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Natco Moves Delhi HC Against Ribociclib Patent

New Delhi: The Delhi High Court has sought responses from the Controller of Patents, Swiss pharmaceutical company Novartis AG, UK-based Astex Therapeutics and other parties on a petition filed by Natco Pharma challenging the grant of a patent covering ribociclib, a drug used in the treatment of breast cancer.
According to the news reported by ET, Justice Anup Jairam Bhambhani directed the concerned parties to respond to Natco’s petition. The case relates to a July order passed by the Deputy Controller of Patents and Designs granting a patent to Novartis and Astex. Natco has challenged the order, alleging that the patent authority failed to properly consider its objections concerning the alleged extension of patent protection for the same invention.
Natco has contended that granting a second patent for ribociclib would effectively allow Novartis and Astex to extend their exclusive rights over the molecule beyond the expiry of the earlier patent. The company has described this as a case of “double patenting”, arguing that the subsequent patent could enable the multinational companies to continue asserting rights over the same invention even after the earlier patent expires.
The dispute concerns a patent application titled “Pyrrolopyrimidine Compounds as CDK Inhibitors”, filed by Novartis and Astex in 2011. The application covers ribociclib, a cyclin-dependent kinase inhibitor used in the treatment of early, advanced and metastatic breast cancer. Natco had previously opposed the grant of the patent application before the patent authorities.
Natco argued that the second patent lacked an inventive step because ribociclib had already been covered by Novartis and Astex in an earlier genus patent application having an earlier priority date.
Natco subsequently challenged the July order before the Delhi High Court through its counsel Afzal Badr Khan of S. Majumdar & Co. Novartis and Astex, meanwhile, have questioned the maintainability of Natco’s petition, arguing that an alternative statutory remedy is available to the company under the Patents Act.
Delhi High Court will first determine the maintainability of Natco’s petition before proceeding further with the matter. The court has listed the case for hearing on September 16, reports ET.
Mpharm (Pharmacology)
Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

