Abbott’s "Humira" Patent Unilaterally Revoked by Indian Patent Office

In a rather bizarre incident, the Indian Patent Office (IPO) granted a patent to Abbott Laboratories relating to Humira, its best selling biologic meant to cure severe forms of arthritis. And then proceeded to revoke it a month later on its own accord!
On receiving the rather pithy “cancellation” order from the IPO, a visibly shaken Abbott approached the Delhi High Court. Justice Muralidhar promptly stayed this unusual action by the IPO and issued a notice to it, returnable by the 27th of April. (the judges’ order is dated 22nd Jan, 2009).

It turns out that a not so diligent Controller at the Delhi Patent Office had granted the patent without taking into consideration a pre-grant opposition filed by Glenmark. When this was pointed out by an upset Glenmark, the said Controller, in a bid to cover up her mistake, proceeded to take the law into her own hands and issued a “cancellation” order to Abbott.

Abbott’s petition before the Delhi High court alleges that the patent office has no power under the Indian Patents Act to unilaterally revoke/cancel a granted patent. The only power of revocation vests with the IPAB and the High Court (as a counterclaim). Further, a Controller may review his/her own order, but this has to be done at the instance of a petition filed by an interested party.

Abbott then proceeded to argue that the only remedy in such an unusual situation is for Glenmark to file a post grant opposition. They cite the Supreme Court order in the Valcyte case which had ruled on similar lines, asking an aggrieved patient group that was denied the right to hearing at the pre-grant stage to take up their grievance as a post grant opposition.

From the facts, it would appear that there is no “foul” play here. Rather, the Controller appears to have taken this decision on her own accord without consulting her superiors. Her blatant ignorance of the law may perhaps make out a case for ramping up legal training at the IPO.

It might also make out a case for subjecting entry level patent examiners to the patent agent exam, in order to test their proficiency with basic legal principles.

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13 thoughts on “Abbott’s "Humira" Patent Unilaterally Revoked by Indian Patent Office”

  1. Hey Shamnad,

    The Controller could have salvaged the situation by adopting the procedure under section 78, rather than ‘cancelling’ the patent. Section 78 allows the Controller to suo moto correct any clerical error in any matter entered in the register. As the grant of a patent being a matter entered in the register, the Controller could have taken a less controversial course of ‘giving notice of proposal’ to correct the register [under section 78(3)] informing the patentee that the patent was wrongly/accidentally/inadvertently (whatever) entered into the register as granted, an error which overlooks the mandate of section 43. Section 43 states that the application can be granted only if it is not refused by virtue of the power vested in her by the Act. As we know, the earlier version of section 43 specifically mentioned “the application has been opposed and the opposition has been finally decided in favour of the applicant”. This is now compressed into the phrase “application has not been refused… by virtue of the power vested in him”.

    Had this course been followed, the Controller could have heard the patentee’s grievance and could have also explained the patentee about the pending opposition. As the law does not permit the grant of a patent while a pre-grant opposition is pending, the Controller would have been in a different situation altogether.

    I second your thoughts on the importance of testing their proficiency on basic legal principles.

    1. Sir, the link for the order provided below is inaccessible as the link is down. I can’t find this order of Justice Muralidhar anywhere
      Is there anywhere/anyway I can access it? Really need it for a case

  2. Thanks Feroz,

    Your idea is a good one. But would the grant of a patent without considering a pre-grant amount to a “clerical error”?

    Wouldn’t it be better to ask the Controller for a “review” of the decision under section 77(f)? For the scope of review under this provision is rather wide and not just limited to “clerical errors”.

  3. Shamnad, I don’t see a one-step solution out of this situation. The Controller can review under section 77(1)(f) only on an applicaton made to her. Who will make such an application in this case? Certainly not the patentee. There is no suo moto review power under the Act. Remember we are trying to salvage something that has gone horribly wrong. So we many not have perfect answers.

    The first step would be to show that there has been a ‘clerical error’ in entering the patent in the register as granted. I am told that the patent office has some technology (software) which alerts any grant that is made overlooking a pending opposition. I am not sure why that did not come to help here.

    The second step will be to hear the applicant (who is now the ‘patentee’) and inform the patentee that pursuant to correcting the clerical error, we may have to set right the procedure and hear the opposition at the earliest.

  4. Feroz,

    Glenmark would have to make it. As my blog post states, the IPO found out about this error only after Glenmark pointed it out. Asking Glenmark to file an application for review would not have been that difficult, I think.

    You’re right that this is an extra ordinary situation and we may not have perfect answers.

  5. Any intimation (even in form of a letter) in such a case from Glenmark should be considered and deemed as an application for review of the Controller’s decision.. Ultimately an interested party despite filing its pre-grant opposition in time should not suffer because of error/ommission on the part of an official at IPO….We can not ignore the commercial interested involved…. we can opt for deeming provision in such extra-ordinary circumstances…

  6. shamnad n feroze,
    i wud refrain from responding to the main issues in this post, as they r mostly matters of personal legal opinion. however, i am responding to put the record straight regarding the reference to valcyte case. since i was involved (on behalf of roche) therein, i can say that valcyte judgment was, largely, neither the result of any merit-based argument/analysis of the case, nor was it a very reasoned order. so, it shud not b acting as precedence.
    -aditya kant

  7. The passing of orders by the Registrar without considering the requests made by either of the party/ clearing the interlocutory petition happens pretty often in the Trademarks department as well. And every time it is the party against whom the unfair, unjust and unreasonable order is passed who is aggrieved because there seems to be literally no way out other than to shell the extra money either on a review petition/ appeal. It is high time the Acts are reviewed and amended to make provisions in favour of the aggrieved under such situations. Unwarranted expenditure to the aggrieved for no fault of his is preposterous. JUSTICE PLEASE !!!!!

  8. i am not sure how testing for legal skills at the entry level will help , rather legal training after joining will be very helpfull.if you test at the entry level , you risk loosing the merit, afterall you cannot expect an engineer or science post graduate to be legally knowledgable.morever even if you wish to test the jobs of examiner and attorney are different.afterall an examiner doesnt need to know about claim drafting ,or drafting a petition.

  9. Hi Shamnad,

    Thanks for this informative post.
    What is the status of this patent now? Where can I search this information. The given link for the order is dead now.

    Thanks in advance.

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