IMPLICITY

Cipla-Bayer and public health

Posted in consumerism, human rights, market, public policy, sex. and drugs by Gautam on May 24, 2009

The United States has a set of regulations in place where in the Food and Drug Administration is required to ensure that any drug being authorised by it for production and marketing is not already listed as a patent under the ‘Orange Book’.  At a primary level this is indicative of a practice of very key norms of co-ordination between two regulatory mechanisms that are in place with different objectives-namely the drug administration and the patent regulations- just so that they can be in effective harmony while plugging significant loopholes in a system and ensure vital efficiency in redressal.

In India the case is different; not only does our nation fail to establish an interplay between different regulatory authorities, with relation to this specific issue, our notion of patents itself is presumptively flawed given mixed governance with all the promises of socialist tendencies and a skewed approach to free markets; add to that widespread poverty, hunger and major health problems plaguing our demography. If this lack of coordination be the issue in hand, the challenge relates to a balance between the degree of access of essential drugs, the ease of patent acquisition and enforcing norms of patent prerogatives.  Thus if a patent violation is seen, emphasis be laid on why such violation has been permitted by existing administrative mechanisms and at the same time ensure redressal and plugging such loophole.

In November 2008 Bayer Corporation of Germany approached the High Court of Delhi against the Union, the Drug Controller General of India and Cipla seeking an order that the DCGI should consider the patent status of its drug Sorefenib Tosylate and its generic versions before granting marketing approval to any generic drug company and consequentially refuse such grant to generic versions of a drug, if its patent is in force.  This relates to what is called the patent linkage system which establishes a co-ordination network between different regulatory mechanisms to enforce patents.  The High Court heard arguments to this case during the month of February and ordered an injunction to the marketing approval Cipla till a final order in the matter was passed.

The issue is a remarkable public health concern because a patent linkage system in place will delay the entry of cheap generic drugs in the market that are vital to the health of a masses.  At the same time, a patent has no value if it cannot be monitored and enforced under law. Enforcement is not possible without proper and regulated monitoring which is already a major problem in fragmented Indian drug industry and the gravity of which can be gauged by the fact that about 20 percent drugs marketed in India are spurious drugs despite having both Central and State drug regulatory agencies.  The centre took note of this criticality through an Amendment to the Drug and Cosmetic Act in 2008 which passed by both houses successfully.

However, the result of this case is significant in so much as the issue of patent linkage systems is concerned.

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6 Responses

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  1. Jane Whittle said, on May 25, 2009 at 12:52 am

    well placed perspective.
    you might want to have a look at http://www.orangebookblog.com/ for a further know about on the fda and patent law in the United States

  2. gautam said, on May 25, 2009 at 8:54 pm

    thanks. have been to the site; as a matter of fact the recent post on the federal circuit decision relating to reliance on the ‘sliding scale doctrine’ was something I was pondering on of late.
    Was also a result of a statement that made me think further about it… “whether the society is creating an IPR regime for commercial activity or for the promotion of intellectual activity”.

  3. Malavika said, on May 31, 2009 at 1:38 pm

    a patent linkage system precludes the operation of legally valid mehanisms of parallel imports and compulsory licensing of generic drugs.

    also, i think it calls for more stringent patent protection than the TRIPS mandates, doesn’t it?

    linking marketting approval, registration of a drug and patent rights can’t be too beneficial for us. registration of a generic drug allows for the drug to be immediately released into markets once the the patent of some rich MNC’s drug expires. barring registration of a generic drug if a patent for the same is in force would prevent such a thing from happening.

  4. Jane Whittle said, on June 11, 2009 at 12:16 pm

    The critical issue regards ‘Patent Linkage’ lies more in the matter of the administrative implications of such regulations.
    Gautam was kind enough to send me a petition to the Indian government against ‘Patent Linkage’ per fora one of your High Court’s decisions. It will be insightful for a cursory view of the entire issue. http://www.gnaipr.com/Acts/Form_No_1_._44_-_letter_for_its__amendment_16-3-2009.pdf

  5. Ritika said, on June 20, 2009 at 8:23 pm

    faloop 🙂
    anyway, you made a statement saying “our notions of patents itself are presumptively flawed”
    tell me about it.

  6. gautam said, on July 1, 2009 at 2:21 pm

    i’ve sent you something on it.
    ‘faloop’; i feel missed.


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