Patent Infringement and Person in the Know

The Appeal

In this matter, the High Court of Delhi was called upon to decide an appeal by F. Hoffmann-La Roche AG against Natco Pharma Limited regarding the manufacture and sale of the drug “Risdiplam.” The appellants, holders of Indian Patent IN 3343971 concerning compounds for treating spinal muscular atrophy, sought an injunction to prevent Natco from producing and selling Risdiplam.

Facts of the Case

The facts of the case are straightforward. F. Hoffmann-La Roche AG is the patentee for Risdiplam, marketed under the brand name EVRYSDI, used for spinal muscular atrophy. Natco Pharma began manufacturing and marketing Risdiplam, which the appellants argued amounted to patent infringement under Section 48 of the Indian Patents Act.

• Key Question: Whether Natco’s actions amounted to patent infringement.
• Defense: Whether Natco could invoke statutory defenses to avoid liability.

The Procedural Background

The dispute arose after a single judge of the High Court declined the injunction against Natco, leading the appellants to file the present appeal. Natco admitted making and selling Risdiplam but asserted a defense under Section 107 of the Patents Act, relying on Section 64(e) and Section 64(f), which allow revocation if the invention lacks novelty or inventive step.

Court’s Reasoning on Appellate Review

The Court clarified the law on appellate review, citing Wander Ltd. v. Antox India P Ltd. (Supreme Court: 1990 Supp SCC 727). It emphasized that appeals against discretionary reliefs like injunctions are not appeals on facts but on principles. The appellate court would intervene only if the lower court’s discretion was arbitrary or legally unsound.

The Legal Provision

Legal provisions examined included:

Coverage vs Disclosure

The Single Judge focused on whether Risdiplam, though covered by earlier patents (WO916, US955), was disclosed sufficiently to destroy novelty. The Court discussed the difference between:

• Coverage: Compound encompassed within a broad claim.
• Disclosure: Compound specifically taught or enabled in prior art.

Key precedents included:

• Novartis AG v Union of India (2013 6 SCC 1)
• Astrazeneca AB v Intas Pharmaceutical Ltd (2020 84 PTC 326 Del)

The Division Bench clarified that disclosure must be enabling—it should guide a skilled person to create the compound. Mere theoretical coverage is insufficient.

The Obviousness

Under Section 64(f), the Court examined whether a skilled person could derive Risdiplam from earlier patents. The difference between Risdiplam and “Compound 809” was only a nitrogen atom replacing a CH group. The Court noted that such substitutions were routine in chemical synthesis and supported by chemical principles like the Grimm’s Hydride Displacement Law.

Person Skilled in the Art

The Court highlighted that when inventors of both patents are the same, they are “persons in the know.” Therefore, minor modifications by such inventors cannot justify new patents, as it risks evergreening — obtaining extended monopolies for trivial changes.

Public Interest and Policy

The Court emphasized that patent protection is for true inventions. Extending monopolies through obvious changes undermines public access to affordable, life-saving drugs. Hence, public interest must guide judicial interpretation in pharmaceutical patents.

Conclusion and Decision

The Division Bench found no fault in the Single Judge’s reasoning. Since the lower court applied correct legal principles and exercised discretion properly, the appeal was dismissed. The finding of a credible defense of obviousness justified denying the injunction.

Case Summary

Disclaimer

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Written By

Advocate Ajay Amitabh Suman
IP Adjutor [Patent and Trademark Attorney]
High Court of Delhi