Second medical use patents

Patent cliffs remain one of the biggest issues facing the pharmaceutical industry. In 2012 and 2013, a number of high-value branded drugs have lost or will lose their patent protection (for example Sanofi and Bristol-Myers’ Plavix, Novartis’ Diovan, Eli Lilly’s Cymbalta, Novartis’ Reclast and Merck’s Propacae). The resultant erosion
of earnings is vast.

In the light of this, originators’ ability to extend the patent life of their medicines through securing good secondary patents (composition patents, patents for new polymorphs/formulations, synthesis patents and patents for new therapeutic uses) is key.

‘Second medical use’ patents (new therapeutic uses for known active ingredients) are an important component of the potential second-line patent protection. In the UK, patentability of a second medical use was confirmed by the Court of Appeal decision in Actavis v Merck…

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