Articles

Reaffirming standards: Bioavailability v. Therapeutic efficacy and Coverage v. Disclosure

By Dr. Malathi Lakshmikumaran, Swati Upadhyay and Swati Sangwan

The first article in this issue of IPR Amicus elaborately discusses a recent Delhi High Court Division Bench decision which revolved around interpretation of ‘enhanced efficacy’ under Section 3(d) of the Patents Act, 1970. The decision focused on two pivotal issues - whether the enhanced bioavailability data could be construed as proof of enhanced ‘therapeutic efficacy’, and the concept of ‘coverage v. disclosure’ in patent applications. According to the authors, the present judgment resets the high bar for the pharmaceutical companies and reminds them of the intricacies of the provision of Section 3(d) which is exclusive to the Patents Act in India. Additionally, this ruling clarifies that the protection under Section 48 will also extend to those substances that are not specifically disclosed but are obvious to a person skilled in the art and/or can be anticipated.

Exploring the uncertainties surrounding Sections 15 and 21(1) of the Patents Act

By Ankit Anand and Pulkit Doger

The article examines a recent Bombay High Court decision wherein the Court had analysed the Order issued by the Controller under Section 21(1) of the Patents Act [deemed abandonment]. The article closely examines Section 21(1) and Section 15 of the Act and observes that there is potential confusion in the applicability of the two provisions. As per the High Court, the patent application is to be deemed abandoned if the Applicant fails to comply with all the requirements imposed on him under the Act, though the quality of those responses is a separate consideration. Further, observing that the Controller in this case issued a hearing notice informing the Applicant that the patent application was deemed to be abandoned, the authors highlight that the Applicants may seek an opportunity to be heard even in cases where no response to the FER was submitted at all. According to them, the Applicant can hence seek to re-initiate prosecution of patent applications which are already deemed abandoned under Section 21(1).

Ratio decidendi

• Patent for a product is not deniable for lack of inventive step when a patent for the process involved in manufacturing the said product was earlier granted to the applicant – Madras High Court
• Patentability of a lamp made from cow ingredients and certain leaves – Madras High Court upholds denial under Section 3(p) relating to ‘traditional knowledge’
• Patentability of computer programme – Madras High Court clarifies Section 3(k) while allowing grant of a patent
• Patent for a salt formulation for dry food products – Madras High Court overrules rejection under Section 3(e) as ‘admixture’
• Patentability – Filtrate material acting merely as a medium for facilitating doping is not a ‘reactant’ under Section 3(d) – Higher cost than prior art is not material for ‘industrial capability’ under Section 2(1)(ac) – Madras High Court
• Patentability – Bioavailability per se does not establish therapeutic efficacy under Section 3(d) – Madras High Court

News Nuggets

• Patents – Delhi HC sets aside abandonment, finding lack of diligence by Patent Agent – CGPDTM directed to have Code of Conduct by December 2024 to regulate Patent and Trademark Agents
• Patents – Finding of lack of inventive step without discussing prior arts is wrong
• Copyright infringement – AI music generators sued by group of US music labels
• Geographical Indication (GI) tag for Indian Basmati rice rejected by New Zealand
• Copyright infringement in news feed – ANI sues PTI for alleged copying of a video