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Inadequate reasoning by the Controller in refusing a patent application has remained a matter of concern for courts in India in many appeals. In Steigerwald Arzneimittlewerk Gmbh vs The Assistant Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 423/2022], the High Court of Delhi set aside the order of the refusal of the appellant's patent application 1285/DEL/2009 for "Method for the Production of a Plant-Based Medicament" for similar concerns. After reviewing the impugned order, the Court found that the respondent Controller had rendered the invention obvious without providing any reason.
Case of the Appellant
The appellant submitted that the respondent refused their patent application on the grounds of lack of novelty and inventive step under Section 2(1)(j) of the Patent Act, 1970, without giving adequate reasons. The appellant argued that the respondent had failed to appreciate that the novel and inventive technical features of the claimed method were characterised over the prior art. The appellant submitted that it was unclear as to how and/or why the characterising feature of Claim 1 was obvious in view of the cited prior art documents.
According to the appellant, it clearly demonstrated that the impugned order was a non-speaking order. Explaining the characteristic features of the invention, the appellant submitted that the claimed invention was based on a suitable mixing sequence, which enables a recovery of the lead substance of the individual extracts, ensures the required stability and guarantees the efficacy as well as the harmlessness for later use as a medicament. This mixing sequence, according to the appellant, evolved into a specific method for creating herbal medicinal extracts (e.g., Iberis Amara, Menthae Piperitae) to achieve the required stability by preventing crystal formation. According to the appellant, this unique mixing sequence produced a surprising technical effect that was not present in traditionally prepared plant-based medicaments containing the osthol content ("lead substance").
Respondent's Reply
The respondent argued that merely stating the process steps for mixing different extracts, as disclosed in prior art D1, without any significant data showing enhanced efficacy of the medicament when given to a patient/any other data showing higher stability, lacks inventive step. The respondent Controller submitted that D1 disclosed all the components except one - Cardui mariae fructus. According to the respondent, all the ingredients used in D1 were also in highly purified form as in the claimed invention, and the purpose of the medicament was also similar. Therefore, the claimed invention was obvious to a person skilled in the art.
The respondent Controller contended in D2 that all the ingredients, as well as various other parameters and factors, leading to a highly purified product and its use in the treatment of a similar disease, made the whole process, if studied in conjunction with the D1 disclosure, obvious to the person skilled in the art. The respondent Controller contended that, in the problem-solving approach followed by the appellant to arrive at the claimed invention, it was essential to provide comparative data to show that the claimed invention was technically superior to D1. The respondent Controller further submitted that the appellant failed to disclose any data demonstrating that the claimed invention had enhanced efficacy when administered to a patient.
The Controller also submitted that the appellant failed to provide any other data showing higher stability. With respect to the rejection under Section 3(d) & 3(e), the Controller submitted that the claimed invention related to a mere admixture of 9 plant extracts/drugs resulting in aggregation of properties. The Controller submitted that the claimed surprising and superior effect of the method for combining plant extracts in a certain ratio and in a specific sequence was not supported by the disclosure in the complete specification. Since no significant data was provided to explain how the stated process steps were inventive, the claimed invention was non-patentable under Section 3(d) & 3(e).
Court's Analysis and Findings
On the Subject of Invention
On reading the complete specification, the Court found that the claimed invention relates to a method for the production of a plant-based medicament (Iberogast) containing Iberis amara, Menthae piperitae folium, Matricariae flos, Carvi fructus, Mellissae folium, Angelicae radix, Liquiritiae radix, Cardui mariae fructus and Chelidonii herba in alcoholic extract form and a medicament produced by this method. The prior art disclosed that it was problematic to obtain a constant effective substance content in the finished medicament and to obtain a consistent, reproducible quality.
The present invention solved this problem by providing a method for producing a plant-based medicament according to Claim 1. The crucial factor in solving the problem in prior art was the sequence of additions of the individual drug extracts. The claimed mixing sequence (addition sequence) prevented the formation of crystals of the ingredients (secondary plant substances) of the herb extracts. The claimed invention thus enabled maintaining a constant effective substance content in the finished medicament and a consistent, reproducible quality in the final package over a longer period.
On Section 2(1)(ja)
According to the Court, the impugned order mainly focused on the cited documents D1 and D2 and states that if the process disclosed in D2 is studied along with D1, it would render the present invention obvious for a PSITA. In the impugned order, it was stated that since D1 disclosed all the components except one Cardui mariae fructus, which is also present in a highly purified form, similar to the present invention, and the purpose of using/application of this medicament is also similar, the present invention is obvious for the person skilled in the art. The reasoning given by the learned Controller for the rejection of the subject application was that in this invention, by merely stating process steps of mixing different extracts, which are disclosed in prior art D1, without any significant data to show enhanced efficacy of the medicament when given to a patient/any other data showing higher stability, lacked inventive step.
Referring to Table 13 given in D1, the appellant contended that the ratio given in the bracket was not the same as the claimed ratio of the subject application. The respondent maintained that, similarly, in the case of D2, all the ingredients and various other parameters and factors leading to a highly purified product and use of the same for the treatment of the same disease made the whole process, if studied along with the D1 disclosure, obvious to a person skilled in the art. The Court found that the prior art D1 and D2 did not disclose the exact three-step sequence using the specified ratio of the ingredients. Additionally, D1 and D2 also failed to disclose the exact ratio of the Liquiritiae radix extract and Angelicae radix extract that are mixed in Step (A) of the mixing process, as claimed by the appellant.
The Court found that the Complete Specification states that the three-step sequence, along with the specified ratio of mixing Angelicae radix and Liquiritiae radix extracts, is crucial for the desired result of the present invention. The Court observed that to establish the obviousness to PSITA, it was required to be explained as to how the teachings of D2, either alone or with D1, would reach the claimed sequence, along with a specified ratio of mixing Angelicae radix and Liquiritiae radix extracts in a defined volume ratio of 1:6-3:1 in Step (A).
The Court held that the respondent's reasoning that the similarity of the ingredients in the present invention and in D1 would lead to similar-sized crystals could not be accepted without explaining that the claimed sequence was not disclosed in D1, which, if used, would prevent/inhibit the crystal formation. The Court cited ruling in Agriboard International LLC vs Deputy Controller of Patents and Designs [2022 SCC Online Del 940], wherein it was held that the Controller while raising the objection under Section 2(1)(ja) of the Act, ha to analyse as to what is the existing knowledge in the cited prior arts and how the PSITA would move from the existing knowledge to the subject invention claimed in the patent application under consideration.
The Court noted that without such an analysis, the rejection of the patent application on this ground under Section 2(1)(ja) would be contrary to the provision itself. The Court therefore ruled that the impugned order with respect to D1 and D2 was devoid of the reasoning as to how and/or why the PSITA would be motivated to modify the teachings of the cited prior art documents to arrive at the claimed invention.
On Section 3(d) & 3(e)
The Court found that the respondent Controller rejected the subject application on the grounds of Sections 3(d) and 3(e). Citing the ruling in Nippon Steel Corporation vs Controller General of Patents, Designs [2024:DHC:6514], the Court observed that it is important to note that while raising the objection under Section 3(d) of the Act, the "known process, machine, or apparatus" needs to be specified. Therefore, to raise an objection under Section 3(d) of the Act, the learned Controller must provide reasoning as to how the claimed method, including the three steps with the specified ratio, is "known" in the light of prior art.
The Court found that the reasoning provided by the respondent Controller regarding the objection under Section 3(e) was insufficient to warrant refusal, as the Complete Specification of the subject application discusses that the specific ratio mentioned in Claim 1 and the three steps result in a desirable result. The Court noted that the desirable effect, as per the Complete Specification, is achieved by combining the plant extracts in certain ratios and sequencing, and that accurate compliance with the correct mixing order is essential to obtain a stable product with defined recovery rates of the Lead Substance.
Court's Decision
The Court set aside the impugned order on account of several infirmities found therein, and remanded the matter for fresh consideration, with a direction to the respondent Controller to pass a detailed order with adequate reasoning.
Concluding Comments
This case joins the growing list of cases remanded by the appeal court for want of adequate reasoning by the respondent Controller in refusing a patent application. The Court referred to the ruling in the 'Agriboard International' case to reconfirm that the Controller should analyse as to what the existing knowledge is in the cited prior arts and how the PSITA would move from the existing knowledge to the subject invention when the objection under Section 2(1)(ja) is taken as a ground for refusal of a patent application.
Inadequate reasoning by the respondent Controller in this case led the Court to rule that the Controller failed to properly evaluate the appellant's technical advancements as required under the inventive step analysis. The Court made it clear that without such an analysis, the rejection of the patent application under Section 2(1)(ja) would be contrary to the provision itself. This case has been rightly sent back to the Controller for fresh consideration and passing a detailed order with adequate reasoning. After this ruling, it is expected that every refusal of a patent application by the Controller in the future will include adequate reasoning to support and warrant the rejection.
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