Delhi High Court Upholds Order Allowing Natco to Manufacture SMA Drug, Cites Public Interest

Delhi High Court Upholds Order Allowing Natco to Manufacture SMA Drug, Cites Public Interest

Introduction

The Delhi High Court has upheld a single-judge's order refusing to restrain Natco Pharma from producing a drug used in the treatment of Spinal Muscular Atrophy (SMA).

Factual Background

Roche, a Swiss drugmaker, had claimed that Natco Pharma's proposed production of Risdiplam, a drug used to treat SMA, infringed its patent rights. Natco argued that Roche's patent was invalid and that it had raised a credible challenge to the patent's validity.

Procedural Background

The single-judge bench Justice Mini Puskarna had refused to grant Roche interim relief, holding that Natco had raised a credible validity challenge. The Court also considered the public interest in making the drug available at an affordable price. Roche appealed against the single-judge's order.

Issues

1. Patent Validity: Whether Natco had raised a credible challenge to the validity of Roche's patent for Risdiplam.

2. Public Interest: Whether the public interest in making the drug available at an affordable price outweighed Roche's patent rights.

Contentions of the Parties

Roche: Natco's proposed production of Risdiplam infringed its patent rights, and the Court should restrain Natco from manufacturing or selling the drug.

Natco: Roche's patent was invalid, and Natco had raised a credible challenge to the patent's validity. Allowing generic supply would be in the larger public interest.

Reasoning and Analysis

The Division Bench of Justices C Hari Shankar and Ajay Digpaul agreed with the single-judge that Natco had raised a credible validity challenge, particularly in light of Roche's own statements in foreign patent proceedings. The Court also emphasized that appellate courts should not lightly interfere with discretionary orders refusing interim injunctions.

Decision

The Delhi High Court dismissed Roche's appeal and upheld the single-judge's order refusing to restrain Natco Pharma from producing the drug.

Implications

The judgment highlights the importance of considering public interest in patent disputes, particularly in cases involving life-saving drugs.

In this case Roche was represented by Senior Advocate Sandeep Sethi with advocates Pravin Anand, Archana Shanker, Shrawan Chopra, Prachi Agarwal, Devinder Rawat, Elisha Sinha, Achyut Tewari, Krisha Baweja, Aayush Maheshwari and Sumer Seth from Anand & Anand.

Meanwhile Natco was represented by Senior Advocate J Sai Deepak and advocates Afzal B Khan, Samik Mukherjee, Amrita Majumdar, Dominic Alvares, Avinash Kr Sharma and Sharad Besoya from S Majumdar & Co.