[Ip-health] I-MAK Challenges Patents on Lifesaving HIV Drug Combination in Europe, India

[Tahir Amin]

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[ Picked text/plain from multipart/alternative ]
Hi Judit,

This is in relation to an earlier mail we posted on this. Because of some
technical problems with the www.i-mak.org URL please dont post the earlier
message but the one below.

Thanks

Tahir

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Due to technical difficulties www.i-mak.org is temporarily unavailable. For
copies of relevant documents please visit
http://i-mak.squarespace.com/lopinavirritonavir/.


August 16, 2007


New York =96 Today, a U.S.-based non-profit organization, the Initiative fo=
r
Medicines, Access & Knowledge (I-MAK) announced its filings of critical
patent challenges <http://www.i-mak.org/lopinavirritonavir/> on the HIV dru=
g
combination Lopinavir/Ritonavir. This drug combination is manufactured and
sold by U.S. drug company Abbott Laboratories under the brand name Aluvia(r=
).
I-MAK's patent submissions were filed at the European Patent Office and the
Indian Patent Office.

The tablet form of Lopinavir/Ritonavir is considered to be important for
patients compared to the older soft-gel capsule form. The tablet does not
require refrigeration, does not have dietary restrictions, and lowers the
number of pills a patient must take per day.  However, Lopinavir/Ritonavir
is an old drug, and has been known and formulated for several years. Merely
reformulating old drugs in a different way, without showing inventiveness,
is not patentable under either European or Indian law.

Today, I-MAK challenged the validity of Abbott's patent applications and
Abbott's attempts to prolong its exclusivity over the drug. To date, no
patent has been granted on the Lopinavir/Ritonavir tablet in Europe, India
or the U.S. It is believed that the patent is also not granted in Brazil,
South Africa or China.

*Access Issues for Lopinavir/Ritonavir Tablet*
The World Health Organisation recommends Lopinavir/Ritonavir as a leading
second-line antiretroviral (ARV) therapy. The present cost structure by
Abbott Laboratories - $2200 per patient, per year as its middle-tier price
and $500 per patient, per year as its lowest price =96 remains a serious
barrier to scaling up access to HIV treatment worldwide. Further, the price
of $500 is only offered to a small number of countries, and developing
countries with large numbers of People Living with HIV must purchase the
drug at significantly higher prices.

The Clinton Foundation HIV/AIDS Initiative has been among the organizations
pursuing cost and price reductions for Lopinavir/Ritonavir by encouraging
the entry of generic competition.  President Clinton announced a reduced
generic price for Lopinavir/Ritonavir in May 2007, and urged Abbott to do
more to enable generic production and lower its own pricing in the
developing world. To date, there is no change in Abbott's refusal to licens=
e
the Lopinavir/Ritonavir tablet to generic companies or to reduce its prices
in developing countries.

Currently, very few generic versions of the drug are available. Cipla, an
Indian generic company who pioneered the lowering of prices on first-line
HIV drugs in 2001, is currently offering a generic version of the
Lopinavir/Ritonavir tablet.

I-MAK's submissions raise serious questions on the validity of Abbott's
claimed exclusivity, which, if successful, should open the door for
suppliers to provide (or continue to provide) the drug at lower cost.

*Basis of Patent Challenge*
I-MAK's patent submissions are based on legal and scientific grounds.  The
crux of the argument is that the tablet is not inventive: under the law, a
drug must be an invention to obtain a patent. The I-MAK submissions argue
that Abbott is claiming inventiveness by merely adding known substances,
like the polymer PVP to the old drug combination Lopinavir/Ritonavir, using
a previously patented technology, Meltrex(r) (or melt-extrusion).

"Abbott's application on the Lopinavir/Ritonavir tablet is not inventive
and, if granted, would prevent others from supplying low-cost versions of
the drug," stated Tahir Amin, Director of I-MAK. "It is an egregious exampl=
e
of how the public is harmed by improper extension of patent life by Abbott
Laboratories."
*
Background on Lopinavir/Ritonavir Tablet*
Lopinavir and Ritonavir are HIV medications classified as protease
inhibitors. Entities including international organizations Clinton
Foundation HIV/AIDS Initiative, Medecins Sans Frontieres, The Global Fund t=
o
Fight AIDS, Tuberculosis and Malaria and UNITAID have highly prioritized th=
e
Lopinavir/Ritonavir combination to save the lives of patients across the
world.

Abbott Laboratories has come under scrutiny in the past for its
unconscionable pricing practices on Lopinavir/Ritonavir, such as the 2004
Ritonavir price hike <http://www.cptech.org/ip/health/aids/norvir.html> and
the more recent
controversy<http://www.keionline.org/index.php?option=3Dcom_content&task=3D=
view&id=3D90>against
the Government of Thailand for issuing a compulsory license on
Lopinavir/Ritonavir.

*About the Initiative for Medicines, Access & Knowledge (I-MAK)*
I-MAK is an independent not-for-profit public service organization
consisting of lawyers and scientists working to protect the public domain
against undeserved patents. I-MAK works globally to ensure that patents do
not act as a barrier to research and restrict the public's access to
affordable medicines. Previously, I-MAK has supported patient's groups in
filing against the Lopinavir and Ritonavir patents individually, as well as
against the previously known soft-gel capsule of Lopinavir/Ritonavir.


*Contact:*
Tahir Amin,  I-MAK Director (UK: +44 771 853 9472)
Priti Radhakrishnan, I-MAK Director (US: 1 510 364 9698)


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Tahir Amin
Initiative for Medicines, Access & Knowledge (I-MAK)
+44 771 853 9472