The Delhi HC, in the case of F- Hoffmann -La Roche Ag Vs. Zydus Lifescience[order dated 9.07.2024], recently issued an injunction in favour of the Plaintiffs (F- Hoffman- La Roche) on grounds of fairness, equity, and balance of convenience.
The Plaintiff filed an infringement suit (a Quia timet action) to prevent the Defendant from launching a biosimilar[1] of the Plaintiff’s “Perjeta,” which comprises “Pertuzumab[2]” and is used to treat metastatic breast cancer. The Plaintiff claimed that the Defendant’s product infringed upon their patents IN 268632 and IN 464646 and additionally, sought an injunctive relief under Order XXXIX Rules 1 and 2 against the Defendant.
IN 464646, titled as “Pertuzumab Variants And Evaluation Thereof”, is a process patent relating to the method of making a composition with Pertuzumab and one or more variants. IN 268632, titled as “Pharmaceutical Formulation Comprising Her2 Antibody”, relates to an aqueous pharmaceutical formulation comprising Pertuzumab and excipients such as sucrose, histidine acetate buffer, polysorbate, and has a pH range of 5.5 to 6.5. The Plaintiff had submitted during the initial hearings that as the Defendant’s product was awaiting a commercial launch, it was not possible to map the claims of the Suit Patents with the potentially infringing product. The Plaintiff also submitted that they are unaware of the specific processes used in making the Defendant’s product. The Plaintiff, however, contended that the only feasible process to produce the infringing Similar Biologic was by utilising the method outlined in its process patent, i.e., 464646.
While deliberations on the grant of an interim injunction were pending [in I.A. 4196/2024], the Defendant launched its product under the brand name “Sigrima”. Further, the Defendant entered into a with a third party to co-market “Sigrima” in India. The Plaintiff aggrieved by the launch, pressed for an injunction and submitted that during the hearings in respect of I.A. 4196/2024, the Court specifically inquired from the defendant, about the expected time of approval of Defendant’s product and the Defendant had assured that the regulatory authority will take at least three months before taking a final decision.
Pertinently, the court observed, “despite specific inquiries in subsequent hearings, the Court was not informed that regulatory approval was imminent. It has now come to light, through this application, that the Defendant received approval from the Central Drug Standard Control Organisation, Ministry of Health and Family Welfare on 04th April 2024. Pertinently, in the hearings conducted after this approval – on 24th April 2024 and 13th May, 2024 – the Defendant chose not to disclose this significant development to the Court.”
Given that the matter was under active consideration, the court observed that, “it was reasonable to expect that the Defendant would provide timely updates about significant developments. Specifically, when the Court explicitly inquired about the timeframe for regulatory approvals during the hearings, the Defendant had a duty to disclose any pertinent information regarding the launch of the impugned product.”
Further, the Court observed that transparency holds a lot of significance in a proceeding of this nature, particularly in a quia timet case. The court further highlighted the significance of fairness in commercial disputes. As per the Court, the basic principle of equity, which states that that no party should gain an undue advantage by withholding information or acting in a manner that could be construed as contrary to the spirit of fair legal proceedings, was severely impacted by the Defendant’s conduct.
The court also held that the balance of convenience is in favor of the Plaintiff, as the potential harm to the Plaintiff from denying of the injunction would far outweigh any inconvenience caused to the Defendant, who will merely be delayed from benefiting from a product whose legality is yet to be fully adjudicated.
Given these circumstances, the court was inclined to grant an injunction that would protect the Plaintiff’s interests while conclusively resolve the substantive issues by preventing entry of the infringing product into the market.
Though the court has granted an injunction, however, to decide the interim injunction application, the court would have to delve into the claims of the suit patents, determine infringement with the understanding of the scope of the patents held by the plaintiff and the product of the Defendant. Considering the technical complexity of the matter, the Court may also consider appointing an independent Scientific Advisor who would provide neutral expert analysis on the scientific aspects critical to the case, thereby aiding the Court in understanding the nuances of biologic medicine and patent law. To ensure a thorough exploration of the technical issues, the Court also indicated considering the process of ‘hot tubbing’ for simultaneous questioning of experts from both sides.
[1] Biosimilars are designed to be highly similar to the reference product, but not identical.
[2] A monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer
