Digging deep into the maelstrom of intellectual property in pharma
One key issue that has emerged recently in UK and European patent law is the concept of ‘plausibility’.
The term has no explicit basis in statutory law but, over time, has developed as a minimum standard to be met by a patent disclosure, to prove an effect asserted for a claimed invention. The principle underlying the requirement is the prevention of purely speculative patent claims.
It can be particularly relevant to pharmaceutical patents, especially those for medical uses, where definitive proof of efficacy (i.e. clinical trial data) is typically not available when the earliest patent filings in a drug discovery programme are being considered.
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