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High Court refuses interim injunction against Zydus' breast cancer drug

Gireesh Babu, New Delhi
Friday, October 11, 2024, 08:00 Hrs  [IST]

In a setback to Swiss multinational pharma company F-Hoffmann-La Roche, the Delhi High Court has dismissed an application filed by the company seeking injunction against Zydus Lifesciences Ltd's breast cancer drug Sigrima, a biosimilar of Pertuzumab.

Roche alleged that Zydus has infringed two of its patents for its HER2 positive breast cancer drug Perjeta through its biosimilar product.

The Swiss manufacturer, and its subsidiary Genentech Inc, approached the High Court alleging that Zydus has launched Sigrima despite an ongoing litigation related to patent infringement of the drug pending with the Court.

The Court observed that Roche needed to establish that Zydus' product is likely to or is actually infringing their suit patents, through 'claim construction' and 'claim mapping', which is to detail the patents and their scope in order to establish that the generic product may infringe the patent protection.

"Mere registration of a patent in favour of a patentee like the plaintiffs is not itself sufficient for seeking the grant of an ad interim injunction in an application under Order XXXIX rules 1 & 2 CPC of the present nature in a suit for infringement of a patent," observed Justice Saurabh Banerjee, in an order issued on October 9.

He observed that Roche was unable to demonstrate anything in the manner of claim mapping and had not averred/referred/argued anything in the manner of the same, in its application with the Court. 

"...the grant of relief of an-injunction is of a discretionary nature, for grant of which the party like the plaintiffs (Roche and Genentech) herein have to satisfy a Court of law by setting out that it has a prima-facie case in their favour with the balance of convenience also in their favour and that they are likely to suffer irreparable loss and injury as well as ‘claim mapping’ or like in a suit of patent infringement of the present nature, in terms of the aforesaid, the plaintiffs have been unable to make out any case in their favour and against the defendants (Zydus) in the absence thereof," said the Judge.

The Court also vacated an interim order passed by a previous bench, on the matter.

Roche has in July 9, 2024, received a temporary injunction order against Zydus from a previous bench of the High Court, restraining the latter from marketing, selling their product Sigrima till the next date of hearing.

The bench in February, 2024, refused to grant injunction on various grounds including lack of claim mapping being present on the record on that date. The company later filed the claim mapping with that bench, on April 2, 2024.

Roche claims that it has two patents related to the product, one which was granted on November, 2023 and valid till April 15, 2034, and another granted on September, 2015 and expected to expire on October 19, 2025.

It alleged that Zydus has purchased 480 vials of Perjeta in January 2023, and in February, 2024, it came across an information that the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to manufacture and market Pertuzumab 30 mg/ml concentrate solution for infusion (420 mg 14 ml single-dose vial) to Zydus.

It also alleged that despite the matter was pending with the other bench, Zydus received regulatory approvals and made the drug available in the market without informing the Court. Zydus has also entered into a semi-exclusive licensing agreement with Dr Reddy's Laboratories for co-marketing the drug under the brand name Womab. A litigation with Dr Reddy's is also pending for proceedings, it added.

Zydus argued that Roche was aware that Sigrima will be soon launched, but was unsuccessful in obtaining an ad-interim injunction in their favour. The Court did not ask Zydus to launch the biosimilar product and the company did not give any undertaking of any kind to the previous bench regarding the launch.

The interim injunction granted on July 9, is against the settled principles with respect to irreparable loss/mischief to ensue the plaintiffs, among other things, it added. It also pointed out that public interest is of paramount importance n patent matters, especially those relating to drugs.

According to information from online pharmacy stores, Perjeta 420 mg injection is prices at a maximum retail price of Rs. 2.36 lakh per pack, while Sigrima 420 mg injection has an MRP of around Rs. 79,995 per pack.

While dismissing the application of Roche, Justice Banerjee also observed that while there may have not been any specific order, from the orders passed by the previous bench, there seems to have been an implied understanding that the company should have reported the approval and launch of the drug with the Court.

"Even otherwise, principles of natural justice demand the defendant (Zydus) to act judicially and with utmost care, prevention and precaution, more so, whence admittedly the defendant is not a fly by night operator and it claims to be one of the pioneer entities," said the Court.

"The defendant is well aware of the far-reaching impact when it is involved in proceedings pending adjudication before a Court of law and when the actions of the defendant have a corollary effect on the outcome/decision thereof," added the Order.

 

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