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Delhi High Court rejects applications filed by Cadila Healthcare and Hetero Drugs against Roche's suit

Gireesh Babu, New Delhi
Thursday, September 14, 2023, 08:00 Hrs  [IST]

The Delhi High Court has dismissed petitions filed by Cadila Healthcare and Hetero Drugs seeking rejection of suits filed by Swiss drug manufacturer Hoffman La Roche on disputes related to the biosimilar versions of cancer drugs trastuzumab and bevacizumab.

The development comes as a result of Roche's suit in the High Court seeking a declaration that approval granted to Cadila's drug for pre-clinical or clinical trial protocols as well as manufacturing authorization granted by the Drugs Controller General of India (DCGI) for manufacturing and marketing of the biosimilar version of trastuzumab be declared invalid and also for permanent injunction restraining the Indian firm from selling, marketing or distributing its drug in Indian market as trastuzumab. The company sought similar action against Hetero Drugs in a matter related to manufacturing similar versions of bevacizumab.

Roche alleged that Cadila and Hetero are attempting to ride on the goodwill of its drugs to take unfair advantage of the same in selling their respective drugs by terming them as biosimilar, in the absence of conducting requisite tests and/or obtaining requisite approvals in consonance with the applicable laws.

Rejecting the applications of Cadila and Hetero in a detailed order, Justice Jyoti Singh said that Roche has set out the causes of action, on which it may or may not finally succeed.

"Substantial part of the cause of action pleaded in the plaints relates to alleged non-compliance/violation of the Drugs Act, Drugs Rules and Biosimilar Guidelines," said the Judge.

"Therefore, when Plaintiffs (Roche) plead that the approvals granted to the impugned drugs violate the applicable laws for several reasons, spelt out in the plaints, it cannot be said that plaints disclose no ‘cause of action’, especially when Cadila/Hetero claim ‘biosimilarity’ with their well-known and approved drugs," said the Order.

"Insofar as the contention of the Defendants (Cadila/Hetero Drugs) regarding challenge to competence of regulatory authority in the suits is concerned, a categorical stand has been taken by the Plaintiffs that they are not challenging the competence and discretion of the Drugs Regulatory Authority i.e. DCGI, but the allegations are that provisions of the Biosimilar Guidelines and the applicable laws have been violated by the Defendants," observed the Judge.

Cadila and Hetero Drugs approached the High Court with two applications under Order VII Rule 11 CPC by which they requested the Court to reject the respective plaints in the two suits. The Court observed that the Order VII Rule 11 CPC is an independent and special remedy, where a suit can be dismissed at the threshold or at any stage, if the Court is satisfied that any of the grounds mentioned therein exist, so that a litigation which is meaningless or on the face of it is bound to prove abortive, should not proceed further. It provides four grounds on which the Court can consider rejection of the plaint if an application is filed, including that the plaint discloses no cause of action.

Roche, in its suits, alleged that the drugs of Cadila and Hetero were approved for manufacturing and distribution by the regulatory authority without following the procedures under Drugs Act, Drugs Rules and Biosimilar Guidelines. It alleged that Cadila and Hetero claim similarity with Roche's ‘Trastuzumab’/‘Bevacizumab’, respectively without establishing biosimilarity through appropriate tests and conditions laid down in the applicable laws.

Roche alleged that potential deficiencies in the drugs of Cadila/Hetero will not only dilute and damage its reputation but will be detrimental to public interest as doctors, patients and other stakeholders in the medical community will be misled into believing that the drugs of Cadila/Hetero, claimed to be biosimilar are associated with its world known innovator drugs; and in the absence of enough data of adequate testing pertaining to safety, efficacy, quality, composition, use of the International Non-Proprietary Names is not only legally impermissible but is adding to public confusion.

Cadila argued that it has received the manufacturing and marketing license from the DCGI for launch of biosimilar version of trastuzumab on October 28, 2015. In August 17, 2016, Roche filed the suit challenging Cadila's drug Vivitra and seeking injunction restraining letter from selling, marketing and representing its drug as trastuzumab. It added that trastuzumab does not enjoy patent protection since May 3, 2013. The data relating to ‘Trastuzumab’ is publicly available and Indian law does not recognize any data exclusivity provisions as the same are considered TRIPS-Plus provisions and India only follows TRIPS.

Allowing an ex-patentee to claim any form of ownership in an international non-proprietary name (trastuzumab) as a result of goodwill or reputation obtained by it during the period the patent was valid will entirely destroy the patent regime and provide an easy route patentees to evergreen their patent and file passing off suits against manufacturers of generics or biosimilars, it argued.

Hetero argued that there are no pleadings to support the allegation of misrepresentations amounting to alleged passing off against the company. Plaintiffs have been unable to plead how Hetero’s drug is biosimilar to Plaintiffs’ ‘Bevacizumab’ or why the approvals granted by an expert body are illegal.

It may be noted that Roche has been entangled in various legal battles with companies including Reliance Life Sciences, Biocon and Mylan in connection with its innovator drugs in the past.


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Shubhankar Gupta Sep 15, 2023 12:15 PM
Could the author give details of the case name/ number or information pertaining as to when the matter was taken up by the DHC
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