[Ip-health] Final hearings begin in Bayer's appeal against Indian move to allow production of more affordable cancer drug: Further compulsory licences on high-price patented medicines expected

Katy Athersuch katy.athersuch at gmail.com
Fri Jan 18 06:45:37 PST 2013


*Final hearings begin in Bayer's appeal against Indian move to allow
production of more affordable cancer drug*

* *

*Further compulsory licences on high-price patented medicines expected*


*18 January 2013 -* This week, final hearings began in Chennai, India, in
the appeal that German pharmaceutical company Bayer has filed against
India’s first-ever compulsory licence (CL).   In a related development,
India is currently identifying other patented drugs on which CLs are

*Bayer case - *The patent on the cancer drug sorafenib tosylate (marketed
as Nexavar) was granted to Bayer in March 2008.  Generic company Natco
applied for a CL in July 2011, which was granted by the Indian Patent
Controller in March 2012.

The CL allows a more affordable version of *sorafenib tosylate *to be
produced and marketed, and brought the price of the patented drug down from
over US$5,500 per month to $175 per month - a reduction of 97 per cent.
Under the terms of the compulsory licence, Bayer is being paid a six per
cent royalty on sales by Natco.

In their appeal, Bayer have argued that the Patent Controller erred in the
decision to grant a compulsory licence, and should have allowed the company
more time to ‘work’ the patent, over and above the three years entitled
under law. Indian CL provisions require a generic competitor to wait three
years after the grant of a patent before an application for a licence to
market a more affordable generic version can be filed.

In the hearings, Natco is currently defending the Patent Controller’s
decision before the Intellectual Property Appellate Board (IPAB). India’s
Controller of Patents deemed that Bayer had failed to price the drug at an
affordable level and had made insufficient efforts to make the medicine
available. The hearings, which are being held in Chennai, are expected to
conclude next week.

*Further compulsory licences expected - *In a related development, an
expert committee established by the Indian Ministry of Health has
recommended that the government consider issuing CLs on three other cancer
drugs - trastuzumab, ixabepilone and dasatinib. The three drugs are
patented in India and cost approximately Rs. 70,000 (US$1,290) per vial,
Rs. 60,000 ($1,110) per vial and Rs.2,700 ($50) per tablet, respectively.
The Department of Industrial Policy and Promotion is now expected to
formally implement the recommendations of the Committee.

*MSF position - *Médecins Sans Frontières (MSF) welcomes the steps the
Indian Ministry of Health is taking to identify patents on drugs that are
exorbitantly priced and face no generic competition.

Eight years after India amended its patent law to implement the
international trade rules enshrined in the TRIPS agreement, new medicines,
including drugs to treat HIV and hepatitis, are now patented in the country
and are too expensive and unavailable for those who need them most. MSF’s
Mumbai clinic pays as much as US$1,775 per person per year to access just
one patented drug for HIV, raltegravir, for example.

MSF hopes that India will continue to use all the means at its disposal –
including compulsory licences – to address patent barriers and bring down
high prices on the medicines that are vital to many in India and the
developing world.

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