Leading pharmaceutical organisations from India and abroad have sought  amendment to Section 146 of the Patents Act, 1970 to ensure that patent working disclosures under that section complement other provisions of India’s patent laws and foster ongoing efforts to increase the ease of doing business in India.

It will increase patent office efficiency, and do not burden Indian patent owners.

The rationale underpinning Section 146 of the Patents Act, 1970 is outdated, vague, and creates significant uncertainty for patent owners in India. The majority of disclosures required under Section 146 are either unnecessary to determining if a patented invention has been “worked” in India or are so vague they are nearly meaningless, said a joint presentation by Organisation of Pharmaceutical Producers of India (OPPI), Pharmaceutical Research and Manufacturers of America (PhRMA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers Association (JPMA), and INTERPAT representing the world’s leading research-based biopharmaceutical companies, to Indian patent office.

Section 146 appears to require the Patent Office to publish the information regarding licences in Form 27. However, required disclosures seem to conflict with other provisions of the Patents Act. For example, Section 69(4) of the Patents Act requires the India Patent Office to keep confidential registered patent license agreements when accompanied by a confidentially request, said the Associations.

Scope of Form 27 has not been updated or amended in nearly 45 years, and therefore does not reflect the realities of today’s globalized nature of innovation and patenting activity. In addition, filing Form 27 is burdensome because many of the requested disclosures are vague and unclear, said Kanchana TK, Director General, OPPI.

The Associations are concerned that third parties can abuse Form 27 disclosures to misappropriate legitimate intellectual property rights. Published Form 27 details, for each patent in India can be accessed by anyone through Indian patent office website, with no precautionary means for ensuring confidentiality of the submitted information. Besides, current information may be misused by third parties by initiating actions that are frivolous or intended for pecuniary gain under various public interest provisions of the Patents Act.  

The Associations request, at a minimum, that the India patent office amend Form 27, and relevant regulations, to limit patentee statements to whether or not a patent was worked in India. At a minimum, the Associations urged the India patent office to exempt confidential or proprietary information from its annual working statement disclosures. That means striking sections of Form 27 that relate to the “quantum and value” of the patented product and “licensees and sub-licensees.”

In addition, the India patent office should continue to exempt certain situations of non-working; i.e. regulatory delays or market conditions that would otherwise prohibit patentees from making, using, offering for sale, selling or importing the product in India. It would be appropriate to reduce the reporting frequency of Form 27 to every three years.

The Associations submitted a detailed presentation to Indian patent office in response to the circular issued by the Office of the Controller General of Patents, Designs & Trademarks, inviting comments on the provisions of working of patents under Section 146 of the Patents Act, 1970 (as amended) read with Rule 131 of Patent Rules 2003.