Protecting second medical use – opportunities and pitfalls

Written by Caroline Pallard

Innovators continue to develop drugs to further understand how to optimise the use of known drugs. The European patent system allows for protection of a known substance or composition for treating a disease in further therapy of the same disease, provided that such further therapy has not yet been published and provides new and surprising advantages to the patient. In recent years, since Enlarged Board of Appeal Decision G02/08, the European Patent Office (EPO) has been increasingly flexible in allowing the protection of second or further medical uses of a known substance or composition.

Such second or further medical use could potentially be as broad as to be related to “any specific use of such substance or composition in a therapeutic method” (Article 54(5) of the European Patent Convention (EPC) 2000), provided that such use is not comprised in the state of the art, thereby opening up the possibility to protect “any such specific use in a therapeutic method” where it meets all other EPC requirements. It seems to mirror the exponential development of personalised medicine, wherein specific drugs are tailored to the individual patient based on patient (genetic) context.

Caroline Pallard, European patent attorney and partner at NLO, wrote the article 'Protecting second medical use – opportunities and pitfalls'. This article was first published in the 2018 edition of IAM Life Sciences.

Article: Protecting second medical use – opportunities and pitfalls

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