[Ip-health] MSF: Indian Court gives boost to access to medicines as latest appeal by Bayer is rejected

[James ARKINSTALL]

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INDIAN COURT GIVES BOOST TO ACCESS TO MEDICINES AS LATEST APPEAL BY BAYER=
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IS REJECTED=0D
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New Delhi/Geneva =E2=80=93 9 February 2010 =E2=80=93 In a welcome move for =
access to=0D
medicines, the Delhi High Court has rejected the appeal filed by the=0D
German pharmaceutical company Bayer Corporation against an earlier court=0D
order which had rejected the implementation of a drug regulatory system=0D
which essentially linked registration of medicines to their patent status.=
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In August 2009, the Delhi High Court had rejected the petition filed by=0D
Bayer Corporation, seeking to stop the Drug Controller General of India=0D
(DCGI) from granting marketing approval to a generic version of a cancer=0D
drug patented by Bayer.=0D
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=E2=80=9CWe are delighted with this decision =E2=80=93 at the moment in Ind=
ia we are=0D
seeing a number of multinational pharmaceutical companies trying to use=0D
litigation to stifle generic competition,=E2=80=9D said Dr. Tido von=0D
Schoen-Angerer of M=C3=A9decins Sans Fronti=C3=A8res=E2=80=99 Campaign for =
Access to=0D
Essential Medicines.  =E2=80=9CBy rejecting Bayer=E2=80=99s attempts to int=
roduce patent=0D
linkage, the Indian courts have ensured that public health safeguards like=
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compulsory licensing can be used to open up generic production of=0D
life-saving medicines including antiretrovirals for millions in India and=
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beyond.  We hope this judicial precedent of safeguarding public health in=
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patent disputes will continue, as matters such as these, and the=0D
forthcoming Novartis case go up to the Supreme Court.=E2=80=9D=0D
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Anand Grover, counsel for Cancer Patients Aid Association added: =E2=80=9CI=
n=0D
India, we do not have a patent linkage system.  The patent system and the=
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drug regulatory system are two separate and independent mechanisms and=0D
this is Parliament=E2=80=99s intent. We hope that Bayer and other pharmaceu=
tical=0D
companies respect this fact. A patent holder cannot use the DCGI, a=0D
government agency, to enforce its private rights. This was an attempt to=0D
introduce a TRIPS-plus requirement in India, which has been rejected.=E2=80=
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Contacts:=0D
INDIA: Ms. Leena Menghaney, MSF Campaign Coordinator +91 9811 3654 12=0D
GENEVA: Mr. Guillaume Bonnet, MSF Press Officer +41 79 203 13 02=0D
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NOTES FOR THE EDITORS=0D
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What was this case about?  Bayer was seeking to ensure that the Indian=0D
drug regulatory authorities did not start the registration process of a=0D
drug, if it was covered by a patent and the patent-holder did not consent.=
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This is known as =E2=80=98patent linkage=E2=80=99 in India.  Establishing a=
 link between=0D
patent status on the one hand and the registration (or marketing approval)=
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of a medicine on the other hand means that a national drug regulatory=0D
authority is required to withhold marketing approval to a generic version=
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of a patented drug, regardless of whether the patent granted is valid or=0D
not.=0D
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Yet a drug regulatory authority=E2=80=99s role is to ensure that medicines=
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marketed in a country are proved to be of quality, safe and effective: it=
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delivers a necessary greenlight before a drug can be manufactured or=0D
marketed. Its role is not to deal with the patent status of the medicines,=
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which is the role of a country=E2=80=99s patent office.=0D
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Without registration, a drug cannot be sold, so if the patent holder does=
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not give consent, it would delay or block other manufacturers from=0D
producing the medicine until after the patent expires.=0D
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What implications does the decision have? The Court=E2=80=99s decision is v=
ery=0D
important because it has stopped Bayer=E2=80=99s attempt to introduce a new=
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barrier to generic competition. Generic competition is the only proven=0D
means of reducing the prices of medicines to more affordable levels.=0D
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The Court=E2=80=99s decision also means that different public health safegu=
ards in=0D
India=E2=80=99s patents law remain useable.  One safeguard, known as the =
=E2=80=98Bolar=E2=80=99=0D
or =E2=80=98early working exception=E2=80=99, allows a generic producer to =
manufacture a=0D
drug even when it is under patent and obtain marketing authorisation in=0D
advance, so that a generic can be put on the market as soon as the patent=
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expires.=0D
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A second safeguard is compulsory licenses (CLs). CLs can be issued to=0D
generic producers if patented essential medicines are not available or=0D
affordable in India, or if other countries which lack production capacity=
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order essential drugs from India. But if Bayer had succeeded in=0D
introducing patent linkage in India, this could have blocked the marketing=
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approval of the medicines made under the terms of the compulsory licence,=
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thereby rendering the compulsory license useless.=0D
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These public health safeguards will become increasingly important, as the=
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effect of the introduction of stricter patent rules for medicines,=0D
required in India since it joined the World Trade Organization and began=0D
applying the TRIPS Agreement, is felt in the country. We hope this=0D
judicial precedent of safeguarding public health in patent disputes will=0D
continue.=0D
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Chronology of the Bayer case.  Bayer first filed a case before the Delhi=0D
High Court in 2008, on the grounds that the Drug Controller General of=0D
India authorised the application for marketing approval to a generic=0D
version of sorafenib tosylate - the anti-cancer drug for which Bayer has=0D
obtained a patent in India.=0D
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The petition was first heard by a single judge bench which dismissed the=0D
petition in August 2009 and made it clear that =E2=80=9CBayer=E2=80=99s arg=
ument of=0D
inferring drug agencies=E2=80=99 role in patent policing or enforcement is=
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unacceptable=E2=80=9D.=0D
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This is the second case brought by pharmaceutical companies against the=0D
Indian government in a bid to enforce greater patent protection in India.=
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In a separate case, Novartis is challenging another vital public health=0D
safeguard in India=E2=80=99s Patents Act, and having lost its case in the M=
adras=0D
High Court in Chennai in 2007, the Swiss drug company has taken its appeal=
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to the Supreme Court.=0D
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- - - - - - - - - - - - - - - -=0D
James ARKINSTALL=0D
=0D
Managing Editor=0D
M=C3=A9decins Sans Fronti=C3=A8res - Campaign for Access to Essential Medic=
ines=0D
www.msfaccess.org=0D
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+33 1 40 21 2837 (office)=0D
+33 6 13 99 7751 (mobile)=0D
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Follow us on Twitter:  http://twitter.com/MSF_access=0D
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