The pharmaceutical industry is off late pushing for an invocation of the Compulsory Licensing of higher end drugs in
Readers will remember an earlier blog posting commented on Natco’s application for Tarceva. It now turns out that Natco has also applies for a compulsory license for Pfizer’s ‘Sutent’. CH Unnikrishnan of the Mint reports:
“Even as the government considers pricing patented drugs sold in
Known as compulsory licensing, this provision can be invoked by a country if a drug maker is willing to make and supply copies of patented drugs in a medical emergency or to export to least developed countries, which are yet to be covered by the TRIPS regime.
Setting off what could become a trend, Hyderabad-based cancer specialty company Natco Pharma Ltd has requested the government to grant it a compulsory licence for two high-cost drugs: Sutent, a renal cancer drug of Pfizer Inc., and Swiss drug maker F Hoffmann-La Roche Ltd’s lung cancer medication, Tarceva. Both drugs are currently protected under global patents. “We have applied for granting compulsory licence for Erlotinib, the generic version of Tarceva, and Sunitinib (Sutent) to the government,” Natco’s chief operating officer Rajeev Nannapaneni said.
Cipla Ltd, one of the country’s top three drug makers, has similar plans.
The target of compulsory licence requests are largely new cancer drugs already launched by multinational firms under patent protection. Often, these drugs are priced at the same level across the world. Tarceva, for instance, costs about Rs1.5 lakh for a month’s treatment. Another cancer drug, Glivec, marketed by Novartis AG, is priced at Rs1.2 lakh for a five-week treatment cycle. Pfizer’s Sutent, currently awaiting a patent grant in
“The improved operating environment (IP and regulatory) in
Cipla says it wants to sell the drug at Rs1,600 a tablet, one-third of its market cost. Natco wants to price it at about Rs1,000.
“Access to these medicines is a serious issue in a country like
In April, Union health minister Anbumani Ramadoss had asked Novartis to withdraw a patent litigation it is engaged in in
Patent experts say there are several clauses in Indian patents law that local drug makers can use to push for compulsory licences. Patent holders, for instance, are not allowed to claim their product prices are high because they do not have manufacturing facilities in the country. In such a scenario, the government can permit a local drug firm to make and sell the patented product at lower prices. Most of the patented drugs of multinational drug firms are imported today.
Next, said Shamnad Basheer, an associate at the Oxford Centre of Intellectual Property Studies, patent rules allow multinational pharmaceutical firms, when granted a patent, a lead time of three years to bring the prices of their drugs to a level that does not inhibit patient access to the drug. After three years, if the government is convinced that the use of the drug is limited because it is not affordably priced, it can issue a compulsory licence to a drug maker that promises to bring prices down. “As of today, this can certainly kick in for a number of pharmaceutical process patents that were granted more than three years back,” Basheer said.
There is a third provision in the Indian Patents Act to enable a compulsory licence: if a globally patented drug was being manufactured in
According to the Doha Declaration of the WTO, compulsory licences to export to least developed nations have been made TRIPS-compatible. The rules mandate that the importing country must notify the WTO’s council for TRIPS of the name and expected quantity of the product, verify that it has insufficient or no manufacturing capacity for the product, and confirm that it has granted or intends to grant a compulsory licence.
Still, in all these instances, it is the WTO member-country’s responsibility to ensure and prove that its intent on compulsory licensing is in public interest. “In fact, it is widely thought that owing to the various preconditions, it is onerous to apply for and operate such a licence,” said Basheer.
Late in 2006,
From what is stated above, it is cleat that in cases such as NOVARTIS’ controversial drug ‘Glivec’, what must be taken into account by the Controller in deciding the grant of a compulsory license to CIPLA and others, is the use of the drug to public advantage. Furthermore, the time elapsed since the sealing of the patent and the measures already taken by the patentee or licensee to make full use of the invention also helps bolster their claim for the grant.
In a developing country such as India where death rates mount due to the mere fact that the right drug was not available to them, this move of the pharmaceutical companies is the need of the hour and indeed praiseworthy. While it is uncertain whether any form of compulsory license will be granted, it is certainly hoped that a look toward the thousands ailing in