I have been severely critical (many posts among those here) of the Indonesian government's irresponsible assertions of ownership of potentially pandemic pathogenic viruses isolated from their citizens. The question of Intellectual Property is a difficult one in many instances but when it comes to a public good involving a global scourge, some of the gray areas become more black and white. The world has been struggling with the issue regarding the global influenza surveillance system for two years now, precipitated by Indonesia's refusal to cooperate any longer, resulting in a significant gap in scientific knowledge about the genetics and biology of avian influenza in humans. Indonesia is now the world's hotspot for the disease so its non-cooperation is a potentially serious problem.
Hence the news, revealed by Ed Hammond, that the US CDC and St. Jude's Children's Hospital in Memphis, Tennessee, are stoking the fires of resentment by their own irresponsible and outrageous behavior is more than dismaying. It is utterly infuriating:
In a development that is likely to raise more pressing questions about reform of the WHO Global Influenza Surveillance Network (GISN), an international patent application has surfaced in which the US Centres for Disease Control (CDC) and US National Institutes of Health claim ownership of Indonesian influenza genes.A recent patent search has revealed that the CDC, which is a WHO collaborating centre, is applying for a patent for a new vaccine against influenza, particularly for bird flu (H5N1). The vaccine incorporates genes from a H5N1 strain isolated from an Indonesian human victim of bird flu in 2005.
The strain that contains the genes was transferred to the WHO GISN by Indonesia for characterization for public health purposes, but may wind up as the property of the US government.
Under US law, the US government agencies would offer licenses to the technology to pharmaceutical companies. The patent application indicates that the US government intends to pursue the claim in most countries of the world, including Indonesia itself, as well as neighboring countries.
The application was first lodged in the United States on 16 February 2006, and then filed with the World Intellectual Property Organization (WIPO) on 16 February 2007. It was first published as application WO2007/100584 on 7 September 2007 on a WIPO internet database, but is only now coming into public light.
[snip]
The US patent claims are especially relevant to the ongoing discussions of the WHO Pandemic Influenza Preparedness Inter-Governmental Meeting (WHO PIP IGM). The WHO PIP IGM was formed by the World Health Assembly in 2007, in response to developing country concerns about the WHO GISN, particularly the appropriation of GISN materials for making commercial vaccines that are costly and un-affordable to developing countries, and a lack of benefit sharing related to influenza viruses. The next negotiating session of the PIP IGM is scheduled to begin in Geneva on 9 November.
The question of WHO Collaborating Centres asserting patents related to WHO system viruses has been raised repeatedly in the PIP IGM's deliberations. In addition to the US CDC, there is evidence that another US-based WHO Collaborating Centre, St. Jude Children's Research Hospital in Memphis, Tennessee, has improperly capitalized on its WHO status in order to make proprietary claims.
According to sources, in a closed session at the WHO Interdisciplinary Working Group on Pandemic Influenza Preparedness, convened in Singapore from 31 July through 4 August 2007, the Director of the WHO Collaborating Centre at the US CDC stated to governments that the Centre had no interest in patents related to GISN materials. The Working Group meeting took place more than a year after the US CDC filed for patent related to the Indonesian, Thai, Hong Kong, and Korean H5N1 genes.(Ed Hammond, Third World Network)
The CDC patent application is for a DNA vaccine. In this technology, DNA sequences that code for viral proteins are injected into the subject's cells, using various kinds of technologies. Once inside the human cells in the person being vaccinated, the cell's own protein synthesizing machinery makes viral protein which is seen by the immune system and antibodies produced. Some of the patent covers genetic tweaking of the Indonesian virus (and some other viruses) to enhance this process. But access to the relevant genes is possible because both CDC and St. Jude's are WHO Collaborating Centers, i.e., among a handful of laboratories that receive influenza virus strains from all over the world for characterization, research, and as a source of vaccine seed strains. These seed strains are made available to pharmaceutical companies, free of charge, who then make vaccines from them, vaccines that the virus donor countries fear they will not be able to afford. Now we find these two WHO reference laboratories are improperly taking advantage of their status as Collaborating Centers to potentially profit by privatizing the "property" freely given to them by impoverished countries like Indonesia.
Maybe there is more to this story than appears in this account. If so, let's hear it from CDC and St. Jude's. Because what we see is something that is so inimical to ethical standards it demands a public defense -- if there is one. These institutions have world class scientists who wouldn't dream of committing scientific misconduct. Apparently they don't mind committing public health misconduct, however. If even some of this is true, they are bringing shame and deserved loss of credibility and trust onto their respective institutions and themselves.
I am disgusted.
Medicine & Health
Comments
Ah, why are you disgusted?
The patent systems works perfectly in it's intended way.
Preserving monopolies and keeping those pesky third world nations down in the gutter.
(A bit oversimplified of course, but still...)
Posted by: student_b | August 27, 2008 8:06 AM
student_b: Not the point. I am disgusted by who used it for that purpose, not the purpose for which it was uesd.
Posted by: revere | August 27, 2008 8:20 AM
I am reminded of the hoopla over the HIV virus between le France and the Americans back in the early days of the disease. Did that accomplish anything? Who cares who "owns" the damn thing?! If these games keep being played, the only people hurt will be the rest of us. How can anyone really hold genes as property? Maybe the technique being used, or even the instruction manual? There is something very sneaky about it all... Very sneaky indeed.
Anyone remember the whole mess CDC had going a few years back with the antiretroviral trials in Africa?
Posted by: Ren | August 27, 2008 9:27 AM
CDC denies it.
Others are apparantly equally (or even more)
disgusted about Ed Hammond.
CDC and St.Jude's didn't take advantage of being WHO-reference-laboratories. The sequences are freely available
Posted by: anon | August 27, 2008 10:46 AM
I have posted more detail concerng the patent claims and the denials attributed to CDC at Immunocompetent.
In a nutshell, there is simply no question that CDC is a patent applicant, and the patent application covers Indonesian, Thai, and other H5N1 genes.
One clarification: The patent claims the genes BOTH as incorporated into a DNA vaccine plasmid and apart from the plasmid (i.e. as bare complementary DNA transcribed from the viral RNA). The key phrase in the patent's Claim #1 is "or its insert". (The "insert" is the H5N1 gene.)
Notably, it also claims any DNA or RNA that is 95% or more homologous to either the "insert" or the entire vaccine plasmid.
In patent terms, these are both use and "composition of matter" claims.
This is serious problem, because the US has stated to Indonesia and other countries that it has no interest in patenting WHO GISN materials. Well, those claims are looking more and more like lies, especially as CDC seems to be going into denial mode rather than stepping forward and admitting that they've got a major problem on their hands.
Posted by: Perezoso | August 27, 2008 11:26 AM
anon, Perezoso: Let's clear the air and find out who is right. I have no automatic reason to give CDC the benefit of the doubt any longer. Sadly.
Posted by: revere | August 27, 2008 11:29 AM
Hold it. Not so fast. This may be one of those days when I agree with Revere. The issue of intellectual property isnt solved, nor is the issue of whether a virus is patentable (I doubt it) but both agencies are producing a vaccine that is/may be made from Indonesian samples.
Now, I certainly dont agree with Ms. Supari's approach but the question as Revere points out is whether they are doing something illegal. I dont know. I can say that I know for a fact that several Indonesian nationals visited and are visiting several labs around the US even as we speak. They must remain nameless.It leaves though the questions and whether the vaccine is made from a original virus or a reconstructed DNA virus and then melded in. I believe and Revere can correct me on this, but like software if you take an existing program and then change it "significantly" then it is a whole new program and patentable. Same with a virus. You change it genetically and then you got a new virus vis-a-vis by genetic coding. In a computer program certain algorithms have to change significantly and that is specified in hundreds of worldwide and US court rulings. If a virus was removed from a body that belonged to a family, then they would have claim rather than the Indon government unless their laws are different. That comes down to the argument as to whether a bug is property or not. Is it a DNA/RNA program that is licensable? Not a lot of law out there on this one.
The virus vaccine that you have heard me speak of many times before is one that Webster had two years ago was made from a de-engineered virus to take out the hairy parts that would kill embryonic eggs. Prior to that, injecting eggs with the H5N1 virus would kill them and you would get no useable materials. So they de-engineered and re-engineered it into eggs and made a vaccine. That means that the killer part which would be the defining part of H5N1 was modified and it was on the genetic level. Said vaccine was so hot that it in its own right, "Would make you very, very sick", Webster.
So its reasonable to assume that Webster kept working on this and perhaps made a new virus out of the old samples, then made a vaccine. This is extremely possible and more likely probable. If this is the case then the "Big Idea" might just be patentable and we might be jumping a little too early. The first post about HIV comes to mind very well but its not a turf thing so much as it is the science behind this. Modifying a genetic code would be the "significant change" as required by US and international courts and there wont be a leg to stand on other than the right to complain about it.
But this still doesnt remove the problem of sample sharing. For the time being its an Indonesian sample that will if unchecked likely mutate into a highly pathogenic form, which its not now. If St. Jude and the Doc, modified it into a highly pathogenic form then this may be the "weaponized" flu thing you have been reading about in the back channels. Indeed if it was used or got out then it would be a weapon of mass destruction. You have seen me post that bug research IS bio warfare. This is where Ed. Hammond may have come into this. Revere could concur or disagree here. It would explain a lot of Supari's chattering statements of late...It would also mean that they are running an intel operation in the US and have an espionage ring going. Now they are into my back woods. Bad move Supari and that one will likely get your immunity status revoked if its true. .
If St. Jude and CDC have been collaborating together then this puts all the pieces together and it means that we may now have a working vaccine for H5N1. This is good. If its like what I posted then its probably very legal and it renders Ms.Supari and her arguments moot as every court on the planet (save Indon) would rule against them.
The question...Was it genetically altered in any way? This is for Revere and a couple of others to answer because I dont have the bug brain power to make that determination. On the other hand I do know a covert op when I see one and for once the US might just be acting in its own interests and that is something I applaud. If it goes beyond that to a legal issue then leave it to the courts to decide. But I dont want Ms. Supari running around saying we are weaponizing H5N1 because its a half truth and half lie. If it gets out she is right if it doesnt then she is wrong.
This one isnt going to go to bed in the very near future. But this post by Revere gives us a much bigger picture.
Posted by: M.Randolph Kruger | August 27, 2008 11:49 AM
Here's a link to the application:
http://www.wipo.int/pctdb/en/wo.jsp?IA=US2007004506&WO=2007100584&DISPLAY=STATUS
The lead inventor on the app works for NIH.
I'm with Randy - this is a us military deal.
Posted by: Steph | August 27, 2008 1:18 PM
I've attempted to look over the patent application in question. The claims are to a bunch of specified sequences (including variants of 95+% identity), as well as uses of those specified sequences in DNA vaccines, and uses of the encoded proteins in recombinant protein vaccines.
The sequences are given in tables and figures. Unfortunately, I haven't been able to view them (problems with Adobe). However, the patent description indicates that some (maybe all?) of these sequences have been modified in ways that the inventors think will make them better for vaccines. Here's an excerpt:
It sounds to me that the heart of this invention is the various modifications made to the HA and other genes to make them more immunogenic than the wild-type sequence.
I couldn't tell where the original sequences came from, although it's probably in there somewhere. Also, I couldn't tell whether any of their claims involve use of a sequence that's unmodified from the natural isolate, but it seems unlikely.
In any case, I doubt the inventors are attempting to patent "'property' freely given to them by impoverished countries like Indonesia." As best I can tell, they're attempting to patent an idea for how to modify the coding sequences of certain influenza genes to make better vaccines.
If so, is that wrong?
Posted by: qetzal | August 27, 2008 1:19 PM
Also note that Terrence Tumpey is a named inventor on the app - recall that he has worked with the 1918 flu.
http://www.eurekalert.org/multimedia/pub/3119.php
Posted by: Steph | August 27, 2008 1:23 PM
The last two inventors are Wing-pui Kong and Zhi-Yong Yang, selected work below:
WP Kong et al. Protective immunity to lethal challenge of the 1918 pandemic influenza virus by vaccination. Proceedings of the National Academy of Sciences DOI: 10.1073/pnas.0607564103 (2006).
Immunization by Avian H5 Influenza Hemagglutinin Mutants with Altered Receptor Binding Specificity
Zhi-Yong Yang,1* Chih-Jen Wei,1* Wing-Pui Kong,1 Lan Wu,1 Ling Xu,1 David F. Smith,2 Gary J. Nabel1
I feel like a gossip now.
Posted by: Steph | August 27, 2008 1:31 PM
The CDC connection to the application may be Tumpey, who worked (works?) out of the CDC lab in GA. He's NCID.
Posted by: Steph | August 27, 2008 1:33 PM
quetzal et al.: Yes, I think it is wrong. CDC and NIH are not businesses. They have a public health mission. They are in a unique position to acquire information, knowledge and reagents (in this case viruses) and in return should not be arrogating to themselves or even the US gov't the intellectual "property" rights associated with it. They should be placing their discoveries/inventions in the public domain where anyone -- including businesses -- can use it for their own purposes without having to get permission or pay a license fee.
As for St. Jude's as a private organization they are in a slightly different position, but in the case of pandemic influenza I personally find it distasteful that they are also taking advantage of a unique position to privatize discoveries/inventions of urgent and vital concern to everybody on the planet. I feel the same way about keeping sequences private until they publish. That's fine if you are working on other things but not pandemic flu. If you want to work on the hot topic of pandemic flu you should give up the usual perquisites that academic think they are entitled to (I disagree but that's a different subject). If you work on pandemic flu it's all transparent and in the public domain, not a source of revenue for your institution or a way to enhance your reputation and resume. The mater is too urgent to allow the kind of selfish behavior we allow in the rest of academia. St. Jude isn't a business and it shouldn't be acting like that's all it is.
As for CDC, they can deny they haven't filed a patent application, but there seems to be such an application. If the argument is that it is CDC scientists or NCID or some other excuse, I really don't care. That's not the point.
Posted by: revere | August 27, 2008 2:17 PM
A link the PDF containing the entire international application is here:
http://www.wipo.int/pctdb/en/wadList.jsp?IA=US2007004506&LANGUAGE=EN&ID=id00000005519539&VOL=75&DOC=0104b5&WO=07/100584&WEEK=36/2007&TYPE=A2&DOC_TYPE=PAMPH&PAGE=0&ACCESS=D
Be forewaened: It's over 400 pages and 30 megabytes, mainly because of all the damn sequences of the plasmids and other genetic constructs that are claimed.
Tumpey is indeed the CDC connection in terms of people. The WHO Collaborating Centre is the connection in terms of where NIH presumably got the WHO GISN materials. Remember, though, that CDC and NIH are both part of HHS (the US health ministry). So, from an international perspective, the difference between a CDC application, an NIH application or (as in this case) a both application is immaterial. I have written before that in the WHO context, you can't have half a ministry (CDC) make a "no patents" claim, while they are passing the material to the other half of the ministry (NIH), which is patenting away. That just doesn't fly. The patent application is a major blow to CDC's international credibility on GISN issues, because of the apparently false statements it has made to other governments, denying interest in patenting the material.
Qetzal: I disagree with you about the intent of the inventors. Claims on specific DNA sequences are many and are clearly spelled out in the patent application. If it was as you state, the patent application would read very differently.
Further, patent law is not a matter of guessing as to the general intent of the inventors. Specificity is required, and above all else, the claims of the patent (meaning those paraphaphs that follow "We claim:") essentially define the scope of the invention. The wording in claims construction is very carefully calculated, very deliberate and very important - this is one of the main things that the lawyers get paid for. And in the case of this patent application, Table 1 (referenced in Claim 1) sets forth specific genetic constructs that are claimed in the invention. Table 1, in turn references the SEQ ID's of the contstructs, whose full sequence is given elsewhere.
Posted by: Perezoso | August 27, 2008 2:21 PM
The goals of IP protection and of global public health are NOT in opposition to one another. Public bodies (WHO/NIH/CDC) that are funded to provide public service/health are not misbehaving by getting IP for their discoveries/techniques. Not negotiating with the Indonesians is probably the mistake.
What you choose to do with the IP and how you license it to the manufacturers will be the true test of what CDC and St Jude's are up to.
Getting IP protection on this stuff is responsible behaviour. Not getting IP protection allows the wolves to descend. It is quicker, easier and cheaper to just patent and license (at peppercorn and if necessary with stipulations about price in the developing world or by using the license fees to pay for manufacture and distribution in the developig world- they do have to protect those rights once granted). The alternative is to have to fight in court for years some company who is smart enough to lock upo the IP (and in teh meantime people die). This IP protection on the part of CDC does not imply that the information will not be publicly available or unduly restricted. It's up to the IP holder to decide what to do at that stage.
I don't understand why this is infuriating if it is done in the public health interest. This comes down to the subsequent behaviour of the holder not the act of seeking IP protection.
Posted by: NM | August 27, 2008 8:20 PM
Perezoso,
I agree they're claiming specific sequences. I never meant to imply otherwise, but if I was unclear, my apologies.
What's not clear to me is where the novelty in the claimed sequences lies. I think it relates to the specific modifications they describe that are supposed to improve immunogenicity. Obviously, they're claiming the complete sequences with those modifications, but I presumably they're not attempting to claim the wild-type sequences that lack those modifications.
But I could be wrong. I haven't analyzed the sequences enough to be sure.
In any case, I gather revere considers all that a secondary issue at most. He objects to CDC being involved in any patents related to pandemic flu. I'm frankly not sure how I feel about that.
Posted by: qetzal | August 27, 2008 8:52 PM
NM: We disagree. There is no need for patents. This could be licensed in a way that allows use without permission and royalties and prevents others from doing the same.
Posted by: revere | August 27, 2008 8:55 PM
1. Ed Hammond is not a source of news, he is an anti-biotechnology activist prone to exaggeration and inflammatory rhetoric. He's not quite Jeremy Rifkin, but he does swim in the same sea.
2. I read the patent when he first put out his press release (which apparently wasn't picked up by any source more credible than "Third World News"). My interpretation is that it was the altered construct, not the original sequence, that was being patented. Specifically, codons were optimised to improve translation.
3. Has anyone thought to call up Dr. Webster or whomever is responsible for the patent and simply ask them if they intended to patent the original sequences?
Posted by: Monotreme | August 27, 2008 9:21 PM
How would one do that, worldwide, without resort to the patent system?
Publishing on the web is one thing but you would still have to have the legal muscle to dislodge squatters.
Posted by: NM | August 27, 2008 9:24 PM
Mono: I think that is an unfair characterization of Ed Hammond. And in this case he is a source of news. Moreover I know him personally and he is nothing like Jeremy Rivkin. He knows technology and he respects it. Regarding the use of patents, this is a rigged system designed by the big players that militates against innovation and requires permissions over ever increasing periods of time. It is a monstrosity in general but in this connection even more so. For CDC, DHHS or St. Judes to be using it is more than distasteful.
NM: There are plenty of public and permissionless licensing arrangements (a la Creative Commons and Science Commons) available (as an example, see here).
Posted by: revere | August 27, 2008 9:47 PM
Hammond is a source of news and in some cases his lib ass is better than our lib media by a factor of 3. I dont like his politics or the Bush/conservative bash that he and others are wont to do but he was dead on about the flu conference info. They had to throw him out to get the info that we all pay the governmet officials to release.
I would have liked to have been a fly on the wall in that part where the Big Pharma people were having their say. Not so much as I disagree with their position that they are in the biz to make money, but someone has to be funding the research for Webster and the et. al. of the application. I want to know if its US bucks rather than pharma bucks. If so they have my blessing as we can start making the stuff in quantity.
The law sometimes has to be tossed in lieu of good common sense. There may not be any law thats applicable but this one is going to end up in front of a jury or administrative law judge pretty quick. I am not quick to dismiss anyone in this world as I learned a long time ago that its better to listen first. Hammond launched his lib torpedo and now someone is going to get hit. Lets see who sinks.
I think from looking at this application (in depth) that there were dozens of alterations made that my not so educated in the field brain can see. They upped it, lowered it against what I looked at in GenBank. Thats what its going to get down to and its now less of an HIV battle than a new one.
Going to be interesting.
Posted by: M. Randolph Kruger | August 27, 2008 10:10 PM
revere, Ed Hammond is a source of news the same way you or I are, that is, he presents facts mixed with his own opinions. He is not an unbiased reporter. You are entitled to your opinion about his veracity, but mine stands: he isn't a reliable source of information. I would suggest that anyone who wants to understand the patent read it themselves and if they don't understand either the scientific or legal ramifications that they get an unbiased opinion from a content expert.
I would also suggest, again, that before uncritically accepting Mr. Hammond's interpretation of the patent that someone actually interview the patent holders. That's what a real reporter would do.
For the record, I think the CDC's past record of withholding flu sequences was shameful and have said so on many occasions. Further, I believe that Bermuda rules should apply to all flu sequences - release them to GenBank, not this cockamamie GISAID, within 24 hours of their completion. Finally, I don't think any sequences from flu viruses should be patented.
Posted by: Monotreme | August 27, 2008 10:56 PM
NM: So-called "defensive patenting" is a symptom of the problem, not a solution. It's done because of proprietary pressures from other IPR claimants. The solution is not to patent more, it is to remove the item from patentability (for example, by public domaining it).
Also, it not responsible to claim to own something that is not yours. (Again folks, sovereignty and ownership are not the same thing.) It's bizarre to me that some of the people that spew venom at Supari for asserting sovereignty over the viruses contradictorily have no problem with patent claims on H5N1.
Monotreme: Getting people to read the patent themselves is EXACTLY what I've been trying to do. I posted the link here. Check out the comments at my blog.
You spew a lot of unsustantiated innuendo in my direction about "reliabilty". Let's see whose facts about the patent claims are accurate at the end of days - mine, or the alternative versions (often from people who haven't a clue about intellectual property) from the people that are having a hard time stomaching this news. There's more than a little "shoot the messenger" mentality going on. Would folks prefer ignorance to larning the truth about CDC and others patent claims? I hope not.
There are a lot of other patent applications out there too... we shouldn't just focus on this one, althoug
Posted by: Perezoso | August 27, 2008 11:16 PM
Perezoso, am I to understand that you are Ed Hammond? If so, then why haven't you contacted the patent holders and asked them if they intended to patent the original sequences?
FYI, I have been working towards getting flu sequences released *for years*. revere can vouch for this.
Or you can read this opinion over at Fluwikie which I wrote back in April 25, 2006.
The CDC should release their flu sequences to the world's scientists
Posted by: Monotreme | August 27, 2008 11:44 PM
Mono; The question is not whether Ed is a reporter or not. Sometimes he is, as when he was in Geneva reporting on the negotiations there. That was news. I'm not going to argue with you about objectivity, since that's a useless argument. If that's the standard, no one is a reporter or a journalist. Not useful. Maybe you knew about the application before he drew your attention to it. I didn't. It was news to me, if not to you. Let's talk about the issue, not Ed Hammond. I think I've made my take on the appropriateness of making IP claims in this area quite clear. It doesn't depend on his interpretation or yours.
I will indeed vouch for your persistent demand the sequences be made available. This is another area where CDC and St. Judes falls short. This application exists. It makes use of material that is known to them before others because of their position as reference labs. In my view, this forfeits their ability to make use of the information for intellectual property claims. This is not a legal opinion but an ethical one when it comes to pandemic flu. It is my opinion.
Posted by: revere | August 27, 2008 11:48 PM
revere, your blog reads as if you are citing a reporter not another blogger, though perhaps that is not what you intended. There are basic standards for journalism which anyone claiming to be a reporter should adhere to. For example, if one is doing a story on this patent, then it seems only fair to get the patent holders' view of what is actually claimed.
As I've suggested many times, I don't think primary sequences should be patented. If that is what the CDC, or the St. Jude did, then I oppose it. I'm just not willing to come to that conclusion based on Mr. Hammond's interpretation.
I think all flu sequences should be released as soon as they are completed (to GenBank) and be available to whomever wants to make whatever vaccine they wish. If companies have proprietary technology associated with their vaccine, then it is reasonable for them to protect that technology with a patent. It is not reasonable to try to prevent others from making vaccines based on the same original sequences, imo.
Posted by: Monotreme | August 28, 2008 12:06 AM
Revere and Ed: At the outset, let me just say that I share your concerns regarding the WIPO application, and find it abhorrent that the US govt. is simultaneously suggesting that it isn't patenting GISN material while it files WIPO applications.
However, in the current legal environment I tend to agree, with Monotreme, that defensive patenting may have been the only option. The real question is how the US Govt. will subsequently use its patent.
I've been reading the patent, doing some BLAST searches and trying to untangle the legal position all morning. A contact who is an expert in CC filled me in on some of the legal reasoning behind the patent apps.
First off:
Public domain-ing of copyright (let alone patent material) is of dubious legality in many jurisdictions (Australia for one) and would instantly invite a savvy company to put in a patent application.
Science Commons at present only really deals with copyright information - and has not yet developed a system of public domain patenting
The leader in public domain patents is probably the CAMBIA project, which is at present recommending defensive patenting under the current scheme with license conditions which stipulate common open source clauses.
This doesn't suggest that the current system is the right one, or that we shouldn't push for an open patent system...merely that in order to protect the open nature of the vaccine and sequences, the US govt. may not have had any choice but to patent...
Posted by: Rieux | August 28, 2008 12:16 AM
Mono: More of Hammond's interpretation here. I don't agree with your claims of what makes a person a journalist or reporter, but I don't think my post hangs on that in the least. He revealed the existence of the application (which is verifiable), not what the filers of the application thought of it (or what I thought of it, for that matter).
Rieux: This is beyond my legal expertise so I won't comment. But even if everything you say is exactly correct (which it may be) it doesn't explain why CDC has denied having filed a patent.
Posted by: revere | August 28, 2008 12:21 AM
Revere: I agree! The CDC shouldn't be suggesting that it isn't patenting "isolated genetic material" when it plainly is.
However, we shouldn't get confused about what the problem is here. It isn't that the CDC patented. Rather, the big questions are how they are going to license; why they have misled the GISN and WHO regarding patent apps on GISN samples; and whether there is an inherent ethical problem in the use of a freely shared sample in the creation of a vaccine which will be appropriated by a government (and likely used solely for the benefit of its citizens).
Given the rather slimy practices here, I don't hold out much hope that the CDC will act magnanimously in its use of its patent...but that's my opinion.
Posted by: Rieux | August 28, 2008 12:54 AM
CDC doesn't deny they have co-filed the patent, of course.
They deny that it claims for the Indonesian virus.
CDC and NIH claim for the patent, I can't see how St.Jude's is involved.
they claim for "plasmids" from a list of 150 flu-A sequences and even for their
>95% similars. The Indonesian sequence is just one of the 150 and the list even contains those wellknown viruses from 1934 and 1918.
With the 95% similars this would include almost anything of flu-A in those 4 segments. Absurd that CDC+NIH
would claim for rights on all these viruses.
IMO CDC's and NIH's public task is to encourage flu-research
not to hinder it with patents.
from pandemicchronicle:
---------------------------------
The influenza virus was used because A) it was relevant to current scientific endeavors, B) They have to use something, and C) Test animals are easily and meaningfully [translatable to human beings] utilized with the influenza virus. The CDC was involved because H5N1 was included in the testing [a currently relevant disease] and H5N1 can only be worked on in labs meeting a certain BSL level.
Mr. Shaw also stated that the US Centers for Disease Control [CDC] is fundamentally opposed to the patenting of any biologicals. The CDC’s interests lie in public health and it is in the best interest of public health to have open access, and patenting biologicals is directly counter to the open access that is needed.
CDC said:
Response to Query on the recent Edward Hammond Blog, “WHO-linked centre lays patent claim on bird flu virus”
Unfortunately, this blog is not correct and offers misinformation.
The National Institutes of Health has filed for a patent; a CDC scientist is listed on this patent application.
The patent is for a prime boost vaccine strategy where you receive two vaccines; the first is a prime which contains a DNA vaccine for the HA sequence of the influenza virus only, the second is a boost vaccine with a protein. The two together are intended to offer amplified and focused protection against the influenza virus.
So the patent is, in principle, for a method of vaccination and is definitely not specific to H5.
It is definitely not a patent on a virus from Indonesia.
Posted by: anon | August 28, 2008 1:22 AM
If I had the first Meccano set with wheels and my friend persuaded me to share it. And that smart friend built the first car and told me I'd have to pay him/ ask permission if I wanted to build a car, even though in my own time I might have got round to building a car (or not). Why would I want to share with that friend ever again? Why would anyone share?
Or am I missing the point?
Posted by: miso | August 28, 2008 4:07 AM
anon, thanks for the information.
As I've said before, an unbiased reporter would have gotten this information before writing a story on this issue.
Posted by: Monotreme | August 28, 2008 6:22 AM
Mono - You're being rather naive. See my comment about what matters in patent law. The inventors could tell you or me that they intended to patent blue cheese and not H5N1, but that doesn't change what's on the appliction (although I don't have nearly as magnanimous a view as you about at least some of the inventors).
Besides, look, with Bayh-Dole and an NIH flu CRADA with Medimmune (and others) that might come into play here (I dunno if they do or not), I strongly suspect Rieux is closest to right here with respect to how CDC / NIH will handle their patent, if issued.
Although I strongly disagree on so-called "defensive patenting". The object here, folks, is to try to preserve the GISN by stopping the ripoff. "Defensive patenting", which is really an excuse for confronting the problem, will only exacerbate the patent feeding frenzy. What we need is to remove GISN materials from patentability.
Posted by: Perezoso | August 28, 2008 7:06 AM
"excuse for NOT confronting the problem", that should read...
Posted by: Perezoso | August 28, 2008 7:08 AM
St. Jude's and CDC patents on Vietnam and Indonesian H5Ni samples have been well known for over one year. It's the sort of stuff that people in the developing world talk about but somehow doesn't quite make it into the US media. These patent actions are probably one reason WHO pulled its guidelines on virus sharing off the WHO website (with no warning to member states) some time back - it was obvious that this was in violation of the GLs, so trash the GLs.
And people wonder why Indonesia gets paranoid.
The other thing that is bugging the Indonesians is the US Navy NAMRU lab in Jakarta. No Indonesian scientists allowed in the door. How odd.
And then there's the famous (again, famous everywhere except in the US) case of the Indonesian H5N1 sequences that found their way into the US biodefense lab at Los Alamos.
Also keep in mind that the Indonesians never said that they didn't want to send H5N1 samples to WHO and its CCs. They just wanted to send them with a MTA (Materials Transfer Agreement). This document is required by law on any transfer of biological materials into (or out of) the US, but WHO has resisted the use of MTAs for transfer of isolates under the GISN, in response to pressure from the US. Why? The MTA would give the Indonesians continuing rights over the virus, as specified in the Convention on Biodiversity but wait a minute, isn't there ONE COUNTRY which has not signed the Convention on Biodiversity? Which country, you ask? This week's Intellectual Property Prize goes to whoever submits the correct answer to that one.
Posted by: anonymous | August 28, 2008 7:26 AM
Perezoso, I may be naive, but you are ignorant of science, both content and culture. Do you even know what codon optimisation means? As regards culture, if a scientist says they are not claiming a patent on a sequence, for example the H5N1 sequence from Indonesia, but then goes ahead and sues someone who uses that sequence, but not their proprietary technology, that scientist's reputation will be ruins. This is why this whole thing could have been settled by simply asking scientists involved.
Your accusations keep escalating in seriousness. Now you are adding deliberate lying to your charges. revere, are you going along for the ride?
Posted by: Monotreme | August 28, 2008 9:22 AM
Mono: You want to make this about Ed Hammond. My post was about the patent application and the issues related to it. Whether Ed is a "reporter" or "journalist" is a red herring as far as I'm concerned and Ed and I disagree on a number of issues related to WHO and Indonesia. He is not bound by my opinions and vice versa. I would also like to say that while you are a scientist you do not speak for scientific culture. I am also a scientist and also do not speak for scientific culture. But there are some aspects of what you might call the culture that I consider inappropriate for pandemic flu science, and hoarding or non-disclosure of sequences is one of them, although it is entirely consistent with how we do science in other areas, i.e., could be said to be part of the culture. Ed may not know as much as you or I about how scientists operate, and in that sense could be called naive in that regard, but I think you are equally or more naive with respect to how patent law is used by the players. There is a culture there, too, and it is not just a matter of law any more than scientific culture is a only a matter of "scientific method," nor is it a matter of scientific reputation. I also consider your view of how reporters operate to be very naive. The evidence for that is all around you but you seem to adhere to some comic book or idealized version of it.
Posted by: revere | August 28, 2008 9:56 AM
revere, this is about Ed Hammond because your blog takes his interpretation of the patent at face value. If you had read the patent and come to your own conclusions, then we could discuss what those are. Thus far, I haven't seen your analysis of what the patent does or does not mean.
Withholding sequences was wrong imo, but not the type of behaviour that goes against scientific culture, unfortunately. Although these practices are changing, hiding primary data for as long as possible has been common among scientists. However, deliberate, public lying is harshly punished.
As regards journalism, I will admit to not being an expert on this. However, I think most journalists would see Mr. Hammond's press release as a "hit" piece. These do occur in some publications, but are not considered good journalism.
Frankly, I would be shocked if a good journalist, like Helen Branswell, would write a highly negative piece like Mr. Hammond's without first talking to the patent holders and getting opinions from unbiased content experts. But perhaps you think differently about this.
Posted by: Monotreme | August 28, 2008 10:08 AM
I, for one, am rather glad all this has come up.
I find the argument the US Gov. had to patent as a defensive move rather amusing. The US has created this situation by first extending patent law into areas in which it has no business and then aggressively trying to export its new line on what can be patented – on behalf of some of its larger chemical/pharmaceutical corporations. Others are not sure that IP rights should cover patents rightly owned by Mother Nature and the argument that failure to allow investors, in research, to protect their investment through patents is wrong. It means we need to re-examine the system and find other ways to remunerate the labs for the work they do so they keep on doing it.
Personally I do not think that Indonesia, the lab or the sick bird or human have the rights to the virus if anyone does it might be the virus itself but I do not think we are read for viral patent holders yet. If man – in his usual arrogance – feels he must take upon himself these rights then they should be communally held and we should jointly pay into a fund to reimburse those that provide a useful service.
This is just a tip of the iceberg and I hope it leads to a complete re-examination of IP rights, WIPO, TRIPS/Doha declaration, medical patents and much else beside.
The current system is iniquitous and needs root and branch reform; unfortunately it has US backing and it is generally advantageous to multinational corporations based in the G8 so it will be an excruciating David and Goliath battle.
Let the games begin.
Posted by: JJackson | August 28, 2008 10:16 AM
Mono: As far as I am concerned, and as far as the post is concerned, this is not about Ed Hammond, as much as you insist on making it so. My position has consistently been that the IP system, which as JJ points out the US has promoted aggressively, is an inappropriate instrument when it comes to pandemic flu and using it is what I considered dismaying, and I included St. Judes in that because we see some of the same kind of behavior there. St. Judes is not on the patent application. Right now I think I am the only one saying this and I intend to keep saying. it. Ed and I probably disagree as he sees the use of this system by Indonesia as acceptable and I do not. He and I have met and exchanged communications but we are separate people with different interests and different opinions.
JJ has expressed much of how I feel about this. I don't want to argue about Ed Hammond, as much as that seems to be the only thing you DO want to argue about. I am trying to raise the very point JJ has broached, as I have consistently done here, and arguing about Ed Hammond is not the point.
Posted by: revere | August 28, 2008 10:43 AM
you are a bit being accused of sensationalism too
with your headlines
Posted by: anon | August 28, 2008 11:08 AM
Revere, you are incorrect. Without a patent, a potential manufacturer has no need for a license. They can just do it. They already can just do it in every nation where there is not an issued patent. Indonesian law controls what can or cannot be done in Indonesia on patented or unpatented inventions.
The reason for patents in vaccines is to allow for upfront investment necessary for development of vaccines to be recouped. If the vaccine were not patented, then manufacturer X could spend the money and go through the development process, clinical safety trials, clinical efficacy trials, and then manufacturer Y says “thank you very much”, reverse engineers the vaccine and sells it at a fraction of what manufacturer X has to charge because reverse engineering something that is known to be safe and effective is trivial compared to making something safe and effective from scratch.
If these vaccine sequences have been deposited in public domain data bases, then they are public domain and anyone is free to do anything with them, including include them in patent applications. If they are in the public domain, nothing about them is patentable. They can be attached to a patentable invention the same way that any obvious thing can be. If I patent a machine, I can have a claim where I claim the patented machine painted red. Painting a machine red is “obvious to someone skilled in the art”. It does not infringe on the rights of the manufacturers or suppliers of red paint.
If making a vaccine from the deposited sequence by method ABC is “obvious to someone skilled in the art”, then making a vaccine with that deposited sequence is not patentable and any patent that issues will be invalid.
A MTA as in the linked to article only covers those who have agreed to it. If you are willing to force each and every recipient of every dose of vaccine to read and understand the MTA and agree with it as a condition of receiving the vaccine, maybe you can make an MTA model work. All it takes is giving away a few doses without an MTA and the MTA becomes unenforceable under US law.
If the vaccine does become public domain, the liability rests on those (and only those) who agreed to the MTA and then broke the MTA agreement.
The only reason these virus sequences can be identified as derived from Indonesian strains is because the sequences of those Indonesian strains have been published. If they are published then they are in the public domain. Once something is in the public domain, it is not patentable anywhere in the world (except the US and in the US only by the inventor, but they have to prove they invented it before the public disclosure).
If they have included other public domain sequences then they are not “patenting” those public domain sequences. You can’t patent something that is in the public domain. Including those sequences is like including the patented machine painted different colors. The color of the machine is not a patentable feature, but you can claim a patented machine of a specific color.
Posted by: daedalus2u | August 28, 2008 12:11 PM
daedalus2u,
if you want to reward companies who are doing research and trials, then you needn't do it
by giving them patents. Give them grants or tax-reductions or such payed from public money.
Make a vaccine-tax, whatever. Patenting is not the right way. It restricts follow-up
research based on it. It causes significant delays due to secrecy.
Posted by: anon | August 28, 2008 2:08 PM
Actually the purpose of the patent system is to foster disclosure, which it does. A patent application requires sufficient disclosure so that someone skilled in the art can replicate the invention. If there were not such things as patents, manufacturers and researchers would keep all of their information proprietary and no one would see it.
I don’t disagree that there are problems with the patent system, but until there is something better, it is all we have.
There are no laws stopping anyone from doing the research, making the vaccines and then giving them away for free. No laws that is except for the laws of economics. People keep trying to repeal the laws of economics, but those repeals never seem to work.
If you make paying for vaccine research political, then you put it in the hands of politicians and lobbyists. The money goes to those with the best lobbyists, and those who have bought the most politicians, not the best scientists, or the best vaccines. Look at what happened with the anthrax vaccine. Look at what happened with swine flu. That is the whole problem with universal health care, the insurance companies make enough profits to pay lobbyists to block universal health care that cuts them (and their profits) out.
I don’t know enough about the flu vaccine and this particular patent application vs. more traditional methods of flu vaccine production to know if this application is necessary, or is just window dressing. I am pretty sure that there are people who can tell. If traditional methods work well enough for bird flu, then this patent may be worthless. If traditional methods don’t work for bird flu, then this patent may be a gold mine.
The only thing that the patent system lets you protect are inventions, that is new ideas that are useful, novel and are not obvious to someone skilled in the art. If all it takes to get compensated for doing “research” is to lobby the right politicians and grease the right palms, who is going to bother to spend money on scientists and research labs? No company that cares about the bottom line is going to spend money on things that don’t add to it. The money will go for lobbying and marketing and not for research trying to find stuff that is new.
Posted by: daedalus2u | August 28, 2008 3:32 PM
daedulus: The parties involved here are not businesses (CDC, St. Judes). They have been giving away their work in other ways for many years. The purpose of the patent system was to spur innovation and protect the rights of the creator of the idea. It has now been transmogrified to a monster that spurs monopoly. The system aside, the question here is the propriety of its use by these parties for these purposes.
Posted by: revere | August 28, 2008 3:47 PM
Revere, I think we both agree that there is a big public health problem in getting the commercialization of pharmaceuticals for drugs that are not likely to be “block-busters”. By block buster I mean a drug that will have a large market in the developed world that will support multi-billion dollars in sales.
Commercialization of drugs is difficult. Commercialization of injectable drugs from natural products (which flu vaccines are) is extremely difficult. The problem with the flu vaccine recently was that batches became contaminated and the contamination wasn’t caught until very late in the manufacturing process which rendered useless large quantities of vaccine. That produced a vaccine shortage. That was in conventional flu vaccine, grown on fertile chicken eggs. As natural products, fertile chicken eggs are difficult to obtain germ free and free from contamination. The traditional way to deal with this contamination is to start out with more eggs than one “theoretically” needs, follow them through and hope one ends up with enough vaccine. If one guesses wrong one ends up with more vaccine than is needed which can’t be sold and is useless the next year, or one ends up with not enough because there was more contamination than one assumed.
Big pharma only spends research money on things it can make money on. Usually that is knock-offs of “block-buster” drugs of other manufacturers, Viagra knock-offs for example. The value to public health of another Viagra knock-off is not large. The problem is that the value of something to public health cannot be monetized. If the value to public health cannot be monetized, then a company cannot develop something to add to public health and then capture some of the monetized value of that public health increment.
The value to public health is only known after the fact. Budgets are allocated in what is typically a zero-sum process by people who do not understand the economics behind what they are budgeting for. Such systems are easy to game, and gaming the budget system is typical. That is essentially what “pork” is. That is what lobbyists are hired to do. If a system of rewarding public health improvements was put into place that rewarded actions after the fact, it would be looked upon by many as pure “pork”. It would be much easier to “game” the public health reward system to obtain large rewards than to actually achieve large public health benefits.
I am trying to commercialize a nitric oxide product. The recent experience of NitroMed in that regard has made that more difficult. What NitroMed did, was develop a combination of 2 genetic drugs (BiDil® isosorbide dinitrate/hydralazine hydrochloride) that had specific synergy for people of African descent. They got FDA approval for this, raised a lot of money and spent it all on marketing. The marketing decisions were made by those who put in the money. They wanted a “block-buster”, and so they priced and marketed it as if it was a “block-buster”. It turns out it wasn’t a “block-buster”, and so the sales couldn’t support the marketing effort that had been put forth.
If we look at the NitroMed stock price for 2004 to present (aug 06) they are 18.25, 22.61, 2.55, 1.90, 1.01. It had a peak over 25 but is now about 1.00.
The (relative) failure of NitroMed had nothing to do with technology or science, it was purely the