[Ip-health] Cancer drug puts licence, patent rules to test

[Adrienne.MacDONALD@geneva.msf.org]

Cancer drug puts licence, patent rules to test=0D
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Latha Jishnu / New Delhi=C2=A0January 16, 2008=0D
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http://www.businessstandard.com/common/storypage.php?autono=3D310813&leftnm=
=3D1&subLeft=3D0&chkFlg=3D=0D
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THE drugs manufacturing industry is on a state of alert following two=0D
landmark developments over a cancer treatment medicine.=0D
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For one, the first application for a compulsory licence (CL) filed in=0D
India, has put a key provision of the Indian Patents (Amendment) Act, 2005=
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under the scanner. The application has been filed by Natco Pharma of=0D
Hyderabad for Roche=E2=80=99s erlotinib (brand name Tarceva), which is used=
 in the=0D
treatment of lung cancer.=0D
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For another, Cipla - India=E2=80=99s top drug maker - has announced it will=
 soon=0D
launch a generic version of the drug, which could be the first instance of=
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violation of a patent in the country.=0D
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Natco Company Secretary Adi Narayana told Business Standard that the=0D
company had decided on a compulsory licence rather than a post-grant=0D
opposition to the drug as this seemed a better strategy. The application is=
=0D
for the export of 30,000 tablets to Nepal and Natco has offered Roche a=0D
five per cent royalty.=0D
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The industry sees this as a test case for compulsory licensing as the law=
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stipulates a two-year waiting period for exports after a patent is granted.=
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The erlotinib patent was granted in July last year.=0D
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Natco filed a pre-grant opposition to erlotinib but lost the case. It=0D
subsequently filed the application for compulsory licence with the=0D
Controller General of Patents on September 15. Narayana believes it should=
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be easier to secure the licence for an LDC (least developed country) like=
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Nepal.=0D
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Natco, a small generics manufacturer (turnover of Rs 217 crore in 2006-07),=
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shot into the limelight with a case against Novartis over the blood cancer=
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drug Glivec, the first major tussle with a global pharma firm since the=0D
introduction of the product patent regime.=0D
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In the landmark case against the Swiss pharma giant that is now before the=
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Supreme Court, Natco has challenged the composition of the patent office=E2=
=80=99s=0D
appellate board, which is hearing the Glivec matter. =C2=A0The patents offi=
ce=0D
has yet to convene a hearing on the compulsory licence with Roche.=0D
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While Narayana says Natco applied for the CL as =E2=80=9Ca law-abiding comp=
any, not=0D
wanting to invite trouble=E2=80=9D, Cipla is taking a risk against the Roch=
e patent=0D
to launch its version of erlotinib =E2=80=9Cvery soon=E2=80=9D. Cipla Joint=
 Managing=0D
Director Amar Lulla, however, feels there is no risk because the patent is=
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very weak.=0D
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=C2=A0Patent experts point out that erlotinib belongs to the tyrosine kinas=
e=0D
family of inhibitors that are used in the treatment of various cancers.=0D
Erlotinib is a derivative of gefitinib which was introduced by Astra Zeneca=
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before 1995, the cut-off year for patents in India. Astra Zeneca has been=
=0D
denied a patent for gefitinib in India.=0D
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Legal opinion suggests that Cipla could seek revocation of the patent=0D
through a counter claim when Roche files a suit for infringement. This may=
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also explain why it has not opted for a post-grant opposition.=0D
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The patent for erlotinib was initially sought by Pfizer in the US. Roche,=
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OSI Pharmaceuticals and Genentech have an agreement for the global=0D
development and commercialisation of the lung cancer inhibitor.=0D
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It is a high-cost drug with each tablet costing Rs 4,800. This means that a=
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lung cancer patient could pay close to Rs 1.5 lakh a month for treatment.=
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Cipla plans to sell the drug for a third of this cost (Rs 1,600 a tablet)=
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while Natco will price it at about Rs 1,000.=0D
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This is why organisations such as Medecins Sans Frontieres (MSF), which=0D
treat poor patients the world over, are watching these developments with=0D
interest.=0D
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=E2=80=9CThis is a test case and we are watching and waiting to see the=0D
government=E2=80=99s response to the application,=E2=80=9D says Leena Mengh=
aney, India=0D
coordinator of MSF.=0D
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Menghaney thinks India=E2=80=99s compulsory licensing provisions are restri=
ctive=0D
and discourage generic competition which cuts prices of essential drugs.=0D
=E2=80=9CNo other country has a three-year waiting period, not even the US,=
=E2=80=9D she=0D
points out. =C2=A0Although compulsory licenses are given in the case of a p=
ublic=0D
health emergency when drugs are either unavailable or unaffordable, health=
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officials argue that it is incorrect to make a distinction between one=0D
disease and another.=0D
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So, although heart ailments, cancer, diabetes and asthma are not classified=
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as a public health emergency, they say all patients who suffer from=0D
life-threatening conditions should have access to medicines at affordable=
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prices.=0D
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+++++++++++++++++++++=0D
Adrienne MacDonald=0D
Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Campaign for Access to Essential Medicines=0D
Rue de Lausanne 78=0D
1211 Geneva, Switzerland=0D
+ 41.22.849.8909=0D
+ 41.79.293.0270 (m.)=0D
www.accessmed-msf.org=0D
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