This article is written by Aakanksha Pandey, I.P.E.M Law Academy, CCS University, LL.B. 3rd year during her internship at LeDroit India
Scope of the Article
• Discusses the pre-grant opposition provisions of the Patents Act of 1970.
• Examines the legal requirements found in Section 25(1) of the Act concerning the grounds of opposition prior to the grant of a patent.
• Covers the various grounds upon which an application for patent may be opposed (not new, lack of inventive step, non-patentable subject matter and incorrectly obtained).
• Examines how a formal objection is made via a representation along with the authority of the controller to make an initial decision.
• Looks at the role that third parties (competitors, NGOs and groups interested in the public good) have in instigating oppositions.
• Protests against weak or frivolous patents using pre-grant opposition as a method of eradicating those types of patents.
• Summarises emerging trends impacting opposing patents e.g., concern over evergreening in relation to pharmaceuticals and technology.
• Illustrates the use of strategic planning in opposing patents using opposition proceedings as part of the different methods that can be used to oppose or defend a patent.
• Will only consider the Indian law and not engage in a thorough analysis of other jurisdictions.
• Will not cover the post-grant opposition to patents or patent litigation to any significant extent, except where there is a need for clarity on the points of distinction between these aspects of patent law and pre-grant opposition.
Abstract
The pre-grant opposition procedure is an effective way of protecting the patent system in India by allowing anyone to challenge the validity of a patent application before it has been granted. The Patents Act 1970 (Section 25 (1)) regulates this process so that inventions are granted patent protection only if they meet the legal criteria for patentability: novelty, inventiveness and patentable subject matter. It therefore also acts as an effective means of maintaining the patent system’s quality and integrity by stopping the issue of weak patents or patents which do not meet these criteria.
This article will review the legal framework around pre-grant opposition including the procedural and substantive aspects. It will also look at current trends around pre-grant opposition particularly in industries such as pharmaceuticals and technology where evergreening and strategic patenting are prevalent. Finally, it will also assess issues surrounding pre-grant opposition such as delays and potential abuse of the system, and provide a framework for reforming pre-grant opposition in order to create a balance between the promotion of innovation and the protection of the public’s interest.
Keywords: Pre-Grant Opposition, Patentability, Section 25(1), Evergreening, Patent Law
Introduction
To incentivise inventors to innovate through the patent system, providing them with the exclusivity of their inventions for a limited period is essential. However, this exclusivity must be weighed against public interest to ensure that no monopolies are established in high-value inventions/technologies due to the fact that they do not comply with legally required criteria. One of the main legal provisions to that end in India is pre-grant opposition under Indian Patent legislation.
The Patents Act 1970 of India provides for third parties to challenge a patent application prior to it being granted (pre-grant opposition). Through pre-grant opposition, transparency, accountability and quality assurance of the patent system will be increased by providing competitors, researchers, and public interest groups with the opportunity to present relevant evidence and arguments as to why a patent application should not be granted. The value of pre-grant opposition is further enhanced as India continues to develop as an international hub for technologically advanced and/or pharmaceutical research. The purpose of this article is to consider; the procedural framework of pre-grant opposition; the grounds for pre-grant opposition; and any developing trends surrounding pre-grant opposition in India.
Legal Framework Governing Pre-Grant Opposition
The basis for pre-grant opposition comes from the Patents Act, which was passed in 1970, Section 25(1), that allows “any person” to make opposition to the grant of a patent after the publication of a patent application but before it has been granted.
The broad wording of “any person” indicates the inclusive nature of the mechanism that may allow any person to submit an opposition to the patent’s grant, including competitors and other civil society organisations and individuals. In this way, the Indian system stands out amongst many other jurisdictions, which restrict opposition rights.
An applicant must submit their opposition to the patent Controller as a representation along with evidence to support their grounds for the opposition. The patent Controller must then review the representation along with the patent application and the applicant’s response to the representation.
The legislation has changed over time, particularly since the 2005 amendments brought Indian patent law into conformity with India’s international obligations under the TRIPS agreement. Nevertheless, India continues to have a strong pre-grant opposition mechanism as a means of safeguarding against the issuance of patents that should not issue.
Grounds for Pre-Grant Opposition
25(1) presents many options available for a pre-grant opposition and is intended to prevent patenting for what is not a valid invention and creating valid patents.
Lack of novelty
Patentable inventions require novelty in order to be granted patent protection. If prior art exists that shows that the invention is like an existing document, (prior art), it can be opposed on the ground of lack of novelty. Prior art (accepting the example of 3) could be a published document, an existing product or an earlier patent.
Lack of an inventive step
An invention must also show an inventive step apart from being new. This means that an invention must not be obvious to someone skilled in the art. If a purported patent is clearly an obvious difference from what is already known, then it won’t satisfy the test for patentability.
Non-patentable subject matter
Section 3 of the Patents Act of 1970 states that there are categories where a patent is not capable of being granted. Section 3 lists discoveries, scientific theories, business methods, or certain pharmaceutical derivatives as non-patentable subject matter. A pre-grant opposition can also be made against such an application for those reasons stated.
Obtaining a Patent Wrongfully
If it is established that the inventor of an invention obtained their idea or innovation from another inventors, this could be a ground for an opposition to that patent application. This serves to protect the rights of the true inventor of that invention.
Failure to Fully Disclose
The patent specification must provide a complete and clear description of the invention being patented. If the patent specification does not clearly or completely disclose the invention, this could also be grounds for an opposition.
Other Grounds
There are additional grounds for opposing the granting of a patent such as not providing required information to the patent office and; not meeting statutory requirements. These restrictions are in place to preserve both the administrative and substantive integrity of the patent system.
Procedure for Filing Pre-Grant Opposition
Pre-grant opposition procedures support even-handedness and speed of the examination of a patent application.
Representations
Anyone has a right to oppose by way of filing a representation opposing the granting of a patent after the application has been published. The representation must be supported by evidence and must clearly articulate the reasons for the opposition.
Controller’s Examination
The Controller of Patents will examine the representation marshal all material with respect to the patent application at the same time and provide the applicant an opportunity to respond. By this process, fairness and natural justice will be served.
Hearing & Decision
In some cases, a hearing will be held so that both parties can express their positions. After the consideration of all submissions, the Controller may:
• Grant the patent,
• Refuse to grant the patent,
• Require amendments to be made to the application.
Timeframe
The opposition must be filed between the time the application is published and the time the patent is granted. It is important to file within this time frame; otherwise, the right to oppose is lost.
The Role of Courts and Other Appellate Mechanisms
Previously, the Intellectual Property Appellate Board (IPAB) had jurisdiction over all patent-related appeals; however, it was recently dissolved by the Indian government. As a result, all appellate authority for patent-related matters will now reside exclusively with the High Courts of India. Therefore, in addition to the ability to appeal decisions made by the Patent Controller, individuals also have recourse to the High Court of jurisdiction in order to obtain judicial review of those decisions, which will help ensure consistency and uniformity of patent law enforcement across the country.
The judicial system has an essential role in determining how courts interpret the statute and ensuring that a balance is struck between the need for innovation and the public interest.
Changing Trends in Pre-Grant Opposition
Expanded Use in the Pharmaceutical Industry
In the pharmaceutical sector, pre-grant opposition has been used extensively to challenge attempts at evergreening, that is, obtaining multiple patents for minor changes to existing products in order to extend the term of exclusivity for that product.
A leading case example of the judiciary being proactive in relation to evergreening strategies is Novartis AG v Union of India. The decision in Novartis demonstrates the judiciary’s proactive approach in restricting evergreening practices, allowing only those inventions that meet the standard of being a true invention to be patented.
Technological Developments
With the introduction of electronic databases and advanced searching methods, the ability of individuals to obtain prior art has been greatly enhanced, thus resulting in greater quality and efficiency in the pre-grant opposition process.
Diverse Stakeholders Participation
There has been a growing engagement from new businesses or startups, SMEs and civil society organisations because of improved comprehension about IPR and strategic implications associated with opposition mechanisms.
Strategic use and concern of misuse
The pre-grant opposition has a critical role, but also there are concerns raised regarding the competitive strategic misuse of pre-grant opposition by competitors to delay issuance of patents which hampers innovation and generates uncertainty for applicants.
Challenges to the Pre-Grant Opposition Mechanism
As with all systems that have advantages, there are numerous challenges associated with the pre-grant opposition process.
Delay of Patent Issuance
The opposition process can potentially delay the issuance of patents which could affect the commercial interests of the applicant.
Possibility of Frivolous Opposition
The broad based criteria references any individual is eligible to file an opposition, creating opportunity for frivolous or vexatious opposition.
Burden on Administrative Function
Increasing requests for opposition place a significant administrative burden on the Patent Office and may affect their overall efficiency.
Recommendations and Future Directions
To enhance the effectiveness of the pre-grant opposition process, consideration should be given to:
Streamlining the process’ timelines to eliminate delays
Development of safeguards against frivolous opposition
Increased administrative capacity in the Patent Office
Enhancing public knowledge and accessibility of opposition processes
These measures may help find the appropriate equilibrium between encouraging creativity and safeguarding the public’s welfare.
Conclusion
Pre-grant opposition is an important protection mechanism within India’s patent system and ensures that the quality, integrity and trustworthiness of the patent system are properly maintained. Anyone can oppose a patent application before it is granted (under Section 25(1) of the Patents Act 1970) and promote a greater degree of public involvement in assessing patents, thus making India different from many other jurisdictions. The patent office will receive comments from many stakeholders, including competitors, academics and consumer groups. This open access to the examination process enables the patent office to carry out a more thorough examination because it receives input from a wider range of individuals and organisations, including competitors, researchers and public interest groups.
In conclusion, pre-grant opposition provides a number of benefits, as this blog illustrates. Among the benefits identified through this examination of opposition include:
• A tool for screening bad patents and preventing the issuance of unjustified monopolies (e.g. by providing an opportunity for stakeholders to comment on whether a patent meets the requirements of novelty, inventiveness and patentable subject matter); and
• A means to promote competition and maintain an efficient marketplace. In general, this process safeguards the public’s well-being as well as consumer access to medicines or other essential products manufactured in the pharmaceutical industry by allowing people to oppose patents before they are granted.
Despite this, there are many barriers that prevent pre-grant opposition from being effective. There are delays in processing opposition applications, administrative obstacles, and concerns regarding strategic or frivolous use of the opposition process, which could hinder innovation and disrupt business certainty. The broad-based nature of the opposition process is one of its biggest strengths; however, it also creates a need for safeguards against the wrongful use of the process. The move of appellate review from specialized tribunals to High Courts has highlighted the need for uniformity and efficiency in the resolution of these matters.
Taking these factors into consideration, it is evident that the future of the pre-grant opposition process ultimately depends on striking a careful balance between competing interests. On the one hand, the system will continue to promote thorough review and public participation; on the other hand, the system will also need to facilitate the timely and effective resolution of disputes to avoid unnecessary delays in issuing patents. The efficiency of the system can be greatly improved by simplifying procedures, enhancing administrative capabilities, and utilizing technology to conduct prior art searches and manage cases.
