In a recent case decided by the Delhi High Court in Best Agrolife Limited vs. Deputy Controller of Patents and Anr., the Court remanded an order of patent grant by the Patent Office for a fresh consideration because the order was legally infirm and unreasoned, resulting in violation of principles of natural justice. The order was related to a patent application filed by GSP Crop Science, concerning a synergistic suspo-emulsion formulation of Pyriproxyfen and Diafenthiuron.
The Petitioner in this case, Best Agrolife, filed a pre-grant representation against GSP’s patent application. The Patent Office went ahead to grant a patent despite the pre-grant representation. Following this, Best Agrolife filed a writ petition claiming violation of principles of natural justice as the order of the Patent Office did not address grounds in Best Agrolife’s representation, and as amendments made by GSP before grant were not notified to Best Agrolife. After analyzing the facts, the Court came to the conclusion that the Patent Office’s order, granting the patent, was legally infirm and unreasoned. It went on to state that the Patent Office violated principles of natural justice by not analyzing Section 3(d) and prior art cited, and by not sharing the amended claims with the Petitioner. It therefore remanded the matter back to the Patent Office for a fresh order.
Relevant paras of the decision of the High Court reads as follows:
“34. Petitioner has unequivocally and categorically taken a stand that it had raised the ground of non-patentability of the impugned patent under Section 25(1)(f) read with Section 3(d) of the Act in the pre-grant opposition, replication and written submissions and extensive arguments were addressed on this issue before Respondent No. 1. Adverting to the impugned order, it is palpably clear that Respondent No. 1 has not even taken note of Section 3(d) in the entire order and consequently not dealt with the submissions made in respect thereof. At this stage, it is condign and warranted to bring forth the objections raised by the Petitioner under Section 3(d) in the pre-grant opposition and the same are extracted hereunder for ready reference:-
“IV. CLAIMS 1-11 OF THE IMPUGNED PATENT APPLICATION ARE NOT PATENTABLE UNDER SECTION 25 (1) (f) READ WITH SECTION 3(d) AND 3(e) OF THE PATENTS ACT
b) …..Section 3(d) of the Patents Act provides that a known substance may include combination of known substances. The claims of the impugned application relate to a suspo-emulsion formulation comprising a combination of known substances i.e., Pyriproxyfen and Diafenthiuron with inactive excipients and therefore must fulfil the requirements of Section 3(d). The Opponent submits that claims of the impugned application relate to a suspo-emulsion formulation comprising a combination of known substances i.e., Pyriproxyfen and Diafenthiuron with inactive excipients. However, from the prior art documents cited herein, the formulation/ composition of the impugned application is already known. Moreover, the applicant has not provided any technical data and/or experimental proof of any enhancement in the significant improvement in therapeutic efficacy i.e., no experimental data has bene provided by the applicant to prove the alleged efficacious nature of the SE formulation/composition claimed by the applicant in the impugned application. The data provided in the specification of the impugned patent application only provides the average number of whiteflies after treatment with claimed formulation and the % leaf infection by Liriomyza Trifolii on Tomato Leaf miner, which does not indicate any enhancement of efficacy of the claimed formulation as no mortality rate has been provided by the applicant. Additionally, no comparison has been made by the applicant w.r.t the claimed formulation with any prior art SE formulation. Failing this, no efficacy can be claimed by the applicant in respect of the claimed formulation of the impugned application.
c) Therefore, the Applicant’s claim to a SE composition containing a known combination of two agrochemical compounds with excipients is not patentable under Section 3(d) of The Patents Act.”
35. Petitioner had evidently contested the grant of patent on the ground that the patent application related to a suspo-emulsion formulation comprising of a combination of known substances, i.e., Pyriproxyfen and Diafenthiuron with inactive excipients and therefore, must cross the requirement of showing ‘enhanced efficacy’ as required under Section 3(d) of the Act. It was the case of the Petitioner that from the prior art documents cited therein, the formulation/composition of the impugned application was already known. Moreover, the applicant had not provided any technical data and/or experimental proof of any enhancement in the therapeutic efficacy. The data provided in the specification of the patent application only provided average number of whiteflies after treatment with claimed formulation and % (percentage) leaf infection by Liriomyza Trifolii on Tomato Leaf miner, which did not indicate enhancement of efficacy, as no mortality rate was provided. Additionally, according to the Petitioner no comparison was made by the applicant of the claimed formulation with any prior art suspo-emulsion formulation. Pithily put, the opposition was that given that the combination of Diafenthiuron and Pyriproxyfen was known in the prior art, i.e., D2, the applicant was required to show that the suspo-emulsion composition of Diafenthiuron and Pyriproxyfen is a new form of known combination of the two and that the new form resulted in enhancement of known efficacy of the existing combination, in order to cross the threshold test of Section 3(d).
36. Reading of the impugned order leaves no scintilla of doubt that Respondent No. 1 has not even adverted to Section 3(d) and the opposition raised on the ground provided under the said provision albeit it would have been a different matter if the ground urged under the said provision was rejected on merits. Non-consideration of the ground per se, in my view constitutes violation of principles of natural justice. In fact, non-consideration of Section 3(d) is self-evident from para 3 of the impugned order, extracted hereunder, where Respondent No. 1 has enumerated the grounds raised by the opponent:-
“3)The opponent raised following grounds:
a) Section 25(1)(b) Lack of Novelty
b) Section 25(1)(d) Prior Publication and Prior Knowledge
c) Section 25(1)(e) Lack of Inventive step / Obviousness
d) Section 25(1)(f) Non-Patentable Invention [Section 3(e)]
e) Section 25(1)(g) Lack of Sufficiency of disclosure.”
37. This facet of the case becomes extremely significant and important in view of the judgment of the Supreme Court in Novartis (supra), wherein the Supreme Court held that amendment to Section 3(d) cannot be underscored. Relevant paras of the judgment are as follows:-
“87. We are clearly of the view that the importance of the amendment made in Section 3(d), that is, the addition of the opening words in the substantive provision and the insertion of the Explanation to the substantive provision, cannot be underestimated. It is seen above that, in course of the Parliamentary debates, the amendment in Section 3(d) was the only provision cited by the Government to allay the fears of the Opposition members concerning the abuses to which a product patent in medicines may be vulnerable. We have, therefore, no doubt that the amendment/addition made in Section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of Section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.
88. We have so far seen Section 3(d) as representing “patentability”, a concept distinct and separate from “invention”. But if clause (d) is isolated from the rest of Section 3, and the legislative history behind the incorporation of Chapter II in the Patents Act, 1970, is disregarded, then it is possible to see Section 3(d) as an extension of the definition of “invention” and to link Section 3(d) with clauses (j) and (ja) of Section 2(1). In that case, on reading clauses (j) and (ja) of Section 2(1) with Section 3(d) it would appear that the Act sets different standards for qualifying as “inventions” things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in Section 3(d) in the year 2005.”
38. Emphasising on the amendment to Section 3(d), the Supreme Court observed that the amendment brought about with effect from 01.01.2005, was one of the crucial amendments that saw the Bill through the Parliament and acts as second tier of qualifying standards for chemical substances/ pharmaceutical products to leave the door open for genuine inventions, while at the same time, keeping a check on the repetitive patenting or extension of patent term on spurious grounds. As noted by the Supreme Court, the Parliamentary debate focused on agricultural chemicals as well. It was also observed that there is wider distinction between the concepts of invention and patentability, a distinction that was at the heart of the Patent Act, as framed in 1970 and which is reinforced by 2005 amendment to Section 3(d). The impugned order is, however, completely silent on the pre-grant opposition of the Petitioner under Section 3(d) and therefore, not only violates the principles of natural justice but also is in the teeth of judgment of the Supreme Court in Novartis (Supra).
42. In order to appreciate and examine the arguments of the respective parties, it would be pertinent to refer to Section 3(d) and 3(e) of the Patents Act, which are extracted hereunder:-
“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 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.
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;
(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;”
43. Both Section 3(d) and 3(e) fall under Chapter II of the Act. Section 3(d) provides that a mere discovery of a new form of a known substance which does not result in enhanced efficacy of that substance shall not be an invention. Explanation to the Section provides that ‘combinations’ shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy. Section 3(e) provides that a substance obtained by a mere admixture resulting only in the aggregation of properties of the components thereof shall not be an invention. Plain reading of the two provisions, indicates that Section 3(d) entails an assessment of ‘enhanced efficacy’ of the claimed composition in comparison to the efficacy of the known substance while the assessment under Section 3(e) is with a view to determine the synergistic effect of claimed composition with the individual properties of each component comprising the composition. Legislature in its wisdom has enacted two different provisions and the tests for both are different. The Supreme Court in Novartis (supra) has observed that Section 3(d) is not ex majore cautela and sets up a second tier of qualifying standards in chemical substances/pharmaceutical products to encourage genuine inventions, at the same time keeping check on evergreening. Section 3(d) provides a safeguard to patentability of a new form of known substance if it does not pass the threshold of enhanced efficacy. Thus, the Respondents may not be wholly correct in arguing that an adjudication under Section 3(e) of novelty or a product not being a mere admixture would cover the adjudication under Section 3(d). There is merit in the contention of the Petitioner that the patent applicant has claimed a suspo-emulsion of admixture/combination of Diafenthiuron and Pyriproxyfen and therefore, the applicant would have to pass the test under both Section 3(d) and 3(e), albeit on different aspects by showing enhanced efficacy over known combination of a suspo-emulsion qua Section 3(d) and synergistic effect over the mere additive effect of individual components of suspo-emulsion composition. Therefore, it was incumbent upon Respondent No. 1 to take note of the pre-grant opposition under Section 3(d) and deal with the same, in accordance with law and the material placed on record.
44. This Court also finds prima facie merit in the contention of the Petitioner that synergistic effect can be demonstrated by a combined effect of increase in bio-efficacy and stability of the admixture beyond the sum of their individual effects. However, if bio-efficacy/stability is to be tested in respect of Section 3(d), the test would be bio-efficacy/stability of the form, i.e., suspo-emulsion in this case and not the admixture, over and above the closest prior art brought forth by the opposer, which is the known substance as a comparator. Petitioner has also raised a plea that the data provided by Respondent No. 2 related to bio-efficacy/stability and not with respect to enhanced efficacy as compared to the prior art, i.e., the alleged known substance. Therefore, once the Petitioner had raised opposition under Section 3(d) and 3(e) both, Respondent No. 1 was required to deal with the opposition, looking at the scheme of the Act and the intent of the legislature in enacting two separate provisions.
45. The impugned order shows that the pre-grant opposition has been rejected on a finding that the data provided by Respondent No. 1 regarding stability and bio-efficacy of composition shows synergistic effects and the composition claimed has reduced toxicity in comparison to toxicity exhibited by individual components of the composition. In my prima facie view, none of these factors are germane to answer the real question of opposition raised under Section 3(d). Respondent No. 1 ought to have examined whether the data and other factors brought forth by the Applicant had the effect of enhancement of efficacy from a known substance, which is the legislative intent of amendment of Section 3(d).
46. In any event, even assuming for the sake of argument that there can be an overlap in a given case between the findings under Section 3(d) and 3(e) and a finding under one could cover the adjudication under the other, Respondent No. 1 ought to have deliberated on the issue and given its finding that no separate adjudication was required with respect to the test of enhanced efficacy under Section 3(d), once a finding is rendered under Section 3(e) that the composition claimed was not a mere admixture or that for any other reason, Section 3(d) was inapplicable. Had the objection been rejected on merit, Petitioner would have taken recourse to further remedies under the Act. Petitioner is right in its argument that all these reasonings are being provided by the Respondents in their reply before this Court while none of this finds mention in the impugned order. It is a settled law that when an order is passed by an Authority competent to pass the order, it must be tested for its validity based on the reasons mentioned therein and cannot be supplemented by reasons mentioned in the counter affidavits filed in Court. As held by the Supreme Court in Mohinder Singh Gill & Anr. v. Chief Election Commissioner, New Delhi & Ors., (1978) 1 SCC 405, that if this was permitted then an order bad in the beginning may by the time it comes to Court on account of a challenge, gets validated by additional grounds later brought out.
47. Touching on the violation of principles of natural justice, Petitioner has brought out that a number of crucial and relevant documents placed on record by the Petitioner were not even considered by Respondent No. 1. The documents relied upon include D1 being US 2011/0053772 under the ground of lack of novelty, D3/D5/D6/D8/D9 under the ground of lack of inventive step. Perusal of the impugned order supports the contention of the Petitioner. While it cannot be disputed that being a quasi-judicial Authority, Respondent No. 1 has the power and discretion to decide the relevancy or otherwise of the documents relied upon by the parties, however, the least that is expected is that in case the Authority comes to a conclusion that the documents are irrelevant, it must record a reasoned finding to that effect. No reason is discernible from the impugned order as to why the documents were not considered by Respondent No. 1 and to this extent, as rightly contended by the Petitioner, the impugned order is non-speaking and unreasoned. In fact, by non-consideration of the documents, there is also a breach of principles of natural justice. Petitioner had cited the documents, as according to it, they were of relevance in deciding the pre-grant opposition and consequently impacting the grant of patent.
48. Another aspect of the matter that needs examination is the contention of the Petitioner that Respondent No. 2 had sought to amend the claim two days prior to passing of the impugned order, i.e., on 06.04.2022 and the amendment was allowed without notifying the Petitioner and granting the Petitioner an opportunity to respond to the amendment. Learned counsels for the Respondents had sought to contend that the first amendment was a mere deletion of repetition of few words in the claim, i.e., a typographical error, while the second amendment was only to incorporate the exact range of thickener to bring it within the scope of the specifications. Nature of amendments was so trivial that this objection of the Petitioner is untenable in law.
49. Insofar as the first amendment is concerned, this Court finds force in the contention of the Respondents as what was sought to be amended was a mere typographical error. However, with respect to the second amendment the plea of Respondents cannot be accepted. By the second amendment Respondent No. 2 sought to amend the range of the thickener from 0.025-05% to 0.05-0.25%. Patents Act is a complete Code which provides a mechanism and a procedure for carrying out amendment of an application, specifications, etc., before the Deputy Controller of Patents under Sections 57 and 59 thereof. Admittedly, the procedure, as mandated under the Act, was not followed by Respondent No. 1 before permitting Respondent No. 2 to carry out the amendment. In fact, the amendment was allowed two days prior to the passing of the impugned order, without even notifying the Petitioner of the same, leave alone giving an opportunity to respond. Assuming that the amendment was trivial or insignificant in the perception of the Respondents, which is the case being set up at this stage, it may not have been so for the Petitioner and given an opportunity it may have been able to justify the opposition. It is pertinent to note that strangely and significantly the order impugned herein does not even mention that an amendment was made to the original claims and specifications by Respondent No. 2, which were allowed.
50. Therefore, holistically read, the impugned order suffers from legal infirmities, as aforementioned, being a non-speaking and unreasoned order, besides there being violations of principles of natural justice.51. In Agriboard (supra), a Co-ordinate Bench of this Court has remanded the matter back to the Competent Authority for a fresh consideration on the ground that the decision refusing to grant the patent was unreasoned. Reliance was placed on the judgements of the Supreme Court in Assistant Commissioner, Commercial Tax Department v. Shukla and Brothers, (2010) 4 SCC 785 and Manohar v. State of Maharashtra & Ors., AIR 2013 SC 681. Relevant paras are as under:-
“22. The Supreme Court in Assistant Commissioner v. Shukla and Brothers (supra), has categorically held that passing of a reasoned and a speaking order is an integral part of the principle of audi alteram partem. The relevant paragraph reads as under:
“9. The increasing institution of cases in all Courts in India and its resultant burden upon the Courts has invited attention of all concerned in the justice administration system. Despite heavy quantum of cases in Courts, in our view, it would neither be permissible nor possible to state as a principle of law, that while exercising power of judicial review on administrative action and more particularly judgment of courts in appeal before the higher Court, providing of reasons can never be dispensed with. The doctrine of audi alteram partem has three basic essentials. Firstly, a person against whom an order is required to be passed or whose rights are likely to be affected adversely must be granted an opportunity of being heard. Secondly, the concerned authority should provide a fair and transparent procedure and lastly, the authority concerned must apply its mind and dispose of the matter by a reasoned or speaking order. This has been uniformly applied by courts in India and abroad.”
23. The said reasoning has been reiterated by the Supreme Court in Manohar v. State of Maharashtra, (2012) 13 SCC 14 : AIR 2013 SC 681 wherein it has been categorically observed that application of mind and recording of reasoned decision are the basic elements of natural justice. There can be no doubt that scrupulous adherence to these principles would be required while rejecting patent applications.
24. In the opinion of this Court, while rejecting an invention for lack of inventive step, the Controller has to consider three elements-
- the invention disclosed in the prior art,
- the invention disclosed in the application under consideration, and
- the manner in which subject invention would be obvious to a person skilled in the art.
25. Without a discussion on these three elements, arriving at a bare conclusion that the subject invention is lacking inventive step would not be permissible, unless it is a case where the same is absolutely clear. Section 2(1)(ja) of the Act defines ‘inventive step’ as under:
(ja) “inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
26. Thus, the Controller has to analyse as to what is the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention, captured in the application under consideration. Without such an analysis, the rejection of the patent application under Section 2(1)(ja) of the Act would be contrary to the provision itself. The remaining prior arts which are cited by ld. Counsel having not been considered in the impugned order, the Court does not wish to render any opinion in this regard.
27. In view of the above discussion, the impugned order dated 16th June, 2021 rejecting the patent application of the Appellant is set aside and the matter is remanded back to the IPO for a fresh consideration. As part of the said consideration, the IPO is permitted to consider the prior art D1 as also other prior arts and the ISR issued by the PCT office, which are now cited by the Respondent.”
Citation: Best Agrolife Limited vs. Deputy Controller of Patents and Anr., Decided by Delhi High Court on 7 July, 2022, available at: https://indiankanoon.org/doc/152746873/, visited on 11th July, 2022.
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