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Statement of Lawyers Collective

in solidarity with the

“TobekaDaki 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 TobekaDaki. 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) 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. 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). In 2012, the Indian patent office issued India’s first compulsory license on sorefanibtosylate, 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 . Emcure received CDSCO permission to import trastuzumab in 2012 which it markets as “Biceltis” while Roche continues to sell trastuzumab under a new brand name, “Herclon.”

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 leading Roche to announce a 30% price cut to Rs. 75,000 (approx. USD1117) per vial. 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. In August 2013, while Roche’s divisional patent applications were rejected by the Kolkata Patent Office, the 2007 patent lapsed due to Roche’s failure to file a timely renewal. 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).

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 trastuzumabclinical 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. Subsequently Roche also sued Reliance Life Science for their trastuzumabbiosimlar. 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, ZydusCadila has also been sued by Roche.

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 SankalpRehabilitation 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.

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. Its long standing dispute with Ciplaover the patent on erlotinibhas 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. Roches’ infringement proceedings against Dr. Reddy’s Laboratories and Natco Pharma Ltd. over erlotinib still continuewell past patent expiry.

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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 Avastinand used in the treatment of non-small cell lung cancer.Again Roche has no patent on this drug in India. These cases are not only designed to extend Roche’s monopoly on trastuzumaband 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 andother 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 andother countries, far stricter price controls andinvestigating and stopping Roche’s anti-competitive litigation tactics to harass drug regulatory agencies andbiosimilar manufacturers.

#ForTobeka

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