Cipla Withdraws Revocation Plea for Novartis’ Onbrez Patents, Informs DIPP in an RTI Reply

OnbrezMany of our readers may have been wondering about the status of the application that Cipla made to DIPP in October 2014 for revocation of Novartis’ patents for the drug Onbrez. DIPP’s recent reply to an RTI application (RTI) has put an end to this wondering. Mr. Pradeep Kumar, who filed about 27 RTIs between October 2014 and June 2016 seeking the status of this application, was informed by the DIPP on June 13 that the application had been withdrawn by Cipla. The matter has since been treated as closed.

Cipla’s application for revocation

On October 21, 2014 Cipla had made a representation to DIPP seeking revocation of five patents granted to Novartis for the respiratory drug ‘Indacaterol’ (brand name: Onbrez), along with launching a cheaper generic version of it (covered here). This plea had been made under section 66 (revocation in public interest) read with section 92(3)(ii) (compulsory license in case of extreme urgency) of the Patents Act (it is perplexing why section 92 was sought to be invoked when the request seemed only for revocation). Cipla argued that Novartis had exercised its patent in a manner prejudicial to public interest and mischievous to the State by “not making available to the public, adequate quantities of the drug at reasonable prices for the patients in India for a disease [Chronic Obstructive Pulmonary Disease] which is prevalent in epidemic proportions”. It stated that Novartis was not manufacturing the drug in India and importing only a small quantity of it, which fulfilled only 0.03% of the requirement of the drug in India. It further noted that it sold the drug at a more affordable price of Rs. 300 a month as opposed to Rs. 2,000 a month charged by Novartis.

Comments by the Health Ministry

After receiving the representation, DIPP had written to the Health Ministry (MoH), Department of Pharmaceuticals (DoP), Department of Health Research (DHR) and Indian Council of Medical Research (ICMR) for their inputs/comments on it. MoH was requested to give its views on the following three points to help DIPP decide if it was a fit case for grant of compulsory license (CL) under section 92: (i) whether the circumstances of national emergency, extreme urgency or a case of public non-commercial use existed in India in respect to COPD and the drug ‘Indacaterol’, (ii) whether this drug was the only drug preferred for treatment of COPD and (iii) whether MoH provided this drug under its Health Programmes for COPD treatment. These questions reflect that DIPP took Cipla’s application to be for CL instead of that for revocation of the patents. Although Cipla had strangely sought to invoke section 92 along with section 66 and had also mentioned that the condition of circumstances of extreme urgency had been fulfilled, its prayer throughout seemed only for revocation and not CL.

The Times of India on December 15, 2014 had reported that MoH had found no merit in Cipla’s arguments for a licence under section 92 and had suggested that “if at all there is an argument for a compulsory licence, it should be considered under section 84” (covered here). However, a contradictory report in the Hindu stated that MoH had recommended that “the patent be revoked and a compulsory licence issued to Cipla” (both of which are not possible together). From the RTIs it seems that neither of the reports was completely true. In its reply to an RTI seeking confirmation of the ToI report, DIPP stated that MOH’s suggestion referred to in the RTI was not available with it. And in response to another one it informed that MoH in its reply sent to DIPP (after a reminder) had stated that “from a public point of view MoH supports DIPP in its efforts to find out a way that may lead to issuance of CL and consequent decline in the price of subject drugs”. The DIPP found this comment to be vague and requested MoH to furnish specific comments on the questions asked.

Infringement suit against Cipla

Soon after MoH’s reply to DIPP, Novartis sued Cipla before the Delhi High Court for infringing its Onbrez patents by launching its generic version (covered here). This, according to the Hindu report, had left DIPP wondering “whether…[it] could indeed move on revocation, with the case going on in court”. But the Delhi HC, in its order granting temporary injunction against Cipla in January 2015 (covered here), clarified that the grounds for CL or revocation (under section 66) could not be raised as defences in an infringement suit and could be urged only before the relevant authority. It also stated that if CL is granted by the competent authority, Cipla could apply to the court for modification/vacation of the injunction.  While the request for revocation was pending before the DIPP, in May 2015, Cipla interestingly offered to pay reasonable royalty to Novartis if it was permitted to continue manufacture of the drug, during the hearings of the cross-appeals filed against the interim injunction order. However, Novartis was reported to have rejected the offer and the matter seems to be still pending before the court.

Final comments by MoH, DoP and ICMR

During the same month, MoH sent its revised comments to DIPP (after about three reminders from DIPP). After consultation with the DCGI and NHSRC, it was of the opinion that there was no case for extreme urgency or national emergency and thus couldn’t lend support to Cipla’s plea under section 92. DoP sent its reply to DIPP only in November 2015 (after about 10 reminders), suggesting it to ask Novartis to justify why it was selling the drug at Rs. 2,000 a month as against Rs. 399 by Cipla. It referred to section 83(g) of the Patents Act that states “that patents are granted to make the benefit of the patented invention available at reasonably affordable price”. However, DIPP didn’t pay heed to this recommendation. Every time it was asked in the RTIs as to when it planned to approach Novartis as per DoP’s recommendation, it evaded the question by stating that it did not fall under the definition of ‘information’ under the RTI Act. Citing the same reason, the question related to its proposed course of action on MoH’s recommendation was also evaded. Apart from MoH and DoP, ICMR had also sent its reply to DIPP in April, 2015, but its content is not known. While DoH never sent one.

Inaction by DIPP and Withdrawal of revocation plea  

Even after receiving feedback from these bodies, it is surprising to note that, DIPP neither ever took any action/steps nor held any meetings/ discussions/ deliberations (internal or external) to discuss the matter though it simultaneously kept saying that the matter is under process. Finally, on June 13, in its reply to an RTI, it disclosed that Cipla has withdrawn its representation for revocation of Novartis’s Onbrez patents and thus the matter had been considered as closed. The date of withdrawal was not mentioned nor could I find any news report on this withdrawal. But it seems to have been made between May 3 and June 13 because in its reply dated May 3, DIPP had stated the matter was under process.

Trajectory of Cipla’s application

By the time Cipla withdrew its representation, more than one and a half years had lapsed from the time it had submitted it. The trajectory of this matter as culled out from the 27 RTIs filed by Mr. Pradeep Kumar and DIPP’s replies to them is noted below. This may give a clearer picture of the delays and inaction on part of the DIPP and other bodies who were asked for their inputs/comments.

  • October 21, 2014 – Cipla made a representation to DIPP for revocation of 5 patents held by Novartis for Onbrez
  • October 27, 2014 – DIPP received the representation
  • November 5, 2014 – DIPP requested MOH for inputs/comments
  • November 7, 2014 – DIPP requested DoP, DHR and ICMR for inputs/comments
  • November 17, 2014 – DIPP sent reminders to MoH & DoP
  • December 11, 2014 – MoH sent its reply
  • December 15, 2014 – ToI reported that MoH declined Cipla’s plea
  • December 22, 2014 – DIPP asked MoH for more specific comments
  • January 15, 2015 – DIPP sent a reminder to MoH & DoP
  • January 28, 2015 – DIPP stated that MOH’s suggestion referred to in ToI report is not available with it
  • March 18 & April 7, 2015 – DIPP sent reminders to MoH & DoP
  • April 22, 2015 – ICMR sent its reply to DIPP
  • May 5, 2015 – MoH sent revised comments to DIPP refusing to support Cipla’s plea
  • May 21, July 10, August 6, September 2, September, 24 & October 9, 2015 – DIPP sent reminders to DoP
  • October 26, 2015 – DoP sent interim reply stating that matter was under consideration and comments will be forwaded to DIPP in the first half of November
  • November 7, 2015 – DoP prepared comments to be sent to DIPP
  • November 24, 2015 – DoP sent comments to DIPP suggesting it to ask Novartis to justify its price of Rs. 2000 per month as against Rs. 390 by Cipla
  • Till May 3, 2016 (at least) – DIPP didn’t hold any meetings/discussion/deliberations on the matter nor approached Novartis, but kept saying that matter under process
  • June 13, 2016 – DIPP in its RTI reply disclosed that Cipla has withdrawn its representation and thus matter has been treated as closed

Questions raised

  • Why did DIPP take so long in deciding on the matter and why didn’t it conduct any meetings etc. nor approached Novartis as recommended by DoP?
  • Shouldn’t such decisions that may have a huge impact on public health be decided at the earliest?
  • Shouldn’t there be a time limit imposed on the Central Government under the Act/Rules for such decisions to be taken?
  • Why did the other bodies like MoH and DoP take so much time to send their inputs/comments and had to be given several reminders?
  • Shouldn’t all the documents pertaining to the matter like recommendations by MoH, DoP etc. be uploaded on the website for public viewing?

Did Cipla opt for the right route?

As noted in an earlier post on this matter as well as the Delhi HC’s temporary injunction order, Cipla’s arguments for revocation based on the availability, affordability and local working of the drug seemed more in the nature of arguments for a CL under section 84. However, Cipla could not have made an application under section 84 because it never approached Novartis for a voluntary license (a pre-condition to grant of CL under section 84). Nonetheless, was section 66 the right route to take? As noted in the same post, Cipla’s case for revocation under section 66 was very weak. It was highly unlikely that the lack of sufficient availability, unaffordable pricing and non-working of the drug would have been construed as being ‘mischievous to state’ or ‘generally prejudicial to the public’. May be it’s this realization that led Cipla to withdraw its representation. But we still wonder why a legally savvy company like Cipla opted for the section 66 route in the first place.

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