Madras High Court Pulls Up Patent Office For Mechanical Pre-Grant Notices; Orders Decision On 14-Year-Old Merck Cancer Drug Application

Madras High Court Pulls Up Patent Office For Mechanical Pre-Grant Notices; Orders Decision On 14-Year-Old Merck Cancer Drug Application

Introduction

The Madras High Court has cautioned the Intellectual Property Office against mechanically issuing notices upon receipt of pre-grant patent oppositions, observing that such an approach makes it “very easy to defeat the rights” of patent applicants. The Court directed expeditious disposal of a 14-year-old patent application filed by Merck Sharp & Dohme B.V. relating to a cancer drug.

Factual Background

The case concerns a patent application filed in July 2012 by Merck Sharp & Dohme B.V. for the compound acalabrutinib, the active ingredient in the cancer drug marketed as Calquence. Despite the drug being commercially available in India since 2020, the patent application had remained pending without a final decision for over 14 years

During the pendency of the application, four pre-grant oppositions were filed. The petitioner alleged that instead of deciding the application, the authorities allowed the opposition to accumulate by repeatedly postponing consideration of the matter

Procedural Background

The petitioner approached the High Court seeking directions for disposal of the pending patent application and oppositions. The Court examined the statutory framework governing pre-grant oppositions, particularly Rule 55(3) of the Patents (Amendment) Rules, 2024.

Under Rule 55(3), the Controller is required to be prima facie satisfied about the merits of a pre-grant opposition before issuing notice to the applicant. The Court noted that the Controller cannot automatically issue summons or notices merely upon receipt of an opposition.

The Bench acknowledged that certain delays between 2019 and 2022 could be attributed to the Covid-19 pandemic. However, it observed an unexplained lull between October 2023 and February 2024 during which no final decision was taken, resulting in additional oppositions being filed.

Issues

1. Whether the Intellectual Property Office can mechanically issue notices upon receipt of pre-grant oppositions without prima facie satisfaction under Rule 55(3).

2. Whether prolonged delay in deciding a patent application amounts to failure of statutory duty.

3. What directions are necessary to ensure compliance with the Patents Act and Rules.

Contentions of the Parties

The petitioner contended that the authorities had failed to discharge their statutory obligation by not taking a final decision on the patent application. It was submitted that mechanical issuance of notices on every pre-grant opposition defeats the legislative intent of requiring prima facie scrutiny. The respondents contended that pre-grant oppositions were part of the statutory process and required adjudication.

Reasoning and Analysis

Justice N. Anand Venkatesh observed that the official respondents were not acting upon the application and were postponing a final decision for various reasons, thereby allowing oppositions to accumulate. The Court declined to examine whether the oppositions were genuine but emphasised that the Controller must apply his mind whenever a pre-grant opposition is received.

The Court underscored that Rule 55(3) imposes a mandate that the Controller must be prima facie satisfied before issuing notice. Mechanical issuance of summons or notices defeats the statutory framework and makes it easy to frustrate the rights of applicants, particularly since pre-grant oppositions can be filed by any person, including those from outside India.

The Court held that the rulemaking authority intentionally incorporated the requirement of prima facie scrutiny to prevent abuse of the opposition process. Failure to adhere to this mandate undermines the patent system and delays innovation.

Decision

The Madras High Court directed the Joint Controller of Patents and Designs to:

• Decide all four pending pre-grant oppositions within three months; and
• Screen any new oppositions strictly in accordance with the Patents (Amendment) Rules, 2024, ensuring that notices are not issued mechanically and that only valid challenges are entertained.

In this case the appellant was represented by Mr. Vindhya S. Mani, Advocate. Meanwhile the respondent was represented by Senior Panel Counsel K.V.Muthu Visakan, Mr. Sathish Kumar and Ms. S.Suba Shiny, Advocates.