The case of F. Hoffmann-La Roche AG & Another v. Natco Pharma Limited revolves around the contentious balance between patent rights and the public’s access to affordable medicines. The dispute concerns Risdiplam, a crucial drug for treating Spinal Muscular Atrophy (SMA).

• The plaintiffs, global pharmaceutical giants, sought to enforce their patent rights over Risdiplam, alleging infringement by the defendant, an Indian pharmaceutical company. The defendant, however, challenged the patent's validity, citing concerns over evergreening, prior disclosures, and the fundamental need for affordable healthcare.

Detailed Factual Background:

• F. Hoffmann-La Roche AG and another claimed patent infringement against Natco Pharma Limited, alleging that their Indian Patent No. 334397 (IN'397) was being violated by Natco’s attempts to manufacture and sell a generic version of Risdiplam.
• The suit patent was granted for a compound used to treat SMA, a severe genetic disorder affecting motor neurons.
• The plaintiffs had secured patents for Risdiplam across various jurisdictions and marketed it under the brand name Evrysdi.
• The compound was developed to offer an oral treatment alternative for SMA, a disorder traditionally requiring complex treatments.
• The suit patent had a validity period of 20 years from May 11, 2015, expiring in 2035.
• The defendant countered the claim, arguing that Risdiplam was already covered under an earlier international genus patent, WO 2013/119916 A2.
• They contended that the species patent IN’397 was an attempt to extend monopoly rights beyond the permissible limits, a practice commonly referred to as "evergreening."
• The plaintiffs had made admissions in foreign jurisdictions acknowledging that Risdiplam was part of the earlier genus patent, thereby invalidating their claim to a separate species patent.

Detailed Procedural Background:

• The plaintiffs filed a suit seeking an interim injunction against the defendant, restraining them from manufacturing and selling Risdiplam.
• The defendant opposed the injunction, challenging the validity of the patent on grounds of anticipation, lack of inventive step, and misrepresentation.
• Public interest arguments were raised by interveners, highlighting that the high cost of Risdiplam under the plaintiffs' pricing structure made it inaccessible to most SMA patients in India.
• The interveners contended that allowing generic manufacturing would significantly lower the price, making life-saving treatment accessible to those in need.
• The court conducted extensive hearings, reviewing technical arguments, documentary evidence, and international patent proceedings.
• The case drew attention due to its implications on India's patent jurisprudence and its approach to balancing intellectual property rights with healthcare accessibility.

Detailed Description of the Patent and How It Was Defeated by Prior Art:

• The suit patent (IN’397) claimed a novel compound, Risdiplam, for treating SMA.
• The compound was described using a Markush structure, meaning it covered a broad set of chemical derivatives.
• The patent specification detailed how the compound was developed to enhance SMN2 protein production, thereby improving motor function in SMA patients.
• The defendant argued that Risdiplam was already disclosed in an earlier patent, WO 2013/119916 A2 (the "genus patent").
• This genus patent broadly covered a range of compounds, including Risdiplam, without naming it explicitly.
• The defendant demonstrated that a person skilled in the art, upon reading WO’916, could easily derive Risdiplam by following the disclosed chemical structures and synthetic pathways.
• The court found that the genus patent sufficiently anticipated Risdiplam, making the species patent IN’397 vulnerable to invalidation.
• The principle established in Novartis AG v. Union of India, (2013) 6 SCC 1—that a known compound cannot be re-patented without demonstrating a significant enhancement in efficacy—was applied.
• Since the plaintiffs failed to show that Risdiplam offered an unexpected improvement over the disclosed genus compounds, the court found that the species patent lacked novelty and an inventive step.

Admissions Made by the Plaintiffs and Their Effect:

• One of the key aspects that led to the court’s decision was the plaintiffs’ own admissions in foreign jurisdictions.
• In the United States, the plaintiffs had applied for a Patent Term Extension (PTE) for their earlier genus patent, arguing that Risdiplam was covered under it.
• Similarly, in European and Australian proceedings, the plaintiffs made statements suggesting that Risdiplam fell within the scope of the genus patent WO’916.
• The defendant used these admissions to argue that the plaintiffs could not now claim that Risdiplam was a distinct invention warranting a separate species patent.
• The court agreed, stating that these admissions demonstrated that Risdiplam was not a novel invention, but merely one among many compounds already disclosed in WO’916.

The court also relied on AstraZeneca AB v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746, which held that prior admissions in foreign jurisdictions can be used to assess patent validity. The plaintiffs’ contradictory positions—claiming in foreign jurisdictions that Risdiplam was covered under the genus patent, while arguing in India that it was a novel compound—significantly weakened their case.

Detailed Discussion on Judgments Cited and Their Context:
Novartis AG v. Union of India, (2013) 6 SCC 1 – This case established that evergreening is not permitted under Indian patent law. The court held that mere discovery of new forms of known substances without enhanced efficacy is not patentable. The defendant relied on this precedent to argue that IN’397 was an attempt at evergreening.Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511 – This judgment clarified that patents do not enjoy a presumption of validity and must be scrutinized rigorously. The court applied this principle in assessing whether the defendant had raised a credible challenge to the suit patent.F.

Hoffmann-La Roche Ltd. v. Cipla Ltd., 2009 SCC OnLine Del 1074 – This case reinforced that mere patent registration does not guarantee validity. The court relied on this precedent to evaluate the defendant’s challenge to IN’397.AstraZeneca AB v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746 – This case held that prior admissions in foreign jurisdictions could be used to assess the validity of a patent. The defendant relied on this judgment to argue that the plaintiffs’ statements in other countries should be taken as admissions undermining their claim in India.

Final Decision:
The court denied the plaintiffs’ request for an interim injunction, allowing the defendant to manufacture and sell Risdiplam. However, it directed the defendant to maintain records of sales and financial transactions to ensure potential compensation if the plaintiffs ultimately prevailed in the suit.

Law Settled in This Case:
The court reaffirmed that mere grant of a patent does not confer automatic validity and that patents can be challenged based on prior disclosures. Prior admissions in foreign jurisdictions can be used to assess patent validity. It reiterated that public interest is a crucial factor in determining interim relief in pharmaceutical patent disputes. The ruling reinforced the principle that patent rights cannot be used to unjustifiably extend monopoly periods through evergreening. It also clarified that statements made by patentees in foreign jurisdictions can be relevant in assessing the validity of a patent in India.

Case Title: F. Hoffmann-La Roche AG & Another VS. Natco Pharma Limited
Date of Order: 24.03.2025
Case Number: CS(COMM) 567/2024
Neutral Citation: 2025:DHC:1907
Court: Delhi High Court
Hon’ble Judge: Justice Mini Pushkarna

Disclaimer:
The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com, Ph no: 9990389539