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Test Of Enhanced Efficacy In Relation To Phytase Under Section 3(D) Of The Patent Act 1970

This article delves into the case of Patent Application No. 5326/CHENP/2008, titled "Phytase Variants with Improved Thermostability," which raised pertinent questions regarding the scope of Section 3(d) and the assessment of enhanced efficacy in patent applications.

The appellant in this case sought a patent for "Phytase Variants with Improved Thermostability." The patent application was initially rejected by the Controller of Patents on November 15, 2016. The rejection was based on two key sections of the Patent Act of 1970: Section 3(e) for certain claims (Claim Nos. 8 to 11) and Section 3(d) for the main claims of the application.

Section 3(e) and Claim Nos. 8 to 11:
Claim Nos. 8 to 11 were rejected under Section 3(e) of the Patent Act, which deals with inventions dealing with composition lacking synergism. The court upheld this rejection since the appellant failed to demonstrate that the composition claimed was more than the sum of its parts, essentially finding that the patent lacked synergism.

Section 3(d) and Enhanced Efficacy:
The primary focus of this case rested on the rejection of the main claims under Section 3(d) of the Patent Act of 1970. Section 3(d) is a crucial provision that restricts the patenting of new forms of known substances unless they exhibit significantly enhanced efficacy. This provision has been the subject of numerous legal disputes and has raised questions about what constitutes "enhanced efficacy."

The appellant contended that their invention's improved thermostability should be construed as an enhancement of a known substance, phytase. To support this claim, the appellant relied on Example 8 and Table 5 of the specification, which demonstrated improved thermostability of the phytase variants.

The respondent did not contest the improved thermostability but argued that thermostability was a natural or desirable property of phytase and that increased thermostability alone did not signify increased efficacy.

Analysis of Enhanced Efficacy:
The critical issue before the court was whether improved thermostability amounted to enhanced efficacy under Section 3(d). The court's decision rested on the understanding that phytase primarily acts as a catalyst to expedite digestion, and improved phytate hydrolysis leading to the enhanced conversion of indigestible phosphorus to digestible form was not a mandatory requirement to establish improved phytase efficacy.

The court's reasoning was based on the premise that if a phytase variant could withstand and remain functional at higher temperatures due to increased thermostability, it inherently contributed to the improved efficacy of the enzyme in real-world applications. As the patent application demonstrated increased thermostability, which was not contested by the respondent, the court concluded that the Ld. Controller's decision to invalidate the patent under Section 3(d) was unwarranted.

The Concluding Note:
This case provides valuable insights into the interpretation and application of Section 3(d) of the Patent Act of 1970. It underscores the importance of a nuanced analysis of enhanced efficacy in relation to subject matter biochemical product namely Phytase and highlights that improvements in properties relevant to an invention's function, such as thermostability in this case, can indeed constitute enhanced efficacy.

Date of Judgement: 20/09/2023
Case Title: Novozymes Vs Assistant Controller of Patents & Designs
Case No. (T) CMA (PT) No.33 of 2023 (OA/6/2017/PT/CHN)
Neutral Citation No:N.A.
Name of Hon'ble Court: High Court of Madras
Name of Hon'ble Judge: Senthil Kumar Ramamoorthy, JJ

Information and discussion contained herein is being shared in the public Interest. The same should not be treated as substitute for expert advice as it is 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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