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.
Background:
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
Disclaimer:
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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