Bayer AG Loses Battle To Block Generic Cancer Drug In India's Top Court
December 15, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Indian drugmaker Natco said Monday it intends to go forward with producing a genetic version of Bayer’s cancer drug Nexavar, despite the German drugmaker's attempt to stop it via India's Supreme Court.
The court ruled Friday that Bayer did not have sufficient standing to challenge an global compulsory license allowing Natco to sell a generic version of the kidney and liver cancer drug.
The case has been closely watched by global pharmaceutical companies worried that cheaper copycat drugs in the Third World could vastly undercut profits and create quality issues.
But under the global Trade-Related Aspects of Intellectual Property Rights agreement, Bayer was bound by a clause thar allows countries to issue compulsory licenses on certain drugs that are priced too high for most segments of a nation's population.
Bayer has been fighting Natco since 2012, when the firm was first given permission by the Indian patents office to sell generic Nexavar at 8,800 rupees ($141) per month, a massivr discount from Bayer's price tag of 280,000 rupees. Now that it's officially lost the case, local health authorities are lauding the decision as a boon to the sick and poor in need of the sometimes life saving treatment.
"[It] demonstrates the independence of the Indian judiciary" in upholding the nation's right to legislate "with public health interests in mind", Leena Menghaney, South Asia regional head of Doctors Without Borders' access campaign, told the South China Post.
Menghaney added that it was clear to the court Bayer had recouped its drug research and development costs in just one year.
"We are analysing the (court) order and will determine any future course of action afterwards," Bayer said in a statement, expressing it was "disappointed."
In a related case, Swiss drugmaker Novartis was overruled by the Indian Supreme Court in 2013 when it attempted to win patent protection for its cancer drug Glivec. The high court and even lower, regional Indian courts have revoked exclusive patent protection from other global drugmakers, including Pfizer, Roche and Merck.