[Ip-health] Campaign for Affordable Trastuzumab welcomes the dismissal of Trastuzumab’s divisionals

K.M. Gopakumar kumargopakm at gmail.com
Tue Aug 6 10:45:48 PDT 2013

Campaign for Affordable Trastuzumab welcomes the dismissal of Trastuzumab’s
The Campaign for Affordable Trastuzumab urges the Government of India to
act without delay to allow generic manufacturers to produce biosmilars of
6 August 2013

New Delhi

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, an Indian patent[3] was granted to
Genentech (the original developer, later acquired by Roche) for a
combination of the HER2+ antibody. 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

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 Nexavar and revoking the patent for Hepatitis-C
drug Pegasys 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.

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