A writ petition filed by Best Agrolife Limited (Petitioner) seeking quashing of the order dated 08.04.2022, passed by Deputy Controller of Patents and Designs, dismissing the pre-grant opposition and allowing the grant of patent No. IN 394568 in favour of GSP Crop Science Pvt. Ltd has been allowed by the Hon’ble Delhi High Court.

Petitioner filed a pre-grant opposition under Section 25(1) of the Act, opposing the grant of patent on several grounds including lack of novelty under Section 25(1)(b) and non-patentability under Section 25(1)(f) read with Section 3(d) and 3(e) of the Act as well as objecting to the scope of the claims. In addition to the Petitioner, six other persons also filed pre-grant oppositions against the patent application. GSP Crop Science Pvt. Ltd. filed a reply to the pre-grant opposition on 18.06.2021. On 06.04.2022, Respondent No. 2 made certain modifications in the claims. Vide impugned order dated 08.04.2022, the Controller granted the subject patent and aggrieved by the same, petition was filed by the Petitioner.

It was contended by Counsel appearing on behalf of the Petitioner that:-

• While granting the subject patent, the Controller has not only passed a non-speaking and unreasoned order but has not even dealt with the substantive grounds raised by the Petitioner, more particularly the ground of non-patentability under Section 3(d) of the Act.

• Reading of the impugned order shows that the Controller has not even taken note of the ground raised by the Petitioner under Section 3(d), despite the same being raised in the pleadings and written submissions and extensive arguments being addressed in respect thereof.

• Since the controller failed to take note of the objection under Section 3(d), the controller has also not noted that there is a failure to compare the data of the formulations as disclosed in the prior arts cited in support of Section 3(d) of the Act as also to consider whether the composition, as claimed, would cross the threshold of Section 3(d) or not, especially when prior arts cited by the Petitioner disclosed suspo-emulsion formulations of Pyriproxyfen and Diafenthiuron.

• An inquiry envisaged under Section 3(d) is independent of an inquiry under Section 3(e). Section 3(d) deals with assessment of ‘enhanced efficacy’ of claimed composition in comparison to efficacy of known substance and not merely comparison of efficacy with individual components of the composition while Section 3(e), on the other hand, deals with assessment of synergistic effect of claimed composition over individual properties of each component of the composition. Succinctly put, test for Section 3(d) is ‘enhanced efficacy’ while that for Section 3(e) is ‘synergistic effect’ and both operate in two different fields.

• Even assuming for the sake of argument, that Section 3(d) was not applicable in the present case or that it was sufficient to deal with the parameters under Section 3(e) of the Act for the purpose of opposition under Section 3(d), the Controller ought to have so mentioned in the impugned order and given a reasoning for arriving at such a conclusion.

• US 2011/0053772 was not considered with respect to the challenge on lack of novelty. Controller did not deal with several documents filed by the Petitioner viz. D3, D5, D6, D8 and D9, regarding lack of inventive step under Section 2(1)(ja) of the Act.

• Controller did not consider the submissions of the Petitioner with respect to Section 3(e) of the Act and granted the patent solely on the basis of manipulated and unauthenticated data submitted.

• The controller allowed the amendment to the claims made by on 06.04.2022 i.e., two days prior to the impugned order, without notifying the Petitioner, which is in complete violation of the principles of natural justice as well as the procedure prescribed in the Manual of Practice and Procedure, by the Patent Office.

• Without following the due procedure and without even putting the Petitioner to notice, the amendment was allowed. Claim 4 and 7 were amended. Even assuming that the amendment to Claim 4 was a mere typographical error, claim 7 was amended to incorporate ‘narrow down scope of protection by reducing the range of amount of thickener’. By allowing the amendment, GSP was permitted to enlarge the scope of protection without even giving an opportunity to the Petitioner to respond.

The Respondents rebutted based on the following:-

• The writ petition is not maintainable in view of the judgments in Ucb Farchim Sa v. Cipla Ltd. & Ors., and Mylan Laboratories Limited v. Union of India and Others, 2019, wherein Court has held that the remedy of a person who is unsuccessful in a pre-grant opposition, to prevent the grant of a patent and is a ‘person interested’ within the meaning of Sections 25(2) and 64 of the Act, is to file a post-grant opposition under Section 25(2) or a revocation petition under Section 64 and await the decision of the Controller. If he is still aggrieved by the decision of the Controller under Section 25(4) of the Act, the statutory remedy is to file an appeal under Section 117A of the Act. Petitioner has made out no ground for this Court to exercise the writ jurisdiction.

• While much has been argued by the Petitioner with regard to non-consideration of the opposition under Section 3(d), as a matter of fact, Petitioner never pressed the said objection. In any case, the objection is completely frivolous.

• Petitioner admits that patent was sought in respect of a composition. A composition or an admixture falls entirely in the scope of examination under Section 3(e) and Section 3(d) would have no relevance in the present case. Reading of the provisions show that the moment the Petitioner refers to known substances being mixed together, the same automatically entails an examination under Section 3(e) and not under Section 3(d). Section 3(e) presupposes that the composition/admixture is of two or more known substances and therefore, what needs to be examined is whether the same exhibits a synergistic effect, which is not a mere aggregation of the properties or effects of two or more substances. Court would have to apply the ‘pith and substance’ test in respect of admixtures/ combinations and if so applied, only Section 3(e) is applicable.

• As far as non-consideration of documents is concerned, it was submitted that all relevant documents were considered and merely because the Petitioner chose to file several irrelevant documents, the controller was not bound to consider them.

• Petitioner, during the hearing did not press the documents D3, D5, D6, D8 and D9 and therefore, the decision was given considering the remaining documents cited by the Petitioner. In any case, relevance or irrelevance of the document is a fact-finding exercise and within the domain of the Controller and Petitioner cannot call upon this Court in a writ petition to adjudicate on this issue.

• With respect to the argument regarding amendments to claims No. 4 and 7, it was submitted that the amendment to claim No. 4 was sought on account of a mere typographical error, where some repetitions had occurred. The second amendment was with respect to claim No. 7 where a correction and reduction in the range was sought to bring the same in line with the specifications. The amendments were very trivial and did not change the nature or the complexion of the claims.

• The Petitioner did not even press its ground with any degree of seriousness on Section 3(d) during the pre-grant opposition. Secondly, the substance of the challenge under Section 3(d) was identical to a challenge under Section 3(e) which is evident from the documents placed on record along with the present writ petition. Thirdly, controller has considered the data provided in the application as well as additional data provided in its reply on the pre-grant and has arrived at a considered decision that composition has stability, bio-efficacy and reduced toxicity. Section 3(d) may not be specifically mentioned in the impugned order but the relevant parameters for assessment and the reasoning can be deciphered. Further, when an order comprehensively rules on ‘novelty’, the very premise of Section 3(d), i.e., combination being a Known-substance is inapplicable.

Having considered the rival submissions on this aspect and given careful cogitation, the Court held that :-

1. There cannot be a debate that the Act provides a remedy of post-grant opposition or a revocation petition to a ‘person interested’, who is unsuccessful in a pre-grant opposition as well as an appeal thereafter under Section 117A of the Act. Nonetheless, if the Petitioner is able to substantiate the pleas that Respondent has committed a manifest error leading to violation of principles of natural justice or has failed to exercise a jurisdiction vested in it or there is non-consideration of vital grounds or documents, Petitioner cannot be non-suited in a writ petition.
2. The Court held that it is a matter of prudence and discretion as to whether the writ Court would entertain the writ petition in the given facts and circumstances. The Court noted that that Petitioner has alleged violation of principles of natural justice on many-fold grounds. Thus, if the Petitioner is able to substantiate each or any of the above pleas, there would be a violation of principles of natural justice and in those circumstances, the writ petition is maintainable.
3. Although the Petitioners may have remedy of post grant opposition or of seeking suo moto revocation as well as filing of a counter claim, that, by itself can be no basis to non-suit the Petitioners, if the Petitioners were right in their grievance that the authority has committed manifest or jurisdictional error while considering the representation by way of opposition or for that matter decided the objections on palpable misreading and misapplication of the relevant provisions of law.
4. The law provides for remedy of pre-grant opposition by virtue of Section 25(1) of the Act. If such a remedy is provided, the authority is obliged to consider the representation by way of pre-grant opposition under Section 25(1) keeping in mind the parameters of law by observing principles of natural justice.
5. The court also referred to the judgment of Gilead Pharmasset, LLC v. Union of India & Anr., wherein the Court held that if there is breach of principles of natural justice, then notwithstanding the alternative remedy by way of appeal the Court would have jurisdiction to entertain the writ petition.
6. 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 the Controller. Adverting to the impugned order, it is palpably clear that controller has not even taken note of Section 3(d) in the entire order and consequently not dealt with the submissions made in respect thereof.
7. The Court also noted that, non-consideration of Section 3(d) is self-evident from para 3 of the impugned order, where the Controller has enumerated the grounds raised by the opponent.
8. With regard to the argument of the Respondents, that, the Controller has comprehensively ruled on novelty and held that the composition is not a mere admixture, the very premise of Section 3(d), i.e., combination being a known substance goes and no separate finding was required to be given under Section 3(d), the Court held that:-

• this position adopted by the Respondents is both factually and legally incorrect when placed in the context and perspective of the provisions of Section 3(d). While with respect to Section 3(e) Controller has observed that the composition under the patent application is not a mere admixture and the data provided by the Applicant regarding stability and bio-efficacy shows synergistic effect, the order does not state anything about the efficacy.
• 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.
• Section 3(d) is not ex major 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 controller 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.
• 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, Controller 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.
• 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. The Court held that, none of these factors are germane to answer the real question of opposition raised under Section 3(d). Controller 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).
• The court also held that, 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, Controller 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.

1. The Court also held that 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 that they have not been considered by the Controller.
2. While it cannot be disputed that being a quasi-judicial Authority, Controller 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 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.
3. The Court also held that, insofar as the first amendment is concerned, Court finds force in the contention of the Controller and the patent applicant as what was sought to be amended was a mere typographical error. However, with respect to the second amendment applicant sought to amend the range of the thickener from 0.025-05% to 0.05-0.25%.
4. The Court held that even 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 which were allowed.

It was therefore concluded that 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. Petitioner has been able to make out a case for remanding the matter to controller for reconsideration of the pre-grant opposition, confined to the issues raised before this Court in the context of Section 25(1)(f) read with Section 3(d) of the Act, non-consideration of the documents as referred to above and the amendment to claim No. 7.