Novo Nordisk A S v. Union of India

9. As per the above order, the Opposition Board’s recommendation had to be circulated within a period of one week. Thereafter, the final hearing of the post-grant opposition had to take place on 18th October, 2021. However, the court is informed that, for various reasons, including non-availability of the hearing officer concerned, the hearing did not take place.

10. The recommendations of the Opposition Board were supplied to the parties after a lapse of about four months i.e., on 16th February, 2022. The Patentee, however, was not satisfied with the said second recommendation of the Opposition Board. Thus, the Patentee filed a representation dated 13th May, 2022 seeking revision of the recommendation of the Opposition Board. Thereafter, two writ petitions came to be filed, being W.P.(C)-IPD 14/2022 titled Sun Pharmaceuticals Industries Ltd. v. Union of India filed by the Opponent and W.P.(C)-IPD 15/2022 titled Novo Nordisk v. Union of India filed by the Patentee. In its writ petition, the Opponent sought early hearing of the post grant opposition. On the other hand, the Patentee raised various grounds challenging the recommendations of the Opposition Board. These writ petitions were disposed of by the Court on 3rd June, 2022 in the following terms: “9. Having heard the learned Senior Counsel and the other learned counsels for the respective parties, the following directions are passed: (a) Representation dated 13.05.2022- filed by the Petitioner in W.P.(C)-IPD 15/2022 shall be decided by the Competent Authority, within a period of two weeks from today. Needless to state the representation shall be decided in accordance with law. (b) Insofar as the post-grant proceedings relating to the patent in W.P.(C)-IPD 14/2022 are concerned, the proceedings shall be held before the Controller on 01.07.2022.”

11. As per the above order, the Patent Office had to decide on the representation dated 13th May, 2022 filed by the Patentee within a period of two weeks. Thereafter, another writ petition being W.P.(C)- IPD 17/2022 titled Novo Nordisk A/S v. Union of India came to be filed by the Patentee on 21st June, 2022 seeking a direction to the Patent Office to decide Patentee’s representation dated 13th May, 2022 before fixing the hearing in the post grant oppositions as per the order dated 3rd June, 2022 passed by the ld. Single Bench in W.P.(C)-IPD 15/2022.

12. Vide the impugned order dated 29th June 2022, the ld. Deputy Controller considered the representation of the Patentee dated 13th May, 2022 and disposed of the same. The hearing in the post grant opposition under Rule 62(1) of the Rules was scheduled by the ld. Deputy Controller vide the same order on 04th July, 2022.

13. In view of the impugned order, passed by the ld. Deputy Controller on the same day, W.P.(C)-IPD 17/2022 was dismissed as withdrawn on 29th June 2022, with liberty to take appropriate remedies as may be available in law. The said order is extracted below:

2. It is submitted on behalf of the counsel for the petitioner that the petitioner got an e-mail by which purportedly the representation of the petitioner has been disposed of.

3. In view of the subsequent events, the petitioner seeks permission to withdraw the present petition with liberty to approach to take appropriate remedy as available in law.

4. The petition is accordingly dismissed as withdrawn with liberty as prayed for.

14. The submission of the Patentee is that the impugned order passed by the ld. Deputy Controller is not a decision/order in the eyes of law as no actual decision has been rendered on the representation of the Patentee. On merits of the recommendation of the Opposition Board, the submission of Mr. Lall, ld. Senior Counsel appearing for the Patentee is six-fold: i) The names of the members constituting the Opposition Board is still not known to the Patentee as the same is not reflected in the document i.e., the recommendation. ii) During the pendency of the post grant opposition, the affidavits filed on behalf of the Opponent were given up as the Patentee had sought cross-examination of the said witnesses. The said affidavits having been given up, the same could not have been relied upon by the Opposition Board in its recommendation. iii) The second recommendation of the Opposition Board dated 16th February, 2022 is almost identical to the first recommendation which was earlier submitted on 21st August, 2019. A tabular chart is referred to establish this allegation. Thus, there has been gross non-application of mind by the Opposition Board in the second round. iv) That the representations, despite the orders passed by the Court, have not been properly decided by the Patent Office and this by itself would be a violation of the principles of natural justice. v) The two affidavits of Mr. John F. Carpenter and Ms. Dorthe Kot Engelund filed on behalf of the Patentee have not been considered by the Opposition Board. vi) The recommendation of the Opposition Board dated 16th February, 2022 referred to an affidavit of Ravindra Agarwal dated 29th September, 2014 whereas no such affidavit has been filed on record.

15. Ld. Senior Counsel relies upon the judgment of the Supreme Court in Cipla Ltd. v. Union of India and Ors. (2012) 13 SCC 429 to argue that principles of natural justice ought to be followed during the proceedings in a post-grant opposition, especially in the proceedings of the Opposition Board. He submits that the recommendation not being made afresh by the Opposition Board would go to the root of the matter. He submits that the second recommendation being verbatim and identical to the first recommendation is contrary to law. Further, the Patent Office has also failed to comply with the orders passed on 3rd June, 2022 as the representation has not been properly decided by the ld. Deputy Controller. It is finally submitted by Mr. Lall that on these grounds, the matter ought to be remitted to the Opposition Board afresh for consideration after also taking into consideration the two affidavits which have been missed out.

16. On the other hand, Mr. Rajshekhar Rao, ld. Senior Counsel appearing for the Opponent submits that the entire effort of the Patentee has been to ensure that the hearing in the post-grant opposition does not take place at all. He relies on the various sequence of events which have taken place to argue that repeatedly, challenges are being filed qua proceedings before the Opposition Board itself so as to ensure that the matter does not come up before the ld. Deputy Controller for final hearing and the Patentee continues to enjoy patent protection. The post grant opposition was filed way back in September, 2014 and despite 8 years having passed by, the opposition continues to remain pending. He further points out that irrespective of whether the Opponent’s evidence is on record or not, the grounds raised in the post grant opposition shall be considered by the Patent Office inasmuch as Rule 57 of the Rules does not mandatorily require filing of evidence. As per the Rules, the Opponent has the option of filing evidence if it chooses to do so. In order to avoid further delay in this matter, the Opponent had given up the evidence by way of affidavits which were filed by it. The Opponent had also given up cross-examination of the Patentee’s witnesses to its detriment only in order to seek expeditious hearing of the post-grant opposition.

17. Mr. Rao, ld. Sr. counsel further submits that the list of dates would show that repeated writ petitions and affidavits have been filed at different stages by the Patentee which is also contrary to the procedure laid down by this Court in Pharmacyclics LLC vs. Union of India [W.P.(C) 12105/2019 decided on 20th November, 2019]. He submits that this is not a fit case for interference under Article 226/227 in view of the fact that the writ petition is nothing but an obstacle to stop the hearing from continuing before the Patent Office which is now scheduled on 20th July, 2022.

18. Mr. Harish V. Shankar, ld. CGSC appearing for the Patent Office submits that the entire procedure being followed by the parties is contrary to the scheme of the Act and the Rules as also the clear dictum of this Court in Pharmacyclics (supra). The parties ought to be made to adhere to the timelines prescribed in the Act and the Rules, failing which, such delays are bound to take place. He submits that the matter is fixed for 20th July, 2022 and the hearing in the post grant opposition ought to be permitted to go on. Analysis and Findings:

19. Heard. The Court has considered the matter and has perused the record. The scheme of filing pleadings, evidence, documents and the manner of hearings to be conducted in a post-grant opposition has been laid down by this Court in detail in the judgment of Pharmacyclics (supra). The relevant portions of the said judgment are set out below:

27. The next window for evidence is provided in view of Rule 62(4) which provides that, five days prior to the hearing, a party can rely upon ‘any publication’ which may have not been filed earlier, provided five days’ notice is given to the other party together with details of such publication.

28. The question that has, therefore, arisen is whether after the completion of the pleadings i.e. Opposition, Patentee’s reply and Opponent’s rejoinder (Rules 57 to 59) along with the evidence thereof, can any party file further evidence or rely on further documents.

29. On an overall reading of the scheme of Rules 55A to 63, it is clear that the Rules contemplate a twostage decision making. Stage one is reference to the Opposition Board of all the pleadings and the evidence. Stage two is decision by the Controller which is to be rendered after receiving the recommendations of the Opposition Board and after affording a hearing, if sought. Thus, at the stage of the Controller taking a decision, the Controller is expected to have all the pleadings, documents and evidence relied upon by the parties and the recommendations made by the Board on the basis of the said material and oral submissions by the parties.

30. Thus, it is clear that under usual circumstances, there should not be any variation between the material being considered by the Opposition Board and the Controller. All the material to be relied upon by the parties ought to be presented to the Opposition Board and thereafter to the Controller.”

20. After laying down the scheme of the Act and the Rules to be followed in post-grant opposition, as set out above, the Court also culled out the general principles to be followed in post-grant oppositions which are extracted below:

21. In the above scheme, there is no scope for parties being given repeated opportunities to file affidavits in evidence, documents, additional documents, etc. The Patent Office and the parties have to strictly adhere by the scheme of the Act and the Rules as the clear legislative scheme is that post-grant oppositions have to be decided in an expeditious manner. Even insofar as the recommendation of the Opposition Board is concerned, Rule 56(4) of the Rules makes it clear that upon the pleadings and evidence, as contemplated in Rules 55 and 57 to 60, being completed, the recommendation of the Board has to be given within three months from the date on which the documents are forwarded.

22. In the present case, the pleadings have been completed way back in

2015. However, due to continuous filing of affidavits, reply evidences, additional documents and miscellaneous petitions by both the parties, the Opposition Board’s first recommendation came only in August, 2019. The said recommendation was also rejected by the Controller who referred the matter to the Opposition Board again for fresh recommendation which was issued on 16th February, 2022 i.e., after a lapse of almost three years. Thus, between 2014 and 2022 i.e., for a period of more than seven years, two Opposition Board recommendations have been given but the final hearing in the post-grant opposition is yet to take place.

23. In addition, there have been six writ petitions, including the present one, filed by both the parties wherein ld. Single Judges of this Court have repeatedly considered the present matter. This is not an acceptable turn of events. Post-grant oppositions are extremely time sensitive which is clear from various provisions of the Act and the Rules which lay down as under: i) The post-grant opposition is to be filed within one year; ii) The pleadings have to be completed within a total period of three months as prescribed in Rules 57 to 60 of the Rules; iii) As per Rule 56(4) of the Rules, the Opposition Board has to submit its recommendations within three months from the date on which the documents are forwarded to it.

24. Thus, from the date of the grant of the patent, the intention of the legislature is to ensure that the post grant opposition is filed within a period of one year and within 12 to 18 months thereafter, the Patent Office ought to endeavour to conclude the proceedings in the post-grant opposition. However, long number of years are taken in post-grant oppositions due to repeated filings by parties and the liberal attitude of the Patent Office. In the opinion of the Court, this state of affairs is contrary to the scheme of the Act and the Rules.

25. It is also the settled legal position that the Opposition Board is to merely give a recommendation to the Controller under Sections 25(3) and 25(4) of the Act. The said recommendation has a persuasive value but the ultimate decision is that of the Controller. The recommendations of the Opposition Board are not binding on the Controller. However, the recommendation of the Opposition Board forms a crucial part of the material to be considered by the Controller. The Supreme Court in Cipla (supra) has held as under: “The aforesaid provisions indicate that the Opposition Board has to conduct an examination of notice of opposition along with the documents filed under Rules 57 to 60 and then to submit a report with reasons on each ground taken in the notice of opposition. The Opposition Board has, therefore, to make recommendation with reasons after examining documents produced by the parties as per Rules. Section 25 (4) of the Act says that on receipt of the recommendation of the Opposition Board and after giving the patentee and the opponent an opportunity of being heard, the Controller shall order either to maintain or to amend or to revoke the patent. The procedure to be followed by the Controller is provided in Rule 62 of the Rules, which reads as follows:”

26. The Supreme Court has also considered the manner in which the powers of the Controller are to be exercised in post-grant opposition proceedings and has laid down as under: “Sub-rule (1) of Rule 62 confers power on the Controller to require members of Opposition Board to be present in the hearing after receiving recommendation of the Opposition Board. The Controller, after hearing the parties if they so desire and after taking into consideration the recommendation of the Opposition Board, has to decide the opposition giving reasons. Provisions of the Act and the Rules, therefore, clearly indicate that the Opposition Board has to make its recommendations after considering the written statement of opposition, reply statement, evidence adduced, by the parties with reasons on each ground taken by the parties. Rule 62 also empowers the Controller to take into consideration the reasons stated by the Opposition Board in its Report. In other words, the Report of The Opposition Board has got considerable relevance while taking a decision by The Controller under Section 25 (4) of the Act read with Rule 62 (5) of the Rules. The Opposition Board in a given case may make recommendation that the patent suffers from serious defects like lack of novelty, lack of inventive steps etc., so also it can recommend that the patent shall be granted since the invention has novelty, inventive steps etc. Such recommendations are made after examining the evidence adduced by the parties before it. Unless the parties are informed of the reasons, for making such recommendations they would not be able to effectively advance their respective contentions before the Controller. Section 25 (3) (b) read with Rule 56 (4) cast no obligation on the Opposition Board to give a copy of the Report to either of the parties. So also no obligation is cast under Section 25(4) or under Rule 62 on the Controller to make available the report of the recommendation of the Opposition Board. But considering the fact that the Report of the Opposition Board can be crucial in the decision making process, while passing order by the Controller under Section 25 (4), principles of natural justice must be read into those provisions of the Report/recommendation of Opposition Board, therefore, should be made available to the parties before the Controller passes orders under Section 25(4) of the Act.”

27. Thus, in terms of the judgment of the Supreme Court in Cipla (supra), the Opposition Board’s recommendation has to be given to the parties. Since the Opposition Board is to be constituted of three members, there is no reason whatsoever as to why the names of members of the Opposition Board should either be masked or missing from the said recommendation. As is seen in the present case, the initial recommendation of the Opposition Board did not contain the names of the members constituting the Board. Their signatures were also not visible in the document. In the final recommendations which are on record, only the name of Chairperson of the Opposition Board has been mentioned. This would be completely nontransparent and would result in proceedings being filed and challenges being made to the recommendation. Moreover, in order to preserve the integrity of the recommendation of the Opposition Board, it is necessary to ensure that the names of the members constituting the Opposition Board are clearly reflected both on the cover page and on the final page where the members should append their signatures to the recommendation. It is, accordingly, directed that henceforth the ld. Controller General of Patents, Designs and Trade Marks (CGPDTM) shall ensure that the names of the members constituting the Opposition Board are clearly mentioned on the cover page and the recommendations are duly signed by the members of the Opposition Board.

28. In the present case, the Court notes that the Opposition Board consisted of three members. Mr. Harish Vaidyanathan, ld. CGSC, has handed over a print out of one file noting which contains the name of the member of Opposition Board in the case at hand. The noting reflects that the Opposition Board consisted of three members, namely, Ms. Sudha Javeri, Chairperson, Mr. Shiv Prakash and Ms. Trishla Verma. Thus, the ground in respect of names of the members of the Opposition Board being not disclosed is dealt with by this Court by setting out the names of the said members. Mr. Harish confirms that the Opposition Board consisted of these three members and they have given the recommendations which are on record.

29. Insofar as another ground raised by Mr. Lall, ld. Sr. Counsel, is concerned i.e., two affidavits of the witnesses of the Patentee, namely, Mr. John F. Carpenter and Ms. Dorthe Kot Engelund not having been considered by the Opposition Board, there is clear mention of these affidavits in the recommendation of the Opposition Board while setting out the sequence of events. However, in the concluding parts of the recommendation, the names of these two witnesses appear to be missing. Be that as it may, since the Opposition Board is conscious of the fact that these two affidavits along with other affidavits, have been filed on behalf of the Patentee, the Opposition Board cannot be directed to give its recommendation afresh. It is open to the ld. Deputy Controller, to consider all the affidavits on behalf of the Patentee and the pleadings of the parties placed on record, including the recommendations of the Opposition Board while taking the final decision in the matter.

30. Insofar as the ground relating to the pleadings in the opposition not being supported by evidence is concerned, on a perusal of Rule 57 of the Rules, it is clear that the Opponent is given the option of filing the evidence and the same is not mandatory. The said Rule is set out below:

31. This position in law is also clear from paragraph 39 of Pharmacyclics (supra) which is extracted below:

32. Insofar as the affidavit of Mr. Ravinder Agarwal dated 29th September, 2014 is concerned which was referred to in the second recommendation of the Opposition Board, it appears that the reference was to the notice of opposition called as the written statement u/s 25(2) of the Act filed by the Opponent itself which was dated 29th September, 2014. It is submitted by the ld. Sr. Counsel for the Opponent that no affidavit on behalf of the Opponent has been filed on the said date. If such an affidavit exists, the Controller shall peruse the record and take a decision in this regard.

33. Now, coming to the decision on the representation dated 29th June 2022 which is impugned in the present petition. A perusal of the directions issued by this Court on 3rd June, 2022, clearly shows that the representation dated 13th May, 2022 of the Patentee was to be considered by the Patent Office. However, vide the impugned order dated 29th June, 2022, the ld. Deputy Controller has merely observed that the earlier documents i.e., three affidavits have been withdrawn by the Opponent and one document, i.e., an affidavit of Prof. Daniel Erik Otzen has been submitted by the Patentee on 12th September, 2019. The ld. Deputy Controller then proceeded to fix the matter for hearing of the post grant opposition on 4th July, 2022. This decision does not deal with any aspects raised in the representation filed on behalf of the Patentee.

34. Since the said decision has been rendered by the Deputy Controller who is herself the hearing officer in the post grant opposition, it is directed that the grounds raised in the representation filed on behalf of the Patentee shall also be considered at the time of final hearing. A comprehensive decision both on the grounds raised in the representation as also on merits of the opposition shall be rendered by the ld. Deputy Controller.

35. The matter is now stated to be fixed on 20th July, 2022 for hearing on the post grant opposition. No further documents, evidence, petitions, etc shall be filed by either party with the Patent Office and the matter shall proceed for final hearing on the said date.

36. Considering the time span that has elapsed in the matter, the decision shall be rendered by the ld. Deputy Controller on or before 30th September,

2022.

37. The writ petition is disposed of in the above terms. All pending applications are also disposed of.

PRATHIBA M. SINGH JUDGE JULY 5, 2022 Rahul/DK/SK