Healthy Skepticism Library item: 14955

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Publication type: news

Fate of Generics Hinges on Bayer Case
Times of India 2009 Jan 19
http://www.cbgnetwork.org/2793.html

Full text:

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.