While disposing of I.A. 10533/2024 for injunction in a patent infringement dispute over a biosimilar of Nivolumab between E.R. Squibb and Sons, LLC & Ors. vs Zydus Lifesciences Limited [CS(COMM) 376/2024], the Delhi High Court issued a preliminary injunction order on July 18, 2025, restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRCr-4276). This order came as a quia timet action in view of the alleged "receipt of information by the Squibb (plaintiffs) in April/May 2024, regarding the possibility of the Zydus (defendant) launching an infringing product commercially, gives rise to a cause of action in favour of the plaintiffs to initiate legal proceedings."
Factual Matrix
The plaintiffs hold a patent for the monoclonal antibody Nivolumab (marketed as Opdivo®), used in cancer treatment.The court found that the Indian suit patent (IN 340060) held by the Plaintiff is subsisting until May 2, 2026. Defendant (Zydus) was developing a biosimilar of Nivolumab, called ZRC-3276, and had initiated clinical trials.Squibb contended that Zydus's actions constituted patent infringement and sought an injunction to prevent Zydus from launching the biosimilar before the patent's expiration.It is interesting to note that, vide order dated May 8, 2024, the court restrained the defendant from placing its products on the market without the prior permission of the Court. The order remains in effect to date.
Timelines
- April 2022: The plaintiffs learned that the defendant had applied for clinical trial approval for a biosimilar of Nivolumab.
- May 6, 2022: The plaintiffs issued a cease-and-desist letter.
- May 17, 2022: The defendant responded by citing the Bolar Exemption under Section 107A of the Patents Act. No further action was taken at that time. Subsequently, the plaintiffs discovered that the defendant had registered a clinical trial for its product ZRC-3276 using Opdivo as the reference product.
- September 2022: CDSCO granted permission to the defendant for manufacturing and importing the biosimilar for clinical trials.
- April 2024: The plaintiffs received inquiries indicating the defendant's potential plan to launch the product commercially, prompting them to file the suit as a quia timet action, seeking interim relief via I.A. No. 10533/2024.
Plaintiffs' Case
The present suit concerns the infringement of Indian Patent No. IN 340060, i.e., IN' 060, which is titled as, ―Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer‖. The patent titled 'Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer' was granted on July 1, 2020, after adjudication of four pre-grant oppositions (filed by Indian Pharmaceutical Alliance ("IPA"), Mumbai; Pankaj Kumar Singh, Delhi; Restech Pharmaceuticals, Ahmedabad and Dr. Reddy‟s Laboratories, Hyderabad). According to the plaintiffs, a real, credible, and reasonable apprehension existed that the defendant intended to manufacture, launch, and otherwise deal in Nivolumab during the term of the suit patent without the plaintiffs' authorisation, and thus, the present suit was filed as a quia timet action.
The plaintiffs submitted that the suit patent is valid, subsisting, in India and has been granted in over 50 countries. They asserted that their antibody is defined by specific Complementarity Determining Regions (CDRs) and variable region sequences, covered under Claims 1, 3, and 7 of the suit patents. They alleged that the defendant's product (ZRC-3276), being admitted as bio-similar, must contain the claimed sequences and thereby infringe the patent. The plaintiffs submitted that the defendant had repeatedly imported the plaintiffs' product for research purposes without seeking permission.
According to the plaintiff, there existed a real, credible and reasonable apprehension that the defendant intended to manufacture, launch and otherwise deal in Nivolumab during the term of the suit patent without the plaintiffs' authorisation.
Zydus' Defence
The defendant asserted that infringement must be established through claim-to-product mapping, not product-to-product comparisons. The defendant raised grounds of invalidity, viz., lack of novelty, lack of inventive step, and non-patentability. They cited prior art documents WO 2001/014557 (D1), WO 2002/079499 (D2), and EP '878 (D3), asserting that Nivolumab had already been disclosed. The defendant placed reliance on the Opposition Board Recommendation (OBR), which suggested the invalidity of the suit patent (though it had been set aside and is under judicial review).
The defendant countered that their product binds not only to PD-1 but also to other CD-28 family members, distinguishing it from the suit patent's claimed invention. They asserted that the plaintiffs' product also shows binding to CD-28 members, and that bio-similarity does not establish infringement.
Technical Information of the Invention
After going through the patent specification, the Court observed that "the suit patent, i.e., IN '060, is a therapeutic antibody used in the treatment of various forms of cancer... The antibody in the suit patent is defined by Claims 1 and 3 of IN' 060 and is called Nivolumab (5C4) monoclonal anti-PD-1 antibody." The court further elaborated that"The variable regions of both the heavy chain and the light chain have three CDRs each, and these CDRs are specific to an antibody for binding to an antigen."
Court's Analysis and Decision
Claim Construction
On claim construction, the Court stated that "Claim construction is generally the first and foremost exercise carried out in adjudicating patent infringement suits. The court found that the binding affinity with other proteins, such as human CD-28, is not completely absent."
Court's Findings on Prior Art
The Court noted,"the defendant has not been able to show that Nivolumab was disclosed in the prior arts cited... D3... is not directed to a product like the suit patent... rather it is directed to the use of an anti-PD-1 antibody in the treatment of cancer."
Non-Binding Nature of Opposition Boards' Recommendations (OBR)
On the OBR, the Court observed that "the OBR, as the name suggests, is a recommendation... which only has a persuasive value and is not binding in nature." The Court noted that "the Controller held that the product claimed in Claim 1 of the suit patent is new or novel over the cited prior art."
Inventive Step
On inventive step, the Court observed that "the defendant has not been able to show that in the cited prior arts, there is disclosure or teaching to achieve the sequence for Nivolumab, as per the suit patent."
On Claim Mapping and Infringement
On claim mapping, the Court dismissed the defendant's contention that claim mapping should be between claims and the infringing product, as the court noted that "there existed no commercial product of the defendant against which claim mapping could be done". The Court agreed that it is sufficient that the plaintiffs have mapped with the Nivolumab INN, which is used as a reference product by the defendant for development of its biosimilar product, ZRC-3276. The Court ruled that "by virtue of the said claim mapping, Nivolumab INN is equivalent to Claims 1 and 3 of the suit patent. Therefore, any reference to Nivolumab by the defendant would constitute infringement of the suit patent"
Court's Decision
The Court directed that"the defendants, and all others acting on their behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising or dealing in any bio-similar/similar biologic of Nivolumab, the suit patent, during the pendency of the present suit."
It further stated,"the defendant is also restrained from launching any manufactured product, if any, manufactured during the pendency of the patent of the plaintiffs, even upon expiry of the patent."
The Court directed that"the defendant is accordingly directed to file an affidavit disclosing the quantity of its manufactured bio-similar product of Nivolumab, within a period of four weeks from the date of the judgment."
The Court clarified that"the observations made hereinabove are only prima facie in nature for the purposes of deciding the application for interim injunction. Nothing contained herein shall be construed as an expression on the merits of the case."
Takeaways
Launching biosimilars of a patent is not immune to infringement action. In a quia timet action, the defendant should raise a credible defence. Mere reliance on the recommendations of the Opposition Board is not sufficient, as the court categorically stated that it is a recommendation which only has a persuasive value and is not binding in nature. Speaking on Section 107A (Bolar Exemption), the Court clarifiedthat "manufacturing under the same is allowed only for clinical trials, but not for commercial sale."
This landmark judgement will help patentees enforce their patent rights where infringement by biosimilars/biologics is alleged. However, we may keep in mind that the observations made in this case are only prima facie in nature for the purposes of deciding the application for an interim injunction. Nothing contained herein shall be construed as an expression on the merits of the case. The grant of a quia timet injunction in patent matters is now gaining importance. The courts in India do not hesitate to pass a quia timet restraining order to stem the fear of infringement posed by the defendant in an appropriate case.
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