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Interpretation And Implications Of The Biological Diversity Act In Patent Applications

The interplay between intellectual property rights and biological resources has long been a subject of contention, especially in jurisdictions where biodiversity is rich and bioprospecting is prevalent. The case at hand presents a nuanced examination of the rights and obligations of parties involved when seeking patent protection over inventions that may, directly or indirectly, relate to biological resources sourced from a particular jurisdiction.

In this case . the Petitioner filed application for patent protection for its 'Heat Stable Liquid Rotavirus Vaccine'. The National Biodiversity Authority (NBA) of India asserted that under Section 6 of the Biological Diversity Act, prior permission was mandatory if the invention was based on any research or information derived from a biological resource originating from India.

Relevance of the Biological Diversity Act
The Biological Diversity Act of India, enacted to regulate access to biological resources and associated knowledge, seeks to ensure equitable sharing of benefits arising out of their utilization. Section 6 of the Act mandates that any person seeking intellectual property rights over an invention based on biological resources from India must obtain prior approval from the NBA.

Key Legal Issues:

  1. Definition of 'Biological Resource': Central to the dispute is the determination of whether the 'Heat Stable Liquid Rotavirus Vaccine' qualifies as a 'biological resource' under the Act. The Act does not provide an exhaustive definition, making it imperative to interpret the term contextually and purposively.
  2. Violation of Section 6: The NBA's contention that the Petitioner violated Section 6 hinges on the interpretation of the Act vis-�-vis the nature of the invention. The Act's intent is clear: to regulate and ensure fair and equitable sharing of benefits arising from the commercial use of biological resources.
  3. Benefit Sharing Component: The NBA's decision to approve the application with a higher benefit-sharing component underscores the Act's emphasis on equitable sharing of benefits derived from the commercialization of biological resources. This serves as a deterrent against potential biopiracy and ensures that local communities benefit from the commercial exploitation of their resources and knowledge.

Court's Directive:
The Court's directive to the NBA to determine whether the invention pertains to a biological resource necessitates a comprehensive and reasoned order. The involvement of an Expert Committee, potentially assisted by senior officials from the CGPDTM (Controller General of Patents, Designs and Trade Marks), underscores the complexity and significance of the matter.

Implications and Way Forward:
  1. Clarity on Definitions: There is an inherent need for clarity in defining what constitutes a 'biological resource' under the Act to avoid ambiguities and legal disputes in the future.
  2. Balancing Interests: While protecting national interests and ensuring equitable benefit-sharing is paramount, it is equally essential to strike a balance that encourages innovation and foreign investment.
  3. Collaborative Approach: Encouraging a collaborative approach between the NBA, inventors, and foreign entities can foster transparency, mutual respect, and understanding, thereby mitigating potential disputes and promoting responsible bio prospecting.

The concluding Note:
The case exemplifies the challenges and complexities associated with reconciling intellectual property rights with biodiversity conservation and equitable benefit-sharing. As jurisdictions grapple with similar issues globally, the need for a harmonized approach that respects national sovereignty, promotes innovation, and ensures equitable sharing of benefits remains paramount.

The Case Law Discussed:
Case Title: Inventprise, Inc Vs The Controller Of Patents
Date of Judgement/Order:20.12.2023
Case No. W.P.(C)-IPD 26/2023
Neutral Citation: N.A.
Name of Hon'ble Court: Delhi High Court
Name of Hon'ble Judge: Prathiba M Singh

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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