IN THE HIGH COURT OF JUDICATURE AT MADRAS
N.ANAND VENKATESH, J.
Merck Sharp & Dohme B.V., Represented by its Authorized Singnatory - Petitioner
Versus
The Union of India, Represented By Its Secretary, Ministry Of Finance, Department Of Revenue – Respondent
W.P. (IPD) No. 24 of 2025 and W.M.P.(IPD) Nos.19 and 20 of 2025
Decided On : 12-02-2026
| Table of Content |
|---|
| 1. petitioner's grievances regarding delays and oppositions (Para 1 , 3 , 4 , 5) |
| 2. argument on lack of timely action by authorities (Para 6 , 7) |
| 3. respondents' defense of statutory rights (Para 8 , 9 , 10) |
| 4. importance of timely decision-making in patent oppositions (Para 11 , 13 , 14) |
| 5. court's concern about authorities' inaction (Para 12 , 15) |
| 6. court's directions to resolve the application delays (Para 16) |
ORDER :
N.ANAND VENKATESH, J.
This Writ Petition has been filed challenging the impugned notice issued by the 3rd respondent dated 06.09.2024 in respect of the 4th pre-grant opposition and for a consequential direction to the 3rd respondent to decide upon the 1st, 2nd and 3rd pre-grant oppositions filed against the Patent Application No.408/CHENP/2014 in a time-bound manner within the period stipulated by this Court. The petitioner has also sought for a further direction to the 3rd respondent to summarily dismiss every other pre-grant opposition received in the pending application and also to properly apply his mind on Rule 55(3)(b) of the Patents (Amendment) Rules, 2024, whenever a new pre-grant opposition is filed during the pendency of the present Patent Application filed by the petitioner.
2. Heard the learned counsel appearing on either side and perused the materials placed before this Court.
3. The petitioner submitted a Patent Application in Indian Patent Application No.408/CHENP/2014, which claims the compound acalabrutinib, the active ingredient in the pharmaceutical product Calquence. The further case of the petitioner is that the said pharmaceutical product Calquence has been marketed in India since October, 2020 and it is approved for certain cancer treatments.
4. The grievance of the petitioner is that after the present application was published in the Patent Journal as early as on 03.04.2015 and the First Examination Report was issued in 2017, for which the petitioner had filed a response, the 4th respondent came up with a pre-grant opposition on 28.01.2019. Immediately, notice was issued to the petitioner and the petitioner submitted a reply to the pre-grant opposition. Subsequently, hearing notices were issued and the matter was adjourned from time to time till 2022. Thereafter, the 2nd pre-grant opposition was filed by the 5th respondent on 18.04.2022. Notice was issued and the petitioner submitted a reply to the opposition and hearing notices were issued and the matter was adjourned from time to time and the written submissions were ultimately filed on 09.09.2023. By the time the final order was passed, the 3rd pre-grant opposition was filed by the 6th respondent on 02.02.2024. Once again, the 3rd respondent issued notice based on the 3rd pre-grant opposition. On receipt of the same, the petitioner filed a reply and thereafter hearing notices were issued. When this process was going on, the 4th pre-grant opposition was filed by the 7th respondent on 12.07.2024.
5. It is under these circumstances that the petitioner knocked the doors of this Court mainly on the ground that the inaction on the part of the authorities to decide the application based on the oppositions that has already been made, has resulted in one pre-grant opposition after another being filed, and this process has been going on from 2019 onwards. As a result, even if ultimately the petitioner is able to get the patent after rejection of all the oppositions, it can have effect only up to the year 2032, since the petitioner submitted the application during the year 2012. Thus, it is alleged by the petitioner that the petitioner is being denied the advantage of getting patent on account of the filing of one pre-grant opposition after another and the official respondents, without any application of mind are issuing notices in a mechanical fashion. Therefore, the petitioner has sought to challenge the present impugned notice dated 06.09.2024, which was issued pursuant to the 4th pre-grant opposition, under Rule 55(3)(b) of the Patents
AI
The court mandates that patent authorities must timely and thoughtfully resolve pre-grant oppositions to prevent unjust delays in patent applications.
The right to oppose a patent application is a statutory right that must be honored, even if the opposition is not submitted in the correct format.
The main legal point established in the judgment is that amendments made to patent claims at the instance of the Controller, pursuant to the directions of the Controller, do not violate the principle....
Procedural irregularities in patent opposition must respect principles of natural justice, and amendments to patent claims cannot broaden their scope.
Patents Act requires adherence to procedures in post-grant oppositions, emphasizing natural justice and timely resolutions to prevent delays in patent adjudication.
Patent examination under Chapter IV (mandatory Section 14 hearing) and pre-grant opposition under Section 25(1) (Chapter V) are distinct parallel processes; refusal requires Section 14 hearing and Se....
The Controller does not have the power to extend the time for filing a response to the FER under Section 21 of the Act and Rule 24B of the Rules. However, the Court can exercise its writ jurisdiction....
The recommendation of the Opposition Board is not binding, and a writ petition challenging it is not maintainable; objections can be raised during hearings before the Controller.
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