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The decision of the assistant controller of patents (ACP) dismissing the patent application of Johnson & Johnson USA (J&J) in respect of drug for treatment of the deadly diseases tuberculosis, deserves to be welcomed as a step in the right direction. Tuberculosis is a deadly disease, affecting millions of Indian citizens, killing many of them year after year. Availability of effective drugs to control and contain the deadly disease is a matter of utmost priority not only for the people but more also for the Government.
On the other hand, monopolisation of the drug by patent grant results in denial of its access which offers quicker and better treatment, is matter of serious concern and has to be strongly opposed. The Johnson & Johnson’s new application for patent and its rejection by the assistant controller of patents have to be viewed accordingly.
The assistant controller of patents has rightly rejected the application under the Section 3 (d) of Patents Act 1970 (PA70), that the claim was obvious and does not involve any inventive step and was in the nature of evergreening. In support of its claim, Johnson & Johnson USA relied upon its existing patent for the drug due to expire in July 2023, to emphasize the need of the drug for treatment of tuberculosis deadly diseases affecting millions of citizens.
The drug was been supplied by Johnson & Johnson from USA by orders received from tuberculosis patients at price of US $400. These facts clearly suggest that Johnson & Johnson intend to continue to use and supply the patented drug in the same manner, i.e., by non-commercial exports from USA against orders received from individuals patients from India even after acceptance of its new patent application.
In fact, almost all the drugs patented by multinational pharma companies (Big Pharma) since 2005, covered by them in India about 10,000 patents are used only to block the production, importation or licensing of the patented drug by the Indian Drug Industry. As a result, not only the Indian pharmaceutical companies are prevented from producing and marketing such drugs, but even people requiring such drugs for their treatment of diseases and ailment, are also denied access to such patented drugs. Though they have associate companies operating in India, they do not produce or market these drugs in India. As a result, people of India are denied access to, and treatment by, such patented drugs. They supply these drugs only by exports from USA at US prices in terms of US dollar.
Their intention is clearly to avoid drug price control regulations in India, as this would require them to disclose their costs of production, marketing etc, and also comply with the statutory prices fixed under such regulations.
As a result, though multinational pharma companies have acquired and hold about 10,000 patents for that drugs, people of India are denied access and treatment by such drugs during the entire patent term.
Granting of patents to multinational pharma companies, thus results in total denial of treatment by these drugs to millions of citizens are left to suffer/die untreated during the entire patent term. It is indeed most shocking that this is being followed by multinational pharma companies as a matter of Common Corporate Policy, in total disregard of health and lives of millions of citizens requiring such patented drugs who are left to suffer/die untreated, year after year. In fact millions of tuberculosis patients have been denied access to treatment by this drug and left to suffer/die untreated during last 20 years.
In this context, one cannot overlook or ignore the very grave warning given by former US president Bush in his address to the nation in January 2003, important part from which is reproduced below as a warning against patenting such drugs.
“Today, on the continent of Africa, nearly 30 million people have the AIDS virus, including 3 million children under the age of 15. There are whole countries in Africa where more than one-third of the adult population carries the infection. More than 4 million require immediate drug treatment. Yet across that continent, only 50,000 AIDS victims - only 50,000 - are receiving the medicine they need. Because the AIDS diagnosis is considered a death sentence, many do not seek treatment. Almost all who do are turned away.”
By not producing or marketing the drug in India for 20 years as in Africa even while holding patent for it, Johnson & Johnson has already left millions of tuberculosis patients in India to suffer/die untreated. The new application for patent was intended to continue the suffering for tuberculosis patients for further period of 20 years. Rejection of the Johnson & Johnson’s patent application by assistant controller of patents has prevented yet another patent claim by multinational pharma companies obstructing the availability of vital life saving drugs to people of India.
Reference to the supply and use of the drug during the term of the previous patent is apparently intended to emphasize the need to continue availability and patent protection for the drug.
However, the fact that during the entire patent term of the previous patent the fact that millions of tuberculosis patients were denied access to, and treatment by, the drug cannot be overlooked. This was made possible by use of the amendments of sections 25, 87 etc, of Patents Act 1970 during last 20 years.
The urgent need therefore of amending Patents Act 1970 to remove such provisions, cannot be overemphasized.
Patent law and the patent system have thus being used as barriers not only to treatment of millions of citizens but also to development the drug industry in the country.
What is involved is not only denial of fundamental rights guaranteed to the citizens by Article 21, 19 (1) (g); but also by Article 3 and 25 of Universal Declaration of Human rights, and the sovereign functions and duty of the State.
(Author is a retired advocate)
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