Revised Draft Guidelines for Examination of Patent Applications in the Pharma Industry

This post was first published on 22nd August, 2014.

The Controller General of Patents, Designs and Trademarks (CGPDTM) published the revised draft guidelines for the examination of patent applications in the field of Pharmaceuticals on August 12, 2014. The main intention of said guidelines was to bring in a uniform practice for the examination of patent applications relating to the Pharmaceutical field.

Earlier in the month of February, the CGPDTM had published the draft guidelines with regard to this and had requested for comments and suggestions. The Indian Patent Office had also published the comments received which contained the views of various international organizations and domestic companies with regard to the draft guidelines on June 12, 2014. The revised draft guidelines published last Tuesday were based on these comments and suggestions received.

From the time India agreed to comply with the TRIPS agreement In 1995, there has been a tremendous increase in the number of patents being filed and granted relating to this field. With this increase in patent approvals there has been an equivalent increase in patent litigation and challenges in India. Even a first Compulsory License was issued and cases where section 3(d) was challenged arose in Pharma patenting. From then the Indian Patent system and its compliance with various international treaties had been put to question by various International organizations, Countries and Pharma majors dragging it to be one of the most sensitive issues.

The examination guidelines were developed with an eye to all these issue and to put forward a uniform, consistent way of examination with quality. These guidelines will be of help to examiners and controllers of patents to achieve uniform standards during examination and grant of patents. From the time India started granting product patents, there have been a number of cases where patentability was challenged on various grounds. For these cases there have been court decisions which point out or bring clarity to the issues relating to the patenting in the pharmaceutical field. These guidelines are drawn in light of these court decisions incorporating the court analysis to introduce a harmonious practice among examiners.

The guidelines have even defined the invention and inventive step and brought in more clarity to section 3(d) which does not allow patenting of incremental innovations and how each should be interpreted during examination. The present guidelines even have illustrations where needed to guide the examiners, but these are not to restrict the manner of examination. The examiners are requested to practice these on a case to case basis without prejudice. The guidelines are complementary to the Patent Office‘s practices and procedures and the provisions of the Act will be considered the last word in case of any conflict between the guidelines and the Patent Act and Rules.

Though there has been worldwide criticism that the Indian Patent system discriminates the pharmaceutical products, the Government is of the opinion that special concern and guidelines are required in this field due to the complexities involved with medicines and its availability.




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