[Ip-health] HIV drug patent decision

Baker, Brook b.baker at neu.edu
Mon Jan 3 05:58:51 PST 2011

This is a very important victory for access to medicines.  Bravo to Tahir,
Priti, and IMAK.  

Because of this decision, Lopinavir/ritonavir will no longer be blocked from
manufacture and consumption and/or export in India.  However,the patent
status in countries of import/consumption could still block accessibility.
This makes efforts to force Abbott into the Patent Pool and/or the campaign
to get import compulsory licenses even more critical.  On the plus side,
countries will not have to issue August 30 Decision special CLs, but can use
ordinary compulsory licensing procedures.

Given growing evidence that the India Patent Office is not being uniformly
rigorous in applying its strict patentability standards under Section 3(d)
and thus is incorrectly allowing occasional patents on new uses, chemical
variations, new formulations, and new combinations (even in the absence of
evidence of increased efficacy), it is even more important that there be
resources devoted to expert opposition procedures in India.


Professor Brook K. Baker
Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

On 1/2/11 8:51 PM, "Tahir Amin" <tahirmamin at gmail.com> wrote:

> Pharmaceuticals in India now free to help HIV patients worldwide*
> January 2, 2011
> New York, NY ­ This weekend, India rejected an unmerited drug patent
> application, paving the way for access to lifesaving medication for HIV
> patients across the world. This groundbreaking victory for patients sets an
> important precedent to stop pharmaceutical companies from gaming the patent
> system, marking a new era of hope for millions of people living with HIV all
> over the world.
> This drug combination, Lopinavir/Ritonavir, is considered to be the front
> line of defense for HIV positive patients who have failed to stay healthy
> with the first round of medicines available today. India, the world¹s
> leading supplier of affordable medicines, can now supply this drug to
> patients across the globe who are desperately waiting for treatment.
> The impact of the case is tremendous. There are over 33 million people
> living with HIV today and of these nearly 15 million require access to HIV
> drugs. Cost-savings generated over a three-year period by introducing
> generic Lopinavir/Ritonavir to 43 low- and middle-income countries would be
> sufficient to start 130,000 new patients on HIV treatment who currently lack
> access. That is 130,000 lives that could be saved from opening up the market
> for this drug alone.
> Cheaper generic versions of this drug are ready to reach patients in India
> and across the world. Most recently, the Clinton Health Access Initiative
> has negotiated a price of $440 per patient, per year for generic versions of
> this drug from four suppliers. Enabling competition amongst Indian suppliers
> has been demonstrated to consistently drive down prices on HIV medicines,
> from $10,000 per patient per year in 2000, to as little as $79 today.
> This affordable pricing by generic suppliers in India is in stark contrast
> to the unaffordable pricing by Abbott Laboratories on HIV drugs across the
> world over the last decade. ³*Abbott¹s track record on pricing this drug
> unfairly for poorer countries motivated us to take on this case*², stated
> Tahir Amin, Director of the Initiative for Medicines, Access & Knowledge,
> the not-for-profit organization who brought the legal action. ³*They have
> gamed the patent system for nearly twenty years to extend the patent life on
> this drug. The time has come to say, Œenough is enough¹*.²
> I-MAK reports that Abbott Laboratories holds at least *75 patents* on
> Lopinavir/Ritonavir alone. The rejection of this patent application in India
> was for a combination of existing drugs and techniques. The Indian Patent
> Office has put a halt to Abbott Laboratories patenting which, simply put,
> was not an invention.
> For more information, contact Tahir Amin at 1-917-455-6601 or
> tahir.m.amin at gmail.com, or Priti Radhakrishnan at 1-917-703-2876 or
> priti.radhakrishnan at gmail.com.
> Documents on the case are available at
> http://www.i-mak.org/lopinavirritonavir.
> *
> About I-MAK*
> I-MAK is a team of lawyers and scientists increasing access to affordable
> medicines by making sure the patent system works. We work globally to ensure
> that patents do not act as a barrier to research and restrict the public¹s
> access to affordable medicines. We offer free legal assistance to patients
> worldwide on issues of access to medicines. Previously, I-MAK has supported
> patient groups in India in filing against the Lopinavir and Ritonavir
> patents individually, as well as against the known soft-gel capsule of this
> drug combination. I-MAK has also filed challenges to Abbott¹s patent in
> Europe.

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