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Criterion for Medicinal Preparation and Enhanced Therapeutic Efficacy under Section 3(d) of the Patent Act 1970

This discussion delves into the criteria for medicinal preparations to meet objections under Section 3(d) of the Patent Act 1970, drawing insights from a recent case involving the rejection of a patent application titled "Compositions and Methods for Treating Ischemia and Ischemia-Reperfusion Injury."

Background of the Case:
The patent application in question, filed under No. �9739/DELNP/2011� on 12.11.2011, faced rejection by the Controller of Patent on 13.05.2010. The primary ground for rejection was the purported lack of data demonstrating therapeutic efficacy. The central issue before the Hon'ble High Court of Delhi was the interpretation and application of Section 3(d) of the Patent Act 1970.

Section 3(d) and the Criterion for Medicinal Preparation:
Section 3(d) of the Patent Act 1970 acts as a safeguard against the unwarranted extension of patent monopolies, particularly in the pharmaceutical domain.

It stipulates that mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance, shall not be considered patentable. The case in question revolves around whether the medicinal preparation met the criterion of enhanced therapeutic efficacy.

Controller's Allegation and High Court's Response:
The Controller of Patent asserted that while the appellant may have provided some data, it failed to establish how the data constituted therapeutic efficacy. According to the Controller, enhanced therapeutic efficacy is demonstrated when a substance exhibits superior curative effects compared to existing substances.

The Hon'ble High Court of Delhi, in remitting the case back to the Controller, granted the appellant the liberty to submit trial data supporting the claim. The Court emphasized that the patent specification itself should contain data and results of lab experiments illustrating the enhancement of efficacy. Additionally, any additional data should be submitted prior to the final oral hearing.

Importance of Data Submission and Oral Explanation:
The Court's observations highlight the crucial role of data presentation during the patent application process. It underscores the importance of including comprehensive experimental results in the patent specification to substantiate claims of enhanced therapeutic efficacy.

Furthermore, the Court expressed concern over the practice of submitting additional data in written submissions post-oral hearings, as it may lead to oversight by the Patent Office and hinder a complete understanding of the presented data.

The Concluding Note:
The case discussed sheds light on the nuanced considerations involved in evaluating the enhanced therapeutic efficacy of medicinal preparations under Section 3(d) of the Patent Act 1970. It underscores the need for patent applicants to present robust data in the patent specification itself, ensuring clarity and comprehension during the examination process.

The Case Law Discussed:
Case Title: Ischemix LLC Vs The Controller of Patent
Date of Judgement/Order:22.11.2023
Case No. C.A.(COMM.IPD-PAT) 33/2022
Neutral Citation No:2023:DHC:8496
Name of Hon'ble Court: Delhi High Court
Name of Hon'ble Judge: Prathiba M Singh, HJ

Ideas, thoughts, views, information, discussions and interpretation expressed herein are being shared in the public Interest. Readers' discretion is advised as these are subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue involved herein.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539

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