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The patent application filed by Medilabo RFP Inc. for the invention bearing the title 'Prophylactic or Therapeutic Drug for Neurodegenerative Diseases' was refused under Section 3(i) of the Act. In Medilabo RFP Inc. vs The Controller of Patents (C.A.(COMM.IPD-PAT) 16/2024), the appellant filed an appeal alleging that the order of the Assistant Controller of Patents and Designs lacked in subjective examination of the amended claims, where the appellant had deleted reference to the mode of administration and combination reference from Claim 1.
The subject invention disclosed a medicine/drug composition/pharmaceutical formulation useful for the treatment of a neurodegenerative disease and capable of reducing adverse side effects. The originally filed Claims 3 to 13 disclosed a prophylactic/therapeutic drug in which rifampicin and resveratrol were administered as a dosage regimen based on the subject's body weight, via trans nasal administration over a specified period.
The respondent Controller, in the order of refusal, stated that the notwithstanding the deletion of the claims related to dosage regimen and the disease condition in the written submission submitted by the applicant after the hearing on October 6, 2023, stated that the scope of the claim was not restricted only to the combination of the drugs per se, but their dosage regimen, which according to the Controller was a treatment method not permissible under Section 3(i). The appellant pointed out that the hearing notice had other objections under Sections 2(1)(ja), 59, and 3(d) of the Act, and these objections were not addressed in the impugned order by the Controller.
Appellant's Case
The appellant stated that the respondent Controller had issued the impugned order based on the earlier filed claims, not the amended claims. As per the appellant, these claims were not the final claims for adjudication, as post-hearing amended claims were filed, and the reference to the mode of administration was intentionally deleted to clarify beyond doubt that the invention lies in the claimed composition and not in the route of administration. The appellant contended that the respondent Controller has failed to recognise that the invention claimed in Claim 1 of the subject invention pertains to a composition and not a method of treatment.
According to the appellant, this was evident from a plain reading of Claim 1 in light of the complete specification. The appellant argued that Claim 1 was a product claim and not a method claim. Hence, the refusal of Claim 1 under the objection of Section 3(i) of the Act was manifestly erroneous. Additionally, Claim 2 of the subject invention was also related to a 'kit', a product that includes the medicinal agent of Claim 1 and Claim 2 did not contain 'method of treatment' steps. The appellant argued that the interpretation of the respondent Controller went against the object of the Act, which recognises product/formulation patents subject to the requirements of Section 3(e) of the Act being met, and Section 3(i) of the Act was inapplicable to composition claims.
Respondent's Reply
The respondent Controller maintained that although the Appellant deleted the claims related to dosage regimen and the disease condition, in the written submission submitted after the hearing on October 6, 2023, the appellant submitted that the scope of the claim was not restricted only to the combination of the drugs per se, but their dosage regimen, which is a treatment method. Additionally, in the subject application, if one read the claims and the description in toto, it would be evident that the application was related to a dosage regimen rather than a composition per se. The respondent also referred to all working examples given in the specification, which, according to the respondent, clearly showed that the composition was administered as a dosage regimen in an experimental model (mice) and extrapolated to humans to treat dementia. The respondent maintained that the patent was rejected because the claimed composition was related to a dosage regimen that attracts Section 3(i) of the Act under the method of treatment.
Court's Analysis and Findings
On Non-Consideration of Amended Claim
The Court found that the amended claims submitted after the hearing on October 6, 2023, removed the mode of administration and combination reference from Claim 1. The Court noted that the mode of administration was deleted in the amended claims, while the learned Controller, while considering the original claims, raised arguments regarding the same.
On Objection in Hearing Notice Not Addressed
The Court found that the hearing notice had other objections under Sections 2(1)(ja), 59, and 3(d) of the Act. These objections were not addressed in the impugned order. The Court cited the decision of the Delhi High Court in Adama Makhteshim Ltd vs The Controller of Patents & Designs, C.A. (Comm IPD-PAT) 167/2022, where it was held that the Controller should examine all grounds of objection while deciding an application, even if the application is found to be nonpatentable on any one of the preliminary or technical grounds. Applying this ruling, the Court set aside the impugned order dated December 21, 2023.
Decision of the Court
Setting aside the order of refusal of patent, the Court directed that the subject application be remanded to the respondent Controller for fresh consideration, including the amended claims. In this case, the Court did not consider the merit of the case under Section 3(i).
Conclusion
This case once again highlighted procedural lapses by the Controller in the approach to refusing the patent application. The Controller erred in the first place by not considering the amended claims and secondly, by ignoring the ruling of the High Court in the 'Adama Makhteshim Ltd' case, which clearly mandated that the Controller should examine all grounds of objection while deciding an application, even if the application is found to be nonpatentable on any one of the preliminary or technical grounds.
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