2 weeks after eradication a case of suspected polio

Health Care, Medicine Comments Off

Barely two weeks after WHO declared India as a polio-free nation, an 18-month-old female child, Sumi, a resident of Indrabala village near Baruipur in South 24 Parganas was admitted to a state-run hospital in Kolkata with suspected polio – acute flaccid paralysis (paralysis with disability in movement and fever) on Monday.

The child’s stool samples have been sent to the National Institute of Virology in Pune and School of Tropical Medicine in Kolkata for confirmatory tests. The reports are expected next week.

The last polio case in the country was detected in January last year when a two-year-old girl from Howrah district was afflicted with the virus. There were no reports of other polio cases in the country in the following 12 months, and India was declared polio-free.

Rs. 2.84-Lakh liver and kidney cancer drug to cost just Rs. 8,880/-

Health Care, Medicine Comments Off

The kidney and liver cancer drug sorafenib tosylate (Nexavar) will soon be available to patients at Rs. 8,880/- a pack of 120 tablets. This has been made possible due to the ministry invoking an international trade rule allowing the generic production of an unaffordable drug that is patented. Bayer, a German multinational, holds the patent for Nexavar and sells at Rs.2.84 lakh.

Indian Controller-General of Patents, Designs and Trade Marks granted the first-ever ‘compulsory licence’ in India to Natco under Section 84 of the Indian Patent Act.

The drug is used for the treatment at the advanced stages of kidney and liver cancer. The drug stops the growth of new blood vessels and targets other important cellular growth factors. Though it is not a life-saving drug, it is a life-extending drug. In the case of kidney cancer, it can extend the life of a patient by 4-5 years, while in the case of liver cancer it can extend life by about 6-8 months.

Under the order, Natco will also supply the drug free of cost to at least 600 needy and deserving patients every year. Natco Pharma will also have to pay a royalty to Bayer at the rate of 6%of the net sales on a quarterly basis, and the licence shall be valid till the entire balance period of the patent — it was granted in 2008 and will expire in 2020.

Compulsory licensing under the Indian Patent Law

The Indian Patent Law has provided for adequate powers to the Controller of Patents to issue compulsory licenses to deal with the following extreme and/or urgent situations.

A) Section 84—To prevent the abuse of patent as a monopoly and to make way for commercial exploitation of invention by an interested person.

B) Sections 92 (1) and 92 (3)—Circumstances of national emergency or extreme urgency.

C) Section 92 A—For exports of pharmaceutical products to foreign countries with public health problems.

(A) Section 84—The law provides for compulsory license under section 84 of the Indian Patent Act, to prevent the abuse of patent as a monopoly and to make way for commercial exploitation of invention by an interested person. Under this section, any person can make an application for grant of compulsory licence for a patent after three years, from the date of grant of that patent, on any of the following grounds:

(a) The reasonable requirements of the public with respect to the patented invention have not been satisfied;

(b) The patented invention is not available to the public at a reasonably affordable price.

(c) The patented invention is not worked in the territory of India.

Moreover, Section 89 specifies and explains the general purposes of granting compulsory license under Section 84 as:

(i) That the patented inventions are worked on a commercial scale in the territory of India without undue delay and to the fullest extent that is reasonably practicable;

(ii) That the interests of any person for the time being working or developing an invention in the territory of India under the protection of a patent are not unfairly prejudiced.

Further, the subsection 6 of Section 84 elaborates that the Controller shall take into account the following factors while considering the application under section 84.

(1) The nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patent or licensee to make full use of the invention;

(2) The ability of the applicant to work the invention to the public advantage;

(3) The capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted;

(4) As to whether the applicant has made efforts to obtain a license from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit. Notably, Section 90 of the Act also empowers the controllers to settle the terms and conditions for compulsory licences.