E-DRUG: Berne Declaration: Novartis Glivec patent case in India
----------------------------------------------------
Please find below a 'quick & dirty' free translation of the Berne Declaration press release issued in French concerning the Novartis/Glivec case in India
Lausanne/Switzerland, 31 August 2009
Yet another appeal by Novartis in India
A legal stubbornness that threatens the lives of blood cancer patients
For ethical and public health reasons, the Berne Declaration strongly condemns the appeal filed by Novartis before the Indian Supreme Court regarding its anticancer drug Glivec. Despite three consecutive defeats in justice since 2006, the Swiss multinational pharmaceutical company relentlessly tries to challenge the Indian Law, in particular its section 3(d) - a crucial safeguard against the multiplication of patents around the same substance. A Glivec monopoly situation would deprive thousands of blood cancer patients from access to a vital drug, in India and elsewhere.
In May 2006 and June 2009, Novartis already faced two patent rejections in India for its Glivec (imatinib mesylate), a vital drug against Chronic Myeloid Leukemia (CML), a form of blood cancer. The Swiss company was also defeated before the Indian justice in August 2007, when the High Court of Chennai confirmed the constitutional validity of section 3(d). This unique provision of the Indian Patent Act states that pharmaceutical derivatives of already existing drugs must demonstrate increased efficacy before a new patent can be granted. It aims to prevent "evergreening", a common practice in rich countries referring to the multiplication of abusive and worthless patents on a same substance.
A monopoly situation of Glivec would de facto mean to deprive from access to a vital drug a majority of the 20'000 new Indian patients suffering each year from CML. Novartis claims that 99% of all patients in India needing Glivec receive it for free through its Patient assistance programme, however in reality less than 30% of all potential CML patients in India is benefitting.
One of three Indians still lives on less than one dollar a day, and three out of four on less than two dollars a day. Since a treatment with Glivec costs around 30'000 US dollars a year, a vast majority of the patients rely on Indian generic versions of the drug sold up to 15 times cheaper. Furthermore, many developing countries rely on generic drugs produced in India, affordable at reasonable costs.
Whilst thousands of lives are at stake, in India and elsewhere, Novartis refuses to accept passed court decisions and files yet another appeal. Global world sales of Glivec® have reached 3.8 billion dollars in 2008. These drugs definitely do not need an additional patent in India to be financially profitable.
-----
Déclaration de Berne - Berne Declaration
Patrick Durisch
Responsable Programme Santé - Health Programme Coordinator
Rue de Genève 52, CH - 1004 Lausanne
Tel. direct: +41 21 620 03 06
Fax: +41 21 620 03 00
Email: durisch@ladb.ch
Web: www.ladb.ch