A new set of guidelines for pharmaceutical patent examination has been published by the United Nations Development Programme that seek to help reduce poor quality patents and ensure efficient market entry of generic products.
The guidelines, written by a well-known advocate of access to medicines, aim at advising patent examiners in assessing the patentability requirements of applications relating to pharmaceutical products and processes.
The Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective “do not intend to modify the standards of patentability established by patent law, or to add additional standards,” the document says.
According to the guidelines, several countries including 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.”
The guidelines were written by Carlos Correa, director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law, at the University of Buenos Aires, and special advisor in trade and intellectual property at the intergovernmental South Centre.
According to the foreword of the guidelines, the document proposes “recommendations that can be adopted to incorporate public health perspectives in procedures for granting pharmaceutical patents.”
Pharmaceuticals share common features with other inventions, say the guidelines, but there are elements of patent claims relating to pharmaceuticals that are unique, determined by their intended use.
According to the guidelines, “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.”
By Catherine Saez