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