Many lives at risk if drug company wins court case

Many lives at risk if drug company wins court case

Publication Date: 1/30/2007  
The cost of essential drugs could soon rise substantially, if a pharmaceutical giant wins a court case against patents that allow production of generics.

The case, filed by Swiss company Novartis, kicked off yesterday in India. It challenges Indian patent laws on generic drugs.

A ruling in favour of the company will have far-reaching effects on HIV antiretroviral (ARV) drugs and other essential medicines commonly used in Kenya, and most of the developing world.

Over 50 per cent of generic ARVs used in various treatment programmes by the Kenya Government, private hospitals and NGOs are sourced from India.  

“Our lives are at stake. If Novartis wins this case, we will roll back the gains made in access to cheap medicines. The company and other drug manufacturers should not put patents and profits before lives,” says Ms Monique Wanjala, who has lived with HIV for 13 years.

Speaking yesterday to the Press at a city hotel, Ms Wanjala said she and other HIV positive people have managed to see each new day so far because of generic ARVs.

“Winning the case would set a bad precedent. It is going to affect thousands of people currently on treatment in Kenya and other sub-Saharan African countries,” said Gabriela Chaves of Medecins Sans Frontieres (MSF).

MSF has launched a global campaign to petition Novartis to drop the case, since a favourable ruling will hurt many people. Other pharmaceuticals that have over the years complained about India’s lenient manufacturing practices are likely to follow suit.

Thousands of postcards — reminiscent of a campaign for cheap ARVs six years ago — are being used to pressure Novartis to withdraw the case.

During the just-concluded World Social Forum (WSF) in Nairobi, many discussions centred on the issue, with many delegates signing the cards.  

MSF says that over 80 per cent of 80,000 Aids patients in their treatment programme use generic ARVs from India. More than 12,000 of them are in Kenya.

Ms Chaves said MSF and poor countries may lose out on new medicines if the case by Norvatis succeeds.

Novartis is challenging the legality of section 3(d) of the Indian Patent Act, which allows the country to decline granting patents to drugs that are not new. Included in this are combination drugs or slightly improved drug formulations.

The section says: “Mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of the substance; or the mere discovery of any new property or new use of a known substance; the mere use of a known process, machine or apparatus — unless such process results in a new product or employs at least one new reactant, then it is not patentable.”

This section was added to the patent laws to enable India to continue producing affordable drugs after the country was required, starting in 2005, to review its pharmaceutical patents in line with the World Trade Organisation’s (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).  

The new law also allows an interested party to object to a patent application before it is granted. Novartis says these provisions violate WTO rules and should be declared unconstitutional.

The company argues that it is protecting the international intellectual property standards and its right to obtain patents for its innovative compounds under TRIPS.  

This is not the first time Novartis is involved in a legal tussle over patent rights. In 1998, the company was among 39 that took the South African government to court for its Medicines and Related Substances Act, which was going to allow compulsory licences and parallel import of medicines to the country.

Pressure from civil society

Although they claimed this was a violation of patent rights, they withdrew the case on April 19, 2001 after pressure from civil society groups.

Aids activists say they are under siege once again. They say the Doha Declaration of TRIPS and Public Health gives WTO members the right to protect public health and, in particular, to promote access to medicine for all.  

Hence, developing countries have a right to design their patent laws in a manner that allows this to happen, and the Indian Patents Act is not in conflict with international law, they say.

Further, they add, the new Indian Patents law has affected the production of cheap generics of branded drugs used to manage patients with HIV-resistant strains.  

“If section 3(d) is deleted, then Kenya and other African countries should not expect production of cheap generics until the 20-year patent period is over,” James Kamau of Treatment Action Movement (Kenya Chapter) said.

Currently, ARVs for resistant strains cost 10 times the price of first-line drugs, since there are no generic versions yet. In Kenya, more than five per cent of the 110,000 people on ARV treatment are resistant to first-line regimens.

Initially, India refused to grant patents to multinational pharmaceuticals, allowing drug companies operating within its territory to produce cheap generics of branded drugs.  

This saw prices of ARVs fall from over Sh70,000 for a monthly dose to just Sh500, aiding the rapid scale-up in treatment.  

When the country amended its laws to be TRIPS compliant and to allow pharmaceutical companies to patent in India, there was a rush for the same.  

Patents give the holder monopoly over pricing. They are expected to encourage innovation by enabling a company recoup its investments in research and development of drugs or any other products.

In the late 1990s, patents came under heavy criticism as poor people, who were hard hit with HIV and Aids, could not afford ARV prices that patent holders were charging. That is when India decided to ignore them and allowed its pharmaceatical industry to produce generic versions of these drugs.

However, India has changed its patent laws. Section 3(d) was inserted in the Patent Act as a measure to safeguard the continued production of cheap generic versions of new drugs.

Under this section, patenting of substances of new forms of known substances is not permissible, until the patent applicant convincingly proves it is indeed an innovation.

In January 2006, this section was used by India’s Patent office to reject a patent application by Novartis for a cancer drug, imaninib mesylate, which trades under the brand name Gleevec.

The Patents office argued that the drug represented a new form of a known substance and, therefore, was not an innovation. In May 2006, Novartis filed an appeal for the patents rejection and challenged section 3(d).

Gleevec is used to prolong life for people suffering from chronic myeloid leukemia cancer disease, which affects the bone marrow and blood cells.  

According to MSF, the branded version of the drug sells for Sh180,000 for a monthly dose per patient, while the generic versions produced in India cost less than Sh14,000 for a monthly dose.

“Even new combinations from which the Indian companies are planning to produce generic versions will be in jeopardy if we loose the case,” said Jane Anyango, an Aids activist speaking at the WSF function.  

Currently, says Dr Ivy Mwangi of MSF, major pharmaceutical companies are coming up with combination drugs of known ARV drugs, and seeking patents for them in India.  

For instance, a company producing two ARV drugs as single tablets, say Lamivudine and Stavudine, may decide to combine them into one or slightly improve their nature.  

The company then seeks a patent for this combination, in effect extending the patent life of the drugs, and blocking manufacturing of their generic versions.