Business Economics & Services Team (BEST)
Aggrieved by the Order of the CG, Bayer went in appeal before the Intellectual Property Appellate Board (IPAB)and also sought interim relief in the form of stay to the operation of the CG Order. The IPAB denied interim relief to Bayer and later in March 2013 passed an Order dismissing the appeal and upholding the CG Order. The IPAB however, in its Order raised the rate of royalty on sales to be paid by Natco to Bayer from 6% to 7%. IPAB also held that the government was using its rights under WTO norms to issue compulsory licenses. It added though Bayer had obtained a patent for Nexavar in India in 2008, it could not make available the kidney and liver cancer drug on a large scale and at an affordable price, within the stipulated time.
Bayer challenged the IPAB order before the Bombay High Court, which held that it did not find any merit in interfering with the IPAB Order. The case came to the apex court in the form of an SLP before a bench consisting of Mr. Justice Ranjan Gogoi and Mr. Justice R F Nariman, who dismissed the company's appeal on the ground that lower courts had already ruled against the company's claim and that it had not shown any fresh research and development expense figures to warrant court interference.
Bayer argued that there was a substantial question of law involved since the lower courts’ orders were violative of IPR rules and the company had spent substantial amount for research and development. The Supreme Court asked Bayer about the cost of developing the drug and why it had not submitted the details on R&D expenses involved in developing the drug to the Controller. The apex court noted that the company had realized expenses on developing the drug in the first year itself based on the records produced before the DC
Implications of the Judgment.
Health activists across country welcome the decision and maintain that it was landmark judgment and set the trend for similar cases. It may be noted that a large number of multinational companies operating in India in diverse fields like pharmaceuticals, electronics, telecom etc. have expressed their concern about the circumstances on which the compulsory licenses are granted by Indian authorities. Their apprehensions are that some of the decisions are taken without granting an opportunity to the patent holders to protect their interests. Many feel that this decision will impact the future flow of investments into the country.
(Readers are requested to go through the case studies in details to understand the line of arguments of parties involved)
For more information, pl contact jthac1234@gmail.com,jthac1234@yahoo.com Mobile 9810516770
Bayer’s
Plea on Compulsory Licensing Dismissed by Apex Court
In a significant development, the apex court of India has dismissed yesterday the Special Leave Petition (SLP) filed by the German pharmaceutical company –Bayer -against the decision of the Bombay High Court granting compulsory license for the manufacture of a lifesaving drug –Nexavar-used for the treatment kidney and cancer diseases.
In a significant development, the apex court of India has dismissed yesterday the Special Leave Petition (SLP) filed by the German pharmaceutical company –Bayer -against the decision of the Bombay High Court granting compulsory license for the manufacture of a lifesaving drug –Nexavar-used for the treatment kidney and cancer diseases.
The facts of the
case are in brief are the following:-
The
Controller General (CG) of Patents Designs and Trademarks of India in March
2012 granted Natco Pharma Limited ("Natco"), an Indian drug
manufacturer, a compulsory license for Bayer’s Nexavar (sorafenib), an oncology
drug. The condition was that Natco should produce the drug at a fraction of the
cost sold by the Bayer and to pay 6% royalty on sales to the latter.Aggrieved by the Order of the CG, Bayer went in appeal before the Intellectual Property Appellate Board (IPAB)and also sought interim relief in the form of stay to the operation of the CG Order. The IPAB denied interim relief to Bayer and later in March 2013 passed an Order dismissing the appeal and upholding the CG Order. The IPAB however, in its Order raised the rate of royalty on sales to be paid by Natco to Bayer from 6% to 7%. IPAB also held that the government was using its rights under WTO norms to issue compulsory licenses. It added though Bayer had obtained a patent for Nexavar in India in 2008, it could not make available the kidney and liver cancer drug on a large scale and at an affordable price, within the stipulated time.
Bayer challenged the IPAB order before the Bombay High Court, which held that it did not find any merit in interfering with the IPAB Order. The case came to the apex court in the form of an SLP before a bench consisting of Mr. Justice Ranjan Gogoi and Mr. Justice R F Nariman, who dismissed the company's appeal on the ground that lower courts had already ruled against the company's claim and that it had not shown any fresh research and development expense figures to warrant court interference.
Bayer argued that there was a substantial question of law involved since the lower courts’ orders were violative of IPR rules and the company had spent substantial amount for research and development. The Supreme Court asked Bayer about the cost of developing the drug and why it had not submitted the details on R&D expenses involved in developing the drug to the Controller. The apex court noted that the company had realized expenses on developing the drug in the first year itself based on the records produced before the DC
Implications of the Judgment.
Health activists across country welcome the decision and maintain that it was landmark judgment and set the trend for similar cases. It may be noted that a large number of multinational companies operating in India in diverse fields like pharmaceuticals, electronics, telecom etc. have expressed their concern about the circumstances on which the compulsory licenses are granted by Indian authorities. Their apprehensions are that some of the decisions are taken without granting an opportunity to the patent holders to protect their interests. Many feel that this decision will impact the future flow of investments into the country.
(Readers are requested to go through the case studies in details to understand the line of arguments of parties involved)
For more information, pl contact jthac1234@gmail.com,jthac1234@yahoo.com Mobile 9810516770
