Facts (with Timeline):

On 4th October, 2013, Novo Nordisk (hereinafter referred to as “Patentee”) was issued patent IN 257402.

On 29th September, 2014, which is five days prior to the expiry of one year from the date of grant, Sun Pharmaceuticals Industries (hereinafter referred to as “Opponent) filed a post-grant opposition to the issued patent IN 257402.

On 21st August, 2019, the Opposition Board provided its recommendation to the learned Controller.

On 25th September, 2019 and 26th September, 2019, the hearing for the post-grant opposition was scheduled. Shortly after this, Patentee filed an affidavit of an independent expert, which was taken on record by the learned Controller. In light of this new evidence (the affidavit of the independent expert), the Controller directed the Opposition Board to provide a new recommendation.

The Patentee had later filed an application seeking to cross-examine the Opponent’s witnesses, however, the Opponent withdrew the affidavits of their witnesses in order to expedite the hearing, and also waived their right to cross-examine the Patentee’s witnesses.

The first writ of petition was filed by the Opponent to request directions to issue a copy of the Opposition Board’s recommendations expeditiously, and for disposing the opposition proceedings of IN 257402 in a timebound manner.

An order was passed on 1st September, 2021, regarding the first writ of petition, requiring that the Opposition Board’s recommendations be provided a week from the date of the order, and the hearing was scheduled for 18th October, 2021.

On 16th February, 2022, the Opposition Board provided its second recommendation (post-filing of affidavit of independent expert). The hearing that was scheduled for 18th October, 2021, did not take place due to unavailability of a hearing officer.

The Patentee being unsatisfied with the Opposition Board’s second recommendation, filed a representation on 13th May, 2022, seeking a revision of the second recommendation of the Opposition Board.

Thereafter, two more writ of petitions were filed – one by the Patentee and one by the Opponent. The Patentee’s writ of petition raised several grounds challenging the Opposition Board’s recommendation. The Opponent’s writ of petition sought an early hearing of the post-grant opposition.

In an order passed on 3rd June, 2022, the Court directed that the representation of the Patentee was to be decided within 2 weeks of the date of the order. With respect to the writ of petition of the Opponent, the hearing was scheduled for 1st July 2022.

Patentee filed another writ of petition requesting that the Patentee’s representation be considered before fixing the hearing date for the post-grant opposition.

The Deputy Controller passed an order considering the representation made by the Patentee and then disposed of it. Subsequently, the Deputy Controller fixed the date for the hearing on 4th July 2022. As the matter regarding the representation had been disposed of, the Patentee withdrew his petition with liberty to take the appropriate remedies available under the law.

Issues:

Issue#1 – Can an opponent make a statement without evidence in a pleading relating to post-grant opposition?

Issue#2 – Can further evidence be filed after the Opposition Board has provided its recommendation and after the hearing for the post-grant opposition has been scheduled?

Issue#3 – Should the report of the Opposition Board’s recommendation be made available to the parties (Patentee and Opponent)?

Issue#4 – Is mere observation of a representation and subsequently scheduling a hearing date considered as a decision on the representation?

Analysis:

Issue#1 – Yes. As the Patentee had submitted that the pleadings in the Opponent’s opposition was not supported by evidence, the Court perused through Rule 57 of the Patents Rules, 2003, and determined that an opponent is not mandated to send any evidence supporting their written statement that sets out the opponent’s nature of interest, the facts upon which the opponent bases his case, and the relief that the opponent is seeking. Rule 57 states, “The opponent shall send a written statement…and evidence, if any,..” wherein the bolded part is construed as not making it mandatory for the opponent to provide this evidence. The Court also found additional support to their finding/position by citing to the following portion of their decision in Pharmacyclics LLC vs. Union of India [W.P.(C) 12105/2019 decided on 20thNovember, 2019], “…The Opponent and the Patentee have adequate freedom to file their initial pleadings and evidence by relying upon all the documents and expert testimonies that they wish to;…”

Issue#2 – No. As the Patentee had filed an affidavit of an independent expert after the Opposition Board had provided its recommendation, the Court looked at the Patents Rules, 2003 and the judgment in Pharmacyclics (supra) to see if this was permissible. As per Rule 60, after the completion of pleadings and documents under Rule 57 to 59, a party (Patentee or Opponent) is permitted to seek leave for filing of further evidence. However, Rule 60 further states that such leave can be sought only prior to the hearing date being fixed. That is, after the Opposition Board has given its recommendation, filing of additional evidence would be permissible in exceptional cases with the leave or direction of the Controller, but in any event, the said filing can be done only prior to the hearing date being fixed under Rule 62. Once the hearing date is fixed, parties are not permitted to seek leave to file further evidence.

That being said, the Court mentioned that under Rule 62(4), five days prior to the hearing date, a party can rely on any publication which may not have been filed earlier, provided that five days’ notice is given to the other party together with details of such publication.

Thus, it would be improper to admit the affidavit of the independent expert into evidence as i) it took place after the Opposition Board’s recommendation and after the fixing for the hearing date of the post-grant opposition; and ii) the affidavit is not a publication.

Issue#3 – Yes. The Patentee submitted that the names of the members constituting the Opposition Board was not known to the Patentee, and that the same was not reflected in the recommendation. The Court looked at Cipla Ltd. v. Union of India and Ors. (2012) 13 SCC 429, to resolve this issue. In Cipla (supra), the Supreme Court said that while the Opposition Board’s recommendation was not binding on the Controller, it still had considerable relevance on a decision taken by the Controller for making a decision on the post-grant opposition. The Supreme Court further went on to note that 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 it can also recommend that the patent shall be granted since the invention has novelty, inventive steps etc. 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. Therefore, despite the Patents Act, 1970 and the Patents Rules, 2003 not casting any obligation on the Controller to make available the report of the recommendation of the Opposition Board, under the principles of natural justice, the report of the recommendation should be made available to the parties before the Controller passes an order under Section 25(4).

The Court here also mentioned that there is no reason as to why the names of the members of the Opposition Board should be redacted or absent from the recommendation. In order to preserve the integrity of the recommendation of the Opposition Board, the Court ordered that the names of the members of the Opposition board should be clearly reflected both on the cover page and on the final page where the members should append their signatures to the recommendation.

Issue#4 – No. For the representation filed by the Patentee on 13th May, 2022, the Deputy Controller had merely observed the documents, and then proceeded to fix the matter for hearing of the post grant opposition on 4th July, 2022.

The Court noted that this decision by the Deputy Controller did not deal with any aspects raised in the representation filed by the Patentee. As the Deputy Controller who rendered the decision on the representation was also going to be the hearing officer, the Court directed that the Deputy Controller should consider the grounds raised in the representation at the time of the final hearing. Therefore, the Deputy Controller was required to provide a comprehensive decision regarding the grounds raised in the representation, and on the merits of the post-grant opposition.

Conclusion:

A patentee or opponent can make a statement in the pleadings relating to the post-grant opposition without providing any evidence for the statement. However, it is unclear regarding whether if there is evidence present to support a statement made by a party, then whether the party making the statement is mandated to provide that evidence.

After the Opposition Board has provides its recommendation and after the Controller has fixed a hearing date, no evidence can be filed then. However, publications may be used for support of a position in the hearing provided that at least 5 days’ notice from the hearing date is provided to the other party.

Parties are entitled to receive the report of the Opposition Board which includes the Opposition Board’s recommendation. Parties are also entitled to know the members of the Opposition Board that provided said recommendation.

If a party has filed an application for a representation, then the grounds raised in the representation should be heard prior to disposing of the representation.

Relevant paragraphs:

“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.”

“23. …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.

“27. …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 non- transparent 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.

Citation: Novo Nordisk As Vs. Union Of India & Ors. (W.P.(C)-IPD 19/2022 & CM 68-69/2022), decided by Delhi High Court on 5th July, 2022 available at: https://www.bananaip.com/wp-content/uploads/2022/07/pms05072022wo192022115437-425005.pdf

This post is brought to you by Mr. Nikhil Radhakrishnan, Patent Associate.


This post is brought to you by BananaIP’s Patent Department.

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