Workshops: Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, 6-15 July, 2014

Workshops for patent examiners of the Indian Patent Office in Mumbai, Chennai, Kolkata and New Delhi

Prof. Carlos Correa and Dr. German Velasquez from the South Centre visited the IP offices of Mumbai, Chennai, Kolkata and New Delhi to conduct four workshops with patent examiners from the four patent offices in India on examination of pharmaceutical patent applications from a public health perspective. 25 to 30 controllers and patent examiners for pharmaceuticals in each patent office participated in these workshops.

The purpose of the workshop was to provide a set of general guidelines for the assessment of some of the common types of pharmaceutical patent claims. It responds to growing concerns about the proliferation of patents that protect minor, and in some cases obvious, variants of existing drugs or processes (such as changes in the drug formulation, salts, esters, ethers, isomers, polymorphs of known molecules, combinations of a known drug with other known drugs).

Given the substantial effects that patents can have on competition and, hence, prices of medicines, the criteria that are applied to examine and grant pharmaceutical patents are extremely relevant for public health policies, and not only a matter of concern for patent and industrial policy.

The guidelines discussed at the workshops aimed to increase the capacity of patent offices to evaluate and take the necessary actions, as appropriate under the Patents Act of India, to protect public health in cases where patent applications or grants cover subject matter that does not deserve the reward of a patent monopoly. The workshops were ultimately intended to provide support to the four Indian patent offices by highlighting the areas in which poor decisions have often been made, including in economically important countries.

In this context, the workshops briefly discussed the issue ‘Access to medicines and Intellectual Property: Global problem, international context, challenges and solutions, from the public health perspective’; examined examples of different categories of patent claims for pharmaceutical products, indicating the practice of some patent offices, including recommendations for each category of claims; suggested elements for the development of public health-sensitive guidelines for the evaluation and review of pharmaceuticals patents at the national level (the draft guidelines published by the Indian patent offices were also considered and addressed some of the mechanisms that may be adopted to incorporate public health perspectives into procedures for the granting and review of pharmaceutical patents.

The examiners and controllers were open to new suggestions and participated actively in the discussions. Certain issues were noted as requiring further consideration from the discussions in the workshop. These were shared with the Department of Industrial Policy & Promotion of the Ministry of Commerce and Industries in India.


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