Community opposition filed against tenofovir patent application in India

10 June 2006. Related: Treatment access.

On 9 May 2006 the Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People filed an opposition at the Delhi Patent Office to a patent application for tenofovir disoproxil fumarate (TDF).

“For many of us living with HIV/AIDS, newer drugs like tenofovir offer new hope of continuing treatment. With patents interfering with our lives we have no choice but to oppose them”, says Loon Gangte, from the Delhi Network of Positive People, speaking at a press conference held in Delhi.

The World Health Organisation (WHO) recognises the importance of tenofovir and recommends on their website the drug for use in first and second-line drug regimens in resource poor settings. Widely available in the US and Europe, tenofovir is commonly prescribed because there are fewer known side effects associated with the use of this drug in adults.

However, tenofovir is largely unavailable and often unaffordable in the developing world and treatment providers, such as Medecins sans Frontiers (MSF), are keen to source it from India. The first generic version of tenofovir has been marketed in India since 2005. If the patent application filed by Gilead Sciences is granted, generic production of the drug will be blocked until 2018.

Public interest lawyers providing legal support to INP+ argue that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is a common practice within the pharmaceutical industry, and should not be considered a new invention.

“If this patent is granted, it will set a dangerous precedent for global access to newer essential drugs”, explains Anand Grover, Director of the Lawyers Collective HIV/AIDS Unit. “Tenofovir production, just like that of other newer essential drugs, would remain solely in the hands of a single pharmaceutical company and block the generic competition that is needed to bring prices down,” he added.

The medical humanitarian organization MSF today expresses its support for Indian civil society groups in their legal battle against a patent application for the key AIDS drug tenofovir. ‘In our HIV treatment programmes, high price and a lack of availability is severely restricting access to treatment. We clearly need more than one source for essential drugs,” says Hans van de Weerd Head of Mission of MSF in India.

Cancer patients recently opposed a patent application for an anti-cancer drug on the grounds that the application claimed a new form of an old drug. The patent was subsequently rejected by the patent office. K.K. Abraham from INP+: “This patent application should also be rejected because with the patent we will not be able to afford treatment.”

Under the 2005 Indian Patents Act, anyone can submit comments in opposition of a patent before the patent office decides to grant or reject it.

Source: MSF Press Release (10 May 2006)

Comment

The single most important factor in making HIV a treatable infection throughout the world, irrespective of a countries wealth, was undeniably the ability for Indian generic manufacturers to competitively manufacture antiretroviral drugs at a fraction of cost charged in Western countries.

While some research-based pharmaceutical companies offer discounted prices for some drugs that are lower than generic versions (generally protease inhibitors), reducing costs to more affordable levels has historically only followed price reductions from generic competition.

Additionally, countries not eligible for the discounted price of $208 per patient per year – including Brazil, India, Thailand and China are forced to pay the full price of $ 5,718 per patient per year. Although classed as middle-income countries they often have either high incidence of HIV, generally amongst the poorest members of society, and a lack of heath care systems. In practice this means tenofovir is rarely available in many countries for patients who need second-line therapy.

In a statement from Gilead, the company said that they would use the expected patent responsibly, and would not block access to their medication in India or in other resource-limited countries. They stated that are ‘pursuing a broad policy of non-exclusive, voluntary licensing under this patent to generic manufacturers in India for the local Indian market as well as provision for manufacturers to export product to the 97 developing world countries included in Gilead’s access program’. The statement continued ‘the specifics of these plans have not been finalised, and we will provide more details as soon as possible. We believe that multiple manufacturers will ensure competitive prices and the broadest access possible in these least developed countries.”

Last year, the Indian Parliament approved the country’s new Patent Act, thereby allowing pharmaceutical products to be patented in India. This new law put some serious constraints on generic competition but also included some potentially important features such as “automatic licensing” and the possibility for anyone to object to a patent before it is granted.

Although the law was not passed until last year, from as early as 1995, companies could start filing patent applications for pharmaceuticals in India with the patent offices. The backlog of thousands of patent applications includes antiretroviral drugs (ARVs) such as tenofovir DF and Combivir (AZT/3TC). Although this is a voluntary process, it is expected that all research-based companies have filed patients for all existing ARVs.

Not all patent applications are valid. The Indian Patent Act, if rigorously interpreted, provides several grounds for rejecting a patent, for instance if the pharmaceutical substance claimed is only a new form of a known substance. For example, in January 2006, the Indian patent office rejected the application for Novartis’ anti-cancer drug imatinib mesylate (Gleevac), on the grounds that the application claims a ‘new form of a known substance’ (Novartis’ patent application was related to a particular crystal form of the salt of imatinib mesylate). The rejection was a major victory for the Cancer Patient Aid Association of India and some Indian generic companies, which had both submitted a pre-grant opposition to the patent office. The rejection of the Gleevac patent gives reason for optimism.

Gilead’s patent for tenofovir disoproxil fumarate (Viread) was filed with the Delhi Patent office in 1998. The Lawyers Collective, in collaboration with the Alternative Law Forum, is currently drawing up an extensive list of drugs based on medical needs and for which patent applications are pending in India.

On March 30th 2006, The Indian Network for People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers’ Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds. Clearly concerned that the granting of such a patent will increase the burden on developing countries already struggling to treat patients, INP+ objected to the Combivir patent application on the ground that it does not claim a new invention but instead simply the combination of two existing drugs.