Patent

The Dasatinib compulsory license conundrum


The anticancer meds “nibs” (including Imatinib, Sunitinib, and Dasatinib) have always been mired in controversy. Recently Dasatinib made news when the economic times reported that “The Indian Patent Office has rejected Mumbai-based BDR Pharmaceutical’s application for compulsory licence on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb, the patent holder for the drug.” This post aims to explore whether the CL application has indeed been rejected.

Image from here

CL application by BDR u/s 84 – The patent office decision

Earlier around March this year, BDR had made an application for compulsory license of Dasatinib. Readers may recall that Shamnad had extensively covered this development in his post here. Prashant had captured subsequent developments  in his post here.

Quick review of the timeline of events:

  • On May 04, 2013, BDR received a notice from the patent office intimating that a prima facie case for CL u/s 84 has not been made. 
  • Then on May 13, BDR requested hearing in accordance with Rue 97(1). 
  • A notice for hearing was issued by patent office on May 23. On May 23 BDR also filed a petition under 137 for condonation of delay in complying with prima facie case requirements.
  • Subsequently on June 24, BDR submitted “written submissions” 
  • On July 10, correspondences indicating related to Voluntary license of Dasatinib was submitted to the patent office.
  • On July 15, BDR filed another petition to condone delay in complying with procedural formalities and requested that the evidence regarding voluntary license be taken on record. They also requested a hearing regarding this.

Rule 97 of the patent act states “When a prima facie case is not made out.- 

(1) If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order under any of the sections referred to in rule 96, he shall notify the applicant accordingly, and unless the applicant requests to be heard in the matter, within one month from the date of such notification, the Controller shall refuse the application.”

(2) If the applicant requests for a hearing within the time allowed under subrule (1), the Controller shall, after giving the applicant an opportunity of being heard, determine whether the application may be proceeded with or whether it shall be refused.

At this stage, the hearing on whether a prima facie case has been made is still pending at the patent office. The patent office will conclusively determine whether the CL application is accepted or refused based on the hearing. Obviously the  affidavit which suggests that the CL application has been rejected is erroneous. As the TOI reports, a final decision regarding the CL u/s 84 is expected on Sept 16.

What about CL u/s 92?

Meanwhile the Govt is planning to issue a compulsory license (under Section 92) to Natco and BDR as reported by Times of India over here. Dasatinib was one of three drugs selected by Govt for Compulsory license under Section 92 route (we had blogged about it over here and here). 
Does the controller have discretionary power in case of CL u/s 92?
Section 92 (1) (i) the patents act provides that “the Controller shall on application made at any time after the notification by any person interested grant to the applicant a licence under the patent on such terms and conditions as he thinks fit
So unlike a CL u/s 84, in case of CL u/s 92 it is necessary for the Controller to grant a CL after the Central Govt notification and upon application by an interested person. I don’t think the Controller has power to exercise his discretion, although the terms and condition of the license may be decided by him.
It would be interesting to see which route is finally adopted for Compulsory license of Dasatinib. We will keep you posted!

Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

7 comments.

  1. AvatarAnonymous

    Dear Madhulika:

    Look at the dichotomy in the ToI report v/s Economic Times. I think that the earlier ET person completely messed the reporting. I am pointing this out since I think your reporting is on the correct track 🙂 {and so is the later ToI report).

    Freq. Anon.

    Reply
  2. AvatarAnonymous

    Madhulika – The Controller will still have a discretion due to Section 92(2). The only exceptions that exist where there is no discretion are contained in 92(3) – which requires that there first be a declaration of an epidemic, or a public health crisis relating to AIDS, HIV, TB, malaria etc. While 92(3) uses the term ‘including’ it is presumptive that there first be a finding of a public health crisis.

    Secondly, the entire tenor of Sec 92 is less to do with the working of the patent. Even if a licence is granted under Sec 92, it would presumably only be for non-commercial public use, quite unlike Sec. 84 which covers commercial use as well.

    Regards,

    GN

    Reply
  3. AvatarMadhulika Vishwanathan

    Dear GN,

    Section 92(1) (i) “the Controller shall on application”; I interpreted shall to mean must . But yes you are right, when read along with Section 92(2) it does suggest that the Controller has discretionary power. But the extent of discretion is not as much as is afforded by CL u/s 84 … in the sense of prima facie case determination …

    Regarding your second point, I never suggested anything to the contrary. In fact my previous post on this quite clearly mentions notification for CL u/s 92 would be for public non-commercial use.

    Best,
    Madhulika

    Reply
  4. AvatarAnonymous

    ET messed up because they relied on an incorrect affidavit. I hope that the Court looks at the Affidavit declarant and hauls them up 🙂

    Freq. Anon.

    Reply
  5. Swaraj Paul BarooahSwaraj Paul Barooah

    Anonymous has sent in this comment:
    But for granting a C/L under 92, isn’t there a requirement of notification by the Central in the official Gazette? Also, I am not sure what the author means when she says ‘It would be interesting to see which route is finally adopted for the Compulsory license of Dasatinib’ Can an application filed under section 84 be approved under section 92 is that what the author means?

    Reply
  6. Avatars.s.saggu

    Dear all Dasatinib cancer drug is important to too many patients in India to save their lives…………..pl. do affordable steps to bring the generic version of the same in INDIA as soon as possible because off higher prices where Indians cannot reach……………

    Reply

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