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Ramesh Shankar
Wednesday, March 6, 2024, 08:00 Hrs  [IST]

A large number of civil society organizations, patients’ groups and public health experts in the country have recently urged the Union Commerce Ministry to immediately drop the move to notify the Draft Patents (Amendment) Rules, 2023 on the plea that the amended rules have the potential to significantly hinder access to medicines and medical products. They argue that a comprehensive and detailed analysis of the proposed amendments reveals that many of the changes made in the amended rules 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. There is apprehension among these groups that the proposed amendments in the Patents Rules would 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. It is a fact that the draft amendments have introduced substantial alterations to the pre-grant opposition process. It grants an arbitrary authority to the Patent Controller to determine the ‘maintainability of the representation’. It clearly 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. There is fear among the public health experts and civil society organizations that giving unfettered powers to the Patent Controller, such as deciding the maintainability of the pre-grant opposition application, will not only violate the Patent Act but will also expose the Indian Patent Office to undue influence and throttle its independence. It is apparent that by amending the Patent Rules, the government wanted to streamline the operations of the Indian patent office. But some of the provisions in the new draft Rules have now become controversial.

In August last year, the Union Commerce Ministry had come out with the Draft Patents (Amendment) Rules, 2023. The Commerce Ministry’s objectives were commendable and would go a long way in streamlining the operations of the patent office and expedite patent processing timelines in the country. But, the Ministry should remove the lacunae in the new Rules before notifying it. 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. Experts argue that in the absence of such information, neither the government nor private parties can use the provision of compulsory licenses effectively. As some of the concerns raised by the civil society organizations and public health experts are genuine, the government should carefully consider these concerns and revise the proposed draft amendment rules to ensure that the safeguards enshrined in India’s patent system are protected to ensure public health and access to affordable medicines.

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