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New Form Of Known Substances And Bar Of Section 3 (D) Of Patent Act 1970

Section 3(d) of the Patents Act, 1970, serves as a safeguard against evergreening of patents. This article delves into a recent decision by the Hon'ble High Court concerning the application of Section 3(d) to the compound RTA-408 and its polymorphic forms.

The Controller of Patents, in an order dated 18.09.2020, refused the grant of a patent for the compound RTA-408 under Patent Application No.8486/DELNP/2014. The primary contention revolved around the applicability of Section 3(d) of the Patents Act, 1970. The Applicant, in their defense, posited that RTA-408 was not a known substance and hence Section 3(d) was inapplicable.

Understanding Section 3(d):
Section 3(d) of the Patents Act, 1970, is a provision aimed at ensuring that mere trivial modifications of known substances do not receive patent protection. The provision essentially bars patents for:

"the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant."

This provision is instrumental in preventing 'evergreening', where patentees attempt to extend patent protection by making trivial modifications to known substances without substantial improvement in efficacy.

The High Court's Analysis:
The Hon'ble High Court undertook a meticulous examination of the claimed invention vis-�-vis RTA-408 and its comparison with another substance, TX-63682. The court elucidated that the claimed invention contains additional fluorine atoms, delineating a distinct chemical composition from RTA-408. This differentiation is crucial as it indicates that the invention is not merely a new form of RTA-408 but possesses distinct chemical attributes.

Furthermore, the court took cognizance of the structural similarities between the claimed invention and TX-63682, particularly highlighting the di-methyl substitution in the former. Despite potential structural resemblances, the presence of this substitution underscores the uniqueness of the claimed invention. Hence bar of Section 3 (d) was held not to be applicable in the instant case.

Implications and Conclusion:
The decision by the Hon'ble High Court in this case provides significant clarity on the interpretation and application of Section 3(d) of the Patents Act, 1970. By emphasizing the distinct chemical composition and structural variations, the court elucidated that the claimed invention cannot be categorized merely as a new form of a known substance.

The Concluding Note:
While Section 3(d) serves as a bulwark against the unwarranted extension of patent protection, its application necessitates a rigorous examination of the substance's characteristics. The decision concerning RTA-408 exemplifies the judiciary's commitment to upholding the principles enshrined in the Patents Act, 1970, and ensuring that patent protection is conferred judiciously and in consonance with legislative intent.

Case Title: Mr.Tony Mon George Vs Deputy Controller of Patents & Designs
Date of Judgement/Order:20.12.2023
Case No. (T) CMA (PT) No.150 of 2023
Neutral Citation No:2023:MHC;5451
Name of Hon'ble Court: Madras High Court
Name of Hon'ble Judge: Senthil Kumar Ramamoorthy, 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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