India, South Africa gain from J&J-generic deal, Patent Pool loses out

Johnson & Johnson’s subsidiary Tibotec has granted multiple non-exclusive licenses for a new HIV-AIDS treatment to generic manufacturers including Hetero Drugs Ltd, Matrix Laboratories Ltd from India and Aspen Pharmacare from South Africa. The drug in question, rilpivirine hydrochloride (TMC278)  is still pending approval however. Tibotec would recieve 2-5% of what is received for the pills. The press release by Tibotec is available here
The licensing allows the Indian generic companies to manufacture, market and distribute TMC278 in Least Developed Countries, Sub-Saharan Africa and India, and allows Aspen to regions of Sub-Saharan Africa including South Africa. (Image below taken from here. Darker shades reflect areas of higher populations of AIDS patients) 
However, is this a small benefit made at the cost of sacrificing a bigger benefit? As KEI points out this means that almost all of Latin America, all of North Africa and several countries in Asia including Thailand, Malaysia and Pakistan will not be covered by this deal. This multi-license deal by Tibotec also reflects a bypassing of the Medicines Patent Pool which aims to obtain open licenses for the development of HIV-AIDS medicines in all developing countries, despite requests from the Medicines Patent Pool, as well as from civil societies for Tibotec to join the MPP voluntarily, and to conduct negotiations about licensing transparently and inclusive of all developing countries. MPP had requested a reply from Tibotec by Jan 31st, and this move by Tibotec on Jan 27th makes it seem quite unlikely that Tibotec would join the patent pool. For more on this, see the post by KEI
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3 thoughts on “India, South Africa gain from J&J-generic deal, Patent Pool loses out”

  1. Swaraj,

    I recall having read that Rilipivirine is patented in India (courtesy Patentdaily).

    So, without getting into the Patent pool story here, its worthwhile to note that NO Indian company would have been able to make/ sell commercially, this molecule.

    Coming to Patent Pool loss- I have seen thier meeting in Delhi some years ago. The concept and people are great but its not moved much beyond that.

    Finally, it was Tibotec/ J & J call to give voluntary licenses…. if they wanted, they could have given the IP to the Patent Pool – surely no one stopped them. The decision to NOT enter the Pool (after so much hype) was made by the IP owner… the licensees are merely making hay, while the sun shines 🙂

    F. Anon.

  2. patent pools are just silly. They serve no purpose other than giving fat salaries to their heads, key employees etc., much like NGOs we have in social sector. J&J did good thing,now drug will be “at least” available to least developed countries and that too quite earlier than what might have been envisioned by MPP. Pharma molecules are not about patents alone, there is much know-how needed along with much documentation, manufacturing formulare records, BMRs, Specifications, MOAs, COAs and what not and these things take considerable time. By this licensing, J&J will provide these things handy and cutting short the supply time to these countries at least. And these talks of “almost this area, that area” not covered by this deal is plain BS, since nobody can please everybody.

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