[Ip-health] Business Times (Singapore)- West blocking India's generic drugs

[Terri - Louise Beswick]

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Published September 24, 2009=0D
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West blocking India's generic drugs=0D
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They block shipments at European ports and step up lawsuits to stop the sal=
e of generics=0D
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By YOGI AGGARWAL=0D
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INDIA'S growing presence in the international generic market for medicines =
has led to aggressive steps by European countries and the US to reduce what=
 they see as competition.=0D
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Fastest growing producer of generics: India already has 22 per cent of the =
world generics market and this is expected to rise to 30 per cent.=0D
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The measures adopted range from stopping at European ports the onward trans=
port of Indian generic medicines bound for other developing countries and a=
n unprecedented scale of litigation to stop the sale of Indian generics.=0D
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A Dutch NGO Health Action International (HAI) says that 16 out of 17 consig=
nments of medicines blocked in Holland last year, meant for other countries=
, were from India. The blockade of exports being trans-shipped through a re=
gion to another market is a non-tariff barrier and a violation of European =
Union (EU) regulations.=0D
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Citing information given by Dutch authorities, HAI told a news agency that =
the medicines seized were headed to Peru, Columbia, Ecuador, Mexico, Portug=
al, Spain, Brazil and Nigeria. And the seized consignments comprised drugs =
for heart ailments, dementia, schizophrenia and AIDS, it added.=0D
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The restrictive trade practised by European countries affects them as well.=
 The European Commission in its report on competition in the pharmaceutical=
 sector released last month says it intends to intensify its scrutiny of th=
e pharmaceutical sector under EC antitrust laws, and said as market entry o=
f generic drugs is delayed, costs to Europeans go up.=0D
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India is the largest and fastest growing producer of generic medicines. It =
already has 22 per cent of the world generics market and this, according to=
 a KPMG study 'India Pharma Inc: An Emerging Global Pharma Hub', is expecte=
d to rise to 30 per cent. According to Pharmaceuticals Exports Promotion Co=
uncil (Pharmexcil) - a governing body in India, overseas sales in the first=
 nine months of 2008-09 went up by 21 per cent to US$8.44 billion from US$6=
.97 billion in 2007-08.=0D
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Besides this, the domestic market is close to US$12 billion. While this is =
just a small fraction of the total US$650 billion global pharmaceutical ind=
ustry, it is a significant segment of the generics market because typically=
 they are priced at around one-tenth of patented drugs.=0D
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The generics market itself is set to explode. The KPMG report estimates tha=
t in the US alone, medicines worth US$47 billion are expected to go off pat=
ent in the next three years.=0D
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Add another US$25 billion for Europe and US$10 billion for Japan, and the m=
arket would be huge even if generics are sold for a fraction of this amount=
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The desire to contain Indian competition to European and US dominance also =
seems to be behind a spate of litigation aimed at curbing Indian companies.=
 With a change in the Indian patent law in 2005, now recognising 'product' =
patents on medicines from the earlier 1970 law which only allowed 'process'=
 patents, the pharma giants have rushed in to register patents, often frivo=
lous.=0D
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A study by the intellectual property rights (IPR) law department of Nationa=
l University of Juridical Sciences (NUJS) at Kolkata, has revealed that 9,7=
19 pharmaceutical applications were filed by multinationals between 2005 an=
d 2008; of these 2,734 patents, or less than one in three, were granted.=0D
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The provisions under Indian law say that patents applied for by foreign com=
panies can be opposed at the pre-grant stage, post-grant stage, and under a=
 provision that prevents the issue of a patent for any known substance unle=
ss the new patent makes the product's efficacy substantially higher.=0D
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Although Indian patent authorities grant only one in three, the local drug =
makers don't seem to be alert to the European and American attempts to stif=
le competition.=0D
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Out of the several thousand patent applications only 58 patent applications=
 were opposed between 2005 and 2008; of these, 41 were rejected. Most of th=
e 25 patent applications rejected under the pre-and post-grant opposition c=
ategory were made by foreign drug makers such as Novartis, Pfizer, Gilead S=
ciences and AstraZeneca.=0D
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Most of the cases were filed by Indian drug makers such as Cipla, Ranbaxy L=
aboratories, Sun Pharmaceutical Industries and Torrent Pharma.=0D
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Some of the prominent among them would include:=0D
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=EF=82=B7  The Indian Supreme Court's dismissal of Roche's petition on a ge=
neric version of its erlotinib (Tarceva) from Cipla, which maintained that =
the patent was invalid and should be revoked.=0D
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=EF=82=B7  Following the footsteps of Roche, Novartis has now appealed to t=
he Supreme Court for refusing patent protection for its anti-cancer drug Gl=
ivec, after the Madras High Court rejected Novartis' challenge to a part of=
 Indian patent law.=0D
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'One can see only a few Indian companies coming forward to oppose such friv=
olous patents. The local industry and the NGOs should be made more aware of=
 these provisions to use these tools very effectively,' D G Shah, secretary=
 general of the Indian Pharmaceutical Alliance told a local business newspa=
per.=0D
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Others who opposed these 'frivolous' patents were health based NGOs. The co=
ntention of Indian companies and NGOs is that the patent applications are o=
ften not defensible in law and are only filed to harass local companies. Th=
ese companies claim they want compulsory licensing for patented medicines s=
o that they can be made available at affordable prices for those who need t=
hem. This is reflected in the attitude of Medecins Sans Fronti=C3=83=C2=A8r=
es (MSF), whose spokesman told Intellectual Property Watch earlier this yea=
r: 'Everything that makes the grant of compulsory licensing more burdensome=
, threatens the life of our patients.'=0D
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India is also facing pressure from the US, which has been retaining it on t=
he 'priority watch list', under which Washington can exert pressure on Amer=
ica's trade partners to improve their copyright and patent regimes. In the =
US and European markets, several Indian companies are arriving at a comprom=
ise with companies whose drugs are going off patent to avoid expensive liti=
gation. The compromise often involves delaying the introduction of the gene=
ric version for a short time.=0D
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It is clear that in the battle to extend their profitable patents, big phar=
ma is prepared to go a long way. But with the pressure from world opinion a=
bout the need for more affordable medicines and from Indian companies able =
to make this possible, it is a losing battle for big pharma. The sooner the=
y see the writing on the wall, the better for all.=0D
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