Key points
- It seems there were 15 opponents in this pharma case. The file is almost 9.000 pages.
- The decision is dated 27.10.2021 and was notified 16.05.2022. No notice of delay in issuing the written decision as prescribed in Art. 15(9)(a)(s.2) RPBA is visible in the online file.
- " The therapeutic application is defined in claim 1 as the "treatment of a thromboembolic disorder administered no more than once daily for at least five consecutive days". ... It is implicit in this feature that the treatment has a clinical benefit, in particular that it is effective. Since a treatment without acceptable safety cannot realistically be considered as having a clinical benefit, the aspects of both efficacy and safety have to be taken into account to determine whether the treatment defined in claim 1 is disclosed in the prior-art citations relied on by the respondents (see also decision T 2506/12, Reasons: 2.8)."
- " Since claim 1 concerns a further medical use, attaining the claimed treatment benefit is a functional technical feature of the claim. To meet the requirement of sufficiency of disclosure, the suitability of the treatment for the claimed therapeutic indication must therefore be disclosed unless this was already known to the person skilled in the art.'
- The application as filed contains experimental evidence on this account in example 1 (see pages 11 to 14). Example 1 reports on a phase II study carried out to test the safety and efficacy of different dosage regimens of rivaroxaban, including the once-daily oral administration of 30 mg in the form of rapid-release tablets, in the prevention of venous thromboembolism in patients undergoing total hip replacement. The application reports that the efficacy and safety of this treatment were found to be in (approximately) the same range as standard anticoagulant therapy with enoxaparin"
- " This evidence and the conclusions expressed in the application are presumed credible in the absence of evidence to the contrary."
- " The respondents [opponents] did not provide any experimental counter-evidence obtained with rivaroxaban that might have called the results of example 1 into question or might have shown that the treatment according to claim 1 could not be carried out in any particular embodiment."
- " the board considers that the information provided in the application as filed renders the medical indication of claim 1 of the main request credible. As a consequence, post-published evidence is not required but may also be considered [note: for sufficiency]. According to this evidence, as summarised in the appellant's document D121, subsequent phase II and phase III studies demonstrated the clinical efficacy and safety of the claimed dosage regimen at various od doses in both the prophylactic and therapeutic treatment of thromboembolic disorders, and several of these applications, falling within the ambit of claim 1, subsequently received regulatory approval."
- For these reasons, the ground for opposition under Article 100(b) EPC does not prejudice maintenance of the patent as granted.
- As to inventive step: " At the priority date, the entirety of published clinical data on rivaroxaban was phase I data. It was common ground that the conference abstracts D2 and D11 represented the closest prior art."
- " Both D2 and D11 mention the investigated drug compound only by its internal project code name "BAY 59-7939". The appellant's argument that D2/D11 do not provide enabling disclosure of the active compound does not succeed since the person skilled in the art would have found no difficulty in looking up the chemical identity and preparation of "BAY 59-7939" in the appellant's further publications on this compound. "
- " the features distinguishing the subject-matter of claim 1 from the disclosure of D2/D11 are the use of tablets and the medical use [note: i.e. clinical benefit] achieved with a specified dosage regimen (namely, once-daily dosing of rapid-release rivaroxaban for at least five consecutive days)."
- " Tablets are a conventional dosage form. The appellant did not base its reasoning in favour of inventive step on the choice of tablets over other dosage forms (e.g. capsules)."
- " The issue to be decided under obviousness is whether the skilled person would have had an incentive and reasonable expectation of clinical success regarding the specific regimen defined in claim 1, i.e. once-daily dosing of rapid-release rivaroxaban for at least five consecutive days, in patients, i.e. subjects at heightened risk for thromboembolism.'
- " The board considers that the disclosure of D2/D11 by itself, or in light of common general knowledge, would not have provided motivation to the person skilled in the art to pursue clinical testing of a once-daily regimen of rapid-release rivaroxaban in patients, for the following reasons.'
- [follows extensive reasoning by the Board
- " In summary, the serious concerns about safety in the case of a new anticoagulant did not warrant a "try-and-see" attitude for the dosage regimen, and the known, relatively short, half-life of rivaroxaban would not have supported an expectation of success with regard to once-daily dosing of rapid-release rivaroxaban."
- " the skilled person setting up a phase II clinical trial of a new anticoagulant was not in a routine "try-and-see" situation. Without a reasonable expectation of success with regard to clinical efficacy and safety, the mere wish for patient convenience would not have been sufficient as an incentive for testing an [once daily] regimen of a rapid-release form of the drug.'
- The claims are held to be inventive.
EPO T 1732/18 -
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/06/t-173218-phase-i-clinical-trial-data-do.html
