[Ip-health] Business Standard: Cancer drug puts license, patent rules to test

[Mike Palmedo]

http://www.businessstandard.com/common/storypage.php?autono=3D310813&leftnm=
=3D1&subLeft=3D0&chkFlg=3D

Cancer drug puts licence, patent rules to test

Latha Jishnu / New Delhi January 16, 2008

THE drugs manufacturing industry is on a state of alert following two
landmark developments over a cancer treatment medicine.

For one, the first application for a compulsory licence (CL) filed in
India, has put a key provision of the Indian Patents (Amendment) Act,
2005 under the scanner. The application has been filed by Natco Pharma
of Hyderabad for Roche=92s erlotinib (brand name Tarceva), which is used
in the treatment of lung cancer.

For another, Cipla - India=92s top drug maker - has announced it will soon
launch a generic version of the drug, which could be the first instance
of violation of a patent in the country.

Natco Company Secretary Adi Narayana told Business Standard that the
company had decided on a compulsory licence rather than a post-grant
opposition to the drug as this seemed a better strategy. The application
is for the export of 30,000 tablets to Nepal and Natco has offered Roche
a five per cent royalty.

The industry sees this as a test case for compulsory licensing as the
law stipulates a two-year waiting period for exports after a patent is
granted. The erlotinib patent was granted in July last year.

Natco filed a pre-grant opposition to erlotinib but lost the case. It
subsequently filed the application for compulsory licence with the
Controller General of Patents on September 15. Narayana believes it
should be easier to secure the licence for an LDC (least developed
country) like Nepal.

Natco, a small generics manufacturer (turnover of Rs 217 crore in
2006-07), shot into the limelight with a case against Novartis over the
blood cancer drug Glivec, the first major tussle with a global pharma
firm since the introduction of the product patent regime.

In the landmark case against the Swiss pharma giant that is now before
the Supreme Court, Natco has challenged the composition of the patent
office=92s appellate board, which is hearing the Glivec matter.

The patents office has yet to convene a hearing on the compulsory
licence with Roche.

While Narayana says Natco applied for the CL as =93a law-abiding company,
not wanting to invite trouble=94, Cipla is taking a risk against the Roche
patent to launch its version of erlotinib =93very soon=94. Cipla Joint
Managing Director Amar Lulla, however, feels there is no risk because
the patent is very weak.

Patent experts point out that erlotinib belongs to the tyrosine kinase
family of inhibitors that are used in the treatment of various cancers.
Erlotinib is a derivative of gefitinib which was introduced by Astra
Zeneca before 1995, the cut-off year for patents in India. Astra Zeneca
has been denied a patent for gefitinib in India.

Legal opinion suggests that Cipla could seek revocation of the patent
through a counter claim when Roche files a suit for infringement. This
may also explain why it has not opted for a post-grant opposition.

The patent for erlotinib was initially sought by Pfizer in the US.
Roche, OSI Pharmaceuticals and Genentech have an agreement for the
global development and commercialisation of the lung cancer inhibitor.

It is a high-cost drug with each tablet costing Rs 4,800. This means
that a lung cancer patient could pay close to Rs 1.5 lakh a month for
treatment. Cipla plans to sell the drug for a third of this cost (Rs
1,600 a tablet) while Natco will price it at about Rs 1,000.

This is why organisations such as Medecins Sans Frontieres (MSF), which
treat poor patients the world over, are watching these developments with
interest.

=93This is a test case and we are watching and waiting to see the
government=92s response to the application,=94 says Leena Menghaney, India
coordinator of MSF.

Menghaney thinks India=92s compulsory licensing provisions are restrictive
and discourage generic competition which cuts prices of essential drugs.
=93No other country has a three-year waiting period, not even the US,=94 sh=
e
points out.

Although compulsory licenses are given in the case of a public health
emergency when drugs are either unavailable or unaffordable, health
officials argue that it is incorrect to make a distinction between one
disease and another.

So, although heart ailments, cancer, diabetes and asthma are not
classified as a public health emergency, they say all patients who
suffer from life-threatening conditions should have access to medicines
at affordable prices.

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu