Research Paper 64, February 2016

Implementing Pro-Competitive Criteria for the Examination of Pharmaceutical Patents

This document discusses criteria for implementing the patentability requirements in relation to patent applications covering products and processes, as well as the use of pharmaceutical products. The adoption of rigorous criteria with this purpose is important for four main reasons.

First, although pharmaceuticals share common features with other inventions, there are elements in patent claims relating to pharmaceuticals that are unique, determined by their intended use.

Second, a set of examination criteria will help speed up patent procedures, increase uniformity in the treatment of applications, and offer applicants greater certainty about the possible outcome of the procedures.

Third, there is a proliferation of patent applications in the field of pharmaceuticals claiming polymorphs, salts, formulations and so on, which are often made to prevent generic competition rather than to protect genuine inventions. So-called ‘evergreening’ patents do not contribute to the technological pool, and they limit the market entry of generic products.

Fourth, 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 for public health. Patent offices and examiners play vital roles in ensuring an appropriate balance between protecting inventions and incentivizing innovation on the one hand, and promoting accessibility and affordability of treatments and health technologies on the other. This balancing process is also important for achieving broader development priorities, from national efforts to promote research and development (R&D), technology transfer and pharmaceutical production, to achieving universal health coverage.

Several countries (e.g., Argentina, Ecuador, India and the Philippines) have adopted legislation or policies for examining patent applications relating to pharmaceutical products and processes in a manner that accounts for public health considerations. Analysis of pharmaceutical patent claims has shown that the proper application of patentability standards can prevent the grant of ‘poor quality’ or trivial patents, which, by preventing the timely entry of generic competition, may harm public health.

Importantly, the application of the discussed criteria would not mean to modify the standards of patentability established by patent law, or to add additional standards. Instead, they aim to ensure the correct application of those standards in view of the specific nature of the claimed subject matter and the public health relevance of the decisions.

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