[Ip-health] Indian Court rejects Bayers appeal for patent linkage

[Leena Menghaney]

INDIAN COURT GIVES BOOST TO ACCESS TO MEDICINES
AS LATEST APPEAL BY BAYER IS REJECTED

New Delhi/Geneva =96 9 February 2010 =96 In a welcome move for access to
medicines, the Delhi High Court has rejected the appeal filed by the German
pharmaceutical company Bayer Corporation against an earlier court order
which had rejected the implementation of a drug regulatory system which
essentially linked registration of medicines to their patent status.

In August 2009, the Delhi High Court had rejected the petition filed by
Bayer Corporation, seeking to stop the Drug Controller General of India
(DCGI) from granting marketing approval to a generic version of a cancer
drug patented by Bayer.

=93We are delighted with this decision =96 at the moment in India we are se=
eing
a number of multinational pharmaceutical companies trying to use litigation
to stifle generic competition,=94 said Dr. Tido von Schoen-Angerer of M=E9d=
ecins
Sans Fronti=E8res=92 Campaign for Access to Essential Medicines.  =93By rej=
ecting
Bayer=92s attempts to introduce patent linkage, the Indian courts have ensu=
red
that public health safeguards like compulsory licensing can be used to open
up generic production of life-saving medicines including antiretrovirals fo=
r
millions in India and beyond.  We hope this judicial precedent of
safeguarding public health in patent disputes will continue, as matters suc=
h
as these, and the forthcoming Novartis case go up to the Supreme Court.=94

Anand Grover, counsel for Cancer Patients Aid Association added: =93In Indi=
a,
we do not have a patent linkage system.  The patent system and the drug
regulatory system are two separate and independent mechanisms and this is
Parliament=92s intent. We hope that Bayer and other pharmaceutical companie=
s
respect this fact. A patent holder cannot use the DCGI, a government agency=
,
to enforce its private rights. This was an attempt to introduce a TRIPS-plu=
s
requirement in India, which has been rejected.=94

What was this case about?  Bayer was seeking to ensure that the Indian drug
regulatory authorities did not start the registration process of a drug, if
it was covered by a patent and the patent-holder did not consent.

This is known as =91patent linkage=92. Establishing a link between patent s=
tatus
on the one hand and the registration (or marketing approval) of a medicine
on the other hand means that a national 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.

Yet a drug regulatory authority=92s role is to ensure that medicines market=
ed
in a country are proved to be of quality, safe and effective: it delivers a
necessary greenlight before a drug can be manufactured or marketed. Its rol=
e
is not to deal with the patent status of the medicines, which is the role o=
f
a country=92s patent office.

Without registration, a drug cannot be sold, so if the drug regulator does
not grant approval, it would delay or block other manufacturers from
producing the medicine until after the patent expires.

What implications does the decision have? The Court=92s decision is very
important because it has stopped Bayer=92s attempt to introduce a new barri=
er
to generic competition. Generic competition is the only proven means of
reducing the prices of medicines to more affordable levels.

The Court=92s decision also means that different public health safeguards i=
n
India=92s patents law remain useable.  One safeguard, known as the =91Bolar=
=92 or
=91early working exception=92, allows a generic producer to manufacture a d=
rug
even when it is under patent and obtain marketing authorisation in advance,
so that a generic can be put on the market as soon as the patent expires.

A second safeguard is compulsory licenses (CLs). CLs can be issued to
generic producers if patented essential medicines are not available or
affordable in India, or if other countries which lack production capacity
order essential drugs from India. But if Bayer had succeeded in introducing
patent linkage in India, this could have blocked the marketing approval of
the medicines made under the terms of the compulsory licence, thereby
rendering the compulsory license useless.

These public health safeguards will become increasingly important, as the
effect of the introduction of stricter patent rules for medicines, required
in India since it joined the World Trade Organization and began applying th=
e
TRIPS Agreement, is felt in the country. We hope this judicial precedent of
safeguarding public health in patent disputes will continue.

Chronology of the Bayer case.  Bayer first filed a case before the Delhi
High Court in 2008, on the grounds that the Drug Controller General of Indi=
a
authorised the application for marketing approval to a generic version of
sorafenib tosylate - the anti-cancer drug for which Bayer has obtained a
patent in India.

The petition was first heard by a single judge bench which dismissed the
petition in August 2009 and made it clear that =93Bayer=92s argument of
inferring drug agencies=92 role in patent policing or enforcement is
unacceptable=94.

This is the second case brought by pharmaceutical companies against the
Indian government in a bid to enforce greater patent protection in India. I=
n
a separate case, Novartis is challenging another vital public health
safeguard in India=92s Patents Act, and having lost its case in the Madras
High Court in Chennai in 2007, the Swiss drug company has taken its appeal
to the Supreme Court.

INDIA: Ms. Leena Menghaney, MSF Campaign Coordinator +91 11 46573731