[Ip-health] Times of India: Fate of generics hinges on Bayer case

[James ARKINSTALL]

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http://timesofindia.indiatimes.com/Fate_of_generics_hinges_on_Bayer_case/rs=
sarticleshow/3998349.cms=0D
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NEW DELHI: The fate of generic pharma industry and particularly=0D
accessibility of medicines will be decided when multinational Bayer's case=
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against the government comes up for hearing in the Delhi High Court on=0D
Monday.=0D
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Bayer has taken the Union government and its drug controller to court,=0D
indirectly seeking patent linkages linking regulatory approval of generic=
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medicines with their patent status. In other words, patent linkages mean=0D
that no marketing approval is given for generic versions of medicines,=0D
which have been granted a patent in India.=0D
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This is one of rare instances an MNC suing the Indian government to=0D
introduce higher intellectual property standards, than what is required=0D
under Trips agreement (trade-related aspects of intellectual property=0D
rights), experts say.=0D
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Since the government has been made a respondent in Bayer's petition,=0D
generic industry has asked ministry of health to defend before the court=0D
about the decision of not implementing a Trips-plus provision like patent=
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linkages in India.=0D
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The Indian Pharmaceutical Alliance has asked the health ministry to ensure=
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that registration of generic drugs does not get affected with their patent=
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status.=0D
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The grounds of Bayer's petition are that the drug controller entertained=0D
Cipla's application for grant of marketing rights to generic version of=0D
its anti-cancer drug, =E2=80=98Nexavar=E2=80=99, for which it has obtained =
a patent in=0D
India. If marketing approval were granted, its patent rights would be=0D
affected, it says.=0D
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The case has a huge impact on accessibility of medicine and generic=0D
production in general as it may encourage patent holders to approach=0D
courts to prevent or delay marketing approval of affordable versions of=0D
patented drugs.=0D
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Bayer had earlier requested the drug controller to reject Cipla's=0D
application, as well as grant a hearing to the company before taking any=0D
decision on the matter. But this was not done, it adds.=0D
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The court in its interim order in November directed the drug controller=0D
from taking any decision on Cipla's application.=0D
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By seeking rejection of Cipla's application, the MNC wants to link=0D
marketing approval to the drug's patent status, which has potential to=0D
cause serious harm, experts say.=0D
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This is because patent linkages create barriers to the use of compulsory=0D
licenses, which are issued to generic producers if patented drugs are not=
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available or affordable, or if countries that lack production capacity=0D
order drugs from countries like India.=0D
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Linking patent status and registration of medicines means that the drug=0D
regulatory authority is required to withhold marketing approval to a=0D
generic version of a patented drug regardless of whether the patent=0D
granted is valid or not, they added.=0D
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Moreover, public health experts point out that marketing approval for a=0D
drug is not an infringement of a patent, and the generic company can be=0D
challenged once it launches the drug, not at the stage of applying for=0D
registration.=0D
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During last year multinational pharmaceutical companies lobbied with the=0D
drug controller to reject marketing approval to generic companies on=0D
patented drugs. Any approval of generic versions of patented drugs would=0D
according to them be in violation of their patent rights and would lead to=
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increased litigation.=0D
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Proposals to link registration of drugs with their patent status are not=0D
new and have been promoted by MNCs and their associations. Several=0D
developing countries have faced pressure to introduce patent linkages. In=
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2001, a group of companies took the South African government to court to=0D
prevent it from importing cheaper AIDS medicines, and more recently,=0D
Pfizer sued the Philippine government.=0D
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-------------------=0D
James ARKINSTALL=0D
=0D
Senior Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res - Campaign for Access to Essential Medic=
ines=0D
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www.msfaccess.org=0D
+33 1 40 21 2837=0D
+33 6 13 99 7751 (mobile)=0D