Thursday, July 27, 2023

Oyster Point Pharma Inc Vs The Controller of Patents

Date of Judgement:26.07.2023
Case No. AID No.10 of 2022
Neutral Citation:NA
Name of Hon'ble Court:High Court of Calcutta
Name of Hon'ble Judge:Ravi Krishan Kapur, HJ
Case Title:Oyster Point Pharma Inc Vs The Controller of Patents

Evaluating Inventive Step in Patent Applications: 

Abstract: 

This article analyzes the criteria required to be taken into consideration by the Controller of Patent while assessing the patentability of a patent application concerning inventive step.

It discusses a specific case where a patent application was rejected, but later appealed successfully based on the principles established by the Hon'ble Supreme Court of India and the case of Agriboard International LLC vs Deputy Controller of Patents. 

The article highlights the importance of analyzing existing knowledge, distinguishing prior art, and considering experimental evidence to determine inventive step in accordance with Section 2(1)(ja) of the Patents Act 1970.

Introduction: 

The grant of a patent is subject to several criteria, one of the most crucial being inventive step. This article discusses the legal aspects surrounding the patent application rejection and subsequent appeal related to the inventive step of the subject matter.

Background of the Case: 

The subject matter of the patent application in question involves a stereospecific synthesis of (R)-5(E)-2-pyrrolidin-3ylvinyl)pyrimidine, its salt forms, and novel polymorphic forms of these salts. 

The invention also includes methods for treating various medical conditions and disorders. The Controller of Patents rejected the patent application citing prior art documents D1, D2, and D3 under sections 2(1)(ja) and 3(d) of the Patents Act 1970.

Criteria for Assessing Inventive Step: 

According to the Agriboard International LLC vs Deputy Controller of Patents case, while evaluating the inventive step, the Controller must consider three key elements:

  1. Existing Knowledge: The Controller must identify the relevant prior art, which includes all publicly available information and documents that were accessible before the filing date of the patent application.

  2. Invention Disclosed in the Application: The Controller should thoroughly analyze the invention as disclosed in the patent application under consideration.

  3. Obviousness to a Skilled Person: The Controller needs to assess whether the subject invention would be obvious to a person skilled in the relevant field of art.

The Role of Enhanced Efficacy: 

The Appellant contended that the Controller did not discuss the aspect of enhanced efficacy, which could have been crucial in demonstrating non-obviousness.

 In support of this argument, the Appellant relied upon the judgment of the Hon'ble Supreme Court of India in Novartis AG vs Union of India (2013) 6 SCC 1.

Analysis of the Hon'ble Court's Decision: 

The Hon'ble Court observed that the Controller's order lacked discussion on how the Appellant sought to distinguish D1, one of the cited prior art documents, from the subject invention. The Appellant had pointed out the disadvantages of D1 as prior art, but the Controller failed to address this aspect in the rejection order.

Importance of Experimental Evidence: 

Another ground for allowing the appeal was the Appellant's submission of detailed experiments, comparative studies, and conclusive results in support of the claimed invention, which were discussed in Appendix A, B, and C. The Hon'ble Court noted that these crucial pieces of evidence should have been duly considered before passing the rejection order.

Concluding Note: 

While assessing the patentability of a patent application with respect to inventive step, the Controller of Patent must consider existing knowledge, distinguish the invention from prior art, and analyze the obviousness to a skilled person. 

Furthermore, any aspect of enhanced efficacy or experimental evidence supporting the claimed invention should be given due consideration. 

The case discussed in this article serves as a significant reminder to the patent examiners and applicants about the importance of a comprehensive and well-reasoned analysis when evaluating inventive step under the Patents Act 1970.

DISCLAIMER

Information contained herein is being shared in the public Interest. The same should not be treated as substitute for legal advice as it is subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the facts and law involved herein.

Advocate Ajay Amitabh Suman
IP ADJUTOR
Patent and Trademark Attorney

#IP_Adjutor #Trademark #Copyright #Design_infringement #Patent_infringement #IPR #Intellectualpropertyright #Iprupdate #Iprnews #Iprblog #Legalblog #law #legal

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