Natco seeks license from Pfizer to manufacture a low-cost version of HIV drug


The new year seems to have ushered in with some news for compulsory licensing in India.

As ET reports, Natco Pharma has sought a voluntary license from Pfizer to manufacture and sell Pfizer’s HIV drug maraviroc (sold as Celsentri).In its notice to Pfizer, Natco stated that the US drug costs an arm and a leg to the HIV patients in India, which has approximately 2.3 million HIV positive patients. Celsentri costs about 65k for a month’s dosage whereas Natco claims that it can make a copy of the same which will cost around 15k. To quote ET, “this will be a big test case for the application of compulsory licensing provision in India”. Pfizer,as is expected, will be declining this license to Natco owing the investments made for the R&D of the drug.

This case will thus be a landmark in striking a balance between the affordability of the expensive medicines by the poor masses in India and the investments made by the pharma companies. As per the Patents Act, Pfizer will have six months to reply to the notice of Natco. In the event of a likely rejection of the grant of license, Natco can approach the government for compulsory licensing to sell a affordable version of the drug after paying due royalties to Pfizer. As per the Indian law, the government can invoke the provisions relating to complusory licensing after three years of grant of the patent if the product patented is not affordable for public or if the company fails to launch the product after having obtained the patent.However, most innovator companies have been opposed to the idea of compulsory licensing.

Natco had tried to seek a similar license from Pfizer for its anti-cancer drug to be sold in Nepal  in 2007 but was unsuccessful in obtaining the same.  We have covered this issue on the blog which can be read here, here and here. The outcome of this notice to Pfizer will be instrumental in determining the fate of compulsory licensing in India which has been a fairly recent addition to the Patent Act.

Recently, we had covered the issue of  DIPP discussion paper on compulsory licensing  in the Indian pharma sector which can be accessed here and here.

PS-Image from here.

8 comments.

  1. AvatarHarry

    I am amazed that Compulsory Licensing is being mentioned both here and in the Economic Times (ET) article.

    First let the negotiation for a voluntary licence (VL) proceed in good faith (or not) and await the results. The ET article suggests that the VL is a first step towards CL (in turn suggesting that Natco is deliberately planning a CL). Does India or an Indian Company wish to make pharma companies suspicious of every VL?

    I really wish the media or other writers think of the consequences of their reporting.

    Harry Thangaraj

    Reply
  2. AvatarShamnad Basheer

    I fail to understand your concern Harry,

    We have no vested interest in the outcome of this case. And I suspect that is what journalistic integrity is about. If Pfizer grants it a voluntary license on terms that Natco accepts, why should you or anyone else worry?

    And if it does not, it will move into a CL application. End of story.

    You must remember that Natco itself mentioned to the press that it had sent out this notice for a license. Signifying its intention to move the CL process, if necessary. And both these parties already have a prior history with one CL claim (re Sunitinib and Nepal). So nothing to really be coy about here for any of the journalists or for SpicyIP.

    Reply
  3. AvatarHarry

    Dear Shamnad,

    Thanks for the quick reply. My main (but not only) concern is whether talk of compulsory licensing by reporters will prejudice the outcome of negotiation for a voluntary licence.

    I am favour of CL only when negotiation fails and reasonable terms are not agreed. As was the case of Efavirenz and Brazil.

    And in the case of Efavirenz it was the Brazilian government that applied for a CL, not a company. If in future companies apply for CLs en masse it will only reinforce some views (mostly erroneous) that generic companies wish to profit through CL.

    Harry Thangaraj

    Reply
  4. AvatarShamnad Basheer

    Thanks for clarifying Harry,

    But the generic companies (such as Natco here) themselves wish for this to be known—i.e. that they are effectively seeking a CL. And MNC’s are not stupid either–they can sense where this is leading. so i dont think we should be too guarded about this. let it come out in the open…

    secondly, much as i love our generic companies, we all have to understand that they are in it also for the money…their CL drive comes out of pure business interest. and if patients can also benefit from the cheaper prices that ensue, so much he better. but we should not kid ourselves into believing that they are doing this only for patients.

    Reply
  5. AvatarKshitij Malhotra

    I agree with Shamnad’s view. However, the concern raised by Harry is very much valid. Any negotiations for a VL do not make sense if one of the parties (generic manufacturer) has the recourse of CL. Having said that, I believe the laws (at least in the statutory book) for granting a compulsory license are equitable to address such concerns. Whether practically these laws create equity, time will only tell.

    Reply
  6. Avatarsingh

    I would like to slightly differ from Harry’s point of view over the issue regarding compulsory licensing process.

    NATCO in the past also expressed the desire to file for CL but unfortunately they failed.

    In the market, it might be a ploy to pressurize the MNCs to issue voluntary license otherwise,

    they have a recourse for CL.

    Reply
  7. Avatarpatent litigation

    Though I can understand the source of corporate resistance to compulsory patent licensing (money), I think that in some cases common decency demands it. I think the availability of a low-cost HIV drug is one such instance. Though of course the question is complicated as to where to draw the line in these humanitarian/public health issues, still I think that major corporations should take it upon themselves to do the right thing in the face of such an obvious need.

    Reply

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