The Indian Patent Office (IPO) has proposed updating guidelines for examination of pharmaceutical patent applications to improve the quality, consistency and uniformity of scrutiny, taking into account the evolving interpretation of laws by courts.

It has issued draft guidelines for examination of pharmaceutical applications for patent.

Pharmaceutical patenting in India is extremely important and a sensitive issue because a bad patent can become a burden to society; good patents are essential for promoting innovation and technological development in the country.

In order to achieve these targets, the IPO is continuously upgrading its internal resources, revamping its internal work modules or its public interfaces.

"In an attempt to bring in quality, consistency and uniformity, the office has introduced the guidelines for examination in certain key areas like pharmaceuticals," it said.

Further, many of the issues related to product patenting in the field of pharmaceuticals are now becoming clear through the decisions of courts.

"Therefore, there is a need to update guidelines for examination of pharmaceutical patents, incorporating the analysis of the courts, with the objective that the guidelines shall help in improvement of the examination standard and shall introduce harmonious practice amongst the technical officers of the system," according to the draft guidelines, dated September 4.

Pharmaceutical patenting in India is of utmost concern not only to the people of India, but also for the world community, as India has emerged as the pharmacy of the world, it said.

The present guidelines are prepared with the objective that the guidelines would help the examiners and the controllers of the patent office in achieving consistently uniform standards of patent examination.

Examination of Patent Applications in the Field of Biotechnology:

The IPO, under the Ministry of Commerce and Industry, issued draft guidelines for the examination of applications in this field.

According to the draft guidelines dated September 4, there are some issues relating to the patenting of biotechnological inventions which are of serious concern to the users of the patent system, such as novelty, obviousness, industrial applicability, sufficiency of disclosure and clarity in claims.

In addition, it said, a few special issues have also evolved, such as those relating to moral and ethical concerns, environmental safety, issues relating to patenting of ESTs (Expressed Sequence Tags) of partial gene sequences, cloning of farm animals, stem cells, and gene diagnostics.

"Thus, the patenting of inventions in the field of biotechnology poses challenges to the applicants for patents as well as to the Patent Office.

"Therefore, there is an urgent need to put in place guidelines to establish uniform and consistent practices in the examination of patent applications in the field of biotechnology and allied subjects under the Patents Act, 1970 (as amended)," it said.

The guidelines are intended to help the examiners and controllers of the IPI to achieve uniformity and consistency, it said.

EXPERTS VIEWS:

Mohit Singh, Partner, One Law Partners, said these draft guidelines should resolve a long-standing gap between patent office practice and the law that has emerged over time through judicial pronouncements.

"The incorporation of judicial standards, such as the Delhi High Court's 'Seven Stambhas' framework for assessing novelty, will make the examination process more consistent and predictable," he said.

They also reflect the need for India's patent examination system to keep pace with developments in the global biopharma sector, he added.

"The key benefit of these new guidelines for industry would be greater predictability and certainty around R&D investments and the value of IP, particularly in the biopharma sector," Singh said.