The sale of generic versions of cancer drugs is halted as the Delhi High Court prevents patent infringement

The sale of generic forms of Ibrutinib, a cancer medicine used to treat leukaemia, has been halted nationwide, denying patients access to affordable treatment.

The Delhi High Court recently issued an order prohibiting six domestic companies, Natco Pharma, Hetero, BDR Pharma, Shilpa Medicare, Alkem, and Laurus Labs, from marketing generic versions.

The order was issued based on an infringement of the drug's patent. Pharmacyclics, a subsidiary of US firm AbbVie, owns the Ibrutinib patent, and Johnson & Johnson, an Indian affiliate, markets the drug nationwide.

The Ibrutinib patent is valid until 2026 and commercially available under the registered trademark Imbruvica.

Justice C Harishankar added that the defendants are manufacturing and marketing Ibrutinib without a licence from the plaintiffs, which is undisputed. When a granted patent is prima facie proven to be infringed and used without a licence from the patent owners, the balance of convenience always favours preventing further infringement. I am aware that the drug in question is required to treat a variety of severe conditions, including cancer. However, the law strictly prohibits patent infringement, and it may be challenging to demonstrate that arguments of public interest should be allowed to justify the sale of infringing pharmaceuticals.

This batch consists of six suits and one writ petition. Laurus Labs filed a writ petition in a post-grant application challenging the patent issued to the US corporation before the Indian Patent Office, seeking its revocation.

Given the necessity of the medicine, the court allowed firms to exhaust their stock, subject to filing an affidavit detailing the sales with this court.