[Ip-health] DNA India: Patent office rejects Abbott Labs plea for expensive AIDS drug

thiru at keionline.org thiru at keionline.org
Tue Jan 4 06:04:15 PST 2011

Patent office rejects Abbott Labs plea for expensive AIDS drug

DNA / Priyanka Golikeri / Tuesday, January 4, 2011 4:00 IST

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

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

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."

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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