[Ip-health] Press Release: Campaign for Affordable Trastuzumab welcomes the dismissal of Roche's Trastuzumab divisionals

leena menghaney leenamenghaney at gmail.com
Tue Aug 6 06:34:27 PDT 2013


Campaign for Affordable Trastuzumab welcomes the dismissal of
Trastuzumab’s divisionals

 New Delhi, 6 August 2013: The Campaign for Affordable Trastuzumab
welcomes the decision of the Patent Controller, Kolkata,[1] to dismiss
the divisional applications for patents on Trastuzumab (Herceptin),
the life-saving breast cancer drug controlled by Swiss pharma major
Roche.

Faced with misleading statements by Roche and factually incorrect
reporting by the international media, the Kolkata Patent Office took
the unusual step of explaining its stand in a press release issued
last evening. The note clarifies that the divisional applications
(filed in 2005 and 2008) were dismissed because Genentech/Roche missed
the stipulated deadline for filing of applications, and failed to
appear and make their case when requested to do so by the Patent
Controller.

Hailed as a major breakthrough in cancer treatment, Trastuzumab has a
dramatic impact on the HER2+ variant of breast cancer, significantly
reducing the risk of recurrence and expanding the possibility of a
disease-free life. However, the drug is priced exorbitantly and, at
Rs.9 lakhs for a minimum course of 12 injections, is out of reach for
the majority of Indian women. According to official statistics, more
than 25,000 Indian women (increasingly in the under-45 age group) are
diagnosed with HER2+ breast cancer every year, of whom less than 5
percent are able to access Trastuzumab[2].

The Campaign for Affordable Trastuzumab, launched 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 demanding that the Government of India intervene to
enable the production of biosimilars and ensure that the drug is made
available to all those who can benefit from it.

In the case of Trastuzumab, the basic compound is not patentable in
India since it was developed before India revised its patent regime to
make it WTO-compatible. However, in 2007, a secondary patent[3] was
granted in India to Genentech (the original developer, later acquired
by Roche) on a composition of the drug. This patent is valid until
2019 and is blocking potential competitors from entering the market,
faced as they are with the possibility of being slapped with a patent
infringement suit by Roche. See attached factsheet for more
information about the drug patent landscape.

In April this year, we alerted the Controller General of Patents to
Roche's attempt to protect its monopoly beyond the term of its patent
by filing “divisional” patent applications built around matter
extracted from the original “parent application”. In our letter to the
Controller-General[4], we pointed out that these divisional
applications are clearly designed to keep interested competitors from
investing in the development of affordable biosimilars by creating
uncertainty on the exact status of the patent protection for the drug.

India's patent regime has been globally lauded for its ability to
resist pressures from big pharma and for its stringent provisions
against “evergreening” or extending the legal term of a patent by
seeking fresh protection for non-significant changes in the original
innovation. Moreover, Indian law does not allow the filing of
divisional applications once the “parent” patent has been granted, and
also clearly spells out the timeline for submitting divisional
applications and for responding to queries. As we pointed out in our
letter to the Controller-General, these provisions were ignored by
Roche in a cynical attempt to subvert the legal regime and bring in
“evergreening” through the back door.

Our characterisation of the divisional applications filed by Roche as
frivolous and mala fide is borne out by the statement of the Kolkata
Patent Controller, that Roche lawyers did not bother to appear for
hearings and did not make written submissions despite being given
repeated opportunities to make their case. The Kolkata Patent Office
was therefore entirely within its rights in dismissing these
applications, pending with them since 2006 and 2009.

Despite its unverified claims of having provided the drug at a reduced
price to a small and select group of patients, Roche's reaction to the
decision of the Kolkata Patent Office[5] reveals its determination to
continue its predatory pricing policy even if it means subverting
Indian law to reap a profit that is completely disproportionate to the
cost of development and production of Trastuzumab.

The oft-repeated claim by the pharma industry, that the high prices of
drugs such as Trastuzumab are justified in relation to the costs of
research and development, has now been comprehensively debunked by
none other than the CEO of pharma giant Glaxo Smith Kline.[6] Calling
it one of “the great myths of the industry”, he revealed out that the
cost calculation includes the cost of failed drugs. According to him,
the rate of return on R&D investment has gone up by as much as 30% in
recent years because fewer drugs have flopped in late-stage testing.

Herceptin was approved by the FDA in 1998. The Genentech balance sheet
shows that Herceptin brought in US$ 1287 million for Genentech in
2007[7], the year that it was taken over by Roche. Since then,
Herceptin has been swelling the Roche coffers – along with two other
cancer drugs Avastin and Rituxan, Herceptin has accounted for 32% of
Roche’s total revenue for at least five years. The money Roche has
earned from Herceptin is therefore likely to be several times more
than the upper figure of $800 million quoted for the cost of
development. We should also take into account the hidden public
funding that goes into drug development by corporates – for instance,
clinical trials and supplementary research are usually carried out in
hospitals and laboratories that are supported by public grants.

Recent decisions by India’s Intellectual Property Appellate Board
upholding the compulsory licence for  sorafenib tosylate and revoking
the patent for Hepatitis-C drug pegylated interferon have dealt a
major blow to big pharma’s plans to graze freely in the Indian drug
market. These decisions have been applauded and welcomed by health
rights groups and public interest groups around the world as an
assurance of India’s political will to resist arm-twisting by pharma
MNCs.

Global experience confirms that open competition via generics is a far
more effective mechanism for price reduction than other options such
as the negotiated price reductions being offered by the pharma
industry.  In May 2013, an Expert Committee set up by the Ministry of
Health recommended compulsory licensing for Trastuzumab. This
recommendation is still awaiting a decision from the Department of
Industrial Policy and Promotion (DIPP), Ministry of Commerce.

We are concerned at reports[8] suggesting that DIPP's decision will
depend on generic manufacturers already having applied for marketing
permission for a biosimilar version of Trastuzumab. This approach is
one of putting the cart before the horse – it is unlikely that generic
manufacturers will reveal their hand by applying for marketing
permission without being assured of the a clear field where  patent
barriers will not block their entry into the market. On the other
hand, we have reason to believe that the announcement of compulsory
licensing by DIPP will open the door for marketing applications from
generic manufacturers who have Trastuzumab biosimilars in the
pipeline.

The Campaign for Affordable Trastuzumab urges the Government of India
to act without delay to allow generic manufacturers to produce
biosmilars of Trastuzumab. The lives of thousands of Indian women are
at stake – allowing a single predatory company to control the drug
that can save them is ethically, legally and economically unjustified.

 KALYANI MENON-SEN

Coordinator, Campaign for Affordable Trastuzumab



For further information, please contact:

                                                               Kalyani
Menon-Sen +91-9910306382

                                                                Leena
Menghaney +91-9811365412


________________________________

[1]     See the PIB press release at
<http://pib.nic.in/newsite/erelease.aspx?relid=97629>

[2]     According to doctors at the Tata Memorial Cancer Centre, Mumbai.

[3]     Indian Patent 205534

[4]     See attached factsheet

[5]     http://online.wsj.com/article/SB10001424127887324635904578644100746473088.html

[6]     <http://donttradeourlivesaway.wordpress.com/2013/03/19/gsk-on-rd-and-the-1-billion-rd-myth/#more-5379>

[7]     <http://www.wikinvest.com/stock/Genentech_%28DNA%29>

[8]     <http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/dipp-may-seek-information-from-dcgi-to-manufacture-generic-version-of-roches-anti-cancer-drug/articleshow/21638360.cms>


-- 
Leena Menghaney
Tel: 46573730/1, 9811365412



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