Introduction
On March 15, 2024, the Department for Promotion of Industry and Internal Trade (under the Ministry of Commerce and Industry), after due consideration of stakeholder comments, notified the Patents (Amendment) Rules, 2024 (‘2024 Rules’), with significant amendments to the Patents Rules, 2003 (‘2003 Rules’). The new Rules are an impressive attempt at simplifying procedures and expediting disposal.
We have previously discussed what a patent is and the patent registration procedure. Further, key terms connected with patent law (and the 2024 Rules specifically) have been discussed here. The following is a summary of the patent grant procedure.
Significant changes under the 2024 Rules
Opposition: The Controller must determine prima facie maintainability of a pre-grant opposition. The Controller will refuse the pre-grant opposition if no such case is established. For post-grant oppositions, the opposition board must review the concerned application within two months instead of three.
Form 31 for grace period: The 2024 Rules have introduced Form 31 for applicants to claim the twelve-month grace period if a pending patent has been anticipated by public display under Section 31 of the Patents Act, 1970. However, the 2024 Rules call for documentary evidence through an affidavit to establish that the prior art falls within the grace period.
Request for Examination (RFE): A reduction in the duration provided to file an RFE from 48 months to 31 months from the priority date. This reduction, however, would only apply to applications filed on or after the 2024 Rules’ notification date.
Divisional application: Applicants can file a divisional application (under Section 16 of the Patents Act, 1970) relating to an invention disclosed in a provisional specification, a complete specification, or a prior divisional specification if desired.
This amendment follows from the October 2023 Delhi High Court decision in Syngenta Limited v. Controller of Patents and Designs [C.A. (COMM.IPD-PAT) 471/2022], where it was held that divisional applications could be filed in respect of parent applications whose complete or provisional specification and not just the claims contained multiple inventions.
Extension and condonation of delay: The Controller, under Rule 138 of the 2024 Rules, can grant extensions for any duration specified under the said Rules or forgive delays up to six months. Applicants must make a Form 4 request in this regard.
Inventorship certificate: After a patent has been granted, its inventor may apply to receive a certificate of inventorship of the said patent in India. The 2024 Rules also introduce Rule 70A and Form 8A. Under the former, an inventor can apply for an inventorship certificate by filling out and submitting Form 8A with a fee of 900 rupees – an empowering win for inventors as they were previously not identified in patent certificates.
First Examination Report (FER): Relaxation of the requirement to seek an extension to file a response to the FER before the FER response deadline. Under the 2003 Rules, an extension request was to be filed within six months from when the FER was issued. Under the 2024 Rules, one may file an extension request anytime between six to nine months (an additional three months in case of a deadline extension) from the date of issuance of the FER.
Renewal fee: The 2024 Rules allow a 10% reduction in patent renewal fee if such renewal fee has been paid in advance for four years through electronic mode.
Statement of working: Under the 2003 Rules, a patentee was to file a working statement for every financial year for the patents granted, beginning from the financial year immediately after the year of the patent's grant. Further, the working statement under Form 27 must be filled out only once every three years. Form 27 has, too, undergone certain changes. The patentee does not need to provide the value/revenue that she acquired through manufacture or import in India. The patentee must also disclose if the patent is available for licensing.
Statement and undertaking: Applicants need to file Form 3 only twice (once during filing or six months from such date, and second, within three months of the FER's issuance). Thus, the requirement under Section 8(1) of the Patents Act, 1970, to submit periodical information on foreign applications in respect of the same/similar invention covered by the patent has been relaxed.
The above includes major amendments. The introduction of new forms and fees and changes to existing fees are among the other changes.
Some observations
Under the 2023 Rules, applicants were required to provide information on corresponding foreign applications within six months of filing. This posed a problem when applicants filed for protection in numerous jurisdictions.
The disclosure of a plurality of inventions within the application but not in the original claims was not recognised as a valid basis for filing a divisional application. Further, the disclosure of multiple inventions within a single application, but not in the original claim, was not a sufficient basis for filing a divisional application. Now, the divisional application process somewhat resembles the "continuation patent application" practice in the United States (U.S.) – filed by an applicant who seeks to pursue additional claims to an invention disclosed in an earlier application of the applicant (the "parent" application) that has not yet been granted or abandoned.
Prasanna Mohanty draws attention to the 2024 Rules’ impact on the pharma industry in an article on Fortune India, “Amid the hype over "$100 billion investment" and "1 million direct jobs" that the newly inked EFTA-India Trade and Economic Partnership Agreement (TEPA), signed on March 10, 2024, was to bring, few noticed India has significantly diluted statutory protection against evergreening of patents and unreasonably high cost of medicines.
This dilution is part of the Intellectual Property segment of the treaty. It then found its way to the new Patents (Amendment) Rules of 2024, notified on March 15, 2024, amidst the buzz over the 2024 general elections, making it applicable for all patents - adversely impacting the healthcare of millions of Indians.”
The rationale of a patent system is to incentivise innovation while ensuring adequate public access. Mohanty points out that the following measures introduced under the 2024 Rules embody the TEPA and may further incentivise evergreening practices, which could reduce access to medicines.
The imposition of a 4000 Rupee fee for a “natural person/startup/small entity/educational institution” to oppose a patent and 20,000 Rupees for “others”. This change, intended to "curb benami and fraudulent pre-grant oppositions", may reduce the incentive to question the validity of a patent, which could increase grant numbers but affect public health.
A requirement to provide information on the "working of a patent" only once every three financial years instead of providing timely updates conveniences the patentee.
Form 27 previously required patentees/licensors to disclose whether a patented medication was manufactured in India or imported, the country of import and the quantum and value of the medication sold in India. Mohanty points out that the TEPA provides that a patent cannot be deemed to have “not worked” just because it was imported.
Section 84(1)(b) of the Patents Act, 1970, justifies compulsory licensing if the invention has not been worked in the territory of India. Non-disclosure about the working of an invention was penalised under Section 122 of the Act, but with the requirement now removed, this information will not be available to potential licensees.
Conclusion
The Indian Patent Office is on international competing grounds, given the effort to be on par with the United States and China. These measures may be an effort to make India a leader in grant numbers, but access to knowledge and medicine is just as important, if not more important, in the long run. It may not be the best strategy for India to partake in this race. Stephen Schreiner writes, “Since 2021, the [US patent] invalidation rate has been increasing and is currently at 71% for the first two quarters of 2024. In 2023, all challenged claims were found invalid 68% of the time.” Another article states, "…CNIPA’s overall invalidation rate has been hovering somewhere around 48% in recent years.”
Procedurally, the 2024 Rules streamline the grant of patents by minimising hurdles while imposing heavier penalties for default. The measures may be well-intended, but whether they will impact public access is entrusted to patent examiners, who are doing an excellent job thus far. While the changes brought under the 2024 Rules do not significantly impede oppositions, they seem to have subtly made the opposition procedure more rigorous, which means that applicants (especially international applicants) will find that the application procedure is less taxing.
Coupled with the amendments to the Patents Act, 1970 through the Jan Vishwas (Amendment of Provisions) Act, 2023, which have further diluted patent “working” requirements (a ten-fold reduction in the penalty for non-filing or intentional incomplete filing of Form 27 – a criminal offence), the grant of compulsory licenses is likely to be further affected [See Section 84(2), Patents Act, 1970]. Perceiving this reduction as a lack of seriousness in the requirement to disclose the “working” of an invention in India, foreign pharmaceutical manufacturers who do not manufacture or import to India may be less inclined to disclose this information. As a result, the public may struggle to obtain information on the extent of a patent holder’s commercial exercise of patent rights in India - once again reflecting the . This can directly negate the possibility of fulfilment of one of three conditions under Section 84 of the Patents Act, 1970.
Nevertheless, the Jan Vishwas Act has also empowered the Controller with adjudicatory powers yet to be exercised. Now that the discretion to impose further penalty for contravening the Act lies with him, it is best to wait and watch how the balance shifts.
Sources
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