Claim Mapping is Crucial for Granting Interim Injunction in Patent Disputes: Delhi High Court Dismisses Hoffmann-La Roche's Plea for Interim Injunction

No Interim Relief Without Clear 'Claim Mapping' in Biosimilar Patent Dispute. On October 9, 2024, the Delhi High Court, in the case of F. Hoffmann-La Roche AG & Anr. vs. Zydus Lifesciences Limited, dismissed the plaintiff’s application for an interim injunction seeking to prevent Zydus from marketing its biosimilar drug “Sigrima,” allegedly infringing Hoffmann-La Roche’s patents on Pertuzumab, a drug used to treat HER2-positive breast cancer. The court ruled that without proper claim mapping, the plaintiffs could not demonstrate that Zydus’ product infringed their patents.

In its ruling, the court stressed the importance of claim mapping in patent infringement cases. The court observed that while Hoffmann-La Roche had valid patents (IN 464646 and IN 268632) relating to the Pertuzumab drug, they failed to demonstrate how Zydus’ biosimilar drug “Sigrima” violated those patents.

The plaintiffs, F. Hoffmann-La Roche AG and Genentech Inc., claimed that Zydus Lifesciences' product “Sigrima” infringed on their patents, covering both the composition and the formulation of Pertuzumab. The plaintiffs sought an interim injunction to stop Zydus from manufacturing or selling the drug in India.

Zydus, on the other hand, argued that Hoffmann-La Roche failed to present adequate evidence of infringement and lacked proper claim mapping to show the overlap between the patented claims and the biosimilar product.

The key legal question was whether the plaintiffs had demonstrated a prima facie case of patent infringement and whether an interim injunction could be granted without claim mapping.

Claim mapping was essential to establish the link between the patented claims and the alleged infringing product. The plaintiffs were required to map each patent claim to the corresponding features of Zydus’ biosimilar.

The court emphasized that without such mapping, it was impossible to determine whether Zydus’ product infringed Hoffmann-La Roche’s patents.

The court noted that the mere registration of a patent does not automatically entitle the patentee to an interim injunction. A patentee must demonstrate a prima facie case, balance of convenience, irreparable harm, and claim mapping to justify such relief.

The court dismissed Hoffmann-La Roche’s application under Order XXXIX rules 1 & 2 of the CPC, vacating the interim injunction granted earlier. The court ruled:

"Since the plaintiffs’ have not averred/ referred/ argued anything qua ‘claim mapping’ or like in the present application under Order XXXIX rules 1 and 2 CPC... the relief of an ad interim injunction is not possible."

The court further observed that Zydus had not acted in bad faith, as the regulatory approval for their drug had been transparently obtained, and Hoffmann-La Roche had failed to demonstrate immediate harm.

The Delhi High Court's judgment underscores the critical role of claim mapping in patent disputes, particularly in complex cases involving biosimilars. Patentees must provide clear evidence of infringement to succeed in obtaining interim relief. The ruling serves as a significant precedent in the pharmaceutical industry, especially in disputes involving biosimilar products.

Date of Decision: October 9, 2024

F. Hoffmann-La Roche AG & Anr. vs. Zydus Lifesciences Limited