The Significance And Evolution Of Pre-Grant Opposition In India's Patent Landscape: A Closer Look

Recent changes underscore a concerted and ongoing effort to create a more streamlined, efficient, and balanced pre-grant opposition process in India, aimed at addressing legitimate concerns about potential delays and the filing of frivolous oppositions, while simultaneously preserving the system's fundamental and crucial role in safeguarding patent quality, promoting public health, and protecting overarching public interests, particularly in the critical domain of access to affordable healthcare and essential medicines

The introduction of pre-grant opposition into India’s patent law, particularly following the pivotal 2005 Amendment Act, has established a critical mechanism for ensuring the quality and legal soundness of patents granted within the nation’s borders. This distinctive provision empowers any individual, acting with the broader public good in mind rather than for direct personal or commercial advantage, to formally challenge a patent application before it receives official approval. This inclusive approach has proven particularly vital in addressing significant public health concerns, most notably in safeguarding the affordability of essential medicines, a principle fiercely defended in landmark legal cases such as Indian Network for People living with HIV/AIDS & Anr v. Union Of India & Ors¹.

Beyond its crucial role in the realm of public health, pre-grant opposition serves as a significant safeguard against the contentious practice of ‘evergreening’. This term describes the strategic attempts by patent holders to extend the period of patent protection on existing drugs, often through making minor, superficial modifications that lack genuine inventive merit. In this context, pre-grant opposition has played a decisive role in preventing the unwarranted prolongation of patent terms for life-saving medications like imatinib mesylate (Glivec) and bedaquiline, thereby facilitating the entry of more affordable generic alternatives into the market and increasing access to treatment.

While the benefits of pre-grant opposition are undeniable and widely acknowledged, its practical implementation has faced certain criticisms and challenges. A primary concern revolves around the broadly defined concept of ‘locus standi’, which permits “any person” to file an opposition. This has raised apprehensions about the potential for the filing of frivolous oppositions, strategically deployed with the intent of delaying the patent granting process and hindering legitimate innovation. Addressing the same issue, the IPAB expressed its view that “we are of the view that the practice of filing of Benami opposition by the Benami opponent and crooked imposter has to be stopped. It is the duty of the respondent (Controller General) that such person(s) may not be allowed to take the advantage of multiple layers of opposition. If any opposition is filed either under Section 25(1) or 25(2), which is bogus and without any merit, the same is to be thrown out at the earliest by the respondent with heavy costs and penalty. Only the genuine oppositions are to be entertained.²“

However, empirical data meticulously gathered from the Indian Patent Office reveals that pre-grant oppositions constitute a relatively small fraction of the total number of patent applications filed each year. This suggests that other factors, such as the persistent shortage of qualified patent examiners within the system, are more significant contributors to the delays often experienced in patent processing timelines.

In recognition of the pressing need to optimize the efficiency of the pre-grant opposition system and address the valid concerns raised, India has been progressively refining its patent regulations concerning these challenges. Proposed amendments to the existing legal framework include the introduction of structured fees for filing oppositions. This measure is specifically designed to deter the submission of unsubstantiated challenges and, consequently, to streamline the overall patent examination process. These proposed changes underscore the ongoing and committed effort to strike a delicate and crucial equilibrium between fostering genuine innovation, which is vital for economic growth and societal progress, and safeguarding paramount public interests, particularly within sectors intrinsically linked to public health and well-being.

Exploring the Multifaceted Advantages of Pre-Grant Opposition

1. Navigating the Complexities of Undefined ‘Locus Standi’:

Subsequent to the enactment of the landmark 2005 Amendment Act, the Indian Patents Act of 1970 underwent significant revisions to explicitly permit any third party to formally oppose the granting of a patent. This expansive provision allows individuals or entities to lodge objections without the prerequisite of demonstrating a direct personal or commercial stake in the patented invention, or articulating precisely how the patent’s issuance might adversely affect their specific rights or interests. While this broad scope has attracted a degree of criticism from some quarters, it also presents distinct and valuable advantages that contribute to the integrity of the patent system. Pre-grant oppositions can function as a crucial filtering mechanism, effectively sifting out patent applications that lack genuine inventive merit or do not meet the stringent criteria for patentability, thereby ensuring that only deserving inventions are granted the exclusivity conferred by a patent.

The Supreme Court of India has unequivocally affirmed that objections, even in the absence of direct commercial interests on the part of the objector, can be legitimately raised based on broader public health and nutrition concerns, particularly as they relate to ensuring the affordability and accessibility of essential medicines for the population. Echoing this judicial sentiment, the Delhi High Court, in the landmark Indian Network for People living with HIV/AIDS case, underscored that the pre-grant opposition right extends to any individual or entity with a genuine and demonstrable concern for public health, given the inherently monopolistic nature of patent grants and their potential impact on public welfare.

2. A Robust and Essential Defence Against ‘Evergreening’ Practices:

Over the past eighteen years, pre-grant opposition has emerged as a potent and invaluable tool in preventing the evergreening of patents for a range of critical medications used in the treatment of debilitating and life-threatening diseases such as cancer, tuberculosis, and HIV/AIDS. This mechanism has been instrumental in facilitating the timely entry of Indian generic manufacturers into the pharmaceutical market, enabling them to supply more affordable treatment options to a larger segment of the population. A prominent and well-documented example of this success is the rejection of patent protection for imatinib mesylate (Glivec), a life-saving drug for patients diagnosed with chronic myeloid leukemia. This crucial decision resulted in a dramatic reduction in the cost of treatment, plummeting from approximately `1,50,000 to a more accessible `6,000 per month, significantly improving affordability for patients in need. More recently, pre-grant opposition played a crucial role in preventing the extension of patent protection for bedaquiline, a vital drug in the fight against multi-drug resistant tuberculosis, ensuring continued access to this essential medication at a reasonable cost.

Despite concerns voiced by some stakeholders that pre-grant opposition inherently leads to undue delays in the patent granting process, empirical evidence largely refutes this assertion. The Indian Patent Office’s annual report for the fiscal year 2021-20223 indicated that pre-grant oppositions were filed against a mere fraction of the total number of patent applications published during that period. Furthermore, independent research suggests that the Indian Patent Office’s internal capacity constraints in processing the burgeoning volume of applications in a timely manner are a more significant factor contributing to the delays often experienced in resolving pre-grant oppositions.

The Indian Patent Office has proposed several amendments to the existing rules governing pre-grant opposition, with the overarching aim of enhancing the efficiency and effectiveness of the process. A key suggestion involves empowering the Controller General of Patents to conduct an initial assessment of the maintainability of an objection based on preliminary data submitted by the opponent. This would enable the swift rejection of petitions deemed frivolous or lacking in substantive merit without necessitating a full and resource-intensive examination. Even in instances where an objection is deemed maintainable after this initial assessment, this approach is intended to expedite the overall patent examination process by allowing the Patent Office to strategically focus its limited resources on addressing substantive challenges that have a higher likelihood of impacting the patentability of the invention.

3. Enhancing the Overall Effectiveness and Integrity of the Patent System:

Another significant proposed change involves the introduction of substantial or dynamic fees for filing pre-grant oppositions, a notable departure from the current system which does not impose any such fees on those seeking to challenge a patent application. The suggested minimum fee is `20,500 for individual filers and `40,000 for businesses and other entities. While the precise rationale for linking these fees to the costs incurred by patent applicants remains somewhat opaque and subject to debate, it appears that this measure is primarily targeted at pre-grant oppositions initiated by individuals and public interest groups, particularly patient advocacy organizations that have historically played a crucial role in challenging patents on essential medicines. This proposed fee structure has raised concerns that it could potentially impede the ability of these groups, often operating with limited financial resources, to challenge patents that are perceived as “frivolous” or that may contravene Section 3(d) of the Patents Act, which prohibits the patenting of mere combinations and derivatives of known substances without enhanced efficacy.

The patent prosecution process, with pre-grant opposition serving as an indispensable and integral component, plays a critical role in safeguarding the integrity of the patent system by ensuring that only genuinely innovative inventions that meet the stringent criteria for patentability receive the exclusive rights conferred by a patent. The evolution of pre-grant opposition in India reflects a continuous and ongoing endeavor to strike a judicious and necessary balance between protecting the legitimate commercial interests of patent holders, which are essential for incentivizing innovation, and upholding the broader public good, particularly in areas with significant social impact. While challenges such as the absence of a defined statutory time limit for filing oppositions and the potential for the strategic use of serial oppositions to delay the granting process persist, the system’s proven ability to act as a crucial filter against unmeritorious patents and effectively prevent the evergreening of essential medicines cannot be overstated. The broadly defined ‘locus standi’ provision, despite facing criticism from some quarters, has facilitated crucial public participation, particularly in matters of public health, and has acted as a vital safeguard against the granting of patents that could negatively impact consumers and limit access to essential goods.

Recent amendments to the Patents Rules in 2024 introduced significant changes to the pre-grant opposition process in India, signalling a continued commitment to further refine and optimize the system. These amendments include a mandatory requirement for the Controller to conduct an initial evaluation of the prima facie maintainability of an opposition, the introduction of filing fees, and a reduction in the time allotted for patent applicants to respond to oppositions. Specifically:

* Prima Facie Maintainability Assessment: The Controller is now obligated to conduct an initial evaluation of the substantive merit of a pre-grant opposition based on the evidence and arguments presented by the opponent. If, upon this initial assessment, no prima facie case is established, the opponent is notified, and the opposition is rejected outright unless a hearing is specifically requested by the opponent. Conversely, if a prima facie case is found to exist, the patent applicant is informed of the opposition, and the application proceeds under an expedited examination procedure, reflecting the potential impact of the challenge.

* Introduction of Filing Fees: A fee is now mandated for filing a pre-grant opposition under Section 25(1) of the Patents Act. The prescribed fee is INR 4,000 for individual filers, small entities, startups, and educational institutions, recognizing the potential financial constraints of these groups, and INR 20,000 for all other entities, reflecting a higher capacity to bear such costs.

* Reduced Time for Applicant Response: The timeframe within which patent applicants are required to file a response to a pre-grant opposition has been shortened from three months to a more expedited two months, aiming to accelerate the resolution of opposition proceedings.

* Streamlined Examination and Hearing Procedures: If a pre-grant opposition is deemed maintainable after the initial assessment, the corresponding patent application is subject to an expedited examination process, prioritizing the resolution of applications facing credible challenges. Furthermore, if the opponent requests a hearing to present their case in person, the Controller is mandated to issue a decision, either accepting or rejecting the opposition, within one month from the date of the hearing, ensuring a timely resolution following oral arguments.

These recent changes underscore a concerted and ongoing effort to create a more streamlined, efficient, and balanced pre-grant opposition process in India, aimed at addressing legitimate concerns about potential delays and the filing of frivolous oppositions, while simultaneously preserving the system’s fundamental and crucial role in safeguarding patent quality, promoting public health, and protecting overarching public interests, particularly in the critical domain of access to affordable healthcare and essential medicines.

Disclaimer – The views expressed in this article are the personal views of the authors and are purely informative in nature.