Re: [Commons-Law] Gilead's anti-AIDS drug now at $1 a day in India
Via: "Hasit seth"
Thanks Tahir. That was helpful.
On 8/21/06, TAHIR AMIN wrote:
> 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 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
> > _______________________________________________
> > commons-law mailing list
> > commons-law@sarai.net
> > https://mail.sarai.net/mailman/listinfo/commons-law
> >
>
>
> Tahir Amin
>
>
>
> ___________________________________________________________
> Does your mail provider give you FREE antivirus protection?
> Get Yahoo! Mail http://uk.mail.yahoo.com
>
Thanks Tahir. That was helpful.
On 8/21/06, TAHIR AMIN wrote:
> 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 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
> > _______________________________________________
> > commons-law mailing list
> > commons-law@sarai.net
> > https://mail.sarai.net/mailman/listinfo/commons-law
> >
>
>
> Tahir Amin
>
>
>
> ___________________________________________________________
> Does your mail provider give you FREE antivirus protection?
> Get Yahoo! Mail http://uk.mail.yahoo.com
>
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