The Madras High Court, in its decision dated November 21, 2024, in Intervet International B.V. v. Deputy Controller of Patents and Designs, overturned the refusal order issued by the Controller concerning patent application No. 449/CHENP/2010. The decision underscores and reiterates the critical importance of adhering to the principles of natural justice and providing reasoned orders in quasi-judicial proceedings.
Background/Facts
Intervet International B.V. (“Intervet”) filed a patent application for solvated and non-solvated crystalline forms of 20,23-dipiperidinyl-5-O-mycaminosyl-tylonolide, a compound offering enhanced physical and chemical stability, superior thermodynamic and kinetic properties, and improved filtration efficiency. However, the Controller refused the application citing objections under Sections 3(d) and 3(e) of the Patents Act, 1970.
Intervet challenged the refusal order before the Madras High Court arguing that the invention demonstrated significant technical advancements and economic benefits over the prior art and was non-obvious to a person skilled in the art.
Arguments
In their appeal, Intervet contended that the Controller’s order was a non-speaking order, lacking sufficient reasoning and in violation of the principles of natural justice. They argued that the decision failed to consider the expert testimony of Dr. Ralf Warrass, which substantiated the superior stability of the claimed crystalline forms. Drawing support from the Delhi High Court’s judgment in Regents of the University of California v. Union of India, Intervet argued that the Controller was required to provide specific reasons when rejecting the affidavits of recognized experts.
Intervet also asserted that the Controller erred in applying Sections 3(d) and 3(e) of the Patents Act to reject the application. They contended that the Controller misinterpreted Section 3(d) by asserting that superior stability does not constitute an enhancement of therapeutic efficacy. They emphasized that stability plays a crucial role in therapeutic efficacy, as a more stable drug resists decomposition into by-products, leading to prolonged bioavailability, which in turn reinforces the patentability of the invention. Additionally, Intervet claimed that the application of Section 3(e) was incorrect, as the invention involves a novel crystalline form with unique and advantageous properties, which distinguishes it from prior art. Citing Section 10(4)(a) of the Patents Act, which outlined the sufficiency of disclosure requirements, Intervet disputed that there is no obligation to provide synergistic data for individual components in a claimed composition.
Intervet also argued that the Controller had failed to comply with the Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals, issued by the Patent Office. Referring to the Delhi High Court’s decision in DS Biopharma Limited v. Controller of Patents, Intervet contended that proof of enhanced therapeutic efficacy alone is sufficient to establish patentability, and there is no need for additional pleading or evidence. Furthermore, Intervet highlighted that similar patents had already been granted in jurisdictions such as the USA, Russia, and Japan, demonstrating its patentability on a global scale. Drawing on judicial precedents, Intervet requested the Court to set aside the impugned order on account of violation of principles of natural justice.
The counsel for the Controller defended the rejection, arguing that Intervet failed to demonstrate enhanced therapeutic efficacy, a requirement outlined in the Novartis AG vs. Union of India judgment. The counsel asserted that enhanced stability alone is insufficient for patentability unless it directly translates into improved therapeutic efficacy. The counsel maintained that the impugned order was a reasoned, speaking order that adhered to the principles of natural justice.
Court’s Observations
The Court observed significant procedural and substantive deficiencies in the Controller’s decision. It noted that the Controller’s refusal to grant the patent violated the principles of natural justice by failing to provide Intervet an opportunity to substantiate their claims of enhanced therapeutic efficacy. The Court further emphasized that the impugned order lacked detailed reasoning and analysis, particularly regarding the expert affidavit by Dr. Warrass.
The Court also noted that the prior arts relied upon by the Controller for rejecting the patent application either did not disclose the claimed crystalline forms or were published after the priority date of their patent application.
Referring to Novartis AG v. Union of India and DS Biopharma Limited v. Controller of Patents and Designs, the Court pointed out that “it would suffice if the applicants are able to prove that their claimed invention has enhanced therapeutic efficacy and there is no necessity to take a specific plea in their application that the claimed invention has therapeutic efficacy.” According to the Court, “only in cases of revocation of patents, a specific plea will have to be taken that the invention does not have enhanced therapeutic efficacy and the person seeking revocation also has to prove that the invention does not have therapeutic efficacy and therefore, it is hit by Section 3(d) of the Patents Act. ”, thereby rendering it ineligible for patent protection under Section 3(d).
Conclusion
The Madras High Court set aside the impugned order and remanded the matter for fresh consideration by a different officer, ensuring Intervet’s contentions are fully addressed. The Court has also specifically suggested adherence to the Court’s observations, to allow for amendments to the complete specification or claims as permitted under the law, and that the new order must be issued within six months from the receipt of the order. This decision reaffirms the significance of adhering to the principles of natural justice, particularly the requirement to issue reasoned orders, as emphasized in several recent judicial pronouncements.
Authored by Dr. Neetha Mohan, Patents Team, BananaIP Counsels
Relevant paragraphs
15.The respondent, under the impugned order, has not given an opportunity for the appellants as per the explanation to Section 3(d) of the Act to prove that the appellants’ claimed invention is a new form of known substance, having enhanced therapeutic efficacy. Having not being granted with such an opportunity as per explanation to Section 3(d) of the Act, it is clear that the impugned order has been passed in violation of Section 3(d) of the Patents Act, 1970 and also in violation of principles of natural justice. There is no reasoning whatsoever found in the impugned order to indicate that the crystalline form 20, 23 dipiperidinyl-5-O-mycaminosyl-tylonolide as claimed by the respondent in the pending claim 1 of the patent application constitutes mere discovery of a new form of the known substance. The appellants had submitted a declaration of Dr.Ralf Warrass, an expert, which according to them, clearly demonstrated the higher stability of the claimed crystalline form 20, 23 dipiperidinyl-5-O-mycaminosyl-tylonolide and the stable crystalline forms of tylonolide compound (as claimed in claim 1) is technically advanced than the amorphous forms, disclosed in the cited prior arts and also the other polymorphous forms. But the Expert Affidavit of Dr.Ralf Warrass has not been given due consideration in the impugned order.
16.The decision of the Delhi High Court in the case of Regents of University of California vs. Union of India and others reported in 2019 (79) PTC 55 (Del) supports the case of the appellants as in the said decision also, the impugned order refusing to grant patent was completely silent on the affidavit of experts, submitted by the appellants. The Delhi High Court held that the affidavit of the experts submitted by the appellants cannot be considered to be irrelevant without giving any reason for coming to such a conclusion and the Controller was required to indicate the reasons as to why the affidavit of experts, submitted by the appellants, has been rejected. Stability plays an important role in the therapeutic efficacy of a drug. The appellants claim that a more stable drug will not decompose into its by-products resulting in higher and longer bio-availability, which in turn results in higher therapeutic efficacy. The appellants therefore submitted that the pending claims 1-9 of the instant patent application is fully in compliance with the provisions of Section 3(d) of the Act and the respondent’s finding is contrary to the same. There is no reasoning given by the respondent in the impugned order with regard to the aforesaid contention of the appellants. The guidelines issued by the Patent Office in October 2014, which makes it clear in paragraph 1.17 that “for examination of pharmaceutical patents, incorporating the analysis of the Courts with the objective that the guidelines will help improve the examination standard and will introduce harmonious practice amongst the technical officers of the system”, has not been adhered to as the impugned order suffers from violation of principles of natural justice and it is a non-speaking order with regard to the contentions of the appellants.
17.In paragraph 10.12, Section 3(e) of the guidelines for examination of Patent Applications in the field of Pharmaceuticals, issued by the Controller General of Patents, Designs and Trademarks in October 2014 is simply a codification of the intent to prevent patents on the mere placing together of old integers. This Court fails to understand as to why under the impugned order, the respondent having admitted that “the instant claimed polymorphic form of the compound of Formula 1 by the appellants is a new/ novel form (crystalline form) 20, 23 dipiperidinyl-5-O-mycaminosyl- tylonolide for an already known compound has refused to consider the case of the appellants for grant of patent. No reasons have been given by the respondent under the impugned order for arriving at such a conclusion. Section 64(1)(h) of the Patents Act further elaborates the requirement under Section 10(4)(a) of the Act such that it provides the description of the method or the instructions for working of the invention with complete specification, which is sufficient to enable a person skilled in the art to work on the invention.
18.Moreover, as seen from Section 10(4)(a) of the Patents Act, it does not mandate providing synergistic data of the related activities of the individual constituents of the claimed composition. No reasons have been given by the respondent with regard to the contentions of the appellants in the impugned order for applying Section 3(e) of the Patents Act, 1970. In the impugned order, the respondent has observed that superior stability data can never be interpreted as superior therapeutic efficacy. The reasons for coming to such a conclusion with regard to the appellants Patent Application has not been given by the respondent under the impugned order. The appellants categorically contend that their claimed invention has enhanced therapeutic efficacy and in support of the said contention, they have produced materials, which includes the Declaration of Dr.Ralf Warrass, an Expert in the field. Since the respondent has not given reasons as to why the appellants’ claimed invention will not have enhanced therapeutic efficacy and the appellants have also not been provided with an opportunity to submit further explanation to prove that their invention has enhanced therapeutic efficacy, this Court is of the considered view that the impugned order is a non-speaking order and has been passed in violation of principles of natural justice.
19.In the decisions, relied upon by the learned counsel for the appellants in the case of Novartis AG vs. Union of India (UOI) and others reported in MANU/SC/0281/2013 and in the case of DS Biopharma Limited vs The Controller of Patents and Designs and another reported in C.A. (Comm.IPD-PAT) 6/2021 dated 30.08.2022, it has been held that it would suffice if the applicants are able to prove that their claimed invention has enhanced therapeutic efficacy and there is no necessity to take a specific plea in their application that the claimed invention has therapeutic efficacy. Only in cases of revocation of patents, a specific plea will have to be taken that the invention does not have enhanced therapeutic efficacy and the person seeking revocation also has to prove that the invention does not have therapeutic efficacy and therefore, it is hit by Section 3(d) of the Patents Act. The Patents Act also provides for amendment of the patent application under Section 59, which reads as follows:
’59. Supplementary provisions as to amendment of application or specification –
(1) No amendment of an application for a patent or a complete specification or any document relating thereto shall be made https://www.mhc.tn.gov.in/judis except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment;
(2) Where after the date of grant of patent any amendment of the specification or any other documents related thereto is allowed by the Controller or by the Appellate Board or the High Court, as the case may be —
(a) the amendment shall for all purposes be deemed to form part of the specification along with other documents related thereto;
(b) the fact that the specification or any other documents related thereto has been amended shall be published as expeditiously as possible; and
(c) the right of the applicant or patentee to make amendment shall not be called in question except on the ground of fraud.
(3)In construing the specification as amended, reference may be made to the specification as originally accepted.’
20.As seen from the aforementioned Section, it is clear that by way of disclaimer, correction or explanation, the amendment application can be filed. In the case on hand, the appellants categorically state that their invention has enhanced therapeutic efficacy and therefore, it will not be hit by any of the subsection of Sections 3 and 4 of the Patents Act. The case, as pleaded by the appellants is not a case of altering the appellants’ Original Patent Application. The appellants, at no point of time, claims to have changed their stand with regard to the contents of the Original Patent Application, submitted by them. Therefore, in order to strengthen their case for the grant of patent as prayed for in the Patent Application, the appellants are legally entitled to seek for amendment of their Original Patent Application to give further explanation to strengthen their case for the grant of patent as per the Original Application.
21.Section 59 of the Patents Act, 1970 legally empowers the appellants to file an Amendment Application by way of disclaimer, correction or explanation in respect of their Original Patent Application. In the impugned order, the respondent has not emphasised enough on the points raised by the appellants and no proper analysis has been done on the contentions of the appellants before arriving at the impugned decision. The reasoned orders are the mandate for refusing to grant patent by the respondent. The principles of natural justice are also indispensable and compliance with the doctrine of audi alteram partem are mandatory in the cases of this nature. This Court understands that it cannot assume the role of Controller and substitute the decisions given by the quasi-judicial authority without any valid reason. However, it must be essentially noted that the law is clear as to decision-making process of quasi-judicial authorities should adhere to the principles of natural justice and should pass speaking orders.
22.For the foregoing reasons, the impugned order dated 29.12.2017 passed by the respondent, refusing to grant patent to the appellants, suffers from violation of principles of natural justice and it is a non-speaking order with regard to the contentions of the appellants, which was also raised before the respondent and therefore, the impugned order has to be quashed and the matter has to be remanded back to the respondent for fresh consideration, on merits and in accordance with law, within a time frame to be fixed by this Court.
Citation: Intervet International B.V. v. Deputy Controller of Patents and Designs, CMA (PT) No. 119 of 2023 (H.C. Madras Nov. 21, 2024). Available at: https://indiankanoon.org/doc/127062834/
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