EMA: Granting of a marketing authorisation for the medicinal product Siltuximab [Sylvant] for the treatment of multicentric Castleman’s Disease (MCD) recommended.

1 Comment on “EMA: Granting of a marketing authorisation for the medicinal product Siltuximab [Sylvant] for the treatment of multicentric Castleman’s Disease (MCD) recommended.”

1. I’m a patent anetroty, not an IP lawyer, so my perspective might not include all possible options. However these are my brief thoughts:1. For any disclosure originating from inventors there are of course grace periods available in many territories. You’ll need to contact local anetrotys in each territory to find out how each grace period works. They are different in terms of what you need to make use of it, whether the deadline for filing from the disclosure is from the filing date or priority date, whether the PCT route is still available, what the criteria are for being able to use it etc. For this first disclosure which came as a surprise there may be more chance to meet the criteria (although the ‘evident abuse’ hurdle at the EPO and the confidentiality test in the UK probably won’t be met). Clearly all of this will increase costs.2. For future cases the applicant will need to consider strategies to minimise damage. You could try filing a priority application before submitting the data, and then adding the date to the Convention case, if time-frames permit. There is a risk that the priority case will be considered unsupported/insufficient.3. You could ensure that the data submitted to the database is in a form where is causes minimal damage as prior art. So if several dosages are being tested, then perhaps that could be given as a broad range, so that a claim to a specific dosage would still be novel.4. Depending on the factual situation more complex strategies involve filing more than one application, each directed to a different dosage range, and then you choose which one to carry on with depending on the results of the trial. If the data was not available at the time of Convention filing then you would file it as post-filing data and hope for the best.In general prior art problems tend to be more serious than support/sufficiency problems (although this very much depends on the factual situation). So in general I would advise a strategy of trying to get a priority application on file before the database discloses the dosage information. Clearly though a very thoughtful approach is needed looking at all the time-frames and how these will interact with grace period provisions.Hope this is helpful!