The Delhi High Court recently ruled on an intellectual property rights dispute concerning the availability of a drug used to treat Spinal Muscular Atrophy (SMA). The case involved F. Hoffmann-La Roche AG (the plaintiff) and Natco Pharma Limited (the defendant). The plaintiff sought an interim injunction to restrain the alleged infringement of its patent related to the drug "Risdiplam." The Court, however, denied the injunction, citing public interest and the economic impact of drug pricing.
Justice Mini Pushkarna, presiding over the case, emphasized that
"the availability of a drug for a rare disease at economical and competitive prices is a material factor in deciding an interim injunction."
The ruling noted that since Risdiplam is the only available treatment for SMA in India, its affordability is crucial for public welfare.
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The plaintiff argued that the patent titled "Compounds for Treating Spinal Muscular Atrophy" had not faced pre-grant or post-grant opposition, implying its validity. However, the Court disagreed, stating,
"the absence of opposition does not in any way establish or guarantee the validity of the patent."
Natco Pharma challenged the patent’s validity, arguing non-compliance with Section 8 of the Patents Act. The Court determined that
"whether there was non-compliance can only be established through a full trial and cannot be a factor for granting an interim injunction."
Balance of Convenience and Public Interest
The Court highlighted that the plaintiff does not manufacture Risdiplam in India but imports it. In contrast, Natco Pharma intends to manufacture it domestically at a price significantly lower—nearly 80-90% less than the plaintiff’s price. "These factors are crucial in assessing the balance of convenience," the Court stated.
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The Court also considered the plaintiff’s Patient Assistance Program, through which discounted pricing was offered. However, it noted,
"even with the proposed pricing, the drug remains economically unviable for many patients suffering from SMA."
Furthermore, the ruling acknowledged that a domestic production proposal by Natco Pharma could lead to a price reduction, making the drug more accessible. The Court asserted,
"price reduction benefits all SMA patients, and thus, public interest weighs against the grant of an injunction."
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Economic Implications and the Right to Compensation
Another critical aspect was the potential financial impact on the plaintiff. While denying the injunction, the Court observed that
"no prejudice shall be caused to the plaintiff as it can be compensated through damages if it ultimately succeeds in trial."
However, it added,
"there exists no mechanism for the public to compensate itself if the injunction results in higher drug prices."
Ultimately, the Court concluded that Natco Pharma had established a "credible challenge to the validity of the patent," leading to the decision against granting an interim injunction.
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Counsel for Plaintiffs: Mr. Pravin Anand, Ms. Shrawan Chopra, Ms. Prachi Agarwal, Mr. Devinder Rawat, Mr. Achyut Tewari, Mr. Aayush Maheshwari, Ms. Elisha Sinha, Ms. Krisha Baweja, Mr. N. Mahabir, and Ms. Archana Shanker, Advocates
Counsel for Defendant: Mr. J. Sai Deepak, Sr. Adv. with Mr. Afzal B. Khan, Mr. Samik Mukherjee, Ms. Amrita Majumdar, Mr. Dominic Alvares, Mr. Avinash Kr. Sharma, and Mr. Sharad Besoya, Advocates
Title: F. HOFFMANN-LA ROCHE AG & ANR v. NATCO PHARMA LIMITED
