F Hoffmann La Roche Limited Vs Drug Controller General of India.

Extended Passing Off in Relation to Expired Patent: 

Introduction:

The intersection of intellectual property rights, pharmaceuticals, and competition in the Indian legal landscape has been a subject of significant litigation and jurisprudential development. One such intricate legal issue recently addressed by the Hon'ble High Court of Delhi in the case of F Hoffmann La Roche Limited vs. Cadila is whether a suit filed on the basis of passing off in relation to an expired patent can be maintained. This article analyzes the key aspects of this case, focusing on the doctrine of extended passing off in the context of an expired patent.

Background of the Case:

In the case at hand, F Hoffmann La Roche Limited ("Plaintiff") filed a suit seeking a declaration that the approval granted to Cadila Healthcare Limited ("Cadila") by the Drugs Controller General of India ("DCGI") for manufacturing authorization under the Drugs and Cosmetics Act, 1940, was invalid. The suit was specifically filed invoking the action for extended passing off, pertaining to the characteristic, composition, and quality of a product named 'Trastuzumab'.

Cadila, in response, filed an application under Order 7 Rule 11 of the Civil Procedure Code (CPC) seeking the rejection of the plaint. Cadila's main contention was that the drug 'Trastuzumab' had lost patent protection since May 3, 2013, when the plaintiff's patent had expired, and therefore, no monopoly could be claimed by the plaintiff over it. Cadila also argued that the suit was barred by law due to the availability of an alternative remedy under Rule 122DC of the Drugs Rules, which allows an appeal to the Central Government against the DCGI's approval.

Key Legal Analysis:

Expired Patent and Passing Off:

The central issue before the court was whether the doctrine of passing off could be extended to cover a situation where the underlying patent had expired. The plaintiff, in this case, did not assert rights under the expired patent and expressed no objection to the manufacture and sale of the drug by Cadila as long as it was not claimed to be biosimilar. The court examined whether the cause of action disclosed in the plaintiff's plaint was sufficient to proceed with the case.

Doctrine of Extended Passing Off:

The court recognized the doctrine of extended passing off in relation to an expired patent. Passing off, in intellectual property law, typically deals with the misrepresentation of goods or services as those of another. Extended passing off is a legal concept that extends protection beyond trademarked goods to protect other aspects such as the composition, characteristics, and quality of a product. In this case, the plaintiff sought to protect the reputation and goodwill associated with 'Trastuzumab' beyond the scope of the expired patent.

Alternative Remedy:

Cadila argued that the suit was barred due to the availability of an alternative remedy under Rule 122DC of the Drugs Rules, which provided for an appeal to the Central Government against DCGI's approval. However, the court observed that the mere availability of an alternative remedy does not automatically lead to the rejection of a suit. The court's role at the stage of Order 7 Rule 11 CPC is to determine whether a cause of action is disclosed in the plaintiff's pleadings, and the availability of an alternative remedy is not a conclusive factor for rejection.

The Concluding Note:

In the F Hoffmann La Roche Limited vs. Cadila case, the Hon'ble High Court of Delhi recognized the doctrine of extended passing off in relation to an expired patent. The court held that the cause of action disclosed in the plaintiff's pleadings was sufficient to proceed with the case, even in the absence of patent protection. This decision highlights the evolving nature of intellectual property jurisprudence in India, where courts are willing to protect the reputation and goodwill associated with a product even after the expiration of its patent. 

Case Law Discussed:

Date of Judgement:11/09/2023
Case No.CS Comm 540 of 2016
Neutral Citation No: 2023: DHC: 6522
Name of Court: Delhi High Court
Name of Hon'ble Judge: Jyoti Singh, H.J.
Case Title: F Hoffmann La Roche Limited Vs Drug Controller General of India.

Disclaimer:

Information and discussion contained herein is being shared in the public Interest. The same should not be treated as substitute for expert advice as it is subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue involved herein.

Advocate Ajay Amitabh Suman,
IP Adjutor:Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com,
Mob No: 9990389539