[Ip-health] Statement of Lawyers Collective in solidarity with the "Tobeka Daki Campaign for Access to Trastuzumab"

Lorraine Misquith lorrainemisquith at gmail.com
Wed Feb 8 06:24:01 PST 2017

*Statement of Lawyers Collective *

*in solidarity with the *

*"Tobeka Daki Campaign for Access to Trastuzumab"*

*7 February 2017*

The Lawyers Collective joins people living with cancer and health groups
across the world who are demonstrating today to call attention to the
unethical and inhuman behaviour of Swiss multinational company Roche in
denying access to *trastuzumab* which is used to treat HER2-positive breast
cancer. First and foremost, Lawyers Collective condoles the death of Tobeka
Daki. We were deeply saddened to hear of her passing in November last year.
We salute Tobeka's courage in fighting for access to *trastuzumab* not just
for herself but for thousands of women in South Africa who are forced to
run from pillar to post by Roche's profiteering. We join our friends and
colleagues in mourning for Tobeka and pledging to work towards fulfilling
her vision of access to *trastuzumab* and other cancer medicines for all
women who need them.

A key concern for women living with cancer who need this and other biologic
cancer medicines is the availability and affordability of biosimilar
versions of *trastuzumab*. Most patients in search of affordable medicines
turn to India and although *trastuzumab* biosimilars are now available in
India, Roche is using multiple litigations to thwart and discourage
biosimilar manufacturers from entering the market. We provide an overview
of the situation in India below.

*Trastuzumab: Roche's Patents and Prices in India *

The basic patent on *trastuzumab* which expired around the world in 2014
was never filed in India as it predated India's WTO obligations to grant
product patents. A secondary patent was however applied for and granted to
Genentech in 2007 (Patent No. 205534)[i] <#_edn1> which is a member of the
Roche Group. This patent would have expired in 2019. The use of
*trastuzumab* in India was approved by the Central Drugs Standard Control
Organisation (CDSCO) of India in 2000.[ii] <#_edn2> *Trastuzumab* was not
manufactured in India but imported and sold by Roche at Rs. 1,35,200/-
(approx. USD 2,000) per vial of 440 mg- with discounts a vial could cost
around Rs.1,00,000 (approx. USD 1489.33).[iii] <#_edn3> In 2012, the Indian
patent office issued India's first compulsory license on *sorefanib
tosylate*, used in the treatment of liver and kidney cancer. To pre-empt
any similar action on its cancer medicines, Roche announced a co-marketing
agreement with Emcure Pharmaceuticals Limited in 2012[iv] <#_edn4>. Emcure
received CDSCO permission to import *trastuzumab* in 2012[v] <#_edn5> which
it markets as "Biceltis" while Roche continues to sell *trastuzumab* under
a new brand name, "Herclon."[vi] <#_edn6>

In January 2013, the Health Ministry made recommendations to the Department
of Industrial Policy and Promotion (DIPP) to issue a compulsory license
(CL) for *trastuzumab*[vii] <#_edn7> leading Roche to announce a 30% price
cut to Rs. 75,000 (approx. USD 1117) per vial.[viii] <#_edn8> Even as the
government hesitated in issuing the CL, reportedly due to a perceived lack
of biosimilar producers, a public interest group - Cancer Patients’ Aid
Association filed an application for the revocation of the patent in public
interest under Section 64 of the Indian Patents Act, 1970, for failing to
meet India's strict patentability criteria while also alerting the patent
office to the multiple divisional patent applications on *trastuzumab*.[ix]
<#_edn9> In August 2013, while Roche's divisional patent applications were
rejected by the Kolkata Patent Office,[x] <#_edn10> the 2007 patent lapsed
due to Roche’s failure to file a timely renewal.[xi] <#_edn11> The lapse of
the patent ensured that Roche could not maintain its price monopoly in the
market. In 2016, the Government of India added *trastuzumab* to its
National List of Essential Medicines (NLEM) and brought it under price
control capping the price of the 440mg vial at Rs. 55,812.29 (approx. USD
831.23).[xii] <#_edn12>

*Unfortunately even this price remains out of reach for most women living
with cancer in India and public interest groups are urging the government
to consider far stricter price controls on trastuzumab.*

*Trastuzumab: Roche's Litigation Against Biosimilars *

The lapsing of Roche's patent on *trastuzumab* cleared the way for
biosimilars to enter the market. These biosimilars included those offered
by Biocon Ltd. and Mylan Inc. sold under the brand names Canmab and
Hertraz, respectively. In 2014, in what seemingly appeared as an attempt to
delay the entry of biosimilars in the market, Roche sued Biocon Ltd. and
Mylan as well as India's drug regulator, the Drugs Controller General of
India (DCGI) claiming that Biocon and Mylan misrepresented their drugs as
“biosimilar Trastuzumab” and that their biosimilar versions were not
approved in accordance with the Guidelines on Similar Biologic. Roche had
also claimed that Biocon’s package insert which showed Roche’s *trastuzumab*
clinical trial data results infringed the copyright of Roche’s package
insert. The Delhi High Court passed an ad-interim ex-parte order that
Canmab and Hertraz could not claim any similarity with Roche’s Herceptin,
Herclon or Biceltis (Roche’s brands) but did not entertain arguments on
copyright infringement.[xiii] <#_edn13> Subsequently Roche also sued
Reliance Life Science for their *trastuzumab* biosimlar. In an interim
order (dated April 25, 2016), the Delhi High Court was of the opinion that
approvals granted to Canmab and Hertraz were not in adherence of the
Guidelines issued in 2012. Till a final ruling is given, the interim order
continues to be operative. However, Biocon, Mylan and Reliance Life
Sciences were allowed to sell their versions of *trastuzumab*. The Delhi
High Court will hear this matter on March 6, 2017. A more recent entrant,
Zydus Cadila has also been sued by Roche.[xiv] <#_edn14>

*Roches’ litigation on other drugs*

Roche's use of litigation tactics to prevent or delay generic competition
for its drugs are not new. The Lawyers Collective represents the NGO
Sankalp Rehabilitation Trust in challenging Roche's patent on *pegylated
interferon* arguing not only the merits of the patent but also against its
repeated attempts to disallow public interest groups from challenging
granted patents.[xv] <#_edn15>

In the case of *erlotinib*, marketed by Roche as Tarceva, Natco withdrew
its application for a compulsory license to export the cancer medicine to
Nepal, one of the poorest countries in the world in the face of stiff
opposition from the Swiss MNC.[xvi] <#_edn16> Its long standing dispute
with Cipla over the patent on *erlotinib* has spanned over 8 years, and at
the High Court stage, since only four months were left in the patent term,
no injunction was granted against Cipla's product.[xvii] <#_edn17> Roches’
infringement proceedings against Dr. Reddy’s Laboratories and Natco Pharma
Ltd. over erlotinib still continue well past patent expiry.[xviii] <#_edn18>


In the case of the *trastuzumab* biosimilars, it is of great concern that
Roche has consistently dragged the DCGI to court by casting doubts on the
legality and rigour of the drug regulatory process after realising that
their patents could not withstand scrutiny under India's strict patent law.
This tactic of suing the Indian drug regulator is repeated in the case of
another biologic *bevacizumab*, marketed by Roche as Avastin and used in
the treatment of non-small cell lung cancer. Again Roche has no patent on
this drug in India.[xix] <#_edn19> These cases are not only designed to
extend Roche's monopoly on *trastuzumab* and other biologics on creative
legal grounds but are also intended to send a signal to all potential
competitors that irrespective of the outcomes of these litigations by
Roche, these competitors will have to face long, complex, extremely
expensive legal proceedings all the way up to the Supreme Court. This alone
is enough to deter most competitors from entering the market.

*The Lawyers Collective is dedicated to upholding the right to health in
India and across the world. We believe access to safe, effective and
affordable generic medicines are critical to the fulfilment of the right to
health. We believe that Roche's unaffordable, non-transparent prices,
litigation and other tactics to prevent or delay generic competition for
trastuzumab violate the right to health. Governments are duty bound to
protect the right to health of patients from actions of third parties like
pharmaceutical companies; this includes issuing a compulsory license or
revoking patents on trastuzumab in South Africa and other countries, far
stricter price controls and investigating and stopping Roche's
anti-competitive litigation tactics to harass drug regulatory agencies and
biosimilar manufacturers.*



[i] <#_ednref1>

[ii] <#_ednref2>

[iii] <#_ednref3>

[iv] <#_ednref4> http://www.emcure.co.in/business_marketing.asp

[v] <#_ednref5> http://www.cdsco.nic.in/writereaddata/FORM45%20updated.pdf

[vi] <#_ednref6>

[vii] <#_ednref7>

[viii] <#_ednref8>

[ix] <#_ednref9> http://infojustice.org/archives/30478

[x] <#_ednref10> http://pib.nic.in/newsite/PrintRelease.aspx?relid=97629

[xi] <#_ednref11>

[xii] <#_ednref12>

[xiii] <#_ednref13>https://indiankanoon.org/doc/62291003/

[xiv] <#_ednref14>

[xv] <#_ednref15>

[xvi] <#_ednref16>

[xvii] <#_ednref17>

[xviii] <#_ednref18>F Hoffmann-La Roche Ltd & Anr. vs. Reddy's Laboratories
Ltd &Anr.CS(COMM)  946/2016 in the High Court of Delhi

[xix] <#_ednref19>

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