietor is concerned, to submit appropriate new request. 

10.2.2 However, the case underlying decision R 16/13 (supra) concerned particular circumstances where the board of appeal chose a different document as closest prior art and developed a reasoning of its own starting from this starting point, inter alia stating that the comparative tests which sought to make clear that the claimed invention was inventive over the closest prior art were not relevant. The patent proprietor was not given the opportunity to comment on or to react to it because the problem was not mentioned at all and there was no reason for the patent proprietor to suspect that there was a problem in this respect.

10.2.3 In the present review case the discussion before the board was all the time about sufficiency of disclosure and both parties were given every opportunity to convince the board of their point of view.

The board then came to the conclusion that although the individual steps were sufficiently disclosed, implementing the totality of steps was an undue burden.

10.2.4 Thus, the present case is distinct from the procedural situation in case R 16/13 (supra).

However, the Enlarged Board understands aforementioned argument (a) rather to be linked to argument (b) in that the petitioner feels themselves in a situation where they are left alone in assuming what circumstances (whether they were discussed with the parties or whether they were introduced by the board on its own motion) had triggered the board to come to the negative conclusion about the issue of sufficiency of disclosure.

10.3 Concerning the second argument (b) the Enlarged Board, in addition to the standard for observing the right to be heard according to Article 113(1) EPC mentioned above in point 6., wishes to rely upon the following principles of the well-established case law of the Enlarged Board of Appeal in respect of the reasons of a board of appeal decision (see: Case Law of the Boards of Appeal, 7th edition 2013, chapter IV.E.9.2.9 (b)(iv)):

(1) The right to be heard pursuant to Article 113(1) EPC does not imply that a board of appeal is obliged to inform the parties of all possible reasons for a decision in advance (see e.g. R 16/13, supra, Reasons, point 3).

(2) It is generally sufficient for observing the right to be heard pursuant to Article 113(1) EPC if the grounds given in the written decision correspond to the facts of the case and the arguments put forward by any of the parties to the proceedings, so that the petitioner was aware of it and hence could not be surprised by corresponding grounds (see e.g. R 22/10 of 7 March 2011, Reasons, point 6; R 16/13, supra, Reasons, point 3.3). This applies even more if said grounds could be objectively foreseen or if the party concerned could have developed those grounds based on their own expertise (see e.g. R 22/10, supra, Reasons, point 6; R 16/13, supra, Reasons, point 5.2).

10.3.1 Turning to the board's reasoning in the decision under review to dismiss the petitioner's appeal, the Enlarged Board notes that the decisive argumentation of the board in points 30 and 31 of the reasons concerned the aspect of modifying the inactive SEQ ID NO: 4 by means of recloning the desaturase starting from E. gracilis.

The reasons given by the board are limited insofar as, after the determination of the need for recloning, the board immediately stated its conclusion that the skilled person in fact could perform each of the necessary steps ("isolation of total mRNA, PCR amplification and selection of a group of amplification products with homology to known desaturases, completion of the 5' and 3’ ends by RACE amplification, cloning and expression of the full length sequence to assess its function"), but that combining those steps created an undue burden on the skilled person.

The other two alternative approaches, as mentioned in point 30 of the reasons of the decision under review and relied upon by the petitioner, were not discussed at all by the board but merely referred to as suffering from the same negative conclusion as the recloning approach.

10.3.2 The case at hand is thus marked by the circumstance that the board in the relevant points 30 and 31 of the reasons of the decision under review mentions neither facts nor a sequence of arguments that led it to arrive at the conclusion that the combination of the required steps imposed an undue burden on the skilled person.

The summary of facts and submissions in the decision under review is also silent in this respect.

10.3.3 In the absence of any explicit or implicit reference to facts and to arguments and evidence relied upon by the parties to the appeal proceedings, the conclusion drawn by the board cannot be understood and reproduced by the affected party. Under these circumstances, the petitioner's argument appears to be compelling that the facts considered but not disclosed by the board might or might not justify the board's conclusion. 

10.3.4 As a consequence, for the purpose of establishing whether the petitioner's right to be heard was observed by the board, the Enlarged Board is faced with the following situation: 

Either: The Enlarged Board cannot establish that the reasons for the decision under review are based on facts (and on what facts) and considerations (and on what considerations) on which the parties to the appeal proceedings, in particular the petitioner as the party affected by the decision under review, had an opportunity to comment.

Or: In the event that the parties had been given an opportunity to comment, the Enlarged Board cannot establish that the parties' relevant submissions and arguments were considered and fully taken into account when taking the decision.

Any remaining doubts in this respect concerning either situation must be solved to the affected party's benefit.

11. Under these particular circumstances the Enlarged Board had to assume that a violation of the petitioner's rights under Article 113(1) EPC occurred which qualifies as fundamental within the meaning of Article 112a (2) (c) EPC because it concerned the ground on which the petitioner's appeal was eventually dismissed by the decision under review.

12. Since the petition is allowable with regard to the second complaint, the decision under review is to be set aside and the proceedings before the board are to be re-opened (Rule 108(3), first sentence, EPC).

13. No request for replacement of the members of the board under Rule 108(3), second sentence, EPC has been made by the petitioner, nor does the Enlarged Board see any reason to deviate from the general principle that the proceedings are re-opened before the board of appeal responsible under the business distribution scheme (see: R 15/11 of 13 May 2013, Reasons, point 9), i.e. by the board in its composition that issued the decision under review. However, the need for a change in the composition of the board arises from the fact that one of the members is no longer active. It is for the chair of the board to finally determine the actual composition of the board responsible for hearing and deciding the re-opened appeal case.

14. The order to reimburse the fee for the petition is based on Rule 110 EPC.

Order

For these reasons it is decided that:

1. The decision under review is set aside.
2. The proceedings before the Board of Appeal 3.3.08 are
reopened.
3. Reimbursement of the fee for the petition is ordered.
 



The file wrapper can be found here. Photo "Donkeys loaded up with carriage luggage" obtained via Jennie King Mellon Library and Flickr.



1 comment :

  1. It is the 6th petition for review in which the decision of the BA has been set aside.

    In all cases of a petition for review in which the decision has been set aside in opposition appeal proceedings, the final decision of the BA has been confirmed. It will be interesting to see whether this trend continues.

    Only once, following a petition for review in examination appeal proceedings, the decision of the BA has been reversed going from refusal to grant, cf. R 15/11.

    ReplyDelete

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