PHA-Exch> Fate of Indian generics

[Claudio Schuftan]

   From:    drdabade at gmail.com

http://timesofindia.indiatimes.com/Fate_of_generics_hinges_on_Bayer_case/rssarticleshow/3998349.cms

THE TIMES OF INDIA

Fate of generics hinges on Bayer case

19 Jan 2009, 0000 hrs IST, Rupali Mukherjee, TNN

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.



http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotech/Pharmaceuticals/No_antidote_to_stop_copies_of_patented_drugs_Health_min/articleshow/3991463.cms

ECONOMIC TIMES,

Jan 17, 2009,

*No antidote to stop copies of patented drugs: Health min*

The health ministry has said it is not equipped with technical expertise to
stop domestic pharmaceutical companies from copying patented drugs. The
Delhi High Court (HC), in its interim order on December 19, 2008, told the
Drug Controller General of India (DCGI) not to allow companies to market
generic versions of medicines patented in India. Multinational drug
manufacturers Bayer AG and Bristol-Myers Squibb had approached the court
against violations of their patent rights.

"The office of the drug quality regulator DCGI is not equipped to assess
patentability of drugs. It can only caution generic drug makers. But we
cannot deny marketing approvals," an official in the health ministry, who
didn't wish to be named, said. He said the regulator did not have the
mandate to investigate patent violations. Indian generic drug makers say
that the DCGI's role is limited to regulating safety and efficacy of
medicines and not to look into violation of patent rights that have
commercial implications.

India, which is a signatory of the trade-related intellectual property
rights (TRIPS), is committed to provide patent protection for 20 years.
According to the agreement, a drug maker cannot market the generic
equivalent of a patented drug before the 20-year window period. There are
cases where drug makers have got approvals for selling generic versions of
patented medicines, the official said. Such generic drug makers could be
penalised if the original drug manufacturers patent violation is proved in
the court, he added.

Multinational drug makers, who launch new generation drugs after getting
20-years exclusive marketing rights, criticise the government for practicing
double standards.

"While one arm of the government (patent office) grants patents, the other
arm (DCGI) takes them back by giving marketing licenses to generic drug
makers," an executive of a multinational pharmaceutical company, who wished
not to be named, said.

The controversy started after Indian company Cipla launched its low cost
versions of Swiss drug maker Roche's patented drug Tarceva in India last
year. Although the matter is awaiting the final verdict of the court, Cipla
has been allowed to sell its drugs in public interest as the drug cost
one-third of Roche's medicine. But Cipla will have to pay damages if the
ruling goes in Roche's favour.
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