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[fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

"....But cell culture is no quick fix, Sanofi Pasteur’s Matthews warns. “Vaccine makers lack experience ‘campaigning’ flu strains in cell culture,” he cautions. “It will probably take ten years before that method is routine for flu vaccine production....”


"..Sanofi Pasteur (Swiftwater, Pa.) has received a huge contract to develop cell culture-derived flu vaccine. Baxter (Deerfield, Ill.), and Solvay Pharmaceuticals (Weesp, Netherlands), is investing heavily in methods to manufacture its InfluvacTC influenza product in MDCK cells. But the cost of building a vaccine manufacturing facility — estimates range from $50 million to $400 million — will keep all but the most dedicated manufacturers away. “It only takes standard execution of normal business practices to make cell culture manufacturing work,” says Gerson, “but it still takes a lot of money....”


http://www.pharmamanufacturing.com/articles/2006/033.html?page=2
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

this is for current capacity, but presumably it could be scaled up
(given enough money)

syringes, needles ?? He can't be serious, these are cheap.
They could even be disinfected and reused, I assume.

Capacity was given as 100M ? doses per year, we had this earlier,
I could look it up.

I assume that cell-based vaccine is currently more expensive than
egg-based. (20-50% is my estimate)


----edit1---------
Bohumil : 100M doses per year (monovalent)
Marburg 8M doses in 2007 , 40M in 2009 (trivalent)
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

I believe that on present global capacity, with adjuvants we are still at a max production run of 600million doses in a full year of 24/7 production without issues of needles etc. That means about enough for 10% of the worlds population after a year.

It isn't so much the costs associated with a massive elevation in demand for such disposable (and non re-usable) items such as syringes and needles, it is the limits in production capacity for them. Manufacturers are not going to massively invest in new plant for a one off possible event or demand surge. It would take stockpiling over several years to build up adequate reserves.

Just as vaccine volumes are limited by production capacity, so is everything else in the supply chain. There have been difficulties in meeting normal demand for these items NOW as some plants in China were disrupted by the earthquake, and a few other commodity factors (supply of steel for needles etc).

These are real issues that are almost as difficult to overcome as vaccine production - hence a lot of focus on needle-less injection systems.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

now, is there still a capacity-limit, despite cell-based production ?
Was all the effort and investment into cell-based vaccine plants
invain ?
They said, that hens can't lay more eggs if urged, so we need
cell-based production, which could be scaled up.
Now, are there still (other) problems ?

As for needles, syringes : you could just use other factories
to produce them after some modification, reorganisation.


for vaccine-capacities:
.............................


http://74.125.39.104/search?q=cache:uTU0sKS_HZgJ:www.annals.edu.sg/PDF/37VolNo6Jun2008/V37N6p510.pdf

... recent encouraging results have been reported for the large-scale growth of H5N1virus in Vero cell culture.There is no doubt that cell culture overcomes a number of the difficulties associated
with egg-grown vaccines including bacterial contamination,bio-containment of viruses
pathogenic for production staff,rapid start up of production and probably, ease of scalability.
Nevertheless, production capacity will still be constrained by economic considerations and cost
will remain an important limitation for widespread access to vaccine.

...very promising [is] use of a baculovirus ... in ininsect cell culture

...Under current constraints, living attenuated vaccines have had little impact on control of seasonal
influenza and do not show immediate promise for pandemic control. However, the relaxation of the
regulatory requirement for specific pathogen free eggs or, alternatively,a move to cell culture-based production, could significantly alter this situation.

...Conclusions
The WHO has formulated a ?Global Pandemic InfluenzaAction Plan? to increase vaccine supply which requires an investment of 3 to 10 billion US dollars and sustained commitment over a period of 5 to 10 years.But the WHO has recently announced that the global influenza vaccine supply could achieve
4.5 billion pandemic courses by 2010.However, this appears to be based on the assumption of universal access to the most favourable production and formulation technologies and ability to pay for the final
product, something that is highly desirable but yet to be achieved. Also, we must not forget that the production and administration of vaccine will be a race against the spread of the pandemic, particularly if there has not been any prior development and assessment of candidate strains of the viral subtype involved.Regardless of recent progress,the ability to respond globally and equitably to a future
pandemic will require much more rapid and high-yielding vaccine production capacity than currently available,preferably at a much reduced cost and this will be influenced by the regulatory environment;
needle-less administration could also be a distinct advantage.The development of a truly universal vaccine, protective against all influenza A subtypes, would present the potential opportunity for both reducing the threat of a pandemic and the impact of seasonal influenza.



======================================
that sounds to me as if they could indeed ("probably") scale up
cell-based vaccine production with almost constant (or less)
costs per dose as production increases.
======================================


so, the question is, if they could scale up vaccine production in case
of a pandemic anyway, then why should they invest in more capacities
now, which may not be needed ?

Better prepare to scale up production quickly, make contracts
with additional reserve-workers to be recruited in case of a pandemic,
with bio-reactor owners to rent additional reactors in case
of a pandemic etc.
_________________


http://www.genengnews.com/news/bnitem.aspx?name=16627296

http://www.ifpma.org/Influenza/cont..._WHO_meeting_on_Use_of_H5N1_stockpile_vac.pdf

> This means that monovalent pandemic dose capacity could be sufficiant to cover most of
> the global population by 2010

IFPMA, WHO-meeting, October 2007



www.idsociety.org/WorkArea/downloadasset.aspx?id=11320

life investment cost for life bulk 3B doses of pandemic vaccine within 6 months of declaration
of a pandemic:

timeframe to serve developing world pandemic demand


year time to 1st dose
time until demand served
base aggressive
--------------------------------------------------------
2007 5y >10y 8m 25m
2008 4y >10y 8m 24m
2009 3y 9y 6m 17m
2010 3y 9y 6m 16m
2011 3y 9y 6m 16m
2012 3y 9y 6m 15m
2013 2y 6y 5m 12m

2007 2013
------------------------------
3 0M 0M 300M 700M
4 20M 50M 600M 1400M
5 60M 160M 900M 2100M
6 90M 250M 1200M 2800M



cumulative prepandemic H5N1-courses

year base aggr
-------------------------------
2008 111 1200
2009 389 3600
2010 623 6300
2011 688 9000
2012 684 11800
2013 967 16400

base case assumes yields of 1/3 of seasonal vaccine, access
to novel adjuvants or alum, and stockpiles need to be regenerated every 2 years.
Aggressive case assumes yields of 80%, access to best adjuvants to all



http://74.125.39.104/search?q=cache...tudy+group"+2008&hl=en&ct=clnk&cd=19&ie=UTF-8

>Our estimate is that in a ?best-case? scenario, only 1.2 billion courses (2.4 billion doses)
> could be produced from current capacity within six months, and current stockpiles are limited

> Cell-based inactivated: ...still costs >50% more than egg-based
_________________
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

gs you are much more of an optimist than I am. I am reading this thread and see $50m + for a cell vaccine plant and calculations based on free exchange of technology and production based on money being no object. Even the decision to go whole vaccine seems to have been, at least in part, due to the patents on reverse genetics (although it removes one step from the manufacturing process, which is a good thing). Where are these spare bio reactors? I had assumed there was a bit more to it than commandeering the local brewery. If there are suitable plants have they been identified, what modification would they require, are all the parts required to hand, are there clear plans and identified trained personnel to implement them? These are the types of questions again that I fear should have, but probably haven't, been answered. There will not be time to sort all this out after the pandemic starts, this should be complete by this stage. By now we should have identified a goal and be working through some giant project management sheet towards it.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

Glaxo's reply to WHO's vax estimate Oct. 2007
The forecast that 4.5 billion doses of pandemic influenza vaccine could be produced by 2010 is an underestimate, according to GlaxoSmithKline.
Production capacity of 12 billion doses was a more accurate prediction.
The key reason for that is adjuvant technology", a GSK spokeswoman said.
GSK is currently working on an undisclosed adjuvant that is being used in H5N1 vaccine clinical trials.
Results suggest just 3.8mg of antigen is required to produce an immune response which reflects 80 per cent efficacy.
Seasonal flu vaccines, because they are trivalent, made up of three vaccine strains, require 45mg of antigen.
The GSK spokeswoman said all vaccines would require the adjuvant to be able to reach the 12 billion dose mark and suggested GSK could supply the adjuvant to other manufacturers of pandemic influenza vaccine.

See the couple of threads where I've tried to determine vax capacity.
http://www.setbb.com/fluwiki2/viewforum.php?f=8&sid=40be05b2e862f28d9f02188b774a482d&mforum=fluwiki2
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

Their adjuvant seemed to come out best in trials and there PR man is obviously happy about that but I am not clear what the GSK spokesman was saying. They got about $250m in research funding from the US Gov. to investigate vaccine technologies but I was not aware they had put in the manufacturing capacity to supply 12b doses by 2010. Again I am trying to sort out what can be done in the timescales a pandemic might give us as opposed to what GSK - or anyone else - think they could do if someone guaranteed to pick up the bill.

P.S. The GelVac seems like a good idea. Even if the vaccine does not pan out I like the delivery system. Self administered nasal powder, stable for 4 years, does not need refrigeration, suitable for a lot more than just flu vaccine.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

The other point to add to JJs concerns about plans and planning is that, despite all and best efforts, we are still looking at a large lag time gap between viable vaccine production and pandemic outbreak. Wave 1 will come and go before there is any hope of vaccines playing a significant part, and this is I think universally accepted. Whether the same will be true of wave 2 is in the lap of the gods and dependent on the issues we are discussing here - any significant delay caused by failures in the associated supply chains could mean very easily that wave 2 is upon us before these things are in place, unless meticulously planned for. If we are unlucky and a second wave follows hard on the heels of the first, we could easily find that the worst of the pandemic has passed before significant vaccine is available.

Therefore JJ is right - this all needs more public attention to make sure these issues have been thought through. Also GSGS. It takes time to manufacture moulds,and the making of precision instruments is a specialist skill requiring specialist plant and equipment, and I don't think there are that many manufacturing plants with the basics in place. Additionally, nearly ALL such manufacture takes place in the far east, with export to the rest of the world.

We then move to the realms of politics - how can the west secure supply of these items in the midst of a pandemic? If manufacturing companies are experiencing high absenteeism, manufacture will be slower.

If we were the manufacturers of needles and other medical equipment, in say the US or Europe, don't you think we would probably make sure our own nations needs were met first? Why do you think Asian countries would be any different?

If this situation remains, there may be 'horse trading' of commodities for secured first vaccine supply. The issues are many and complex, and all need tying down in a resources and action plan now - in a pandemic it will not be impossible but it will be difficult, and will affect the speed with which the world can respond.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

> Wave 1 will come and go before there is any hope of vaccines playing a significant part,
> and this is I think universally accepted.

no, else there would be no APAs at all.
The strategy is to delay the wave until vaccine is available. This could be
~4 months with cell-based production.

It took more time for earlier pandemics to reach Europe or USA.
If the virus shows seasonality, as is often seen with influenza,
and the pandemic developes in Asia in winter, it would usually
take until next winter to reach Europe
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

GelVac just issued a press release and the Phase 1 trial is still scheduled for the 4th quarter of this year.
I've had a hard time finding what little info I do have. I have no world supply numbers. Here is from the latest (Dec 2007) progress update from DHHS:

In June 2007, HHS awarded $133 million to sanofi pasteur and Medlmmune for the retrofitting of existing domestic manufacturing facilities of U.S.-licensed biologicals for pandemic influenza vaccine production to increase domestic eggbased seasonal, pre-pandemic, and pandemic influenza vaccine production capacity and for warm-base manufacturing operations through new and converted facilities.

In January 2007, HHS awarded three contracts totaling $133 million to GlaxoSmithKline, Novartis and IOMAI for the advanced development of H5NI influenza vaccines using antigen-sparing techniques toward U.S. licensure and expanded domestic vaccine manufacturing surge capacity. One contract may receive additional funding based upon successful completion of phase I trials.

In May 2006, HHS awarded five contracts for over $1 billion to GlaxoSmithKline, MedImmune, Novartis (formerly Chiron), Solvay, and Dynport (with Baxter) for support of advanced development of cell-based influenza vaccines toward U.S. licensure and expanded domestic vaccine manufacturing surge capacity. These contracts are designed to establish U.S. production of at least 240 million courses of cell-based pandemic vaccine within six months of the emergence of a pandemic influenza virus.
As of December 15, 2007, HHS has obligated $2.3 billion out of the $3.2 billion allocated between the two supplemental appropriations bills for vaccine-related activities.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

I wonder whether they had decided the same way back in 2005,
if they had anticipated the advances in vaccine developement
from 2006-7.

They wanted US-based production, but maybe this is not so important,
APAs would haven been cheaper and the additional money
could have been spent on pandemic research, antivirals, antibiotics,...
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

> Wave 1 will come and go before there is any hope of vaccines playing a significant part,
> and this is I think universally accepted.

no, else there would be no APAs at all.
The strategy is to delay the wave until vaccine is available. This could be
~4 months with cell-based production.

It took more time for earlier pandemics to reach Europe or USA.
If the virus shows seasonality, as is often seen with influenza,
and the pandemic developes in Asia in winter, it would usually
take until next winter to reach Europe

True, if we were all being asked to stock pile 4 months of supplies to aid in social distancing and GSK et al had been paid a retainer to make sure they had dual use capacity and all the needles, delivery & distribution, refrigerated storage were in place then the strategy might become a viable plan but I still doubt it would be possible to stop people getting flu in significant numbers anymore than we stop them catching it each winter.

As to speed of distribution I think SARS might be a better model to look at speed of travel. I find it hard to believe containment is going to work if a pandemic strain has an infectious period prior to symptom onset, especially if we do not improve our current testing and confirmation procedure. Every clinic in an area with endemic AI H5N1 would need a test, not significantly more difficult to use than a home pregnancy test, before detection-before-spread looked a realistic possibility. In 1918 the travel time to Indonesia had not changed much since the days of the tea clippers and Henry Ford's model T was beginning to pickup sales, today most of the worlds major cities have someone in them who was in Indonesia this time yesterday.

I am sorry to be a bit of a doom'n'gloom merchant but encouraging pharma press releases at each stage of trials are about as indicative of success as a favorable review on the dust jacket of a book. We really must start seeing a comprehensive global plan soon - which is WHO's job - and firm commitments from governments on its timetable and funding. Too many people are going to die needlessly if we wait to have the 'I'm not going to ship you needles unless you supply me with vaccine' fight until the pandemic has started, particularly as this might be today - or given our current state of surveillance - yesterday or last week.
 
Last edited:
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

GSGS - I think you have more faith than I over theoretical strategies to delay spread, and pandemic influenza is infectious at any time of year - so I dont believe the North / South Hemisphere seasonal infective patters will hold. 1918 first wave hit the UK in the summer - however, less than perfect atmospheric and (?other?) factors may not be ideal and may help to limit spread and speed of spread.

Lots of the US measures are not mirrored elsewhere - the UK is still centred on business as usual, or as near to as possible.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

but we have flu every year, usually it's not so fast and comes in winter.
I remember the British group examining last year the possible
countermeasures to delay a pandemic wave.
I remember the mitigation paper just a few weeks ago,
showing good chances to reduce the impact of a wave
by ~90%.

I'm optimistic that we will have vaccines in Europe,USA in time,
but it's not so clear to me, how much they will help.
And subsequent waves are a problem, they can be faster.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

tries to predict the timing
effects of countermeasures

without intervention:
- panflu starts in Asia
- 2-4 weeks to build up in the country of origin
- 2-4 weeks to spread from Asia to UK
- 7 weeks until peak in UK

90% travel restriction from all countries : 3-4 weeks
99.9% travel restriction (very hard)from all countries : 3-4 months

- prophylactic antivirals postpone outbreak by duration of prophylaxis,
no immunity developed
- recommended is household prophylaxis, redoubling of stockpile required
- recommended prepandemic vaccine
- recommended is contact tracing of first ~300 cases

current UK-stockpiles (doses in % of population):
prepandemic Vaccine : 2%
antivirals : 25%
antibiotics : 0.4%

40%,25%,14% would almost half the CAR (?)
100%,75%,0.4% would reduce CAR to ~1/8 (?)
school closure, no gathering of children, reduces CAR by ~10%

vaccine available after 4-6 months



link1
link2
link3
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

As usual I am posting about 2 posts behind the front of this thread. By the time I make a coffee, think about what I am going to say, type it out slowly and spell check it 2 or 3 more post have appeared. I am going to have to skip a few steps, obviously the coffee can't go and it would be asking too much of you not to spell check so we are down to 'don't think' or 'type faster'.

Mixin thanks again. The US found itself divested of vaccine production capacity when H5N1 made us sit up and take notice; as big pharma had looked at the climate post swine flu and decided the risk of litigation and the margins elsewhere meant it was time to move out. To their credit the government realised this was their responsibility to redress and have been generously funding research since. Here in europe we have continued to produce vaccine but have not been driving forward with new technologies just keeping the old tried & tested egg based system going. As Vibrant62 points out this has rather left us sitting on our laurels 'we have most of the worlds capacity on our soil so we don't need to worry' Wrong! The egg based capacity is too slow for pandemic use - for the reasons covered earlier - so we dont have to worry about seasonal supplies but by the time this infrastructure produces enough vaccine, even for our own nationals, it wont be needed because the citizenry will either be dead or recovered & immune.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

In 2005 - at about the time FluTrackers was getting started - I wrote an introduction to pandemic flu for the uninitiated (which can be found in the preps/manuals section). My frustration at the speed at which we are moving to viable global response plan - evidenced in this thread - led me to have a look at what I wrote then and how it has changed now.

The text box below has an original section on vaccines and antivirals; were I writing today I would increase my concerns re Tamiflu resistance, dump the section on double doses, and give a slightly improved figure for vaccine coverage but the sad news is I really don't have to change much.

What medicines are available to fight this flu?

This may be a good moment to point out that the flu we are concerned about does not yet exist. Yes there are avian H5N1 strains that have infected and killed humans but it has a very limited ability to transfer from human to human in its current form and must ‘improve’ this capability before it becomes a pandemic candidate. There are two main defences against flu, anti-viral drugs and vaccines.


Anti-Virals
The anti-virals are effective against a wide range of flu viruses and the one attracting the most attention at present - and which is being used to treat current patients - is oseltamivir (sold by Roche as Tamiflu). This is a neuraminidase inhibitor (i.e. it interferes with the function of the N part of H5N1’s protein coat, so blocking the release of more virus). Oseltamivir was developed for seasonal flu and the standard treatment calls for a 5 day course to prevent viral replication. For the treatment of H5N1 patients a double dose for 10 days seems to be the best option leading to a need to quadruple the stock pile. As stocks have become available they have been bought up by the richer industrialized countries but are unlikely to cover all those infected at the higher dose, poor countries have not been able to build significant stockpiles. Unfortunately most plans do not allow for prophylactic usage; in the event of a pandemic all medical staff, and others with unavoidable exposure to infected patients, will need to take Tamiflu continuously and indefinitely which will rapidly consume stocks. A secondary effect of this environment would be strong positive selection for Tamiflu resistant mutations. It is normal to try and prevent this by combination therapy; regretfully there is no combination candidate. The other anti-virals have proved either more difficult to administer, less effective, more prone to resistance.


Pandemics tend to be made up of waves, in 1918 the first wave came in the spring and was serious but it died down over the summer returning in a more virulent form at the beginning of the traditional flu season. This second wave accounted for 90% of the fatalities (At the time the death toll was estimated at 20 million but has been revised up and is currently thought to be 60 to 100 million). The third wave came the following spring after which the pandemic died out. Probably because there were not enough people left to sustain it who had not either already had it or had natural immunity. Typically our natural genetic diversity means about half the population seems to have a natural immunity to any given flu virus.

Vaccines
Vaccines work differently; they train the body’s immune system to attack certain foreign objects. If you become ill with the flu and recover you can not then catch the same flu again, at least for a while, the effect will degrade over time. This immunity is caused by the production of anti-bodies which are simple chemical keys that ‘fit’ to the shape of the molecules on the outside of the virus. These anti-bodies circulate in the blood and if they meet the same pathogen again they bind to it ‘attracting’ a heightened immune response, so killing off the attack before it can get a foothold. All well and good but you can not make the key until you know what the lock is like and antibodies are very specific. Once the pandemic form of the virus emerges there will be furious efforts to make the vaccine. Vaccine is normally produced by infecting fertilised hens eggs with the virus, letting it develop and then heat treating the eggs to kill the virus. The inert virus proteins are then extracted ready for vaccination and our immune system makes anti-bodies just as if we had previously had that illness. As always there is a but, it takes several months to bring a vaccine into production and the only suitable plants are those that produce our current winter flu shots which are already working to capacity. Their capacity is matched to at risk seasonal flu groups (the young, the elderly and those with pre existing medical conditions like asthma) in those countries than can afford it. Current research in H5N1 pre-pandemic vaccines suggest after a full year of production we might cover about 2% of the world’s population. Both Tamiflu and vaccines are produced by commercial organisations for whom there is little financial incentive to invest in extremely expensive production facilities which will be used only once and serve no useful purpose thereafter. I will be looking at likely scenarios for the spread of a pandemic later but suffice it to say at this point this is far too long to be of help to those infected in the first wave (see text box) and for most people in subsequent waves.

Although not a medicine the most important mechanism for combating the virus is our own immune system. This has been evolving in the ongoing war with infectious diseases since long before we evolved into Homo Sapiens. I am not going to try and explain the workings of this complex process here as it would require a sizeable book to do it justice. However if you search on Immune system, antibodies, white blood cells, T cells, cytokine & interferon you should get of to a good start. Try the Wikipedia link in the glossary.
 
Re: [fluWho] WHO: Concerns over Chair's text on sharing of flu viruses and benefits

on the positive site, prepandemic vaccine seems to give
better crossprotection than thought, vaccine production
is faster and more plentiful,
encouraging studies (models) about mitigation strategies
zanamivir is more stable
against resistance, and the spread of H5N1 slowed
down and e pandemic is generally thought less likely now
(per time interval)


then we have surprising oseltamivir resisance in H1N1,
almost 100% Amantadine resistance in H3N2
 
[Immunocompent / E. Hammond (fluWho)] These Beans Have Something to Say About Bird Flu

[Immunocompent / E. Hammond (fluWho)] These Beans Have Something to Say About Bird Flu

These Beans Have Something to Say About Bird Flu

August 21 agosto 2008, 16.43.57 | perezoso

Unless you're a bean breeder, farmer, or epicure, the little yellow beans at left might not look very interesting.

But those humble frijoles are the subject of a lengthy patent dispute that may be headed for the US Supreme Court.

And it's story has many important parallels with the current debate about H5N1 patents.

We?ll start with the bottom line lessons:

1. Patents on WHO GISN materials impede WHO?s ability to execute its mission. The most important H5N1 patent issue is not that claims on GISN genes will stop developing countries from being able to use their own viruses (although this is possibile), it is the privatization of a resource given for public health uses, without compensation and with deleterious effects on WHO and, in particular, the GISN?s, ability to serve public health ends.

2. Other international institutions have protective measures in place and have fought back when public goods they oversee are subjected to patent claim; but WHO has so far sought to downplay theft of its materials, even when WHO?s own Collaborating Centres lay patent claims to H5N1.

3. Claims on genes per se (as a ?composition of matter?) exist and may cause harm but, in fact, it is the broader claims based on WHO GISN materials that are most dangerous, because they encompass not only specific GISN genes; but all things physically and functionally similar.

4. Acting after an offending patent has issued is too late. Rescinding offending patents can take years, during which time the claims remain legally enforceable.

5. Failing to act will only encourage more piracy of WHO GISN materials. In hindsight, WHO?s ongoing failure to protect GISN?s public goods may come to be viewed as the greatest mistake of the current WHO leadership.

The bean you see is either called an enola (by its owner) or a mayocoba (by everyone else).

Like WHO GISN flu strains, the bean's heritage involves being held in the public trust by the International Center for Tropical Agriculture (CIAT), near Cali, Colombia. CIAT is part of an international network of public sector plant breeding institutions called the CGIAR.

Enter Larry Proctor, US farmer and entrepreneur.

In the 1990s, Larry bought a bag of beans at a market in Mexico. He liked the yellow color of the well-known mayocoba beans he bought, which were closely related to beans held by CIAT in the public trust. He took the beans home to Colorado and grew more of them, making sure they didn't cross with any local ones. He renamed them enola and called them his own. He then applied for, and received, a United States patent on the beans he grew and all other beans of that yellow color.

(Nevermind the origin of the beans and that Mexicans and others had grown and eaten such yellow beans for generations. This kind of detail often matters little to the patent authorities, whose idiosyncratic notion of history ? called ?prior art? - is a very convoluted and self-limiting one.)

In many respects, CIAT?s bean variety work parallels that of WHO CC. For flu, a WHO CC?s mission includes collecting, characterizing, and distributing trains, and producing and distributing vaccine seed strains and diagnostics, for public health purposes. In parallel, when it comes to beans, CIAT?s job includes collecting, characterizing, and distributing beans, and producing and distributing bean breeding lines and varieties, for the public purpose of improved agriculture.

To shorten the long bean story, in 2000, when the CGIAR and CIAT found out about Larry Proctor?s patent, they filed legal opposition to it. And although Proctor has lost ruling after ruling in the legal battle, as of today, he retains exclusive rights to those yellow beans in the United States. In June 2008, he filed his latest appeal, with a US federal appellate court. If he loses there, he can appeal to the US Supreme Court, and until those options are exhausted, Larry is the man who owns the beans.

Initially, WHO?s know-nothing attitude about patent claims on WHO GISN materials invites comparison to CGIAR?s. While CGIAR is hardly a darling of NGOs when it comes to intellectual property, in the Proctor case (and some others), it did not look the other way and pretend that Proctor?s patent wasn?t threat to its public mission. This contrasts WHO?s modus operandi when it comes to influenza claims, which is to downplay or ignore them. So, unlike WHO, when faced with patent claims over its public trust materials, rather than rolling over and playing dead, CGIAR defended its public mission by fighting back.

Let?s get down to some specific lessons from the Proctor patent for the H5N1 debate:

In reply to concerns about H5N1 patents, WHO, its proxies, and allied apologists (such as WIPO), typically say something like this (my plain English paraphrase):

"Don?t worry about the flu patent applications because many countries don?t allow patents on genes per se and, anyway, they may not apply for many of those patents in developing countries. Besides, many of the claims cover WHO GISN viruses and genes only in a particular form, such as a specific vaccine. The patent claims won?t stop you from doing other things with the viruses, so there isn?t anything to worry about."

The arguments miss the point.

Although it is possible that some patent claims could stop Indonesia, for example, from doing certain things with its viruses, a key problem with the claims is that they appropriate a public resource for private profit, and return nothing to the donor countries ? who gave the viruses to WHO expressly for public health purposes.

Another key problem is that the patent claims, even if not on an exact copy of a WHO virus or gene per se, can still be very problematic. In fact, it?s the bigger H5N1 claims than those for a particular sequence that present the greatest problem, just like the Proctor patent:

Like many H5N1 patent applications, Larry Proctor?s bean patent includes claims both on the biological material itself (as a ?composition of matter? in patent language) and on anything like it. In the case of H5N1, there are claims on WHO GISN genes as a composition of matter and, frequently, anything genetically or functionally like them. The following two quotes illustrate:

From Proctor:

[I claim:] ?Seed from a field bean variety of Phaseolus vulgaris that is completely yellow in color, wherein the yellow color is from about 7.5 Y 8.5/4 to about 7.5 Y 8.5/6 in the Munsell Book of Color.?

To paraphrase in plain English: I claim any bean seed that?s about the same color yellow as the ones that I bought at the market in Mexico.
From a recent US Government H5N1 patent application:

?WHAT IS CLAIMED IS: 1. A nucleic acid molecule comprising a polynucleotide encoding an influenza protein selected from the group consisting of hemagglutinin A (HA), neuraminidase (NA), M2 Protein, and nucleoprotein (NP), wherein said polynucleotide comprises (a) a plasmid taken from Table 1 (or its insert), or (b) an analog of said plasmid or insert having at least 95% identity thereto.?

To paraphrase in as simple language as possible: We claim any DNA or RNA that has a sequence about like any of four genes from several Indonesian and Thai (and some other) flu strains, which we got from WHO GISN.
(Among other things, ?Table 1? contains slightly modified sequences of WHO GISN strains. These are called the ?insert? in the patent?s language.

Therefore on close reading it is apparent that the US government claims these genes a as a composition of matter, as well as anything 95% or more like them.)

So, just as Larry Proctor patented his beans themselves and any bean the same color, in the US government patent application, Uncle Sam is claiming the Indonesian and Thai genes and anything functionally similar.

Another problem comes with the patent apologists mistaken contention that patent applications aren?t relevant to donor countries unless they are filed in the country of origin of the strain. In the case of Proctor, he didn?t file for patent in Mexico (where he got the beans) or in Colombia (where CIAT is located); but the damage was still done. In fact, Proctor and his attorneys began demanding royalties for every pound of Mexican-grown yellow beans imported into the United States, and suing those companies that didn?t accede to his demands.

Even more important than the ravaging of Mexican bean exporters, arguing that Indonesia shouldn?t be concerned about a patent on its viruses in the US ignores the fact Indonesia did not give the virus to WHO for it to be privatized and used elsewhere with no benefit going to Indonesia. There are also the broader implications for the global system: It was recognized by CGIAR and others that Proctor?s privatization of an international public resource impinged on the value and availability of CIAT?s work by restricting use of genetic materials, and that the patent would encourage more such piracy, undermining CGIAR?s integrity and its ability to serve its public mission.

Much the same undermining process is well underway with H5N1. Except WHO is determined to turn a blind eye to it, even to the point of ignoring patent claims on WHO GISN materials by its own Collaborating Centres.
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http://immunocompetent.com/index.php?blogId=1
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Re: [Immunocompent / E. Hammond (fluWho)] These Beans Have Something to Say About Bird Flu

Re: [Immunocompent / E. Hammond (fluWho)] These Beans Have Something to Say About Bird Flu

whenever you have flu, claim for a patent on "your" virus -
before someone else does it.
Hey, I could create an artificial mutated influenza virus in
my computer and get it patented.
In Mosambique.
 
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