Sponsoring Clinical Trials offers standing to clear the way in Belgium
In Belgium, the question arose before the Brussels Court as to whether a foreign company (which was part of an international pharmaceutical group) that only invests in clinical trials and research & development for a future drug to be launched in Belgium, but that would never itself commercialize that drug in Belgium, has sufficient standing to sue for the revocation of a patent that potentially stood in the way of marketing that drug. The patent holder alleged that the foreign company did not have sufficient standing because (i) it would never itself commercialize any drug in Belgium and (ii) the launch of the drug product was still hypothetical and would only take place after several years.
In its judgment of March 2017, the Brussels Court ruled that the foreign company in question – which owned all the IP and sponsored all clinical trials but did not hold any marketing authorization - had sufficient standing to launch revocation proceedings in Belgium. The Court held that sponsoring an approved clinical trial showed a sufficient financial and personal interest in the outcome of the revocation proceedings. It further decided that a company has standing to initiate revocation proceedings to clear the way for an anticipated drug launch long before that drug is marketed, since there is generally a long period of time between the decision to market a drug and the actual launch and sale of that drug.
