A large number of civil society organisations (CSOs) in the country have urged the Union Ministry of Commerce and Industry to immediately drop the move to notify the Draft Patents (Amendment) Rules, 2023, which according to them has the potential to significantly hinder access to medicines and medical products.
In a letter to the Union Minister of Commerce and Industry Piyush Goyal, the CSOs requested to publish the list of product patents granted by the patent office on New Chemical Entities (NCEs) introduced in the market from January 1, 2005 to September 30, 2023 with the International non-propriety name (INN) of the NCE, patent numbers, name of the patentee, date of filing, date of grant and expiry date of the patent.
They also requested the Ministry to publish the list of pre-grant oppositions filed from January 1, 2005 to September 30, 2023 with the relevant details including the name of patent applicant, name of the pre-grant opposition applicant, patent number, date of filing of the opposition, date of hearing, date of disposal and reasons for delay in disposal.
"A comprehensive and detailed 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 said.
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, they added.
The proposed draft amendments introduce substantial alterations to the pre-grant opposition process. Granting an 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.
The CSOs said that they are afraid that 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 undoubtedly disincentivise the patients, patient groups and civil society organisations by rendering the entire process economically unviable. 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.
The draft amendments propose an extension of the interval for submitting the working of patent statements in Form 27 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.
This creates complete opaqueness on the functioning of the Patent System and allows the patent holder to abuse the patent monopoly without any public scrutiny. Most importantly, 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, they said.
This proposed amendment seriously compromises the ability of the government to effectively monitor the impact of patents on access to medicines. The amendments to Patents Rules in 2020 had already diluted this provision, which created critical gaps in available information. It is unfortunate that instead of addressing those lacuna, the proposed amendments seek to dilute this important provision further, they added.
Similarly, at present, Section 8 of the Patent Act mandates that a patent applicant must periodically disclose their foreign patent applications and related developments, ensuring transparency. It significantly helps the IPO in the delivery of its work.
For instance, information indicating the rejection of a pharmaceutical patent in a foreign jurisdiction aids the IPO in making informed decisions on granting or rejecting a patent in India. The proposed amendment replaces this periodic requirement with a one-time submission, potentially impeding timely updates and critical information sharing. This could lead to the grant of frivolous and unjustified patents due to the lack of information, they opined.
"Considering the aforementioned concerns, we request you to immediately drop the move to convert the 'Draft Patents (Amendment) Rules, 2023' into Patents Rules. They have the potential to. significantly hinder access to medicines and medical products. These amendments could alter the character of India's pharmaceutical sector, which is renowned for supplying affordable generic medicines worldwide. We would also request the Indian Patent Office to reform Form 27 to seek information on the quantum, unit price, total sales turnover and information on the working of the invention in India, including details on import and licensing," demanded the CSOs.
The letter was sent by CSOs including Academy for Applied Research & Training in Healthcare in India, Access to Rights and Knowledge Foundation, All India Drug Action Network (AIDAN), Delhi Network of Positive People, Drug Action Forum - Karnataka, Indian Drug Users' Forum (IDUF), Jan Swasthya Abhiyan (JSA), Manipur Network of Positive People (MNP+), Meghalaya state network of positive people living with HIV AIDS (MSNP+), Meghalaya users forum, North East Regional Network of People Living with HIV in NE INDIA (NERN+), Sankalp Rehabilitation Trust, Sikkim Drug Users’ Forum, Tripura State Network Of Positive People, Vihaan CSC, among others.
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