UNDP Issues Guidelines For Pharmaceutical Patent Examination

The United Nations Development Programme (UNDP) has recently published guidelines for examination of patent applications relating to pharmaceuticals.The guidelines have highlighted the need for examining pharmaceutical patents from the perspective of public health.The guidelines set by Prof. Carlos M Correa strongly recommend nations to set out specific and more stringent standards for pharmaceutical patents. The guidelines also encourage patent offices to exploit the flexibilities allowed by the TRIPS Agreement with regard to the aforementioned guidelines. In his foreword, Mandeep Dhaliwal, Director HIV, Health and Development Group, UNDP stated, “Recognizing the key role that patent offices and patent examiners play in safeguarding balance, some countries have taken steps to provide guidance for how public health considerations may be factored into the examination of patent applications”. The aim of the document (guidelines) is to provide guidance for the development or revision of guidelines on patent examination processes in developing countries. It proposes recommendations that can be adopted to incorporate public health perspectives in procedures for granting pharmaceutical patents.

The guidelines also recognize the fact that countries, such as Argentina, Ecuador, India and the Philippines, have taken steps to give primacy to public health. One of the most important reasons which were cited for publication of these guidelines is that there is a proliferation of patent applications in the field of pharmaceuticals claiming polymorphs and salts. These applications are often made to prevent generic competition rather than to protect genuine inventions. Such ever greening of patents does not contribute to the technological pool. In fact, they limit the market entry of generic products. Further the document mentions that given the impact of patents on the availability, accessibility and affordability of treatments and technologies, the manner in which pharmaceutical patent applications are examined can have critical implications on public health. The guidelines specifically rest on five points including concept of invention, patentability standards, sufficiency of disclosure, flexibilities under the TRIPS Agreement and typical claims relating to pharmaceuticals.

There is reference to The Indian Revised Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals in the guidelines issued by the UNDP. The guidelines also mention certain decisions delivered by Indian Courts to reiterate the importance and need of giving attention to public health.

Sources:  1, 2

Authored by Sanjeevani Patil

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