PHARMA LOBBY WANTS A PROBE INTO DELAYED ORDERS


Mint recently reported that the Indian Pharmaceutical Alliance (IPA) sent a letter [on 17 March 2009] to P.H. Kurian [Controller General of Patents, Designs and Trademarks], T.C. James [Director, Department of Industrial Policies and Promotion] and the Union Government Body that oversees the country’s patent enforcement regulations, asking for a probe be conducted to examine the delay in deciding patent opposition cases.


The alliance, which represents India’s top pharmaceutical companies, including Ranbaxy Laboratories Ltd, Dr Reddys Laboratories Ltd and Sun Pharmaceutical Industries Ltd., alleges corruption on behalf of the patent officials and claims that [pre–grant] patent opposition proceedings and the related law is being misused by department officials and that the guilty officials should be penalized.


It is interesting to note the in the article the author states that the delay in pre-grant opposition proceedings, heard by the Patent Office officials, benefits the opposing party as they can either keep the genuine patent applicants from commercializing their products or they can sell their own generic versions till a final decision is made. On the contrary, a delay in deciding on a post-grant opposition case results in a patent holder enjoying a continued monopoly in the market even if its patent rights are under question. Since the opposing party cannot exploit the market in the latter case, the pre-grant opposition proceedings are more lucrative from a commercial standpoint. Thus, as alleged, eyeing this benefit, several companies are taking undue advantage of the pre-grant opposition proceedings. If this were the logic behind companies causing and supporting delay in pre-grant opposition cases then IPA’s demand for a probe into the delay is quite interesting and surprising, since they themselves are opposing parties in several proceedings before the Patent Offices.


The letter closely follows the dicta of P. H. Kurian, who after taking charge in January, had issued an internal circular urging the heads of the four regional patent offices in Kolkata, New Delhi, Mumbai and Chennai to issue final orders by 31 March in some 600 patent and trademark opposition cases. Some of these cases have been pending for three years.


As per the report, Kurian and James could not be reached for comment.


It is pertinent to note that apart from the above-mentioned demand for a probe examining the delay, earlier this month, the IPA had asked the Union government to re-examine 86 drug patents granted between 2006 and 2008, the first three years of India’s new product patent regime for the drugs and agriculture sector. The body said 67 of these 86 patents were in violation of section 3(D) of the 2005 amended Indian patent law, and the remaining 19 were against section 3(E) of the new law.


Section 3(D) of the Indian patent law doesn’t permit patent grants for mere modifications of known drugs unless they can claim a significant enhancement of therapeutic efficacy compared with the previously known base product. And as per section 3(E), mere combinations of two or more known drugs don’t qualify for patent rights in India.


One has to wait and watch as to where this leads.


4 comments.

  1. AvatarAnonymous

    The reason for the delay in issuing decision/orders after opposition cases is simple. Controllers do not want to expose their inadequacies and hence sleep on the file.As per the Patent Act,after a hearing on an opposition case only the Controller can decide the final outcome of a case and issue a judgment.Therefore it is evident that such unwarranted delays are the sole responsibility of the controllers. In some cases, as rightly pointed out in the article, there might be a collusion with the interested party to deliberately delay issuing a decision thereby enabling the patent holder to enjoy monopoly and earn some more. Of course he may share this booty with the concerned controller.A feasible solution would be to form a team of dedicated Controllers to handle and dispose off such cases immediately.Being an outsider it might take some time for the new Controller General to learn the tricks of the trade and deal with them. But it seems he is taking the right steps in this regard.

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  2. AvatarAnonymous

    Too many cooks spoil the broth.
    There is no provision in the Indian patent act to re-examine granted cases. Such an activity will stretch the thin resources of the patent office, which is already straining under a huge shortage of examiners, further. why can’t the IPA opt for revocation procedures? They can suggest amendments to the patent act in parliament.they can also suggest clarifications and improvements to the patent examination manual being finalized by the patent office.
    If we go about reexamining granted cases, Indian patent office would become the laughing stock among all other patent offices in the world.

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  3. AvatarIndian Patent Agent

    Now look who is trying to act Savior of the Patent System. Pharma lobby !! (read Generic Pharma lobby).

    I had emailed Shamnad pointing out the existence of the circular dated 17th February http://ipindia.nic.in/whats_new/circular_18February2009.htm and asking him to blog on this issue and acknowledge this positive effort by the Patent office and the transparency of the office for which this blog has been aiming at for a long time- unfortunately, I think his busy schedule has kept him off from this.

    Who Benefits from delay?

    Filing oppositions is a well known strategy used by opponents for delay the grant of a Patent and this is acknowledged in all jurisdiction and denial of such knowledge of this would be false.

    Let me remind readers that in case of a pre-grant opposition the window period for such opposition is open till grant. So an opponent can file any number of oppositions just to delay the grant. This is used to the best extent by the opponent. So legally he can file an opposition and if after the hearing the balance of favor lies with the patentee, file another opposition right after the hearing. So it is possible to extent this for as long as the opponent wants and that too legally.

    Even after grant, if the patentee wishes to enforce his patent and file an infringement suit, the case would be dependent on the outcome of the post-grant opposition if pending and will not proceed at the court until the oppositions proceeding is complete (Roche vs Cipla/NGO).

    Therefore an applicant/patentee would not be able to have any monopoly of the Patent until all the Opposition proceeding are complete. Whereas the opponent has nothing to loose, further there is no fees for pre-grant opposition.

    But it is surprising that of all, the Generic pharma lobby writes such letter. I do not find any bonafide intentions here! This looks like trying to pass the blame on to others and trying to come out clean. What all people do to get public attention, after all they need this to show public that they are the saviors and can use the Public Interest issue to their benifit. Election fever is catching up makes people do all crazy things for attention.

    Let common sense prevail.

    Patently Yours

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  4. AvatarAnonymous

    The reason for the delay in issuing decision only one they dont want to do any work blaming others. Now a days every one wants every thing without any efforts same in patent office and trade mark office, they put their responsibilities to others.

    If the people understand their duty or responsiblities, we will never face this type of situation.

    Please read and try to understand its reality whether you are in office, home or else where.

    Reply

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