Policy Brief 23, October 2015

Guidelines on Patentability and Access to Medicines

The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well-understood. Too often these are viewed as to unrelated functions or responsibilities of the State . And the reason is clear: Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. This is the case when patent policy is implemented in isolation from, rather than guided by, public health policy. Today there is greater recognition that patent examiners and the examination of patents play a key role in facilitating or obstructing access to medicines. Given the impact of pharmaceutical patents on access to medicines, patent offices should continue to align their work in support of national health and medicine policies, using the freedom permitted by the TRIPS Agreement to define patentability requirements. The establishment of guidelines for the examination of pharmaceutical patents can constitute a valuable tool that is conducive to this objective.

This policy brief discusses the guidelines for the examination of pharmaceutical patents developed by WHO that serve as a guide for the drafting of internal procedure manuals of national intellectual property offices for the examination of patentability of chemical-pharmaceutical inventions.


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