The world’s innovative drugmakers have responded quickly to the news that Thailand is to issue compulsory licences to buy generic versions of Abbott Laboratories' AIDS drug Kaletra and Plavix, the blockbuster anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb as the country cannot afforded the still patent-protected treatments.
Harvey Bale, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, said that “when a country is grappling with severely-limited resources,” the long-term interest of patients “will be best served by the government initiating direct discussions with the companies that invent, develop and market innovative medicines to directly address key health challenges.”
Dr Bale went on to say that often, originator companies “can actually offer resource-constrained” countries “equal or even better conditions than generic producers, in terms of both price and service, and I urge the Thai Government to discuss this directly with innovative companies.”
It seems this argument will cut very little ice with the Thai authorities and health minister Mongkol na Songkla was reported in The Bangkok Post as saying that he is not worried that pharmaceutical firms may freeze investment in Thailand in protest at his decision to import copycat versions of Kaletra (lopinavir/ritonavir) and Plavix (clopidogrel). "Most of these costly drugs are produced somewhere else, not in Thailand. Nobody knows if they produce these drugs cheaply in other countries and just import into Thailand for expensive and profitable sales," he said.
Novartis launches legal action over India’s patent laws
Meantime, Swiss drug giant Novartis’ legal action in India following the decision by the country’s patent office to decline coverage for its cancer drug Glivec/Gleevec ((imatinib) has begun in Chennai. As well as that particular ruling, the company is also contesting the constitutional validity of much of India’s patents law as a whole.
The Indian Patent Office said Novartis’ Glivec application did not satisfy its requirements for “novelty and inventive step” and the company says that the country’s law, introduced a new “improved efficacy” hurdle for patentability for new forms of known compounds, which Glivec falls foul of, as India deems it to be a new form of an existing treatment that was developed before the cut-off date.
“That Glivec failed the Indian test for patentability indicates the problems in India's patent system,” says the Swiss firm, adding that “our case in India is solely about safeguarding intellectual property. This is not about patient access. In India, 99% of patients who receive Glivec receive it free from Novartis.”
However this view is not universally shared and Unni Karunakara, medical director of Mèdecins Sans Frontiéres’ Campaign for Access to Essential Medicines said "Novartis is trying to shut down the pharmacy of the developing world.” He added that "Indian drugs account for at least a quarter of all medicines we buy, and form the backbone of our AIDS programmes, in which 80,000 people in over 30 countries receive treatment. We cannot stand by and let Novartis turn off the tap." A petition asking the drug major to drop the case has almost 250,000 signatures on it, MSF claims.