Enhanced solubility and Bio-availability and Section 3(d) of Patent Act 1970
Background:
Section 3(d) of the Indian Patent Act 1970 prohibits the grant of patents for inventions that are mere enhancements of known substances, unless such enhancements result in a significant improvement in efficacy.
This provision aims to strike a balance between promoting innovation and ensuring affordable access to essential medicines, particularly in the context of pharmaceutical patents. The interpretation of Section 3(d), particularly regarding the criterion of therapeutic efficacy, has been the subject of several legal disputes and judicial pronouncements.
Case Overview
The case under consideration before the Hon'ble Division Bench, High Court of Delhi, involved an appeal challenging the validity of a patent (IN’176) granted for a medicinal product. The central issue before the Court was whether the properties of enhanced solubility and bio availability, claimed by the applicant, could be construed as evidence of higher therapeutic efficacy, thus satisfying the requirements of Section 3(d). The appellant argued that the enhanced bioavailability of the patented product did not necessarily translate to a higher therapeutic efficacy, as claimed by the patent holder.
Judgment Analysis:
In its analysis, the Hon'ble Division Bench, High Court of Delhi provided clarity on the interpretation of Section 3(d) and its application to pharmaceutical patents. The Court emphasized that the test of efficacy under Section 3(d) should be limited to therapeutic efficacy, rather than considering other properties such as enhanced solubility and bioavailability.
The Court reasoned that while enhanced bioavailability might contribute to the effectiveness of a medicinal product, it does not automatically imply a higher therapeutic efficacy.
Furthermore, the Court noted that the applicant had not claimed any enhancement in therapeutic efficacy in its patent application. Instead, the sole advantage claimed was related to enhanced solubility and bioavailability.
Based on these observations, the Court concluded that the appellant had raised a credible challenge to the validity of the patent (IN’176), as the claimed properties did not establish a significant improvement in therapeutic efficacy as required under Section 3(d).
Implications and Conclusion
The judgment provides valuable guidance on the interpretation and application of Section 3(d) of the Indian Patent Act 1970, particularly in the context of medicinal patents. By clarifying that the test of efficacy is limited to therapeutic efficacy and cannot be extended to properties like enhanced solubility and bioavailability, the Court reaffirmed the legislative intent behind Section 3(d) to prevent the grant of patents for mere incremental improvements of existing substances.
The Case Discussed:
Case Title: Natco Pharma and Novartis AG and another
Judgment/Order Date: 24.04.2024
Case No:FAO OS Comm 178 of 2021
Neutral Citation: 2024:DHC:3198
Name of Court: Delhi High Court
Name of Hon'ble Judge: Vibhu Bakhru and Amit Mahajan,H.J.
Disclaimer:
This article is meant for informational purposes only and should not be construed as substitute for legal advice as Ideas, thoughts, views, information, discussions and interpretation perceived and expressed herein are are subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue of law involved herein.
Written By: Advocate Ajay Amitabh Suman
IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com
Ph No: 9990389539
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