[Commons-Law] Gilead's anti-AIDS drug now at $1 a day in India

[TAHIR AMIN]

Hi Hasit, 

Far from being an expert, but having drafted the
oppositions for patient groups against Gilead's patent
applications for tenofovir disoproxil fumarate
(TDF/Viread) in India, seen the voluntary licenses on
offer and been in meetings with them, I can make a few
comments.

I dont know how much you know about the background to
TDF, but MSF has been pushing them hard since around
2002 to reduce the price of Viread as well as getting
the drug registered (marketing approval) in its 97
"Access Programme" countries (all LDCs bar S. Africa i
believe). Thus far they have only registered in 11
countries and claim to have applied for registration
in 51 more. They blame local authorities and partly
their own naivety for the slow registration - but I
think that's only a partial truth. For example in
China, I understand they havent made an application.
Also they refuse to submit their data for the drug to
the WHO to enable the pre-qualification process (as
often used by generics).

So I think its fair to say Gilead has been dragging
its feet and not lowering its prices since around
2002. We filed the patent opposition on 9 May 2006 and
within a week they had their legal and pr team in
India offering the voluntary licenses. They claim that
they had intended as one of their options to offer the
VLs and so this wasnt a spontaneous gesture. Not
wanting to be cynical, and may be Gilead had intended
to do this, but it seems it was accelarated by the
opposition being filed. Given the worldwide press
around the opposition by patient groups, one could say
they are either very worried that their patent(s) wont
be granted, hence the VLs being a way to get some
control of the market ( (albeit any VL where no patent
exists will be worthless which they acknowledge)
and/or they wanted to overshadow the opposition. 

The VL's on offer are, it has to be said reasonable -
particularly when people like Abbott refuse to offer
VLs on important second line drugs like Kaletra.
However, the key is that Indian Generics cant sell to
Brazil or China (and Thailand - but may be allowed
later), the countries very much in need of TDF at
cheaper prices, but only the 97 LDCs (which dont have
patents anyway - bar S. Africa, but Aspen is already
licensed). Gilead wants to keep these markets for
itself (which of course they have every right to - but
they dont have patents yet in these countries either
and they are also being challenged there). Having
looked at the patents, there is every chance they
might not be granted. 

The tech transfer point does have some validity. While
generics have already processed around Gileads
process, they may not be getting the highest yields
possible. I dont know if that might explain Cipla's
price at the moment (or whether its more to do with
the markets it can access - probably the latter given
Cipla's competence in coming up with another process
and good API). 

The key issue about the VLs is the question of whether
Gilead is trying to control the API market by only
allowing API producers to sell to companies which have
a licence to sell the end product. Gilead claims they
are not and Indian companies can get the API form any
party it wants provided the quality is the same, but
that doesnt seem so clear from the terms I have seen.

All in all, Gilead has made a smart pr move. However,
many of us believe breaking the patents, for which
there are more than reasonable grounds under the
Indian Act, will reap even more benefits for aids
patients, particularly those in Brazil and China - and
consequently make sure that a stronger patent system
is developed.

Tahir

--- Hasit seth <hbs.law at gmail.com> wrote:

> Hi,
> 
>    Can some expert here on AIDS drugs tell us what
> this press-note
> means between the lines. To me it seems that a
> patent holder (Gilead
> still does not have a patent in India, but in US)
> providing AIDS
> medicines at a low price with 5 percent royalty and
> technology
> transfer (cutting the lab-to-market) time seems ok.
> But again, we need
> an expert to opine on this. I posted this here
> because anything
> positive for drug companies never gets any bandwidth
> here.
> 
> Regards,
> Hasit
>
---------------------------------------------------------------
> 
> 
> Gilead's anti-AIDS drug now at $1 a day in India
> 
> By Murali Krishnan, Indo-Asian News Service
> 
> New Delhi, Aug 20 (IANS) Viread, the largest selling
> anti-HIV/AIDS
> drug in the United States, will be available to
> patients in India at a
> special price equivalent of $1 a day, its
> manufacturer,
> bio-pharmaceutical major Gilead, announced Sunday.
> 	
> 	
> 
> 
> Gilead has already entered into generic licensing
> deals with three
> Indian pharma majors - Emcure Pharmaceuticals,
> Hetero Drugs and
> Strides Arcolab - for the drug. The Indian firms
> will make generic
> versions of Viread and distribute it to 95
> low-income countries around
> the world in a couple of months.
> 
> 'Our endeavour is to provide the widest possible
> access to our drugs
> for HIV/AIDS patients. Gilead has devised a tiered
> product pricing
> based on a country's economic status and HIV
> prevalence,' Gilead's
> senior vice-president Gregg Alton told IANS from San
> Jose, California.
> 
> More than 5.1 million people are believed to be
> infected with the HIV
> virus in India - the second largest number of
> infected people after
> South Africa.
> 
> 'Viread will be available at $365 per year in India.
> For African
> countries where the economic status is lower, we
> have priced the drug
> at $203 per year, making it close to 37 cents a day
> for patients,' he
> said.
> 
> There has been much speculation in recent months
> with claims that
> Viread had been overpriced, selling at $5,700 in the
> developed world.
> 
> Alton said, 'That pricing information is inaccurate,
> while we have the
> right to protect our intellectual property in
> developed markets, our
> tiered pricing for countries like India and Thailand
> will ensure that
> Viread will do well and provide better health status
> for patients.'
> 
> Compared with generic versions currently available
> from pharma major
> Cipla, priced at over $1,200 per year, the new
> pricing is bound to
> come as a relief for patients.
> 
> Viread (tenofovir disoproxil fumarate) is on its way
> to becoming the
> frontrunner drug across Europe for HIV/AIDS due to
> its low toxicity
> and resistance levels observed in patients. The
> tablet-a-day dosage of
> the drug also helps in better regimen and compliance
> among HIV/AIDS
> patients taking it.
> 
> On why the three generic Indian manufacturers agreed
> to take a license
> when Gilead does not actually have a patent, Alton
> said, 'There are
> several reasons for these license agreements. We
> will transfer
> technology and know-how to our partners for them to
> be able to produce
> larger, better and higher quality batches of
> Viread.'
> 
> The technology transfer is expected to increase
> efficiency and drive down costs.
> 
> 'We believe that we are the innovators of one of the
> foremost drugs in
> the battle against HIV/AIDS and are hopeful that our
> patents will be
> issued in India as they have in many other countries
> across the
> world.'
> 
> Under the terms of the agreement, the generic
> companies will have the
> right to manufacture and market both the API (active
> particle
> ingredient) and the tablets in perpetuity.
> 
> While the rights to sell API will be limited to
> other pharmaceutical
> companies in India, tablets can be distributed in
> India, Thailand,
> Africa and 43 other countries.
> 
> This offers the Indian licensees a huge business
> opportunity given the
> size of the market. In Africa alone, 45,000 patients
> are currently on
> Viread, of an estimated infected population of 30
> million. In India,
> about 40,000 patients are under treatment on the
> anti-retroviral drug.
> 
> In return, the Indian manufacturers will pay Gilead
> a five percent
> royalty, which is well within the World Trade
> Organization norms, as
> compared with industry practice of much higher
> royalty rates.
> 
> Alton said his company was in discussion with other
> Indian
> pharmaceutical majors even though some of them have
> filed oppositions
> to the Gilead patent filings.
> 
> He said: 'We are in very advanced stages of
> discussions with other
> pharmaceutical companies, including Ranbaxy and
> Cipla, and are very
> positive that they will see value in our offer.'
> 
> Copyright Indo-Asian News Service
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Tahir Amin


		
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