And now for something completely serious ... An Anxious Reader has contacted the IPKat in conditions of the direst secrecy, since millions (or tens of millions) of euros are at stake. Can you help? Says Anxious Reader:
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| The EMA's logo ... |
"The European Medicines Agency (EMA) has created a clinical trial database (known as the EudraCT Database) whose mission is to provide an overview of clinical trials being conducted in the EU (see EU Clinical Trials Register here).
The information published on this site is loaded by the national Medicines Agency from which authorisation for the trial is sought, and posted within 24 hours from trial authorisation.
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| Confusingly similar? |
We have found that information concerning the dose regime for a new drug to be tried out in an upcoming trial has been published on this site. After many emails and phone calls (with both the EMA and the Spanish authorities), we have been informed by the Spanish Medicine Agency that all information introduced in what is called the clinical trial authorisation (CTA), including dose regimes which are mandatory, are published on this website upon authorisation. And there is no way we can preserve the confidentiality of this information.
This mandatory publication is clearly in conflict with the possibility of filing patent applications on dose regimes, given that we would have to file these applications before conducting the dose finding study. Is there anyone out there who can offer any suggestions or advice as to how to deal with this situation?"
The IPKat is, as usual, certain that he knows the answer, but he doesn't want to spoil it for all those experts in the field who so enjoy writing in, so he has acceded to Merpel's request to give them a chance to show how clever they are too. Please post your comments below or, if that doesn't work, email them to the IPKat
here.
