Patent

Breaking News: Natco Withdraws "Doha" Compulsory Licence Application


SpicyIP has reason to believe that the Natco compulsory licensing application in respect of Roche’s “Tarceva” and Pfizer’s “Sutent” has been withdrawn. Apparently, Natco sent a letter to the patent office, requesting that its application be treated as withdrawn. We’ll confirm this news soon. Natco’s decision to withdraw may have stemmed from a fear that it would lose on merits.

For our earlier posts on India’s first “Doha” compulsory licensing application, see here. In short, the dispute revolves around a “Doha style” compulsory licensing application filed by Natco who argued that in view of a public health problem in Nepal, it ought to be granted a compulsory license to export generic copies of Pfizer’s patented anti cancer drug, Sutent (and Roche’s patented drug, Tarceva) to Nepal.

In our latest post, we discuss the patent office decision in favour of Pfizer and Roche’s right to be heard and state:

“It is important to note that this is not a decision on the main merits of the dispute. Rather, it is on whether or not the patentee, Pfizer has the right to be be heard. In a well reasoned judgment running into 13 odd pages, the Assistant Controller of Patents, Hardev Karar (who we predicted in our earlier post would render a “well reasoned” decision) ruled that Pfizer has the right to be heard….

From a close reading of the judgment, it appears that part of the reason underlying the patent office decision to grant such a right to be heard stems from the various “deficiencies” in Natco’s application. The decision notes:

“In the instant case, the documents submitted by the applicant are not admissible because of the following reasons:

i) The letter issued by the government of Nepal, said to be permission for importation of patented pharmaceutical product is not in the language as recognised by Indian patent rules. Therefore, this letter cannot be considered as permission for import by Nepal government.

ii) The requirement for the importation of the patented drug from India has not been notified to the TRIPS Council by the Govt of Nepal.

iii) Rule 96 requires the applicant to set out the terms and conditions of the licence which he is willing to accept. The applicant has not complied with this requirement.”

No doubt, the above statements ought to have been made during the final disposal of the case and not at this stage, which was confined to adjudging whether or not the patentee has a right to be heard. However, these statements indicate that the patent office was concerned that the Doha CL process ought not to be abused by generic manufacturers that wished to make a quick buck. Therefore, the best way to ensure this was to hear the other side as well .”

Natco’s decision to withdraw its application may have stemmed from a fear that it would lose on merits.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

5 comments.

  1. AvatarAnonymous

    Shamnad,

    I think the main reason [as you pointed out] is that Nepal Govt’ letter would NOT qualify as a CL.

    The letter was never a CL in first place!

    Regards,
    Frequently Anon.

    Reply
  2. AvatarDivya aka Divs

    Dear Shamnad,

    I haven’t had an opportunity to look at the order and sources such as Spicy IP have been my link to Natco’s application.

    As regards the non-fulfilment of the requisite documents, shouldn’t these have been ordered to be complied with, even before looking into whether Pfizer could be party to the hearings? Points (i) and (ii) are in the nature of non-fulfilment of pre-requisites..which could have been fulfilled/rectified.. and Rule 96 viz. terms and conditions of the license would bring Pfizer’ interest in purview. Another source also vehemently states that deciding royalty and remuneration was the guiding light behind inviting Pfizer to the hearing.In such a scenario, had i been a deciding authority, perhaps fulfilling the pre-requisites would have been on top of my agenda.

    Had this been ordered.. I THINK the withdrawal MIGHT just have come in a bit earlier. Watsay? I hope am not missing any crucial points!

    Regards,

    Reply
  3. AvatarShamnad Basheer

    Dear Frequently Anon,

    Thanks for comment. You’re right–the application was flawed right from the start. I wonder why they even tried, when they knew that a critical component (permission from the Nepal government) was missing.

    Reply
  4. AvatarShamnad Basheer

    Dear Divya,

    Thanks for your comment. You’re right–as I mentioned in my reply to frequently anon, the application was doomed to fail right from the start. I really wonder why they even bothered–perhaps private consignments shipped to Nepal were caught on the way and this was the only way to regularise/legalise it. Its speculative–but the only way to explain how a savvy player like Natco botches up such an important case.

    The patent office can only examine merits after they’ve dealt with interim applications. And I guess they had to deal with Natco’s interim application (to not hear Pfizer) first before venturing into merits.

    Reply
  5. AvatarDivya

    Dear Shamnad,

    Yes am with you on the interim application bit. But now that Natco has withdrawn its Application, your speculation seems quite a realistic possibility…

    regards,

    Divya

    Reply

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