NEW DELHI: Sale of generic versions of cancer medication Ibrutinib, used to treat leukaemia, has been blocked across the country, denying patients access to affordable therapy.
The Delhi high court recently passed an injunction against six domestic companies Natco Pharma, Hetero, BDR Pharma, Shilpa Medicare, Alkem and Laurus Labs from marketing generic versions.
The order was passed on grounds of an infringement of the drug’s patent. The Ibrutinib patent is held by Pharmacyclics, a subsidiary of US firm AbbVie, while the drug is marketed in the country by Johnson & Johnson, an Indian affiliate of Janssen Biotech.
The Ibrutinib patent is valid till 2026, and it is commercially sold under the registered trademark, Imbruvica.
“The fact that the defendants are in fact manufacturing and selling Ibrutinib, without a licence from the plaintiffs, is not disputed. Where a granted patent is prima facie found to be infringed, and is being exploited without a license from the patent holder, the balance of convenience is always in favour of restraining further infringement.
I am aware that the drug in question is needed for treating various serious ailments, including cancer. That said, the law sternly prohibits patent infringement, and it may not be possible to argue that considerations of public interest should be allowed to justify infringing drugs to circulate in the market,” Justice C Hari Shankar, said in an order, a copy of which was accessed by TOI.
This is a batch of six suits and one writ petition. The writ petition, filed by Laurus Labs in a post-grant application challenged the patent granted to the US firm before the Indian Patent Office, and sought its revocation.
Given the importance of the drug, however, the court permitted companies to exhaust the stock available with
them, subject to their placing, on affidavit with this court with the details of sales.
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