[Ip-health] ALERT: Patent Linkage battle continues in Delhi High Court today

[Kajal Bhardwaj]

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[ Picked text/plain from multipart/alternative ]
ALERT: Patent Linkage battle continues
in Delhi High
Court today

Case threatens access to medicines in India and
across the developing world

Seeks to change the drug regulator into patent
police

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18
November 2009, New Delhi: In keeping with the tradition of multinational
pharmaceutical companies using legal muscle to arm-twist governments of
developing countries into implementing TRIPS-plus measures, the German
multinational pharmaceutical company, Bayer Corporation is persisting in it=
s litigation
to introduce patent linkages in India.

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In
2008, Bayer Corporation sued the government of India
and India =E2=80=99s
drug regulator - the Drugs Controller General of India (DCGI) to implement
patent linkages. The case heard by a single judge of the Delhi High Court w=
as
dismissed in August 2009 with the judge holding that =E2=80=9CBayer=E2=80=
=99s argument of inferring drug
agencies=E2=80=99 role in patent policing or enforcement is unacceptable=E2=
=80=9D.

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In
September 2009, Bayer appealed the decision of the single judge. The appeal=
 is
being heard by a division bench of the Delhi High Court. The hearing in the
case continues today before the Delhi High Court.

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Patent
linkages are a TRIPS-plus measure designed to delay generic competition and
have been pushed on developing and least developed countries through US fre=
e
trade agreements or litigation by multinational pharmaceutical companies.

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What are patent linkages?: To
introduce any drug into the market, whether it is a patented drug or not,
marketing approval from the drug regulator (or the DCGI in India ) is a
must. This is required to ensure the quality, safety and efficacy of a newl=
y
introduced drug. Marketing approval is also known as drug registration.

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Drug regulators are
not concerned with whether there is a patent on a drug being registered wit=
h
them.

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Patent linkage creates
an artificial link between the drug regulatory and patent systems. It requi=
res
drug regulators not to grant marketing approval to a drug on which a patent
exists, regardless of whether the patent granted is valid or not.

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This militates
against the basic nature of patents which are PRIVATE RIGHTS. Patent holder=
s already
have legal avenues to enforce their patents through infringement suits. Ask=
ing
a drug regulator to enforce patents by refusing to register a generic versi=
on means
using public money and the resources of a public authority to enforce paten=
t rights.


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Patent linkage
assumes that all patents granted are valid, that a drug regulator will be a=
ble
to determine which patent covers which medicines =E2=80=93 the European Com=
petition DG
has reported coming across cases where a medicine is protected by hundreds =
of
patents; in the case of one medicine there were 1300 patents =E2=80=93 this=
 is a common
practice of pharmaceutical companies.

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Impact on access to medicines: Bayer=E2=80=99s litigation seeks to undermin=
e India =E2=80=99s carefully crafted patents law which balances
 India =E2=80=99s
obligations under the TRIPS Agreement with its obligations to respect, prot=
ect
and fulfil the right to health.

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In
2005, when the Indian Parliament was amending its Patents Act, it was mindf=
ul
of the impact of patent monopolies on access to medicines not just in India=
 but
across the developing world. Generic ARV production from India combined
with increased funding and =E2=80=98political will=E2=80=99 has seen the dr=
amatic scale up of
HIV treatment around the world.

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The
Indian Parliament has included significant public health safeguards in the
patent law including a prohibition on evergreening (Section 3(d)), several
avenues and levels of scrutiny to ensure that only valid patents are grante=
d, a
research and early working exemption and compulsory licence provisions.

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These
safeguards are now under threat. While Novartis has gone after Section 3(d)=
 and
is attempting to weaken this key provision through its case in the Supreme
Court, Bayer is seeking to undermine safeguards that allow generics to ente=
r
the market as soon as possible i.e. where a patent is invalidated or revoke=
d,
where a compulsory licence is issued or when a patent expires.

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To
enter the market as soon as possible in all these situations, generic produ=
cers
must have all their regulatory approvals and permissions in order. India =
=E2=80=99s patent
law allows them to do this without fear of facing an infringement suit thro=
ugh
what is known as the =E2=80=98early working exception.=E2=80=99

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However,
this safeguard becomes useless if the drug regulator is prevented from givi=
ng
the required approvals because of patent linkages. Thus, where patent holde=
rs
cannot succeed in preventing generic manufacturers from getting their appro=
vals
through the patent law, they are trying to do this through the drug regulat=
ory
system.

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In
the US ,
which has a patent linkage system, the use of the system by patent holders =
to delay
generic entry has been recorded in detail by the US Federal Trade Commissio=
n.
In the EU, where patent linkage is considered to be ILLEGAL, the EU Competi=
tion
DG has documented the widespread use of litigation (including against drug
regulators) in attempts to enforce patent linkages, much like Bayer=E2=80=
=99s case in India . =C2=A0

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How companies use patent linkages to block generic:
the case of Fluconazole in Africa : Medecins Sans Frontieres (MSF) has docu=
mented a typical
case of how patent linkage impacts access to medicines. The case involved a
generic manufacturer attempting to register generic fluconazole in Africa w=
ho was stopped by the drug regulator. According
to the report:

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=E2=80=9CMSF
has learnt that the grounds for this refusal were that the drug regulator h=
ad
been informed by the originator drug company that it had a patent on the dr=
ug
in the country. The drug regulator had no legal obligation to refuse
registration on such grounds, but it had been pressured to do so by the dru=
g
company. Under further investigation, it was revealed that the originator c=
ompany=E2=80=99s
claim was false and that the patent had expired more than a year earlier. T=
he
drug regulator eventually retracted its decision, and allowed the registrat=
ion
of the Indian company=E2=80=99s low-cost generic version of the drug.=E2=80=
=9D

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The
World Health Organisation (WHO) has advised developing countries to reject
patent linkages as they are likely to have a negative impact on access to
medicines. Even the USFDA has stated that it does not have the expertise to
review patent information.

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The
UN Special Rapportuer on the Right to Health has noted that patents are pri=
vate
rights and imposing an obligation on a country=E2=80=99s drug regulator to =
prevent
possible infringement of the private rights of patent holders either by den=
ying
registration or informing a patentee provides patent holders with additiona=
l
opportunities to prolong their monopoly rights and delays the entry of gene=
ric
medicines into the market.

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The
WHO further notes that not only do drug regulators not have the expertise t=
o
assess issues related to patents, they would also lack the resources and
manpower to check the patent status of each product.

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What the creator of the US
law on patent linkages says: The
negative impact of a patent linkage system on access to medicines has been =
highlighted
in the U.S. by Senator Henry
A. Waxman, who co-authored the US Hatch-Waxman Act which introduced the sys=
tem
of patent linkages in the US .
Commenting on attempts by the US
government and multinational pharmaceutical industry to impose this system =
in
the developing world, he stated:

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=E2=80=9CAs we are all
painfully aware, devastating epidemics in the developing world, including A=
IDS,
TB, and malaria are killing millions of people and crippling whole societie=
s.
Even in middle-income countries, leading killers like heart disease, diabet=
es,
cancer and other conditions are going untreated because essential medicatio=
ns
are unaffordable in these countries, costing many times the average citizen=
=E2=80=99s
annual income. While the pharmaceutical industry=E2=80=99s approach is to c=
ure this
problem with a dose of Hatch-Waxman, this would have the lethal effect of k=
eeping
drug prices in these countries unaffordable for many years longer than is t=
he
case now.

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I think it
goes without saying that the U.S.
faced nothing like these kinds of problems when Hatch-Waxman was enacted he=
re.
We did not face a situation where only a tiny percentage of the population =
was
receiving the medicines that they needed to survive. We did not face a
situation where a very large percentage of the young people in our society =
had
already contracted diseases that would swiftly and almost certainly kill th=
em
if they did not receive such medicines.

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If we had,
the solution would certainly not have looked like Hatch-Waxman, which delay=
s
market entry of low-cost generic drugs for years after a life-saving drug
becomes available. That system works in this country because most people in=
 the
U.S. have health insurance that pays for essential drugs and because we hav=
e a
health care safety net to assure that the poorest in our society are not le=
ft
without medical care and treatment. But to impose such a system on a countr=
y
without a safety net, depriving millions of people of life-saving drugs, is
irresponsible and even unethical. In developing countries, we must do every=
thing
in our power to make affordable drugs for life-threatening diseases availab=
le now.=E2=80=9D

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Who is pushing patent linkages?

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1. Multinational Pharmaceutical Companies
(Bayer is to India what
Pfizer is to the Philippines )
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Bayer=E2=80=99s
case in India is similar to
Pfizer=E2=80=99s litigation in 2006 in the Philippines . Pfizer sued the Ph=
ilippines
government owned company and the drug regulator for starting the registrati=
on
of a generic version of a blood pressure and heart disease related drug (am=
lodipine besylate). Pfizer=E2=80=99s patent on
this drug was about to expire and the government company was making its
preparations to provide a generic version in the market as soon as the pate=
nt
expired. While the Philippines drug regulator passed guidelines making it c=
lear
that it would not examine the patent status of a drug, the government in 20=
08
passed the Universally Accessible Cheaper and Quality Medicines Act of 2008=
 making
it amply clear that early working of a patent was allowed under the law.

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2. The United States Government through:

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- Free Trade Agreements: The US has pushed patent linkages in developing
countries through free trade agreements or FTAs. Thus Singapore , Chile ,
 Morocco have introduced some
system of patent linkages or other because of their FTAs with the US .

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- Lobbying by the United
 States Patents and Trademark Office (USPTO) and the US embassy in India :
The USPTO has held meetings across India
in September and October 2009 (in Mumbai and Delhi ) for media and NGOs pus=
hing TRIPS-plus
measures including patent linkages.

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References:

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1.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
WHO Access to
Medicines, Briefing Note =E2=80=93 Data Exclusivity and other TRIPS-plus Me=
asures, March
2006.

2.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
Report of the
Special Rapporteur on the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health, A/HRC/11/12, 31 March 20=
09

3.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
Report of the
Commission on Public Health, Innovation and Intellectual Property Rights
(CIPIH), pp. 150-151

4.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
MSF,
=E2=80=98Access to medicines at risk across the globe: What To Watch Out Fo=
r In Free
Trade Agreements With The United States=E2=80=99, 2004

5.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
EU
Directorate-General for Competition, Pharmaceutical Sector Inquiry -
Preliminary Report, 28 November 2008

6.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
Philippines, BFAD, Department of Health Administrative Order, A.O. No.
2005-0001

7.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
Statement of the Honorable Henry A. Waxman, a
Representative in Congress from the State of California, House Committee on
Ways and Means, 10 June 2003

8.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0
Generic drug entry
prior to patent expiration: an FTC study=E2=80=9D, Federal Trade Commission=
, July 2002