Patent

A Strange Brew of Tamiflu and Swine Flu


 

Image taken from here 
Everything surrounding the Swine Flu seems to be quite mysterious. Starting with allegations that the virus itself may have been a man-made product that got loose, to the scare being exaggerated to sell more drugs for it and put more money in Donald Rumsfield’s pockets, the events and scenarios existing around this disease are proving to be quite interesting. Yet there are more interesting  ingredients involved in this strange soup.
Oseltamivir is one of the best drugs currently available used to fight Swine flu. While Gilead has patented this in other countries under the name Tamiflu, their patent application was struck down in India in March 2009 for [a] lack of inventive step, [b] failure to comply with S.3(d) and [c] failure to sufficiently disclose the invention claimed. This technically clears the path for Indian generic companies to start producing the drug. However, first, as described here, the government created an artificial monopoly of sorts by directly procuring and supplying the drug to hospitals from Hoffman-La Roche and its Indian licensee Hetero Drugs. (Gilead has given an exclusive license to Roche for Tamiflu.). Cipla, which had opposed the Tamiflu patent, naturally weren’t very happy about this and questioned the government about this.
This problem was later sorted out and retail sales of Oseltamivir were allowed. There are currently six private sector pharmaceutical companies who are producing the drug. Of these, Hetero Drugs, Cipla, Ranbaxy and Strides Acrolab are able to indigenously produce Oseltamivir from its raw material. Now, recently, the Parliamentary Standing Commission on Chemicals and Fertilizers has said that as it is a life saving drug, Central Public Sector Undertakings (CPSUs) ought to manufacture the drug as well. To this, the Department of Pharmaceuticals (DoP) has given two reasons as to why this is not possible.
Firstly, the DoP apparently claims that Tamiflu is a patented drug. As mentioned above, the patent application for Tamiflu was rejected in 2009 and I couldn’t find any other patent application for the drug, so I don’t really understand what this objection is based on, if anything.
Secondly, the DoP also claims that it is not economically viable for CPSUs to be making this drug. With 6 private sector companies currently making this drug , this argument too seems weak.
There is of course, a plausible argument that these 6 companies are already handling the disease burden, and that the costs involved in setting up and distributing this drug may now not be justified for the 7th entrant. However, this falls apart for more than one reason.
a) As shown in the graph above, the disease burden has in fact slowly been increasing. (Graph taken from here). Note: This is only over the last few months, as I couldn’t find graphical data for a longer time period.
b) For Central Public Sector Undertakings, economic viability for what has been classified as ‘life saving drugs’, should not be the deciding factor in choosing whether a drug should be produced or not.
c) Considering that they are life saving drugs, 100% reliance should not be placed on private companies, which may not be able to produce sufficient quantities if an outbreak does occur.
It frankly seems like just excuses not to make the drug for some reason – especially when saying that its a patented product! (Perhaps even some inside knowledge into the ‘exaggerated’ scare of it…!?) The Parliamentary panel has put forward similar arguments as to why CPSUs should, in fact, be involved in the production of the drug, so let’s hope that good sense prevails in this decision making process now.

4 comments.

  1. AvatarAnonymous

    Dear Swaraj
    I believe you have just missed the bigger picture. A Govt. body (DIPP) rejecting a patent application and a Govt. undertaking manufacturing that ‘unpatented’ product would pose a serious case of conflict. Further, ‘public good’, as you pointed out in your post in case of an outbreak, is not dependent on the ‘status of patent rights held by the product’. We have what we call ‘compulsory licensing’. Also, I would request if you can put across the relative costs of all the 7 distributors in India.

    Regards
    anon

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  2. AvatarS

    In the first place, compulsory licensing won’t come in the picture as there is no monopoly granted to any drug maker.
    besides, I fail to understand how the government created a monopoly by directing Roche and its Indian partner Hetero when there is no patent protection for oseltamivir in India. At that time, government should have considered the generic rather domestic players like ranbaxy, natco and cipla for bulk production especially to avoid outbreak crisis in future…

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  3. Avataraliasgard

    I think, selection of Roche over other manufacturers has something to do with the use of azide free manufacturing process of Oseltamivir which used (possibly patented) by Roche Pharmaceuticals. The earlier manufacturing process had two reactions steps which makes use of hazardous azides whereas Roche’s process uses a different approach.

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  4. AvatarSwaraj Paul Barooah

    Dear Anon: A product which is not patentable is so because it does not fulfil the required criteria. To say that this decision would be a conflict of interests is to imply that the patent office is basing their decisions on external factors – such as what the government wishes to manufacture.
    Regarding the relative costs, I’m sorry but that’s not information that I am privy to.

    As S has mentioned, the question of compulsory licenses doesn’t even arise in this case.

    Dear aliasgard: Thank you for this addition. If Roche’s process involved a patented product/process, this solves the first mystery and explains why the initial assignment was to Roche (and hence Hetero).
    However, later on, the generics did enter the fray, so there is still a lack of reason as to why PSUs shouldn’t enter it as well.

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