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If a company refuses to supply its approved drug for a well-designed independent trial combining it with a rival's drug, the law would let the trial buy it at manufacturing cost, with results shared back.
A research-access provision, analogous to compulsory licensing but for trial supply: an independent scientific committee can certify an academic or non-profit combination trial as in the public interest, after which the patent holder must supply the drug at a regulated cost-of-goods price or license a generic maker to do so, in exchange for full access to the trial's data and a right to use results in labelling. The provision only bites when voluntary agreement fails and so mostly changes bargaining positions. It addresses the documented pattern of companies declining to supply comparators or partners for trials that might disadvantage their product.
Shares An oncology patent pool for combination trials across companies, Secrecy and intellectual property block collaboration, Too many combinations to test.
Shares An oncology patent pool for combination trials across companies, Secrecy and intellectual property block collaboration, Too many combinations to test.
Shares An oncology patent pool for combination trials across companies, Secrecy and intellectual property block collaboration.
Shares An antitrust safe harbour for cross-company combination trials and data pooling, Secrecy and intellectual property block collaboration.
Shares Secrecy and intellectual property block collaboration, Too many combinations to test.
Shares Secrecy and intellectual property block collaboration, Too many combinations to test.
Shares An antitrust safe harbour for cross-company combination trials and data pooling, Secrecy and intellectual property block collaboration.
Shares Secrecy and intellectual property block collaboration, Too many combinations to test.