Madras High Court via recent judgement dated March 28, 2024, in Genentech vs Controller Of Patents And Designs [(T)CMA(PT) No.57 of 2023 (OA/50/2020/PT/CHN)] addressed Genentech, Inc.’s appeal concerning the rejection of its patent application (No. 5832/CHENP/2014) for “Inhibitors of IAP”—organic compounds intended for cancer therapy.
Genentech’s patent application included 22 claims, later amended to six, focusing on compounds with an oxazolyl moiety. The Controller of Patents cited prior arts (D1 to D4), raising objections under Sections 2(1)(j) and 2(1)(ja) (lack of novelty and inventive step), and Sections 3(d), 3(e), and 3(i) of the Patents Act.
With regard to the inventive Step (Section 2(1)(ja)),the Court found the Controller’s analysis speculative, noting that D1 did not specifically guide a skilled person to select the oxazolyl moiety from numerous possibilities. It held that “The respondent is not required to make any prediction as to whether a person skilled in the field will ever select a particular moiety, but is only required to examine if the claims are patentable.”
With regard to the therapeutic efficacy (Section 3(d)),the Court observed that D1 lacked data on the efficacy of its compounds, making it unreasonable to demand comparative efficacy data from Genentech. The Court held that the Appellant had made a Markush claim, and “…the claim based on oxazolyl moiety needs to be understood in the context as it is one that falls within the same compound with same therapeutic effects.”
The Court emphasized that Markush claims, which cover a family of related compounds, must be clear and precise and it questioned the Controller’s speculative approach regarding the selection of specific moieties.
The Court set aside the Controller’s order dated March 18, 2020, and remanded the matter for de novo consideration by a different Controller and directed that the application be disposed of within six months, considering its 2014 filing date.
This decision underscores the necessity for patent authorities to provide well-reasoned analyses, especially when dealing with complex pharmaceutical patent applications involving Markush claims.
Contributor(s)
Contributor to present post is Abhilasha.
Disclaimer: Views / opinions expressed in present update are solely that of the contributor(s) and are for explanatory / update / informational purposes only and which cannot be quoted in any legal proceedings and will have no legal purpose. Further, same may vary from time to time and case to case. It is neither intended to advertise nor solicit the Firm in any way whatsoever, nor is it purported to create an attorney-client privilege communication. For any clarification and further information, you may contact us at mehta@mehtaip.com.
MehtaIP 