Key points
- “The [patentee] respondent had filed auxiliary request 24 in the opposition proceedings with the letter dated 11 November 2016. It re-filed the request with the reply to the statement of grounds of appeal and referred to the submissions made in that letter. In the [opponent's] view, the reference to the submissions in the opposition proceedings did not fulfil the requirements of Article 12(2) RPBA 2007. Therefore, the request had to be held inadmissible under Article 12(4) RPBA 2007.”
- “The letter [of patentee of 11 November 2016 before the OD] explained the impact of this amendment on the issue of inventive step. [It] was apparent that the amendment in claim 1 [also addressed the objection of insufficient disclosure].”
- “In the appealed decision, the opposition division concluded that the patent could be maintained on the basis of the main request. Thus, the submissions regarding inventive step in relation to auxiliary request 24 in the opposition proceedings remained relevant at the outset of the appeal proceedings and potentially addressed the lack of inventive step objections raised by the appellant in the statement of grounds of appeal. It was also apparent that the amendment introduced in claim 1 of auxiliary request 24 made the claimed subject-matter narrower and closer to the post-filing evidence which had been filed in the context of the issue of sufficiency of disclosure. Therefore, the board decided to admit auxiliary request 24 into the proceedings (Article 12 (2) and (4) RPBA 2007).”
- Claim 1 is directed to “A combination comprising [the compound TMC278] and [a nucleotide reverse transcriptase inhibitor] for use in the treatment of HIV infection wherein the combination is administered once daily”.
- The Board, regarding plausibility of second medical use claims: “In view of this common general knowledge, it would have been plausible [at the filing date] that the combination of [the compound] TMC278 with one or more [ nucleoside reverse transcriptase inhibitor compounds] [which are only functionally defined as] known to be therapeutically effective HIV inhibitors when administered once daily could be effective for treating HIV infection by once-daily administration”
- “However, this initial plausibility cannot be equated with meeting the requirement of Article 83 EPC. It is basic knowledge in the field of pharmaceutical combinations that in the absence of experimental data (or previous related knowledge), the interaction between individual active ingredients at physiological levels is unpredictable; the compatibility of the ingredients and the suitability of their combinations for the envisaged treatment at given doses needs to be assessed in vivo. ”
- “The existence of an initial plausibility nevertheless allows the board to consider post-published evidence which fills the probative gap that existed at the filing date. ”
- “D26 proves that the skilled person could have carried out the treatment of claim 1 to the extent that it concerned the combination of E-TMC278 with emtricitabine and tenofovir disoproxil fumarate. However, this appears insufficient to make credible that every possible combination of TMC278 with NRTIs that are therapeutically effective by once-daily administration would be suitable for treating HIV in a once-daily dosage regime. To find suitable combinations and their corresponding doses among all the possibilities covered by claim 1, the skilled person would have needed to carry out an undue amount of research. ”
- “Therefore, there exist serious doubts substantiated by verifiable facts that the skilled person could have carried out the treatment of claim 1 across its whole breadth without undue burden. As these doubts were not removed by the respondent, the main request does not meet the requirement of Article 83 EPC.”
- As a comment, there are numerous patents granted reciting one particular pharmaceutical compound and generically defined further components - with a number of CJEU caseas about those kind of claims in connection with SPC's.
- In addition, a patent for a first medical use also covers all combination treatments and a patent for a new pharmaceutical compound also covers all combinatin treatments However, in that case perhaps the claims are not directed to combination treatment specifically.
T 0391/18 -
https://www.epo.org/law-practice/case-law-appeals/recent/t180391eu1.html
Reasons for the Decision
1. The appeal is admissible. It meets the requirements of Articles 106 to 108 and Rule 99(2) EPC.
2. Main request - sufficiency of disclosure
2.1 Claim 1 of the main request is directed to a combination of active ingredients for treating HIV infection in a regime of once-daily administration. The claim contains the following two requirements: (i) the combination of active ingredients must be suitable for treating HIV infection when administered once daily and (ii) each of the individual active ingredients must be therapeutically effective HIV inhibitors at a dose that can be administered once daily.
source http://justpatentlaw.blogspot.com/2021/07/t-039118-when-referring-to-earlier.html
