INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali Mittal and Gursimran Singh Narula, Anand and Anand
Anand and Anand Anand and Anand Plot No 17 A First Channel Building Film City Sector 16A Noida Uttar Pradesh 201301 India Tel: +91 120 4059300 Web: www.anandandanand.com
India: A Hot Destination for IP Litigation India has emerged as a major hub for IP litigation. With dedicated IP divisions functioning in High Courts such as Delhi, Madras and Calcutta, right-holders have increasingly turned to these forums for enforce ‑ ment. The Delhi High Court, in particular, continues to lead this space; as per monthly reports published by these Courts, the Delhi High Court has handled nearly 4,000 IP-related commercial matters in the present year, with more than 100 new IP matters being filed every month. Indian courts have delivered numerous decisions that have shaped the IP dispute landscape and have made a remarkable impact globally. The Delhi High Court granted a landmark decision in favour of ER Squibb & Sons by restraining Zydus Lifesciences Limited for infringement of its patent concerning a monoclonal antibody, Nivolumab. The Court noted that the defendant’s biosimilar ZRC- 3276 was admittedly similar to the reference biologic, essentially having similar amino acid sequencing to that of Nivolumab. These admissions were clearly traced to the defendant’s clinical trial applications, which named Nivolumab as the comparator. Illustrative List of Case Law Biopharmaceutical litigation The Court also noted the defendant’s product claimed conformity to the INN Nivolumab. Given that the plaintiff’s patent was mapped with 5C4 antibody (Nivolumab), the defendant’s product would also have the same sequencing. The defendant’s own test data showed that binding specificity of Opdivo (the plain ‑
tiff’s product) and ZRC-3276 were PD-1 antibodies that have higher binding affinity to human PD-1 recep ‑ tors compared to other CD-28 family receptors, and do not bind substantially with human CD-28/CTLA4 or ICOS receptors. Thus, both products fall within the scope of the claims of the suit patent. Ordinarily in patent infringement, a comparison has to be drawn between the claim of the patent and the infringing product; however, since the suit was a quia timet action, such claim mapping could not be produced. The plaintiffs had done the claim mapping with Nivolumab INN assigned by the WHO, which was used as the reference product by the defendant for the development of its biosimilar. Therefore, such an indirect comparison was permissible. The Court also held that the defendants had failed to clear the way and mere filing of a pre-grant opposition was insuffi ‑ cient. The Court held that, when a patent is prima facie found to be infringed, and is being exploited without licence, the balance of convenience tilts in favour of restraining the infringement. The Court also rejected the defendant’s challenge to validity of the patent and restrained the defendants from stockpiling the infring ‑ ing drug during the term of the patent. In Amgen Inc v The Assistant Controller of Patents and Another , the Madras High Court allowed the appeal filed by the patentee against refusal to grant patent. The subject invention related to lyophilised formula ‑ tions containing certain excipients in a specific con ‑ centration for a therapeutic peptibody, referred to as Formula V.
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