Oct 16

Marc Hedlund

Marc Hedlund

Patents and the Flu

Reading this AP article about avian flu concerns, I was struck by its discussion of patents:

The drug that seems most effective against bird flu is Tamiflu, which was created to treat ordinary human flu but is now in short supply and can't be made fast enough because of pandemic fears.
[U.S. Health and Human Services Secretary Mike] Leavitt has been talking with drug and vaccine manufacturers to try to increase the stockpile should a catastrophic outbreak reach North America. The government currently has enough Tamiflu to treat about 4.3 million Americans.
Manufacturing of a new vaccine has just started, and Leavitt said the United States may help finance some of the $100 million production burden.
Earlier this month, U.N. Secretary-General Kofi Annan suggested patent rules might be suspended in an outbreak to allow other companies to make generic forms of Tamiflu, produced by Swiss-based Roche Holding AG. In recent days, a company in India announced plans to do that.
However, Leavitt said the United States supports intellectual property laws that bar such action.

I understand the argument that intellectual property laws incent companies to invest in drug research, and that circumventing those laws could inhibit development of drugs that would ultimately save many lives. It seems absurd, though, not to have a discussion about ways to preserve Roche's interests while providing against the possibility of a pandemic. I'm disappointed to see Leavitt's simplistic response. More people died from influenza during the 1918-19 pandemic than died in all of World War I; I'd hope that it would not be patents that would prevent the government from protecting against a future pandemic. The tech world has good reason to complain about software patents, but in comparison, this is far more troubling.

(Popular Power, the company I founded in 2000 with my friend Nelson Minar, worked with influenza researchers on optimizing vaccination strategies, using surplus computer time contributed by individuals around the world. While the company closed in 2001, I've paid attention to influenza research ever since, which these days is a daily reading assignment. Even the last novel I read, Wickett's Remedy by Myla Goldberg (which was excellent), was all about the flu. I was very happy to catch up with Popular Power's former staff scientist, Dr. Derek Smith (now at Cambridge), while in Amsterdam for EuroOSCon. It has been one of my favorite parts of my career to meet, work with, and become friends with people who do such different -- and especially in Derek's case, so much more meaningful -- work than my own. The computer industry provides a great benefit in that our work touches so many other fields and provides such introductions. I'm glad that my current work is introducing me to similarly wonderful people.)

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Comments: 13

  Phil [10.17.05 12:23 AM]

Given the very real possibility that H5N1 could lead to a global pandemic where 150Million people could die (and some experts think this is a conservative estimate) I think the ethical approach is to ignore IP law for the sake of saving life. Capitalism has given us lots of great things, but this is a case where capitalism and the idea of intellectual property break down.

India and Taiwan have already stated that they may ignore IP law in this case and develop a reverse-engineered form of Tamiflu. The US may be so respectful of IP law that it will lead to the unnecessary death of millions here.

If (when) the general public realizes that millions of sick people are not able to access a medicine that could cure them (or at least give them a fighting chance) because politicians are more worried about profits for big pharma... well, I wonder how long this policy of respecting IP law at the expense of letting a lot of people die will last? One can imagine very violent riots where things don't turn out well for said politicians. Tarring and feathering could make a comeback. Major cultural shifts have happened over smaller things than pandemics. One can easily imagine a major cultural shift over the idea of intellectual property if (when) a pandemic strikes.

But just to add a twist to the discussion, we already know that H5N1 is resistant to a relatively cheap (cheap because it is no longer under patent) anti-viral drug called amantidine. Poultry farmers in several Asian countries started putting amantidine in their poultry feed a couple of years ago in hopes that their birds wouldn't succumb to the flu. H5N1 adapted to this wide application of amantidine fairly quickly and is now totally resistant. Maybe scarcity is what will keep Tamiflu effective for a longer period of time? We already know that there are strains of H5N1 which are resistant to Tamiflu now. It's not known yet how widely distributed these resistant strains are, but it gives us an idea that Tamiflu resistance can develop fairly quickly in H5N1.

  paolo [10.17.05 01:45 AM]

It is a bit sad that we, the rich part of the world, start recognizing the problem of patents and drug research only when it menaces to affect us.
AIDS in sub-saharian Africa has been a pandemia since many years and the same is true for most of the "tropical diseases", the kinds of diseases that disproportionately affect developing countries � e.g., malaria, measles, pertussis, and diarrhoel diseases, also called "neglected diseases".

You say "intellectual property laws incent companies to invest in drug research", but in fact it incents to invest on in research for drugs that cure diseases that affect rich people, as the following report by M�decins Sans Fronti�res prouves:
"Of the 1,233 new chemical entities that were developed between 1975 and 1997 only 13 were for the treatment of tropical diseases. Five were a result of veterinary research, two developed by the US army, three were a result of R&D efforts of pharmaceutical companies of which two are re-formulation of old drugs. The market fails when it comes to R&D for diseases of the poor. The vaccine for tuberculosis was developed in 1923.
The last novel treatment for TB was developed over 30 years ago and is loosing its effectiveness. There is a need for new effective and simple treatments for TB but there is almost no investment in this area.

While you say "I'd hope that it would not be patents that would prevent the government [of USA] from protecting against a future pandemic", I think I must say "I acknowledge that it was and would be patents that did and would prevent the government [of developing countries such as Brasil, India, Nigeria, ...] from protecting against a past and future pandemic (AIDS but also

Also, I think it would be helpful to reckon from beginning that "Roche's interests" are not earth inhabitants' interest. I know that capitalism is the illusion to turn individual's interests into collective's interestes but I'm wondering if we should not start reckoning that, when we speak about basic rights, such as water, education or health, unregulated capitalism is not really the best solution.

See also Lessig's posts about the topic:
The Patent System and Access to Medicine in Developing Countries: The problem
The Patent System and Access to Medicine in Developing Countries: Possible Cures

More info and possible actions at (drugs for neglected diseases initiative)

  gnat [10.17.05 04:22 AM]

The US faced a similar question in 2001/2002 around the anthrax-fighting antibacterial, Cipro. Bayer caved and supported rival drugs so that their patent would not be suspended.

  Marc Hedlund [10.17.05 06:21 AM]

paolo -- You're right to call me out for US-centrism and for ignoring the effects of patents on diseases of the poor. We had talked about running code to support malaria research at Popular Power, for just the reasons you mention.

Thanks for the additional links and comments.

Nat -- doesn't that say it all. It sounds like they gave up on exclusive profits for the one drug in order to preserve patent rights over all. Hmm.

  pwb [10.17.05 11:08 AM]

How hard would it be for Roche to enlist some other producers to meet demand?

  Capnsnarky [10.17.05 11:15 AM]

This is a great, interesting thread. Really thought provoking in regards to the fundamental decision between life and capitalist values. One thing in the comments above. Phil said: "We already know that there are strains of H5N1 which are resistant to Tamiflu now."

I haven't read such definitive statements from medical authorities. What comments I have seen in the press are much less definitive, with the exception of the recent case of a girl in Vietnam covered by Nature [ - sorry, the original article is 'premium' content].

I would [sincerely] like to know where Phil or others have seen authorites [as opposed to commentators] making firm statements backed with data on Tamiflu resistant cases. It seems that this resistance is likely there and developing as we go. But again it would be useful to know what hard data is out there and further the discussion around how we should prepare for the pandemic should it come in the next few months.

Regardless, I haven't seen anyone saying that taking Tamiflu to prevent infection or to control the severity or spread of the infection is a bad idea. [Are there any examples of this that people have found?] It seems that it makes sense to have several options ready in the event that resistance to one treatment or the other develops rapidly.

That is the main point for many of us, including those in the US - we simply aren't ready to protect the majority of human lives. Which is why I think this is an intriguing topic - it does not need to be that way. Let's hope that the US and others don't play this IP brinkmanship until it is truly too late.

  Capnsnarky [10.17.05 11:33 AM]

Just found this tidbit that is somewhat reassuring for those of us in the US [and especially for those that are cynical about our government's ability to prepare for major crises]. It seems that Senator Charles Schumer is looking for a 'middle of the road' path to boost production of Tamiflu without entirely throwing out compensation to Roche..

  Phil [10.17.05 12:14 PM]

Capnsnarky: Here's a link to a story that talks about Tamiflu resistance:

A quote from the article:
The researchers studied 10 randomly selected viral clones - offspring viruses that grew in the culture - to see if they were susceptible to the drug. Six were highly resistant, three were partially resistant and one was highly susceptible.

All were fully susceptible to zanamivir, which is sold as Relenza by GlaxoSmithKline. Both Tamiflu and Relenza are from the class of drugs known as neuraminidase inhibitors.

The question remains: if Tamiflu goes into widespread use against H5N1,how long would it remain effective? I was thinking of buying some Tamiflu a few weeks back, and of course you need a prescription for it. It's such a hassle to go find a doctor, make an appointment, pay $100 (min) just to get a prescription for something I won't need for who knows how long, so I never got around to it. Now, I think it's possibly too late, Tamiflu has flown off the shelves. For a while I was rather resentful that you even need a prescription for Tamiflu. Now, I'm thinking that perhaps it's a good thing that Tamiflu isn't so readily available so it might remain effective for a longer time. Someone mentioned the 1st world/3rd world divide when it comes to drug development. Indeed it exists and market forces have proven unable to address the problem. It's ironic that by the time avian flu hits the first world, Tamiflu might not be effective due to it's use in the 3rd world.

  Capnsnarky [10.17.05 01:55 PM]

Phil -

Thanks for the link and the good info. I think you have an interesting point re: the efficacy of Tamiflu and the irony that it might not be of much use in the near future. I wonder if and how quickly Relenza might also fall to the powerful adaptive abilities of the virus?

  Mark Johnson [10.17.05 08:22 PM]

I read in Scientific American this month that Tamiflu is expensive to make; it's a multistep process that takes nearly a year.

I wonder why Tamiflu gets the headlines when Relenza is also available? (Headlines about resistance to Tamiflu, of course, make sense.)

  Jeroen Wenting [10.18.05 05:30 AM]

Paolo, don't drag things into it you don't understand.
The main reason drugs aren't reaching the poor in Africa is because their own governments impose severe restrictions on distribution.
A dose costing maybe a dollar in the US will of course cost more in Africa given the transportation cost but that's maybe a few cents. But African governments are well known for imposing import duties on medical goods (as well as other aid supplies) which can reach hundreds or thousands of percents.
These are a highly lucrative source of income for these countries, feeding of the charity of Americans and Europeans while keeping their own people impoverished and hungry to generate more shocking TV footage to raise even more funds with telethons in the north.


Indian and Brazilian drugs companies are well known for (with the backing of their governments who hold that foreign patent and copyright laws don't apply there, so companies in those countries can create copycat products at will) not caring one bit about intellectual property rights held by other companies so India and Brazil at least should have no problems.


As to drugs against virusses, such drugs simply don't exist.
The best you can hope for is vaccination and symptom suppression (which sometimes can take the shape of blocking the reproduction of the virus in the body).
There's no killing a virus, so a person infected will suffer the consequences to at least some degree.

  Michael Bernstein [10.19.05 11:46 AM]

Patent nationalization in face of an emergency is hardly unprecedented.

At the outset of WWI, The US government forced the Wrights to cross-licence all their patents to a newly formed Manufacturers' Aircraft Association patent pool. Patent royalties were reduced to one percent.

A similar situation for pharmaceutical patents seems called for. If history is a guide, this will actually cause a resurgence in basic Pharma R&D.

  Justin Mason [10.22.05 11:36 AM]

James Love of recently pointed out that the WTO made an
exception for this in a 30 August 2003 decision, see:

Some quotes:

'is your country eligible to import medicines produced in a foreign country
under a compulsory license? This is important, as is almost certainly the
case, your country would benefit from importing generic medicines produced
under a compulsory license, in order to build up adequate stockpiles or to
obtain needed medicines in the event of a crisis.'

However, many developed-world countries have explicitly made a commitment
never to use this limited TRIPS waiver, namely:

"Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany,
Greece, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand,
Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom and the US."

"Another 10 countries about to join the EU said they would only use the system
to import in national emergencies or other circumstances of extreme urgency,
and would not import once they had joined the EU: Czech Republic, Cyprus,
Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovak Republic and

I bet national health authorities are, right now, wandering government halls
around the world, looking for trade representative asses to kick! ;)

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