[Ip-health] Roche relinquishes Trastuzumab patent in India Campaign urges fast track approval for bio-similars

K.M. Gopakumar kumargopakm at gmail.com
Fri Aug 16 04:32:40 PDT 2013

*Roche relinquishes Trastuzumab patent in India***

*Campaign urges fast track approval for bio-similars*

16 August 2013, New Delhi: Swiss pharma major Roche has just announced that
it is relinquishing the patent for its breast-cancer drug Trastuzumab
(Herceptin) in India. The announcement comes in the face of mounting
challenges - from both civil society and the Ministry of Health - to
Roche's monopoly on this life-saving drug.

*The Campaign for Affordable Trastuzumab* welcomes the announcement,that comes
appropriately on India's Independence Day and brings hope of a disease-free
life for the thousands of Indian women who are battling HER2+ breast cancer.

Now that the patent barrier has been removed, the Campaign urges generic
manufacturers to come forward immediately and apply for licenses to
manufacture and market biosimilars of Trastuzumab.

We call on the government to take all necessary measures to speed up the
development of biosimilars of Trastuzumab. Development and clinical trial
of biosimilars should be publicly funded, and fast-track processes put in
place for regulatory approval, as well as for access to Trastuzumab through
the public health system.

As we have pointed out earlier, the Indian patent on Trastuzumab has been
granted in violation of the provisions of the Indian Patent Act and stands
on very shaky legal ground. A post-grant opposition to this patent has been
pending with the Kolkata Patent Office for more than five years. Earlier
this year, the Cancer Patients' Aid Association had also moved for the
revocation of the Trastuzumab patent.

Official unresponsiveness to these communications has allowed Roche to
misuse this frivolous patent to implement a predatory pricing policy and
block generic entry for more than six years. The human costs are enormous -
more than a million women have been diagnosed with HE2+ cancer in the six
years that this patent has been in force, with less than 10% of them able
to access the drug.

Roche's decision to relinquish the Trastuzumab patent should not be
mistaken for altruism – it is a face-saving gesture in response to the
eroding legitimacy of both the patent and the pricing policy in India. It
is also a tactical move to avoid compulsory licensing, which would have
much more serious and far-reaching implications for its plans in the Indian
market. Roche is already questioning the approval given to Dr Reddy's
Laboratories for the production of a biosimilar version of the lymphoma
drug Rituximab, which will pose stiff competition to Roche's MabThera.
Roche is also planning to launch successors to Trastuzumab in the US and
European markets before 2014, when biosimilars can be expected to enter the

Trastuzumab is not the only case where patent barriers are violating the
right to life of Indian citizens. Our work reveals a consistent pattern of
bureaucratic maneuvers to delay and deflect legal challenges to patents
held by some favored players. There is an urgent need for review and
strengthening of the system for screening applications and awarding
patents, as well as closer oversight of the functioning of patent offices.
This is an issue on which we will continue to focus.

We hope the outcome of this case will strengthen the resolve of our
government to resist arm-twisting by big pharma and their backers in the
global North and continue to take a tough line on patent issues in
international trade negotiations. Millions of people across the developing
world look to India to defend and expand their access to life-saving
medicines at affordable prices. The message is clear - the right to health
cannot be held hostage to the greed for profits of pharma majors.

*Note: The Campaign for Affordable Trastuzumab - initiated in November 2012
and endorsed by over 200 Indian and global patient associations, cancer
survivors, health movements, women's rights activists and eminent jurists –
has been working to highlight the lethal impact of Roche's predatory
pricing policy on women with HER2+ breast cancer, and has been urging the
government to allow production of biosimilars of Trastuzumab. The
Campaign's arguments were vindicated earlier this year with the
recommendation for compulsory licensing for Trastuzumab by an Expert
Committee set up by the Health Ministry to look into the issue.*

For more information, please contact:

Kalyani Menon Das: 9910306382

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