[Ip-health] Campaign for Affordable Trastuzumab response to High Court Order

K.M. Gopakumar kumargopakm at gmail.com
Fri Feb 7 03:18:13 PST 2014


As per the Delhi High Court order delivered on February 5, 2014, Roche has
pressed for an ex-parte ad-interim order restraining Biocon and Mylan from
launching, introducing, selling and marketing trastuzumab (breast cancer
drug) in Indian market. Attached is the copy of the order.
(*http://lobis.nic.in/dhc/MAN/judgement/06-02-2014/MAN05022014S3552014.pdf
<http://lobis.nic.in/dhc/MAN/judgement/06-02-2014/MAN05022014S3552014.pdf>
)*

*Protecting profits more important than protecting patients?*

7-Feb-14, New Delhi: 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.

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*



[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>



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