The decision of the Assistant Controller of Patents (ACP) in dismissing the patent application of Johnson & Johnson USA (J&J) with respect to drugs for the treatment of the deadly disease Tuberculosis (TB), deserves to be welcomed as a step in the right direction. TB is a deadly disease affecting millions of Indian citizens, killing many of them year after year. The availability of effective drugs to control and contain the deadly disease is a matter of utmost priority not only for the people but more so for the Government.
Denial of Drugs
On the other hand, monopolisation of the drug by patent grant results in the denial of its access, which offers quicker and better treatment. This is a matter of serious concern and has to be strongly opposed. The J&J’s new application for a patent and its rejection by the ACP has to be viewed accordingly.
The ACP has rightly rejected the application under Section 3 (d) of the 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, J&J relied upon its existing patent for the drug, due to expire in July 2023, to emphasise the need for the drug for the treatment of TB deadly disease affecting millions of citizens. The drug was supplied by J&J from the USA by orders received from TB patients at a price of US $400. These facts clearly suggest that J&J intends to continue to use and supply the patented drug in the same manner, i.e., by non-commercial exports from the USA against orders received from individual patients from India even after the acceptance of its new patent application.
Out of Bounds for Indian Pharma Companies
In fact, almost all the drugs patented by Multinational Pharma Companies (Big Pharma) since 2005, covered by them in India, about 10,000 patents are used only to block the production, importation or licensing of the patented drug by the Indian Drug Industry. As a result, not only the Indian Pharma Companies (IPC) are prevented from producing and marketing such drugs, but even people requiring such drugs for their treatment of diseases and ailments are also denied access to such patented drugs. Though they have associate companies operating in India, they do not produce or market these drugs in India. As a result, the people of India are denied access to and treatment by such patented drugs. They supply these drugs only by exports from the USA at US prices in terms of US$.
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.
Johnson’s Baby Powder banned in Maharashtra
- In September 2022, the Food & Drugs Administration of Maharashtra cancelled product manufacturing licence of Johnson’s Baby Powder
- The FDA, Maharashtra had drawn samples of Johnson’s Baby Powder at Pune & Nashik for quality check purpose
- The FDA issued a press note and stated, “The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) specification for skin powder for infants in the test pH”
- The product Johnson’s Baby Powder is popularly used for new born babies. The sample declared ‘Not of Standard’ in pH and the use of the product may affect the health of the skin of the new born babies
As a result, though Big Pharma has acquired and holds about 10,000 patents for those drugs, people of India are denied access and treatment by such drugs during the entire patent term.
Granting patents to Big Pharma thus results in total denial of treatment by these drugs to millions of citizens who are left to suffer/die untreated during the entire patent term. It is indeed most shocking that this is being followed by Big Pharma as a matter of Common Corporate Policy, in total disregard to the 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 TB patients have been denied access to treatment by this drug and left to suffer/die untreated during the last 20 years.
By not producing or marketing the drug in India for 20 years as in Africa even while holding a patent for it, J&J have already left millions of TB patients in India to suffer/die untreated. The new application for the patent was intended to continue the suffering for TB patients for a further period of 20 years. Rejection of the J&J’s patent application by ACP has prevented yet another patent claim by Big Pharma obstructing the availability of vital life saving drugs to people of India.
Denying TB Patients of their Fundamental Rights
However, during the entire patent term of the previous patent the fact that millions of TB 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 PA70 during the last 20 years. The urgent need, therefore of amending PA70 to remove such provisions, cannot be overemphasised.
Patent law and the patent system have thus been used as barriers not only to treatment of millions of citizens but also to the development of 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.