Over 25 civil society organisations and patient groups, among others, have expressed their concern to the Union Commerce Minister Piyush Goyal, over the proposed ‘Draft Patents (Amendment) Rules, 2023’.

An analysis of the proposed amendments reveals “that many of these changes would pose a significant threat to the fundamental Right to Health guaranteed under the Indian Constitution. This threat extends to a substantial number of individuals, both within India and beyond its borders,” they wrote in a letter to the Minister. In August last year, the Department for Promotion of Industry and Internal Trade had proposed to introduce Amendments to the Patents Rules 2003.

“The proposed amendments in the Patents Rules gravely undermine the effectiveness of various public health safeguards embodied in the Indian Patent Act, such as pre-grant opposition, compulsory licenses, and transparency within the patent system,” the letter said, outlining specifics.

Calling for the proposed amendments to be dropped, the letter said, they have the potential to hinder access to medicines and alter the character of India’s pharmaceutical sector, which is renowned for supplying affordable generic medicines worldwide. The organisations writing the letter included, the All India Drug Action Network (AIDAN), Drug Action Forum – Karnataka, Jan Swasthya Abhiyan (JSA), TWN Trust India and Sankalp Rehabilitation Trust, among others.

Public health safeguard

Pre-grant opposition is a safeguard for public health, ensuring access to essential medicines and medical products by preventing ‘patent evergreening’ and unwarranted monopolies, it said. However, the proposed amendments introduce alterations to this process, it said. Granting arbitrary authority to the Controller to determine the “maintainability of the representation” exceeds the scope of Section 25 (1) of the Patent Act, which allows any person to file a pre-grant opposition as well as a right to be heard, it explained.

Further, it added, “giving unfettered powers to the Controller, such as deciding the maintainability of the pre-grant opposition application, is not only a violation of the Patent Act but also exposes the Indian Patent Office (IPO) to undue influence and throttle its independence.”

The introduction of a “dynamic and exorbitant fee” for filing pre-grant oppositions marks a stark departure from the current practice of not imposing any such fee. This will disincentivise patients, patient groups and civil society organisations by rendering the entire process economically unviable, it added.

Violation of Article 14

“Treating public interest groups and individuals on the same footing as pharmaceutical multinationals equates to treating unequal entities as equals, which constitutes a clear violation of Article 14 of the Constitution”, it said.

By granting the opportunity to ‘any person’ to submit a pre-grant opposition, the existing provisions facilitate broad public participation in furnishing vital information to the IPO, it said, lamenting that such changes are being proposed during a year when India has achieved progress in enhancing access to the crucial MDR-TB drug Bedaquiline - possible due to a successful pre-grant opposition filed by two individual patients.

The letter also pointed to the “working of Patent/Form 27” provision, where the amendment proposes an extension of the interval for submitting these statements from annually to once every three financial years.

The amendments also suggest removing the requirement of providing information on whether the patented product is manufactured in India or imported, as well as the prices of these products, the letter said. This would create an opaque system, without public scrutiny, the letter said. Most importantly, the letter said, the proposed amendments “adversely impact the use of compulsory licenses”. In the absence of such information, neither the government nor private parties can use the provision of compulsory licenses effectively, it added.

Other suggestions

Among other suggestions, the letter also called for putting in public domain, a list of product patents granted by the patent office on New Chemical Entities

(NCEs) introduced in the market from 1st January 2005 to 30th September 2023; list of pre-grant oppositions filed from 1st January 2005 to 30th September 2023, with details including the name of patent applicant, name of the pre-grant opposition applicant, date and reason of disposal etc.