India’s Patent Amendments

The recent amendments to the rules governing India’s Patent Act has gained widespread criticism.

The Ministry of Commerce and Industry notified the Patents (Amendment) Rules, 2024 .
The amended rules aim to introduce substantial changes to align with international standards, promote innovations among innovators, and protect their rights.
The amendments target key areas of concern in the Indian Patent practice and procedures and are poised to stimulate an increase in patent filing and processing within the nation.

A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.
To get a patent, technical information about the invention must be disclosed to the public in a patent application.

Indian patents are governed by the Indian Patent Act of 1970. Under the act, patents are granted if the invention fulfills the following criteria:
It should be novel
It should have inventive step/s or it must be non-obvious
It should be capable of Industrial application
It should not attract the provisions of sections 3 and 4 of the Patents Act 1970.
Alignment with international regimes: It became a party to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organisation on January 1, 1995.
It amended its internal patent laws to comply with TRIPS, most notably in 2005, when it introduced pharmaceutical product patents into the legislation.
The original Indian Patents Act did not grant patent protection to pharmaceutical products to ensure that medicines were available to the masses at a low price.
India is also a signatory to several IPR related conventions including: • The Berne Convention which governs copyright,
The Budapest Treaty,
The Paris Convention for the Protection of Industrial Property
The Patent Cooperation Treaty (PCT) all of which govern various patent-related matters.

Unique provision for New ‘Certificate of Inventorship’ has been introduced to acknowledge the contribution of inventors in the patented invention.
Grace period: Provision for claiming benefits of Grace period under section 31 has been streamlined by incorporating new forms, i.e., Form 31.
First examination report: Time limit to furnish foreign application filing details in Form 8 has been changed from six months from the date of filing of application to three months from the date of issuance of first examination report.
Statements of working: Frequency to file the statements of working of patents in Form 27 has been reduced from once in a financial year to once in every three financial years.
The provision to condone delay in filing of such statements for a period up to three months upon a request in prescribed manner has been incorporated.
Renewal fee has been reduced by 10% if paid in advance through electronic mode for a period of at least 4 years.

Though the changes bring India’s patent law “almost in line” with those of the US, it underscores the serious consequences for patient and voluntary groups that campaign on public health concerns.
To accommodate the demands of the industrialized countries and to sign free trade agreements, the government has withdrawn those provisions that foreign manufacturers, especially pharma companies, have found troublesome.
There was no discussion in Parliament and no information on the people consulted, nor any data provided to justify the amendments, despite the significant nature of the changes.
Patient health groups who want to access the patent system in an effort to improve access to life-saving medications, now require to pay substantial fees to file pre-grant oppositions. There were no fees earlier.
Discretionary powers with the patent controller to determine who may file pre-grant oppositions runs counter to previous judicial decisions, which unambiguously permitted both organizations and individuals to submit pre-grant oppositions.
The Indian Patent Office faces a glut of patent applications, straining its capacity to handle the workload effectively.

India is regarded as the pharmacy of the world and has now become the most populous country. Hence it is even more imperative for the government to ensure high-quality medications remain within reach and economically viable for the vast segments of the population.
The amendments are anticipated to negatively impact the availability and accessibility of medicines. They would also encourage monopolies and profiteering by big pharma.
So the government must reconsider the proposed amendments to safeguard the accessibility of affordable medicines and remove those suggested provisions which benefit the big global pharma industry.