The Campaign for Affordable Trastuzumab deplores the ex-parte order of the Delhi High Court on a petition by Swiss pharma major Roche, effectively preventing Biocon from marketing of a biosimilar of the breast cancer drug trastuzumab.
[The order is available here: http://lobis.nic.in/dhc/MAN/judgement/06-02-2014/MAN05022014S3552014.pdf]
It seems that the order has been issued with little concern for the Supreme Court guideline on ex-parte injunctions. According to the Supreme Court of India – “Experience reveals that ex-parte interim injunction orders in some cases can create havoc and getting them vacated or modified in our existing judicial system is a nightmare. Therefore, as a rule, the court should grant interim injunction or stay order only after hearing the defendants or the respondents and in case the court has to grant ex-parte injunction in exceptional cases then while granting injunction it must record in the order that if the suit is eventually dismissed, the plaintiff or the petitioner will have to pay full restitution, actual or realistic costs and mesne profits.” [1] Both these directions by the Supreme Court have been ignored in the present order.
The action of the court in giving an interim ex-parte injunction in a case where access to a life-saving drug is at stake, is unwarranted and inexplicable.
The court has prevented Biocon from “relying upon or otherwise referring to HERCEPTIN, HERCLON or BICELTIS including data relating to its manufacturing process, safety, efficacy and sales, in any press releases, public announcements, promotional or other material for the defendants’ drugs, i.e. CANMAb and HERTRAZ”. In effect, the court has prevented the company from marketing the medicine in India. This is tantamount to extending proprietary rights to a non-proprietary term “trastuzumab” which is a chemical name without any intellectual property protection.
The court has also restrained Biocon from relying upon any data relating to trastuzumab’s manufacturing process, safety, efficacy and sales. This is contrary to the provisions of The Drugs and Cosmetics Act of India, which does not allow any exclusive protection of data (data exclusivity) including manufacturing process, safety and efficacy of a drug to any originator company.
Significantly, Roche has cited lack of compliance with the Biosmilar Guidelines of India [2] as a ground for seeking the injunction. The Campaign for Affordable Trastuzumab would like to highlight that Roche was a member of the drafting committee for the biosimilar guidelines. This move by Roche bears out our contention that the guidelines are weighted against innovators in developing countries, and are likely to be used by big pharma to protect its own interests rather than ensure the safety and efficacy of biosimilars.
The Campaign for Affordable Trastuzumab opposes the prioritisation of corporate profits over people’s right to health. We urge the Government to undertake an urgent re-appraisal of the biosimilar guidelines. The guidelines must be geared to encouraging innovation, fostering competition and lowering prices, rather than to enable originators to protect their monopolies and reap unethical profits.
KALYANI MENON-SEN
Coordinator, Campaign for Affordable Trastuzumab
Phone: +91-9910306382*
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[1] (*Ramrameshwari Devi & Ors. vs Nirmala Devi Ors.* ) http://www.indiankanoon.org/doc/183635/
[2] Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India. http://dbtbiosafety.nic.in/Files%5CCDSCO-DBTSimilarBiologicsfinal.pdf<http://dbtbiosafety.nic.in/Files/CDSCO-DBTSimilarBiologicsfinal.pdf>
