Friday, April 03, 2009

From the Desk of Patent Circle: Is Patent-Drug Regulatory Linkage a Necessity? Part II

Case Study – 01
Let us take example of Bristol-Myer Squibb (BMS) patented drug Dasatinib for which Hetero Drugs filed an application with the DCGI for marketing approval of generic dossier of Dasatinib. Suppose the Delhi High Court judgment goes in favor of Hetero and the DCGI gives Hetero the marketing approval but BMS cannot sue Hetero till the generic version is not launched in the market. Now following Hetero’s approval for generic Dasatinib another generic company Cipla too files an application with the DCGI for marketing approval of generic Dasatinib and subsequently obtains the marketing approval. Following Hetero and Cipla, dozens of other generic companies files applications with the DCGI for marketing approval of their generic versions of Dasatinib and subsequently obtains marketing approval. Interestingly BMS cannot stop or sue any of generic company till they launch their generic product in the market.
Now Cipla launches generic Dasatinib in June 2009 and consequently sued by BMS for patent infringement in the Delhi High Court. Now what should be the minimum time period we can expect judgment from the High Court? Let us be too positive to consider such period be around two years. If Cipla wins case then obviously there will be no issue and all other generic companies will be free to enter market without risk. But let us consider judgment is delivered after two years (June 2011) and goes in favor of BMS. Now Hetero launches its generic Dasatinib in August 2011 soon after BMS-Cipla case and sued by BMS for patent infringement. Again let us consider the judgment is made in favor of BMS after two years of court proceedings (around September 2013) and Hetero is prevented for selling generic Dasatinib. Even after BMS wins case each against Cipla and Hetero it doesn’t mean that other companies may not launch their generic launch. Suppose after few months of BMS-Hetero case another generic company launches its generic Dasatinib then again BMS will file and litigate the patent infringement suit. The question is how many times BMS need to go to the Court to enforce its patent for Dasatinib against the generic manufacturers having marketing approval for generic Dasatinib? Does it make any sense that BMS keep fighting multiple infringement lawsuits to enforce the same patent and keep losing crucial patent term and money in just fighting back to back litigations? Is such situation not creating liability on patentees? We know reading this case study seems to be little absurd but one cannot really ruled out such possibility of events. What can be the possible solution to avoid such unjust and unfair liability on patentee? Is such situation not likely to create burden for the Courts and judiciary?


  1. Sunil K.10:35 PM

    Varun u do have substance to think differently. Great to have you in IP profession.

  2. Anonymous12:45 PM

    Now this is what is called putting the words into the mouth...

    Varun, great post but instead of harping on multiple patent enforcement suits, had you emphasised on patent quality emnating through the check points provided in the patent system, there would have been some substance. This is just playing in the hands of MNC pharma....Good Luck!!!

  3. Anonymous6:46 PM

    Dear Anon,

    Does not matter on whose side is VC inclined to? If you/anyone else can play in the hands of copy-cats pharma; why can't [according to u] VC play in the hands of MNC pharma??? After all, its all about money, honey. No body does for charity. Even the copycats are not here for charity. They are in the business without any foundation of their own......

    Instead of accusing each other, lets strive to make the patent system in India more systematic, robust, and plug the loopholes [especially 3(d)], which is a nuisance according to me and hinder innovation and progress in technology.

    Few activists/professionals like you, will bark in the out in the name of "access to medicine for the poor" and many other such causes, without bringing out your real greedy intentions/motives.

    Remember one thing, if there is no innovation from the so called MNC pharma, what u people will copy???

    Hence give due credit to these so called MNC pharma....

    Just think abt it.......

  4. VC | Patent Circle7:47 PM

    I am not biased to anyone, just trying to analyze pros and cons of patent-drug regulatory linkage. I am a dedicated patent professional and only biased to innovation and patent system. It is quite fortunate to be in this challenging field but feel sad politics (in the name of public health) taking front seat here also. No idea till how long India will carry the liability of being considered country of poor which is in fact more because of political selfish interest and will.

  5. Seema Singh8:57 PM

    Innovation is the key of development and precisely Patent System is meant to protect it. Surprisingly, it has got an altogether different definition in Indian scenario where level of innovation is limited to successful copying.

    Robust Patent System gives rise to country like Japan, Germany & USA and manipulated Patent system country like India and Pakistan. Bangladesh is still better which knows their original state of technological development & accordingly they have made their laws.

    We are so called developing country [rightly pointed out by Dr. Yusuf K. Hamied, Chairman, Cipla that “Third world countries including India cannot afford Patent monopoly” Link:] Our leaders have already accepted that we are nowhere better than Bangladesh.

    We are trying to portray an image of technically advanced country by amending patent laws and other side our mental frame has not reached to the level of respecting even Product Patent.

    First of all, we need to believe in Patent System.

  6. Kshitij9:32 AM

    Well written post VC. You have genuinely raised a valid issue of patent enforcement and need for patent-drug regulatory linkage. Despite I am not favoring such linkage but the matter of fact is we cannot make mockery of patent system. I agree we do need regulated monitoring to enforce drug patents. May be Dr. Hamied believe India nowhere better than Bangladesh but I differ with that. I m confident many Indian companies are competitive enough to stand global challenges and far better than Cipla.

  7. Anonymous8:43 AM

    @ Seema Singh

    "..... and manipulated Patent system country like India and Pakistan."

    Please elaborate on what is 'manipulated' about Indian Patent System?

  8. Anonymous2:08 PM


    Filing of multiple patent infringement suits cannot be argued as a negative/ problem by the Innovator company.

    In all jurisdictions, a patent holder files his infringement action when he becomes aware of infringement by a Company. If [as in your case] another company comes in much later, then the option is to file another patent infringement suit. The law in other countries also REQUIRES filing of multiple actions - so how is India different?

    Frequently Anon.

  9. It is probably easier to criticize the system. What is important is to critically analyze the shortfalls and come up with solutions. Drafting robust patents is one way, another is making appropriate modifications in the Patents Act.
    I am totally for innovation and all due credit must go to the innovator company for the efforts

    Chitra Iyer

  10. Aliasgar7:02 PM

    Hey Varun,

    The scenario projected by you does sound absurd but as you said, one cannot really rule out the possibility of such events.

    Lets take into account a similar scenario however this time moving away from the pharma domain:
    Imagine...TVS infringing Bajaj's twin spark technology patent, then honda doing the same followed by yamaha and the likes. In pharma, there is a regulatory check point which is the topic of debate here, however, in cases of patent belonging to mechanical and non pharma domains where there are no regulatory check points how can one tackle the issue of multiple back to back infringement suits? This issue is not India centric, a similar situation can also arise in UK as well US for non pharma patents.