Introduction
Section 3(d) of the Indian Patent Act (hereinafter, “the Act”) bars the patentability of new uses or new forms of known compounds and compositions unless these changes result in significant therapeutic efficacy. Various judgments have established precedents clarifying non-patentability objections, particularly those under Section 3(d) of the Indian Patent Act.
In a recent judgment of the Delhi High Court, Nippon Steel Corporation v. The Controller General of Patents [1], the court held that for objections under Section 3(d), the known compounds or process must be clearly identified, and the Indian Patent Office must apply the test/standard for patent eligibility of the subject matter to ensure natural justice is provided to the applicant.
Facts of the Case
The Appellant, Nippon Steel Corporation, filed an Indian patent Application No. 8620/DELNP/2012 titled “Method for Repairing Inside of Gas Flue or Coke Oven and Device for Repairing Inside of Gas Flue”.
A First Examination Report (FER) was issued on May 2, 2018, by the Indian Patent Office which raised objections such as lack of novelty and inventive step under Section 2(1)(j) of the Act and unity of invention under Section 10. The Appellant responded to the FER along with amended claims.
Subsequently, a hearing notice reiterated the objections under Section 2(1)(j) and introduced an additional objection under Section 3 without specifying which subsection of Section 3 was being applied. Following the hearing, the application was refused under Section 3(d) of the Act, even though it was not specifically mentioned in the hearing notice.
Issues before the Court:
Whether the Controller can simply cite Section 3 in rejecting an application without specifying the subsection at the time of the hearing.
Relevant Rules and/or Law
“Section 3: What are not inventions: The following are not inventions within the meaning of this Act, –
(d) the mere discovery of a new form of known substances that do not result in enhancement of the known efficacy of that substance, the mere discovery of any new property or new use for a known substance, or the mere use of a known process, machine, or apparatus unless such known process, machine or apparatus results in a new product or employs at least one new reactant.
Explanation- For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
Contentions of the Appellant
The Appellant argued that the patent application was rejected under Section 3(d) without the specific subsection being raised in the hearing notice, depriving them of a fair opportunity to respond, thus violating principles of natural justice.
The Appellant referred to Circular No. 4 of 2011 published by the Controller General of Patents, Designs and Trademarks which requires all objections to be clearly communicated in the hearing notice, with adequate time given to the applicant to respond. The Appellant also cited the judgment in D.S. Biopharma Limited vs. The Controller of Patents and Designs & Anr. [2], which emphasized the need for sufficient opportunity to address objections under Section 3(d).
Furthermore, the Appellant contended that the Controller misinterpreted Section 3(d) by excluding the method of operation of the device from patentability without proper reasoning. The claimed method involved novel technical steps, which the Controller treated merely as the application of the device.
The Appellant asserted that the Controller should have evaluated the patentability of the method claims by applying the correct standard for Section 3(d) before arriving at the decision. Methods for repairing industrial devices are granted patents globally, underscoring the flawed nature of the rejection based on preconceived notions rather than technical analysis. Such misinterpretation of the patentability criteria and blatant disregard of the claimed technical features are against the basic tenets of the patent jurisprudence and therefore, the claims of the appellant deserve a reconsideration based on their technical merits.
Contentions of Respondent
The Respondent argued that the method claims could be carried out by a person skilled in the art using the operating handbook or manual of the device, thus representing the mere application of a device, which is not patentable under Section 3(d) of the Act. They contended that claim 1 lacked inventive step and did not introduce any technical advancement or special functional relationship that would qualify it for patentability.
Court’s Observation
The court noted that the core issue involved the patent eligibility of the invention under Section 3(d). It pointed out that Claim 1 was treated as a mere use or application of the device described in Claim 2, falling under the fourth category of Section 3(d) — the mere use of a known process, machine, or apparatus. However, the Controller failed to clearly identify what constituted the “known process, machine, or apparatus” that made Claim 1 non-patentable.
Additionally, the court observed that the novelty objection was not raised during prosecution nor mentioned in the impugned order. This mirrored the issue in D.S. Biopharma Limited (supra), where the Patent Office had failed to provide sufficient reasoning for rejection under Section 3(d).
The Court concluded that since the Controller had acknowledged the novelty and inventive step of the rejected claims, they could not be presumed to involve a “known process, machine, or apparatus.” The order of rejection was therefore erroneous due to:
- Lack of analysis of the technical steps of the claimed method;
- No application of a test for patent eligibility;
- Failure to identify the known substance or device that triggered the application of Section 3(d); and
- Ignoring the fact that Claim 2 of the application involved a novel and inventive device.
The Judgment
The Court determined that the impugned order, having been issued without adequate analysis of the subject matter and featuring insufficient reasoning, runs contrary to the precedents established in Manohar v. State of Maharashtra & Ors. [3] and Agriboard International LLC v. Deputy Controller of Patents and Designs [4]. Consequently, it was deemed not to constitute a speaking order and represented a significant violation of the principles of natural justice. Accordingly, the Court declared the order unsustainable, thereby remanding the patent application to the Indian Patent Office for renewed consideration.
Further, the court directed that the Appellant shall be granted a fresh opportunity of hearing to respond to any of the outstanding objections and the following questions:
- Does claim 1 cover use claims (which are not considered inventions under Section 2(1)(j)) disguised as method claims?
- Whether Claim 1 falls under Section 3(n), being a mere presentation of information?
- Does the invention covered in claims 1, 2, and 3 meet the requirement under Section 2(1)(j)?
Our Analysis
According to Section 3(d) of the Indian Patent Act, a novel use or a new form of known compounds and compositions is considered non-patentable subject matter unless such compounds or compositions exhibit a superior therapeutic efficacy compared to their previous forms. Established precedents in prior judgments indicate that the known compounds or processes must be clearly identified by the authorities to justify the objection regarding the non-patentability under Section 3(d) of the Act.
In the present case, the objection under Section 3 of the Act lacked clarity, as it was devoid of adequate reasoning and did not specify the particular subsection of Section 3 referenced. Consequently, without sufficient time and clear justification, it becomes impractical for an applicant to provide the necessary data to support their arguments. The positive aspect of this judgment lies in the court’s insistence on applying the principles of natural justice, particularly emphasizing the importance of providing clear, detailed objections to patent applicants. The ruling reinforces the necessity for the patent office to specify the exact provisions under which a patent is being rejected and to offer applicants adequate opportunity to respond.
Ongoing Issue of Unreasoned Orders from the Indian Patent Office
This case once again highlights a recurring issue within the Indian Patent Office: the tendency to issue unreasoned or poorly explained orders. Despite multiple judgments and precedents, including D.S. Biopharma Limited, the Office continues to refuse applications based on objections that are either vaguely worded or entirely absent from hearing notices. This trend has caused significant uncertainty and frustration for applicants, who often find themselves blindsided by final refusals that introduce objections never raised during the examination stage. The Court’s reminder to the Patent Office to adhere to the established rules and provide detailed reasoning in decisions serves as a necessary reprimand. However, the persistence of this issue indicates a need for structural reform within the Office to prevent future violations.
Non-Patentability of Use Claims in India
India’s stance on the non-patentability of use claims under Section 2(1)(j) continues to diverge from other major jurisdictions, particularly the European Patent Office (EPO). In India, Section 2(1)(j) restricts patentability to products and processes, thereby excluding mere “use” of a known substance or apparatus. This limitation is evident in the Court’s observation that Claim 1 in this case, which was interpreted as a use claim disguised as a method claim, was unpatentable under Section 3(d) of the Act.
In contrast, the EPO allows for the patenting of new uses of known products, particularly in the pharmaceutical field, provided the new use demonstrates inventive step and industrial applicability. This difference in approach places Indian patent applicants at a disadvantage, especially when their inventions center around novel uses of existing technology.
Remand for Fresh Consideration, Including Examination under Section 3(n)
An important aspect of this judgment is the remand order. The court directed the Patent Office to reconsider the application, particularly with regard to Section 3(n), which pertains to the patentability of presentations of information. This section is often overlooked, as compared to the Patent Office’s heavy reliance on Section 3(d) to reject claims, which is well-documented.
This case highlights the need for a more comprehensive evaluation that includes all relevant sections. By bringing Section 3(n) into play, the court reminded the Patent Office to avoid a one-dimensional approach that could miss critical elements in claims involving data or procedural information.
The court’s instruction to re-examine Claim 1 under Section 3(n) is crucial because by directing the Patent Office to reconsider the application under Section 3(n), the court broadened the scope of the examination. The court’s recognition of Section 3(n) in this context signals an awareness that the claim, though not directly identified as a mere presentation of information by the applicant or the Patent Office, may involve elements that fit within this category.
This indicates the court’s awareness of potential overlapping objections that must be addressed to ensure that decisions are based on solid legal reasoning, rather than vague objections under more commonly used sections like 3(d). This ruling may prompt the Patent Office to more actively engage with Section 3(n) in future examinations, particularly in cases involving procedural, informational, or data-based claims that might have previously escaped such scrutiny.
Conclusion
The judgment in Nippon Steel Corporation v. The Controller General of Patents reinforces the importance of a fair and transparent patent examination process. It draws attention to the ongoing deficiencies within the Indian Patent Office, particularly in its handling of objections and the issuance of reasoned orders. Moreover, the case underscores the limitations of India’s strict interpretation of Section 2(1)(j) regarding the non-patentability of use claims. The remand for fresh consideration, especially under Section 3(n), marks an important step towards a more comprehensive and legally sound approach to patent eligibility in India.
References
[1] C.A.(COMM.IPD-PAT) 323/2022
[2] C.A. (COMM.IPD-PAT) 6/2021
[3] AIR 2013 SC 681
[4] C.A. (COMM.IPD-PAT) 4/2022