Introduction

The opposition before the grant under Indian patent law has become a significant process which facilitates quality and legal validity of patents. Implemented after the passing of the 2005 Amendment Act, this provision permits any individual to institute proceedings to invalidate a patent granted without any actual interest in the commercial exploitation of the said patented invention by the person who obtained the patent strictly in accordance with the public interest. This inclusion was central in removing any issues pertaining public health especially the question of affordability of essential medicines as captured in cases such as Indian Network for People living with HIV/AIDS & Anr v. Union Of India & Ors.

Furthermore, pre-grant opposition provides a large measure of check to what is referred to as ‘evergreening’ – the act of seeking more years of protection of the patent of the existing drugs where in many occasions, no improvement has been made. Most importantly, it has managed to stall attempts in extending the patent term of essential medicines like imatinib mesylate (Glivec) and bedaquiline and promoting the use of cheaper generics.

Till now there seems to be some merits with the pre-grant opposition however the implementation of the same has not been without some trials. Concerning the critiques throughout numerous legislations and some critiques regarding the undefined concept of ‘locus standi’, it has caused complaints regarding frivolous oppositions that may be aimed at extending the time of grant of patents. Although statistics show that pre-grant oppositions account for only a small percentage of patent applications, this implies that there are other factors causing delays in the processing of patents other than opposition proceedings.

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Thus, firstly, as India is gradually improving its patent regulation, it is quite crucial to check the efficiency of pre-grant oppositions. Changes in the legal regulations suggested also define the structured fees to prevent creation of ungrounded challenges and improve the efficiency of the patent examination. These steps are quite important in order to avoid jeopardizing the course of innovation while protecting the public interest, especially within sectors that are closely related to health issues.

BENEFITS OF PRE-GRANT OPPOSITION

1. Undefined ‘Locus Standi’

As mentioned, subsequent to the 2005 Amendment Act, the 1970 Act now stipulates that a third party may reject the issue of a patent in the event of pre-grant objection. “Any person” may file the application without even expressing their interest or providing evidence of how the patent’s issuance might impact their rights. Pre-grant oppositions do have certain benefits, despite the fact that the oppositions are undoubtedly annoying to patent applicants. Such oppositions, for example, might serve as a filter to exclude proposals that are not meritorious and are not eligible for funding.

As per the Hon’ble Supreme Court - “[E]ven in the absence of commercial interests, “such objection can be raised on a wider concept of public health and nutrition and the issue of affordability of medicine at a reasonable rate to those persons who are affected by disease.”

A division bench of the Delhi High Court also weighed in on the matter of Indian Network for People living with HIV/AIDS vs. Union of India, noting that the pre-grant opposition right encompassed anyone with “a concern for public interest in the area of public health and nutrition, to raise an objection,” and that “[t]he grant of patent is virtually a grant of monopoly right against the whole world and that is why such wide ranging right of objection has been designedly given at a pre-grant stage.”

2. Preventing ‘Evergreening’

Pre-grant opposition has been successful in blocking the evergreening of various cancer, tuberculosis, and HIV/AIDS medications during the past 18 years, providing Indian generic producers with the chance to provide reasonably priced alternatives. Pre-grant objection is most famously used in the refusal of patent protection for imatinib mesylate (Glivec), a medication that can save the lives of patients with chronic myeloid leukaemia.

The cost of imatinib mesylate was lowered from ₹1,50,000 for a month’s therapy to ₹6,000 thanks to the patent being denied. Pre-grant objection was recently successful in preventing the extension of patent protection for bedaquiline, a vital treatment for tuberculosis that is resistant to drugs.

Pre-grant opposition has long been condemned for dragging out patent awards, even if it has its uses. The evidence, however, refutes this assertion.

In its annual report for 2021–2022, the Indian Patent Office said that just 481 pre-grant oppositions (0.69 percent) were lodged out of 69,613 published patent applications. Furthermore, only 4,870 (0.35 percent) of the 13,76,014 patent applications that were published between 2005–06 and 2021–22 were pre-grant oppositions. These figures demonstrate that pre-grant oppositions did not cause a delay in patent granted; rather, the severe lack of patent examiners - a point that the Economic Survey has made several references to - has been the main cause of the delay.

Additionally, there’s proof of a significant backlog in opposition representations being resolved prior to grants. According to a recent research, the Patent Office’s incapacity to process the applications on time was the main cause of the delay in the resolution of pre-grant opposition.

Rules governing pre-grant opposition have been recommended for change by the Indian Patent Office on many occasions. The Controller General of Patents can determine if there are maintainability grounds for objection based on the first set of data.

The Controller General has the authority to deny petitions for pre-grant opposition without considering the case’s merits, however it is unclear what these grounds may be. Nevertheless, the patent examination process would be accelerated even in situations where the Controller General determines that the objection was maintainable. This suggests that rather than thoroughly reviewing such dubious petitions, the IP Office was often expected to accelerate its assessments.

3. Ensuring Effectiveness

The second set of proposals include hefty or dynamic fees for pre-grant opposition filings; now, there is no price. For natural people, the minimum charge is ₹20,500; for businesses, it is ₹40,000. These fees are associated with the costs incurred by patent applicants to get their applications processed; the reasoning behind this is not entirely obvious.

Pre-grant oppositions from individuals and public interest groups, particularly patient groups, appear to be the aim of the fees’ introduction. This may essentially put a stop to the ability to challenge “frivolous” patents, which contravene the Patents Act’s Section 3(d), which forbids the patenting of combinations and other derivatives of known chemicals as well as their novel applications.

CONCLUSION

The patent prosecution process, including pre-grant opposition, plays a pivotal role in ensuring that only meritorious inventions receive protection. Examining the history of pre-grant opposition in India, it is evident that the system has evolved to balance the interests of patentees and the public. The undefined time limit for filing Pre-Grant Oppositions and the occurrence of serial pre-grant oppositions pose challenges. The recent amendments allowing any person to file oppositions have led to concerns about frivolous challenges, hindering the patent grant process.

Despite these challenges, undefined ‘locus standi’ in the pre-grant opposition proceedings has its merits. It acts as a filter, preventing the grant of frivolous patents and hindering evergreening. The opposition system ensures public participation, particularly in matters of public health, and prevents the grant of patents that could harm consumers.

Author : Kaustubh Kumar, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

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