T 1229/17

26.04.2022


Three oppositions were filed against the granted patent No. 2277050.

The opposition division decided that the patent could be maintained as amended on the basis of the second auxiliary request filed during oral proceedings (Articles 101(3)(a) and 106(2) EPC).

All parties lodged an appeal against the opposition division's decision.

With their statements of grounds of appeal, both opponent 2 (appellant II) and opponent 3 (appellant III) requested that the decision be set aside and the patent revoked in its entirety.

New documents D35-D43 were filed by the three appellants.

At the oral proceedings, the patent proprietor (appellant I) requested that the patent be maintained on the basis of auxiliary requests 1 or 2. Auxiliary requests 1 and 2 were identical, respectively, to the first and second auxiliary requests decided upon by the opposition division.

Admission of documents

A number of documents were filed during the appeal proceedings: documents D35 to D37, D38 and D39, D40-O2, D40-O3, D41, and D42 and D43. Appellant II requested that documents D39 and D41 not be admitted into the proceedings.

Pursuant to Article 12(4) RPBA 2007 (which is applicable in this case), everything presented by the parties with the statement of grounds of appeal or reply is to be taken into account but the board has the power to hold inadmissible facts, evidence or requests which could have been presented or were not admitted in the first-instance proceedings.

There were no objections against the admission of documents D35 to D38, and the board saw no reasons to hold them inadmissible either. The board thus decided not to exclude these documents from the proceedings (Article 12(4) RPBA 2007).

As to document D39, the following is noted: according to appellant I, D39 was filed as a reaction to document D32, which was itself only filed on the Rule 116 EPC deadline. Yet appellant I would have had the opportunity to file D39 within the time period between the Rule 116 EPC deadline and the date of oral proceedings or at the oral proceedings before the opposition division. The board thus accepts appellant II's arguments that appellant I could and should have submitted D39 in the first-instance proceedings.

The board thus decided to hold document D39 inadmissible (Article 12(4) RPBA 2007).

Documents D40-O2 and D40-O3 were filed after the replies to the grounds of appeal. The requirements of Article 13(1) RPBA 2020 apply (Article 25(2) RPBA 2020). As per Article 13(1) RPBA 2020, any amendment to a party's appeal case after it has filed its grounds of appeal or reply is subject to the party's justification for its amendment and may be admitted only at the board's discretion. The board exercises its discretion in view of, inter alia, the current state of the proceedings, the suitability of the amendment to resolve the issues which were admissibly raised by the other party in appeal proceedings or raised by the board, and whether the amendment is detrimental for procedural economy.

D40-O2, submitted in the context of inventive step, is a two-page document from Teva explaining that they would like to avoid competition for their product Copaxone®. D40-O3, submitted in the context of Article 123(3) EPC, is a compliance program guidance manual from the FDA. As regards D40-O2, the board fails to see how this disclosure may be relevant for the inventive-step discussion. As to D40-O3, appellant III did not provide any justification for filing it, let alone for filing it late. The board thus considers that admitting D40-O2 and D40-O3 would run counter to procedural economy. Accordingly, these documents were not admitted into the proceedings, pursuant to Article 13(1) RPBA 2020.

Documents D41 to D43 after notification of the summons to oral proceedings. The requirements of Article 13(2) RPBA 2020 apply, under which any amendment to a party's case made after notification for oral proceedings shall, in principle, not be taken into account, unless there are exceptional circumstances which have been justified with cogent reasons by the party concerned. The board fails to see any exceptional circumstances that would justify submitting these documents, nor have the parties provided any such justification. Document D41 was allegedly submitted in response to D40-O2 while documents D42 and D43 were submitted as a reaction to D41. Since D40-O2 was not admitted into the proceedings, there is no reason to admit D41 and, consequently, no reason to admit D42 and D43 either. Accordingly, the board decided not to admit any of documents D41 to D43 into the proceedings (Article 13(2) RPBA 2020).

Main request - Article 56 EPC

The patent at issue is generally directed to glatiramer acetate (GA) production methods. As taught in paragraph [0001] of the patent, GA (also known as copolymer-1 and marketed as the active ingredient in Copaxone®) is used to treat the relapsing-remitting form of multiple sclerosis (RRMS). According to the Copaxone® product label, GA consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids, L-glutamic acid, L-alanine, L-tyrosine and L-lysine. Since slight manufacture variations are expected to potentially lead to product variability, the patent aims to provide methods for ensuring product consistency. This is achieved by measuring the amount of pyro-Glu in each GA batch and selecting those batches with a pyro-Glu amount in a predetermined range (which broadly corresponds to the range measured in the commercial product Copaxone®).

Document D1 can be considered the closest prior art. The distinguishing feature between the claimed subject-matter and D1 is that pyro-Glu is measured and this measurement forms the basis for selecting the GA batch that has been produced, the aim being to select a batch comprising 2 000 to 7 000 ppm pyro-Glu.

There is no technical effect linked to this difference over the whole scope of claims 1 and 2, and the technical problem is thus to be formulated as simply providing a process for selecting batches of compositions comprising GA on the basis of a measurement of one parameter.

The claimed solution solves the above problem but it is obvious because the skilled person would just measure pyro-Glu or any other equally likely parameter in order to select batches of compositions comprising GA. As it was common general knowledge that pyro-Glu was produced from glutamate residues that were known to be one of the four amino acids in the GA compositions, the skilled person would certainly have expected some amount of pyro-Glu to be measured in batches of compositions comprising GA. Since the stated range is not associated with any technical effect, it was just one among various equally likely alternative ranges.

The board thus concludes that claims 1 and 2 of the main request lack inventive step (Article 56 EPC).

Auxiliary request 1 - Article 56 EPC

Document D1 is the closest prior art and, as concluded above in relation to the main request, the distinguishing feature is that pyro-Glu is measured and this measurement forms the basis for selecting the batch of GA, the aim being to select a batch comprising 2 000 to 7 000 ppm pyro-Glu.

Since the claimed range for the amount of pyro-Glu is a structural signature which makes it possible to ensure consistency when producing a GA preparation, the technical effect of the distinguishing feature is being able to define a parameter that can be used to select batches which are consistent with, i.e. have the same characteristics as, the commercially approved product. The technical problem is thus formulated as providing a process that makes it possible to select batches of GA which have the necessary quality and suitability for pharmaceutical use. The board is satisfied that the claimed solution solves this problem.

None of the available prior-art documents disclosing GA manufacture, such as D1 and D13, discloses the presence of pyro-Glu in the preparations, let alone that it could be used as a structural signature for the GA composition. In fact, at no point do any of these documents refer to the need to measure any parameters in order to assess product consistency.

The patent was the first document to disclose that evaluating the pyro-Glu content of a sample of GA made it possible to identify non-conforming compositions, which would not be detected by merely looking at molar mass and amino acid composition.

The board thus considers that a skilled person looking for a process to allow them to select batches of GA with the necessary quality and suitability for pharmaceutical use would not arrive at the claimed solution in an obvious way.

The board thus concludes that the claims of auxiliary request 1 fulfil the requirements of Article 56 EPC.

The board considers that the opposition division's decision maintaining the patent as amended on the basis of the claims of what was then auxiliary request 2 (now auxiliary request 1) remains valid.

The appeals are dismissed.


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