Synergistic Effect vs Mere Admixture: Section 3(e) Of The Patents Act, 1970

Introduction

In this article, the Hon'ble Calcutta High Court clarified approaches for assessing inventive step of the invention, and assessing synergistic effect vs mere admixture in patent applications for improved result in light of section 3(e) of the Indian Patents Act. This judgment clarified the steps to identify inventive features of the invention u/s 2(1)(j) and to differentiate patentable subject matter from non-patentable matter under section 3(e)¹ of the Act.

Brief Overview of the Matter

The applicant filed a patent application bearing application number 201731008009, titled "FUNGICIDAL COMBINATIONS" on March 07, 2017, with the Indian Patent Office (IPO), and the Indian application was published in patent journal dated March 29, 2019. Subsequently, a First Examination Report (FER) was issued by the Controller on April 29, 2019, citing objections pertaining to lack of novelty, lack of inventive step, lack of unity of invention and non-patentability under Section 3(d)², 3(e) and 3(h)³ of the Patents Act, 1970. The applicant filed the response to the FER along with an amended set of claims on October 25, 2019. Subsequently, an opposition was filed by the opponent on November 16, 2022 and a pre-grant hearing was fixed on May 22, 2024. Thereafter, a hearing notice was issued u/s 14 by the Joint Controller of Patents & Designs on September 13, 2024, wherein the objections pertaining to lack of novelty, lack of inventive step, lack of unity of invention and non-patentability u/s 3(d), 3(e) was again cited by the Joint Controller.

The details of the subject patent application are provided in the table below.

Order Passed by the Joint Controller Refusing the Patent Application

After considering the written submissions filed by the applicant on October 19, 2024, the Joint Controller passed an order dated October 24, 2024, wherein it was determined that claimed subject matter of invention lacks inventive step, and is also non-patentable under section 3(e) of the Patents Act. Therefore, the application was refused by the Joint Controller under Section 15 of the Act.

The Joint Controller cited the following reasons for refusing the patent application.

1. The claimed subject matter lacks technical advancement, the given technical data in originally filed specification are not suffice to establish the higher efficacy results and does not establish any technical effect. Hence, the claimed subject matter does not constitute an invention step, and is not an invention u/s 2(1) (j) of the Patents Act.
2. The claimed invention is a mere aggregation of known components without showing any synergistic effect and thus non-patentable u/s 3(e) of the Patents Act.

Appeal Filed by the Applicant

An appeal was filed by the applicant (hereinafter referred to as Appellant) before the Hon'ble Calcutta High Court against the order passed by the Joint Controller of Patents & Designs (hereinafter referred to as Respondent).

Submissions Made by the Appellant During the Court's Proceeding

• The appellant submitted that the Indian Patent Office failed to recognise and appreciate the real scope of the present invention and its advancement in agrochemical industry.
• The present invention is an agrochemical which combines fungicides, improving disease control and combating resistance against a combination of a SDHI fungicide along with another fungicide.
• The combination of fungicides shows unexpected advantages and enhanced efficacy in reducing fungal diseases.
• The rejection order was cryptic, did not properly consider all the scientific evidences provided in the specification and order was passed without providing proper reasoning.
• The appellant further submitted that the Patent Office did not issue a Second Examination Report (SER) despite citing new prior art documents in the hearing notice.

Respondent's Submission to the Appeal Filed by the Appellant

• The respondent submitted that the impugned order issued by the Patent Office is provided with proper reasoning which clearly states that the improvement/ enhancement in disease control was only about 4-5% due to the addition of another fungicide, which is not significant.
• The combination of fungicides does not show any synergistic effects. The results are merely an effect of aggregation of fungicides mainly due to the addition of chlorothalonil and TBCS in the mixture of other fungicides in higher dose, hence, the invention is non-patentable under Section 3(e) of the Patents Act.
• The respondent further submitted that failure to issue a SER should not be considered fatal as the original objections raised earlier were eventually dismissed. Since, the respondent was not relying on those initial objections anymore, the lack of issuance of SER did not significantly affect the overall process of evaluating the patent application.

Judgment Passed by the Hon'ble Calcutta High Court

Upon considering contentions from the Appellant and the Respondent, the Hon'ble High Court determined that the rejection order lacked proper reasoning for concluding the invention lacked inventive steps.

The Hon'ble Court cited the case law of Avery Dennison Corporation vs. Controller of Patents and Designs⁴. The Hon'ble Court referenced this case to explain the established principles and approaches for determining inventive step and lack of obviousness in patent applications. The Hon'ble Court highlighted that the Controller of Patents should have followed these well-settled principles in evaluating the inventiveness of the patent application in question. The Avery Dennison case outlines several approaches for assessing inventive step, which includes:

• Obvious to try approach, which analyses whether based on prior art teachings or solutions, it would have been obvious to try and arrive at the subject invention.
• Problem/solution approach, which considers whether the given closest prior art and the objective technical problem, the claimed solution would be obvious to a skilled person.
• Could-Would approach examines whether any instruction in the prior art as a whole would have led a skilled person to alter or adapt the closest prior art in order to arrive at the claimed subject matter.
• Teaching Suggestion Motivation (TSM) test, which examines if the Teaching, Suggestion, or Motivation from prior art would allow an ordinary skilled person to modify or combine prior art references to arrive at the claimed invention.

The Hon'ble Court also cited the Windsurfing case law, which laid out a four-step test to determine inventive step and lack of obviousness: identifying the inventive concept in the patent, determining common general knowledge in the art at the priority date, identifying differences between cited prior arts and alleged invention, and deciding if those differences would be obvious to a skilled person.

The Hon'ble Court stated that the Patent Office should have considered all the experimental data mentioned in the UPL's subject patent application as the impugned order did not consider all experimental data and tables provided by the appellant. The Hon'ble Court stated that the Patent Office failed to analyse how a skilled person would move from existing knowledge to the invention.

The Hon'ble Court further cited the case law of Stempeutics Research Pvt. Ltd. Vs Assistant Controller of Patent & Designs to address the interpretation and application of Section 3(e) of the Patents Act, which deals with what are not considered inventions under Indian patent law.

According to this case law, compounds created by simple mixing that simply results in the aggregation of component qualities or techniques for making such substances are covered under section 3(e). This case involves rules which state that when "old integers are combined in a way that creates a functional interaction yielding a novel or enhanced outcome, constitutes patentable subject matter based on the functional relationships formed by the arrangement of the integers".

This judgment emphasized that most inventions are combinations of old elements, and the mere existence of each element in prior art does not automatically mean the invention violates Section 3(e). The applicability of Section 3(e) should be viewed from a policy perspective, not from the lens of assessing novelty and inventiveness. Section 3(e) is applicable only when a claimed product is obtained by combining known or existing ingredients without showing any synergistic effect, not when components of the claimed product are themselves not known.

The Hon'ble Calcutta High Court cited this case law to highlight that the Controller's rejection of the patent application as a mere admixture under Section 3(e) was flawed. The Hon'ble Court emphasized that the Controller should have considered all experimental data and tables to determine if there was a synergistic effect or working interrelation producing a new or improved result, rather than dismissing it as a mere admixture of known substances. The Hon'ble Court stated that relying on selective data while disregarding other evidence is a serious flaw and even a 4-5% increase in efficacy could have significant long-term impact in agriculture over time.

The Hon'ble Court further cited the case law of British Celanese Ltd. vs. Courtaulds⁶ to provide guidance on what constitutes a patentable combination versus a mere aggregation of known elements. This case law mentions that simply placing old elements side by side, where each performs its own function independently, is not considered a patentable combination. However, when old elements are arranged together in a way that generates a working inter-relation to produce a new or improved results, deemed to be patentable subject matter. According to this case law, a combination must have some functional interdependency between the elements in order to be patentable, where at least one element is performing a task that could not be accomplished in the absence of others. If each element in a combination is simply performing its own part independently, without showing any functional dependency or reliance on the other elements, the invention may lack patentable subject matter.

This case law is referenced to emphasize the importance of considering whether a combination of known elements produces a new or improved result through their interaction, rather than just aggregating their individual properties. The Hon'ble Calcutta High Court used this principle to suggest that the Patent Office should have more carefully examined whether the claimed invention demonstrated such a working inter-relation or synergistic effect, rather than dismissing it as a mere admixture of known substances.

The Hon'ble Court further stated that the Patent Office failed to issue a SER, which is a procedural error. The Hon'ble Court cited the case law of Oyster Point Pharma Inc. Vs The Controller of Patents and Designs & anr⁷, this case is referenced specifically to address the procedural issue of failing or neglecting to issue the SER. This case law emphasized the importance of following the statutory mandate of section 13(3)⁸ of the Patents Act, which requires issuing SER in certain circumstances. This case law rejected the argument that non-issuance of SER could not prejudice the rights of the appellant. This judgment stated that the statutory requirement must be followed regardless of the consequences or ultimate result and concluded that the Controller erred in not issuing the SER in compliance with section 13(3) of the Act.

The Hon'ble Calcutta High Court referenced this case to emphasize that the failure to issue a SER in the present case constituted a procedural flaw. This case law citation supports the court's finding that the Patent Office should have issued a SER, especially when the new prior art documents (D4-D10) were cited in the hearing notice after the amended claims were filed by the applicant.

The Hon'ble Court used this precedent to underscore the importance of following proper procedural steps in patent examination, irrespective of the ultimate outcome. This procedural error was one of the grounds on which the court decided to set aside the Controller's order and remand the matter for fresh consideration. The Hon'ble Court directed the Patent Office to reconsider the application within 4 months, giving the appellant a chance of fair hearing.

Conclusion

The decision of Hon'ble Calcutta High Court's judgment in the case of UPL Ltd. vs The Controller of Patents, Designs and Trademark clarifies section 2(1)(j) and section 3(e) of the Indian Patents Act, 1970. It is concluded from the judgment that the Indian Patent Office needs to clearly explain their reasons for rejecting applications referencing specific prior art documents and analysing how a skilled person would arrive at the invention. The Hon'ble Court emphasized the need for Patent Office to assess the invention as a whole and to thoroughly examine or analyse patent applications, considering all the evidences and data provided by the applicant, rather than selectively focusing on certain aspects. Even small improvements or enhancement in efficacy of an invention can have a significant real-world impact when considered on a large scale. The Hon'ble Court also highlighted the importance to adhere to the proper procedures, such as issuing SER when new prior art documents are cited or claims are amended by the applicant. By remanding the case back to the Patent Office for reconsideration, the Hon'ble Court has provided UPL's patent application an opportunity for more thorough and a fair examination. This decision clarifies the steps to assess inventiveness of the invention under section 2(1)(j) and patentable subject matter under section 3(e) of the Act, potentially benefiting both the inventors and the patent system.

Footnotes

1. Section 3(e): a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

2. Section 3(d): the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

3. Section 3(h); a method of agriculture or horticulture.

4. 2022 SCC OnLine Del 3659

5. 2020 SCC OnLine IPAB 16

6. (1935) 52 R.P.C. 171

7. AID NO. 10 of 2022

8. Section 13(3): Where a complete specification is amended under the provisions of this Act before the grant of patent, the amended specification shall be examined and investigated in like manner as the original specification.

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