[Ip-health] Indian company requests CL to export Roche cancer drug

[Judit Rius Sanjuan]

http://www.thehindubusinessline.com/2008/01/15/stories/2008011550600200.htm

Natco applies for compulsory licence on Roche=92s cancer drug
Payment of royalty offered; hearing at patent office awaited
Product patent

Natco was seeking a CL to export to Nepal. It would take 3 years to
get a CL to sell in India.
Cipla=92s launch of a similar version of Roche=92s Tarceva would be seen
as a patent infringement

P.T. Jyothi Datta

Mumbai, Jan. 14 In a fresh test of the three-year-old product patent
regime in India =97 Natco Pharma has applied for a compulsory licence
(CL) on Roche=92s lung cancer medicine Tarceva, to export the drug to
Nepal.

The Hyderabad-based Natco has applied to the patent office in Delhi
about four months ago seeking a CL, a pharmaceutical industry source
familiar with the development told Business Line. Natco is believed to
have offered payment of a royalty to Roche and the two companies will
now be called for a hearing at the patent office, the source said.

Confirming the development, Roche India=92s Managing Director, Dr Girish
Telang, told the correspondent that he was =93aware=94 of the same, though
he did not have information on the hearing date.

Tarceva is a novel therapy for patients with locally advanced or
metastatic non-small cell lung cancer after at least one round of
chemotherapy has failed. It is believed to prolong and improve the
quality of life, Roche officials had said, when the drug was launched
in India.

Explaining why Natco was seeking a CL to export to Nepal, rather than
to sell in the domestic market, the industry source said that there is
a provision under the Indian Patent Act that allows a company to seek
a CL to export to a least developed country. It would take three years
to apply for a CL to sell in India, the source added.

Roche=92s Tarceva was launched in India in 2006. It is reported to have
got a product patent on the drug in India. But it has been in the
thick of action, with local drug-makers like Cipla looking to launch
erlotinib, the generic version of Tarceva, in India at a reduced cost.

According to media reports, Roche=92s Tarceva costs over Rs 1 lakh per
month. The regimen comprises an oral tablet, taken once a day. A
product-patent entitles a company to exclusively sell the drug for 20
years, and so Cipla=92s launch of a similar version of Tarceva would be
seen as a patent infringement, a pharma industry representative
observed.

However, Cipla reportedly believes that it has a strong case to oppose
the patent, even after it has been granted. Significantly, Natco had
opposed Roche=92s patent application, before the patent was granted by
the Patent Controller=92s office.


Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org