HIV/AIDS patients across the world can rejoice on this: the Mumbai Patent Office has rejected a patent application on a crucial medicine by multinational company Abbott Laboratories.
This rejection allows low cost generic versions of the medicine to continue in the market, and continue getting exported to countries like Thailand, Brazil, Ecuador, etc.
The Patent Office rejected the application for a tablet form of lopinavir/ritonavir (LPV/r) on the ground that the product did not match Indian patentability criteria.
Abbott spokesperson Scott E Stoffel told DNA the company is reviewing the decision and determining its next step.
Experts say the company could appeal to the Intellectual Property Appellate Board.
LPV/r is an important second-line medicine, which is needed when HIV/AIDS patients develop resistance to first-line medicines.
In 2002, Abbott’s LPV/r cost $3,833 per patient per year. After a furore raised by Thailand and Ecuador, the price was brought down to $1,000 (for developing countries), which is still much higher than the $440-486 per patient per year offered by Indian generic companies.
“India is a key source of low-cost HIV/AIDS medicines, and growing patenting in India can directly affect our country,” said Andres Ycaza Mantilla, president of Ecuadorian Intellectual Property Institute.
According to an intellectual property (IP) expert, Abbott’s patent application was for a tablet formulation derived by combining the two medicines — lopinavir and ritonavir. “This product does not involve an inventive step, which is a key criterion for getting a patent in India. Moreover, the technique used for developing this tablet form also did not involve an inventive step. Hence the application was rejected.”
Experts also say that both lopinavir and ritonavir are medicines invented before 1995. As per the Indian Patent Act 2005, medicines and improvements of medicines developed before 1995 cannot be patented, unless it can be established by clinical evidence that there is increased efficacy to the patient.
India signed the trade related aspects of intellectual property rights agreement of the World Trade Organisation in 1995.
Kannikar Kijtiwatchakul, coordinator, health consumer protection programme, Chulalongkom University in Thailand, said Big Pharma often resorts to filing applications for products that don’t conform to patenting criteria of developing countries.
“This reflects a practice adopted by MNCs called ever-greening —- extending the patent life of a product as much as possible by trying to get patents for any improvement of an earlier product,” said Gabriela Costa Chaves, a pharmacist and policy advocacy officer in Brazil.
Tahir Amin, director, Initiative for Medicines, Access & Knowledge, a not-for-profit organisation, said Abbott has gamed the patent system for nearly 20 years to extend the patent life of this medicine.
Chaves said any patent related decision in India has global repercussions, as Indian generics are the main alternative source of procuring AIDS medicines, and as an alternative source, they act as a price regulator in the international market, and highlight the exorbitant prices set by companies.
Recently, a study by the Journal of International AIDS Society, proclaimed India as the supplier of over 80% of total AIDS medicines between 2002 and 2008 to 4 million people in Congo, Mozambique, Tanzania, Kenya, Nigeria, etc and developing countries in South America like Brazil, Ecuador.
According to Kijtiwatchakul, when LPV/r was patented in Thailand, it cost about $2200 per patient annually, but after the country issued a compulsory licence in 2007, which allowed production of generic versions, Thailand could import generic versions of that medicine from India at $699 per patient per year.
“Now the price of generic versions of LPV/r is less than $500 per patient annually. So you can see the price difference.”