Madras High Court Warns Against Mechanical Notices, Orders Decision On 14-Year-Old Cancer Drug Patent

The Madras High Court on 12 February observed that the Intellectual Property Office cannot mechanically issue notices or summons whenever pre-grant patent oppositions are received, warning that such an approach makes it “very easy to defeat the rights” of patent applicants.

Justice N. Anand Venkatesh issued directions in a case involving a 14-year-old patent application filed by Merck Sharp & Dohme B.V. for a cancer drug. Noting that by “postponing the same for one reason and the other” officials allowed oppositions to accumulate instead of taking a final decision, he directed the Joint Controller of Patents and Designs to decide all four pending pre-grant oppositions within three months.

The Bench stated:

“It is clear...that the official respondents were not acting upon the application and taking a final decision and by postponing the same for one reason and the other, pre-grant oppositions were accumulated. Whether these are genuine pre-grant oppositions is a matter into which this Court does not want to go into. It was the duty of the official respondents, who have to apply their mind whenever they get such pre-grant opposition, since it is mandated under Rule 55(3).”

The case concerns a patent application filed in July 2012 for the compound acalabrutinib, the active ingredient in the cancer treatment product Calquence. Although the drug has been marketed in India since 2020, the patent application had remained pending for over 14 years without a final decision.

The Court highlighted that under Rule 55(3) of the Patents (Amendment) Rules, 2024, the Patent Controller must be prima facie satisfied with an opposition before issuing notice. It criticised the authorities for failing to comply with this mandate, noting that they “cannot mechanically issue notice as and when pre-grant oppositions are received.”

While some delays between 2019 and 2022 were understandable due to the Covid-19 pandemic, the Bench observed a “lull” between October 2023 and February 2024, during which no decision was taken on pending applications, allowing additional pre-grant oppositions to accumulate.

The Court further explained:

“If the official respondents are going to take their own time in deciding the application and also mechanically issue summons/notices whenever a pre-grant opposition is made, it is very easy to defeat the rights of someone who files an application seeking for patent. This is in view of the fact that anyone can oppose the grant of patent and therefore, the opposition can emanate from any part of the world and therefore, the rulemaking authority thought it fit to impose a mandate that the controller must be prima facie satisfied on the pre-grant opposition received and that the controller cannot mechanically issue notice as and when pre-grant oppositions are received.”

Accordingly, the 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 line with the Patents (Amendment) Rules, 2024, ensuring that only valid challenges are entertained and that notices are not issued mechanically.

For Merck Sharp & Dohme: Advocate Vindhya S. Mani

For Respondents: Senior Panel Counsel K.V.Muthu Visakan; Advocates Sathish Kumar and S.Suba Shiny