[Ip-health] Hindu Business Line: Bayer-Natco case: Judgment will set benchmark in amended Indian Patent Act
shailly.17 at gmail.com
Sat Mar 3 07:27:37 PST 2012
MUMBAI, FEB. 28:
The final patent-related hearing on Bayer's advanced kidney cancer drug
Nexavar, following Natco's plea for a compulsory license on the medicine,
concluded on Tuesday at the Patent Office.
The outcome of this case is a benchmark, as it tests the compulsory
licensing (CL) provision of the amended Indian Patent Act.
The CL provision allows for a generic drug company, Natco in this case, to
make and sell, a similar version of the innovator's (Bayer) drug, on the
payment of royalty to the innovator. A CL is granted by a Government on
health grounds, where patients are unable to access life-saving medicine.
Bayer had not adequately worked the patent as the price of the drug in
India was too high for patients, Natco's counsel said. Bayer, however,
countered that its price was in line with the research-costs that it had
incurred in developing the drug. Bayer had received a patent on Nexavar in
India, in 2008.
The drug had been imported even earlier, but then, Cipla got into the fray
under-cutting Bayer's price and selling it at one-tenth Bayer's price, the
counsel for Bayer added. Bayer had imported about 4,000 units, but sold
only 400, he said.
Bayer's Nexavar costs a patient Rs 2.8 lakh for a month's medicine. Cipla
sells its version of generic Nexavar at Rs 28,000 per month and Natco's
generic similar is pegged at Rs 9,000.
Administered in the final stages of kidney and liver cancer, Nexavar helps
extend life by a few months, the counsels said. About 8,000 patients in
advanced stages of renal cancer need the drug, Bayer's counsel added.
Cipla launched generic Nexavar in India in April 2010. Bayer had
subsequently taken them to the Delhi High Court, over patent-infringement.
Bayer has now offered to give Nexavar at a subsidised Rs 30,000 to patients
certified by an oncologist.
Natco's counter is that the case related to the market price and not
confined to a patient access programme. A judgement on the case by outgoing
Patent Controller Mr P.H.Kurian is expected shortly.
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