NOVARTIS AG vs NATCO PHARMA LIMITED & ANR.
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Judgment reserved on: 10 October 2023
Written Submissions filed on: 20 October 2023
Judgment pronounced on: 09 January 2024
+ LPA 50/2023
NOVARTIS AG ….. Appellant
Through: Mr. Hemant Singh, Ms. Mamta Rani Jha, Mr. Siddhant Sharma, Mr. Abhay Tandon and Ms. Garima Mehta, Advs.
versus
NATCO PHARMA LIMITED & ANR. ….. Respondents
Through: Mr. J. Sai Deepak, Mr. Guruswamy Nataraj, Mr. Shashikant Yadav and Mr. Rahul Bhujbal, Advs. for R-1.
Mr. Harish Vaidyanathan Shankar, CGSC along with Mr. Srish Kumar Mishra, Mr. Sagar Mehlawat, Mr. Alexander Mathai Paikaday, Mr. M. Sriram and Mr. Krishnan V., Advs. for R-2.
Ms. Rajeshwari H., Mr. Tahir A.J., Ms. Raj Latha Kotni and Mr. Anirudh Ramanathan, Advs. for Interveners- Dr. Charanjit Kumar Sehgal and Dr. Kanchan Kohli.
Mr. Rajiv Nayar, Sr. Adv. with Ms. Bitika Sharma, Ms. Vrinda Pathak, Mr. George Vithayathil and Mr. Manjunathan, Advs. for Intervener- Indian Pharmaceutical Alliance.
CORAM:
HON’BLE MR. JUSTICE YASHWANT VARMA
HONBLE MR. JUSTICE DHARMESH SHARMA
J U D G M E N T
YASHWANT VARMA, J.
S. No.
Particulars
Paragraph Nos.
A.
PREFACE
1-3
B.
ESSENTIAL FACTS
4-10
C.
THE STATUTORY PROVISIONS-PRE AND POST AMENDMENT
11
D.
CONTENTIONS OF NOVARTIS
12-33
E.
NATCOS SUBMISSIONS
34-42
F.
STAND OF INDIAN PHARMACEUTICAL ALLIANCE
43-52
G.
THE OPPOSITION BY DR. KANCHAN KOHLI
53-54
H.
IMPACT OF AMENDED SECTION 57
55-57
I.
THE EXAMINATION PROCESS
58-66
J.
OPPOSITION PROCEEDINGS
67-69
K.
AMENDMENT OF THE PATENT APPLICATION
70-75
L.
FACETS OF PRE GRANT OPPOSITION
76-92
M.
THE HEARING UNDER RULE 55
93-96
N.
THE NATURAL JUSTICE PRINCIPLES
97-100
O.
THE RIGHTS OF AN OPPONENT-A GLOBAL PERSPECTIVE
101-113
P.
THE IMPORT OF SECTION 57
114-117
Q.
BALANCING OF INTERESTS
118-122
R.
THE IMPUGNED JUDGMENT-A BRIEF CRITIQUE
123-127
S.
CONCLUSIONS
128
T.
OPERATIVE DIRECTIONS
129
A. PREFACE
1. The present Letters Patent Appeal raises the important question of the extent of engagement of a pre-grant opponent under the Patents Act, 19701 in the course of proceedings initiated by the Controller requiring the applicant for a patent to amend or modify the application, the complete specifications thereof or any other related document.
2. NATCO Pharma Limited2, the original writ petitioner, had assailed the order of the Controller of Patents3 dated 14 December 2022 in terms of which certain amendments in Indian Patent Application No. IN4145184 filed by the appellant as directed were allowed on the ground that the said order came to be passed without NATCO being afforded an opportunity of hearing.
3. The submission essentially appears to have been that a pre-grant opponent would have the right to represent against both voluntary amendments as well as those that may be directed by the Controller. According to NATCO, the consideration of the application alongside the representations of opposition are not liable to be viewed as operating in separate silos. The proceedings, according to NATCO, clearly merge and thus obligating the Controller to place all pre-grant opponents on notice of any amendments that may be directed by it. It is the aforenoted submissions and the view so canvassed which has been accepted by the learned Single Judge leading to the institution of the present appeal.
B. ESSENTIAL FACTS
4. In order to examine the backdrop in which the matter came to be placed before the learned Single Judge, we deem it opposite to take note of the following important events as set out in the Written Note of Submissions tendered on behalf of the appellant: –
Date
Events
08.11.2006
The subject patent IN518, originated from PCT application no. PCT/US2006/043710 dated 08.11.2006, which was filed as Indian national phase application bearing no. 4412/DELNP/2007 on 08.06.2007 before the Controller of Patents (Respondent No. 2).
24.08.2007
The application was published inviting pre-grant oppositions. The application was examined under Sections 12 and 13 vide a First Examination Report (FER) dated 30.01.2015.
27.05.2016
The Appellant was granted Section 14 hearing on 27.05.2016 vide a Notice of Hearing dated 06.05.2016. However, before any order could be passed by the Controller on the examination and the hearing pursuant thereto, first PGO was filed by Indian Pharmaceutical Alliance (IPA) on 26.05.2016.
06.09.2016
The 2nd PGO was filed by Respondent No. 1 (NATCO).
23.08.2017
The 3rd PGO was filed by Kumar Sushobhan.
13.06.2019
The 4th PGO was filed by Dr. Reddy.
06.12.2019
1st Notice of hearing in relation to 1st to 4th PGO was issued for hearing scheduled on 08th 13th January 2020 [Adjourned at request of one of the opponents].
14.02.2020
2nd Notice of hearing in relation 1st to 4th PGO was issued for hearing scheduled on 16th 19th March 2020.
25.02.2020
5th PGO filed by Hiren Darji [In view of 5th PGO, scheduled hearing of 16th 19th March 2020 was adjourned, and notice dated 26.02.2020 issued on 5th PGO].
17.09.2020
3rd Notice of hearing in relation 1st to 5th PGO was issued for hearing scheduled on 26th 30th October 2020 [adjourned at request of Respondent No. 1 (NATCO)].
18.09.2020
6th PGO filed by G. Srinivasa Rao.
03.02.2021
IPAB vide order dated 03.02.2021 in OA/1/2021/PT/DEL directed Controller to dispose of all the oppositions within three months.
08.04.2021
4th Notice of hearing in relation 1st to 6th PGO was issued for hearing scheduled on 12th 19th May 2021.
07.05.2021
NATCO filed an application requesting cross examination of Novartis experts on their affidavits five days before the scheduled hearing.
12th to 19th May 2021
Hearings held on 1st to 6th PGOs, and order reserved by the Controller.
16.09.2021
Order passed by the Controller rejecting NATCOs request for cross-examination. Writ bearing no. WP (C)-IPD 91/2021 filed by NATCO on 27.09.2021 challenging the said order.
20.05.2022
7th PGO filed by Dr. Charanjit Kumar Sehgal.
12.07.2022
Judgment passed by this Honble Court in NATCOs writ W.P. (C)-IPD 91/2021 granting NATCO permission to file rebuttal evidence and directing Controller to hear NATCO on 05.09.2022 and dispose of all PGOs by 15.11.2022.
26.08.2022
5th Notice of hearing in relation to 7th PGO was issued for hearing scheduled on 07.09.2022.
02.09.2022
8th PGO filed by Dr. Ketakee S. Durvee.
05.09.2022
Second hearing granted to NATCO, and order reserved by the Controller.
07.09.2022
Hearing held in 7th PGO, and order reserved by the Controller.
21.10.2022 & 31.10.2022
6th Notice of hearing in relation to 8th PGO was issued for hearing scheduled on 03.11.2022.
03.11.2022
Hearing held in 8th PGO, and order reserved by the Controller 9th PGO filed by Mrs. Hemavathi R.
04.11.2022
10th PGO filed by Dr. Kanchan Kohli
5. As would be manifest from the seminal events leading up to the grant of the patent, hearing on all Pre-Grant Oppositions5 were concluded on 03 November 2022. The Controller is stated to have framed directions for the appellant to carry out amendments in the patent application in terms of a Notice dated 25 November 2022. The appellant acceded to that directive and submitted amended claims on 05 December 2022. In the hearing which ensued before the Controller, the appellant agreed to amend Claim 4 and reword Claim 5 and consequently the patent came to be granted on 14 December 2022.
6. Apart from the sequence of events which have been alluded to hereinabove, for the completeness of the record we take note of the following additional facts. Aggrieved by the inordinate delay caused in the conclusion of the PGO proceedings and the repeated adjournments which beset the same, the appellant approached the Intellectual Property Appellate Board6 for appropriate directions being issued to the Patent Office for expeditious consideration of its application. The IPAB in terms of an order dated 03 February 2021 directed the Patent Office to take up all objections serially and dispose of the same with expedition. Soon thereafter and more particularly on 07 May 2021, NATCO moved an application seeking an opportunity to cross examine the experts of the appellant whose affidavits were being relied upon in support of the patent application. The Controller without ruling upon the same proceeded to take up the PGOs and commenced a hearing which ensued between 13 to 18 May 2021. This led to NATCO approaching this Court by way of W.P. (C) 5558 of 2021 which came to be disposed of by a learned Single Judge on 27 May 2021 with the following operative directions: –
8. The writ petition is therefore disposed of with the following directions, with the consent of learned counsel:
a) The Controller is directed to dispose of the application dated 07.05.2021 filed by Natco for cross-examination of the expert witnesses cited by Novartis, expeditiously and preferably within two weeks from today. In the event the Controller considers it necessary, further hearing may be granted to the parties for this purpose.
b) In the event the aforesaid application is decided against Natco, the final decision of Novartis patent application not be pronounced for a period of 10 days after communication of the order to Natco.
c) In the event the application is decided in favour of Natco, the matter be fixed for cross examination after hearing learned counsel for the parties with regard to the schedule and modalities for the cross-examination. The Controller will take the submissions into account and pass appropriate orders, in accordance with law.
d) With regard to other pending interlocutory applications referred to by Mr. Grover, I find that the present petition does not concern any other application. However, in order to expedite the final disposal of the patent application, the parties are at liberty to make their submissions before the Controller in this regard, who will pass appropriate orders.
e) After the consideration of the aforesaid application and disposal thereof, the Controller will also endeavour to dispose of the patent application filed by Novartis, as expeditiously as possible and practicable.
f) Learned counsel for the parties assure the Court that their clients will cooperate in the expeditious implementation of the aforesaid directions, and disposal of the proceedings before the Controller.
7. It becomes pertinent to note that at the time when the aforesaid writ petition came to be disposed of, the Controller had not passed any final orders on the patent application or on the PGOs which had been filed. On 16 September 2021, the Controller proceeded to reject the application of NATCO for cross examination. This led to NATCO petitioning this Court again by way of W.P. (C)-IPD 91 of 2021. The said writ petition was disposed of finally on 12 July 2022. While emphasizing on the imperative of the PGO process being concluded systematically and with expedition, the learned Judge observed as under: –
16. Heard ld. counsels for the parties. The chronology of events, in the present writ, clearly shows that the proceedings in the patent application and the pre-grant opposition have been delayed substantially. Blame for the delay cannot be attributed to any one factor or reason, but in the opinion of this Court both parties are to blame. On the one hand, the applicant continues to amend its claims from time to time over a period of five years between 2016 to 2021. On the other hand, the patent application has been exposed to multiple oppositions by several parties due to delay in the examination process. In the opinion of this Court, there ought to be a systematic manner in which proceedings in pre-grant oppositions are conducted. Repeated filing of pre-grant oppositions due to non-existence of any time limits for filing a pre grant opposition and delay in adjudication of one pre-grant opposition, usually results in further pre-grant oppositions being filed leading to further delays in grant of patent. The patent application has the chance of being caught up in the swirl of pre-grant oppositions by Opponents. Amendments by the Applicant who gets wiser with each objection being taken, leads to further delays.
17. It is the settled position in law, as held in M/s UCB Farchim SA v. M/s Cipla Ltd. [W.P.(C) No. 332/2010 order dated 08th February, 2010] that a pre-grant opposition proceeding is in aid of the examination of the patent application. The relevant part of this judgment is set out below:
Distinction between pre-grant and post-grant
opposition
13. In the first instance a distinction has to be drawn
between a pre-grant opposition and a post-grant opposition. While a pre-grant opposition can be filed under Section 25 (1) of the Patents Act at any time after the publication of the patent application but before the grant of a patent, a post-grant opposition under Section 25(2) of the Patents Act has to be filed before the expiry of one year from the date of the publication of the grant of patent. A second significant difference, after the amendment of 2005, is that a pregrant opposition can be filed by any person whereas a post-grant opposition under Section 25(2) can be filed only by any person interested. It may be noticed that the application for revocation of a patent in terms of Section 64 of the Patents Act can also to be filed only by any person interested. In other words, the post-grant opposition and the application for revocation cannot be filed by just about any person who is not shown to be a person who is interested. A third significant difference is that the representation at the stage of pre-grant is considered by the Controller himself. Rule 55 of the Patents Rules requires the Controller to consider the statement and evidence filed by the applicant and thereafter either refuse to
grant the patent or require the complete specification to be amended to his satisfaction. Of course, in that event notice will be given to the applicant for grant of patent who can file his reply and evidence. This Court finds merit in the contention that the pre-grant opposition is in fact in aid of the examination of the patent application by the Controller. The procedure is however different aspect as far as the post-grant opposition is concerned. There in terms of Section 25 (3), the Controller has to constitute an Opposition Board consisting of such officers as he may determine and refer to such Opposition Board the notice of opposition along with other documents for its examination and recommendations. After receiving the recommendations of the Opposition Board, the Controller gives the patentee and the opponent an opportunity of being heard. The Controller then takes a decision to maintain, amend or revoke the patent. The fourth major difference between the pre-grant and the post-grant opposition is that while in terms of Section 117 A an appeal to the IPAB is maintainable against the order of the Controller in a post-grant opposition under Section 25(4) of the Patents Act, an appeal has not been expressly been made available against an order made under Section 25(1) of the Patents Act.
18. The language used in Section 25(1) of the Act is in contrast with the language used in Section 25(2) of the Act. A pre-grant opposition is a `representation by way of opposition in writing by any person. Whereas, Section 25(2) of the Act is a `notice of opposition by any person interested. A Representation under Section 25(1) of the Act does not strictly follow the norms laid down under the Code of Civil Procedure. However, since Rule 55(4) of the Rules contemplates filing a reply statement and evidence, if the applicant wishes to, it can be said that the proceedings is adjudicatory as the same is adversarial in nature.
8. However, insofar as amendments to the patent application and the rights of an opponent in the examination process, the learned Judge significantly observed thus: –
19. The proceeding in a pre-grant opposition and simultaneous examination of a patent application, however, cannot also result in a situation where the pre grant opponent is kept in dark about the developments taking place in the examination process. For example, when amendments are filed by the Applicant, an immediate decision ought to be taken on allowing or disallowing the amendment so that there is transparency and clarity as to what are the claims being considered by the Controller. A short and brief order should be passed in respect of the amendments which should be uploaded on the website of the Patent Office so that everyone concerned would know the decision on the amendment. In any event, if an amendment is being carried out during the pendency of a pre-grant opposition, the ruling on the amendment ought to be sent to the pre-grant opponent as well. Sometime amendments are carried out during the course of hearings across the table as well, when the patent agent of the Applicant attends the hearing before the Controller. In such a scenario, the Controller ought to examine the said amendments and convey the decision to the Applicant, and if the Opponent is present, even to the Opponent.
9. The writ petition was ultimately disposed of in the following terms: –
21. The Applicant justifies filing of the experts affidavit on the ground that the Opponent had filed certain additional documents. Be that as it may, the fact is that three substantive affidavits have been filed by the Applicant along with an amended set of claims on 6th June, 2021. Rulings on the amendment are yet to be issued by the Patent Office. Thus, in the opinion of the Court, an opportunity ought to be granted to the Opponent to rebut the evidence of the Applicant. The Opponent- Natco has agreed to not insist on its prayer seeking cross examination of Applicants witnesses- Dr. Michael Motto, Dr. Allan S. Myerson and Dr. Gauri Billa, if it is given an opportunity to file affidavits of its own experts in rebuttal. The said arrangement is not objected to by the Applicant. In the above background, and in order to expedite the decision on the application and the pre-grant opposition, the following directions are issued:
i) the Opponent is permitted to file affidavits of its own experts in rebuttal to the three expert affidavits filed by the Applicant, within a period of four weeks.
ii) If any documents are filed by the Opponent along with the said expert affidavits, the same shall be dealt with by the Applicant by way of additional written submissions within one week thereafter, without any further documents being filed by the Applicant.
iii) The Opponent is also permitted to file its additional written submissions within two weeks after filing of additional written submissions by the Applicant. The written submissions filed by both the parties shall be considered by the Controller for final decision in the pre-grant opposition;
iv) Parties shall appear before the Patent Office on 12th September, 2022 at 2:30 p.m. Both the Applicant and the Opponent shall be given one hour each to make their submissions.
v) The situation as it exists today is that there has been no ruling on any of the amendments which have been filed by the Applicant. Thus, before the commencement of oral hearing in the pre-grant opposition, the Controller shall communicate orally to both the parties as to which of the amendments are being allowed and which would be the final set of claims which is being considered for grant.
vi) On the said date, after hearing the parties for one hour each, the final decision on the application/pre-grant opposition shall be given by the Patent Office on or before 15th November, 2022. The final decision rendered shall be communicated to all the parties and shall also be uploaded on the website of the Patent Office;
vii) It is clarified that the hearing of any other opposition proceeding which has already concluded is not being re-opened by this Court;
10. Of equal significance was the caveat which stood entered in para 22 of that order and the same is extracted hereinbelow: –
22. The observations made in respect of amendments in the present order shall not be applicable to amendments directed by the Controller under Section 15 of the Act.
C. THE STATUTORY PROVISIONS- PRE AND POST
AMENDMENT
11. Before proceeding to notice the rival submissions, which were addressed and for the purposes of rendering a context to the same, we deem it appropriate to set out some of the relevant provisions which would have a bearing on the issues raised. For the purposes of elucidation, we extract the provisions of Sections 25, 57 and 117A of the Act as they underwent significant changes in terms of amendments introduced from time to time: –
Section 25 of the Patents Act, 1970
Section 25 as enacted
Section 25 as amended by the 2002 Amendment Act
Section 25 as amended by the 2005 Amendment Act
Section 25 as it stands now.
25. Opposition to grant of patent.
(1) At any time within four: months from the date of advertisement of the acceptance of a complete specification under this Act (or within such further period not exceeding one month in the aggregate as the Controller may allow on application made to him in the prescribed manner before the expiry of the four months aforesaid) any person interested may give notice to the Controller of opposition to the grant of the patent on any of the following grounds, namely: –
(a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim;
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912;
(ii) in India or elsewhere, in any other document:
Provided that the ground specific in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation-For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the applicant has failed to disclose to the Controller the information required by section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of a convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title, but on no other ground.
(2). Where any such notice of opposition is duly given, the Controller shall notify the applicant and shall give to the applicant and the opponent an opportunity to be heard before deciding the case.
(3) The grant of a patent shall not be refused on the ground stated in clause (e) of sub-section (1) if no patent has been granted in pursuance of the application mentioned in that clause; and for the purpose of any inquiry under clause (d) or clause (e) of that sub-section, no account shall be taken of any secret use.
25. Opposition to grant of patent.
(1) At any time within four: months from the date of advertisement of the acceptance of a complete specification under this Act (or within such further period not exceeding one month in the aggregate as the Controller may allow on application made to him in the prescribed manner before the expiry of the four months aforesaid) any person interested may give notice to the Controller of opposition to the grant of the patent on any of the following grounds, namely: –
(a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim;
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912;
(ii) in India or elsewhere, in any other document:
Provided that the ground specific in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation-For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the applicant has failed to disclose to the Controller the information required by section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of a convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title, but on no other ground.
(j) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
(k) that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere
(2). Where any such notice of opposition is duly given, the Controller shall notify the applicant and may, if so desired, give to the applicant and the opponent an opportunity to be heard before deciding the case.
(3) The grant of a patent shall not be refused on the ground stated in clause (e) of sub-section (1) if no patent has been granted in pursuance of the application mentioned in that clause; and for the purpose of any inquiry under clause (d) or clause (e) of that sub-section, no account shall be taken of any personal document or secret trial or secret use.
25. Opposition to the patent.
(1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground
(a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912; or
(ii) in India or elsewhere, in any other document:
Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of Section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation.For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the applicant has failed to disclose to the Controller the information required by Section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title;
(j) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
(k) that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere,
but on no other ground and the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.
(2) At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner on any of the following grounds, namely:
(a) that the patentee or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912; or
(ii) in India or elsewhere, in any other document:
Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of Section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the claim of the patentee and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the claim of the patentee;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation.For the purposes of this clause, an invention relating to a process for which a patent is granted shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the patentee has failed to disclose to the Controller the information required by Section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of a patent granted on convention application, the application for patent was not made within twelve months from the date of the first application for protection for the invention made in a convention country or in India by the patentee or a person from whom he derives title;
(j) that the complete specification does not disclose or wrongly mentions the source and geographical origin of biological material used for the invention;
(k) that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere,
but on no other ground.
(3)(a) Where any such notice of opposition is duly given under sub-section (2), the Controller shall notify the patentee.
(b) On receipt of such notice of opposition, the Controller shall, by order in writing, constitute a Board to be known as the Opposition Board consisting of such officers as he may determine and refer such notice of opposition along with the documents to that Board for examination and submission of its recommendations to the Controller.
(c) Every Opposition Board constituted under clause (b) shall conduct the examination in accordance with such procedure as may be prescribed.
(4) 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.
(5) While passing an order under sub-section (4) in respect of the ground mentioned in clause (d) or clause (e) of sub-section (2), the Controller shall not take into account any personal document or secret trial or secret use.
(6) In case the Controller issues an order under sub-section (4) that the patent shall be maintained subject to amendment of the specification or any other document, the patent shall stand amended accordingly
25. Opposition to the patent.
(1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground
(a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912; or
(ii) in India or elsewhere, in any other document:
Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of Section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation.For the purposes of this clause, an invention relating to a process for which a patent is claimed shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the applicant’s claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the applicant has failed to disclose to the Controller the information required by Section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of convention application, the application was not made within twelve months from the date of the first application for protection for the invention made in a convention country by the applicant or a person from whom he derives title;
(j) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention;
(k) that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere,
but on no other ground and the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.
(2) At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner on any of the following grounds, namely:
(a) that the patentee or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;
(b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claim
(i) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January, 1912; or
(ii) in India or elsewhere, in any other document:
Provided that the ground specified in sub-clause (ii) shall not be available where such publication does not constitute an anticipation of the invention by virtue of sub-section (2) or sub-section (3) of Section 29;
(c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the claim of the patentee and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the claim of the patentee;
(d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.
Explanation.For the purposes of this clause, an invention relating to a process for which a patent is granted shall be deemed to have been publicly known or publicly used in India before the priority date of the claim if a product made by that process had already been imported into India before that date except where such importation has been for the purpose of reasonable trial or experiment only;
(e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause (b) or having regard to what was used in India before the priority date of the claim;
(f) that the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act;
(g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;
(h) that the patentee has failed to disclose to the Controller the information required by Section 8 or has furnished the information which in any material particular was false to his knowledge;
(i) that in the case of a patent granted on convention application, the application for patent was not made within twelve months from the date of the first application for protection for the invention made in a convention country or in India by the patentee or a person from whom he derives title;
(j) that the complete specification does not disclose or wrongly mentions the source and geographical origin of biological material used for the invention;
(k) that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere,
but on no other ground.
(3)(a) Where any such notice of opposition is duly given under sub-section (2), the Controller shall notify the patentee.
(b) On receipt of such notice of opposition, the Controller shall, by order in writing, constitute a Board to be known as the Opposition Board consisting of such officers as he may determine and refer such notice of opposition along with the documents to that Board for examination and submission of its recommendations to the Controller.
(c) Every Opposition Board constituted under clause (b) shall conduct the examination in accordance with such procedure as may be prescribed.
(4) 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.
(5) While passing an order under sub-section (4) in respect of the ground mentioned in clause (d) or clause (e) of sub-section (2), the Controller shall not take into account any personal document or secret trial or secret use.
(6) In case the Controller issues an order under sub-section (4) that the patent shall be maintained subject to amendment of the specification or any other document, the patent shall stand amended accordingly.
Section 57 of the Patents Act, 1970
Section 57 as enacted vide the Patents Act, 1970
Section 57, as amended by the 2002 Amendment Act
Section 57, as amended by the 2005 Amendment Act
57. Amendment of application and specification before Controller-
(1) Subject to the provisions of Section 59, the Controller may, upon application made under this section in the prescribed manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification to be amended subject to such conditions, if any, as the Controller thinks fit:
Provided that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification under this section while any suit before a court for the infringement of the patent or any proceeding before the High Court for the revocation of the patent is pending, whether the suit or proceeding commenced before or after the filing of the application to amend.
(2) Every application for leave to amend an application for a patent or a specification under this section shall state the nature of the proposed amendment, and shall give full particulars of the reasons for which the application is made.
(3) Every application for leave to amend an application for a patent or a specification under this section made after the acceptance of the complete specification and the nature of the proposed amendment shall be advertised in the prescribed manner.
(4) Where an application is advertised under sub-section (3), any person interested may, within the prescribed period after the advertisement thereof, give notice to the Controller of opposition thereto; and where such a notice is given within the period aforesaid, the Controller shall notify the person by whom the application under this section is made and shall give to that person and to the opponent an opportunity to be heard before he decides the case.
(5) An amendment under this section of a complete specification may be, or include, an amendment of the priority date of a claim.
(6) The provisions of this section shall be without prejudice to the right of an applicant for a patent to amend his specification to comply with the directions of the Controller issued before the acceptance of the complete specification or in the course of proceedings in opposition to the grant of a patent.
57. Amendment of application and specification [or any document related thereto] before Controller.
(1) Subject to the provisions of Section 59, the Controller may, upon application made under this section in the prescribed manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification [or any document related thereto] to be amended subject to such conditions, if any, as the Controller thinks fit:
Provided that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification [or any document related thereto] under this section while any suit before a court for the infringement of the patent or any proceeding before the High Court for the revocation of the patent is pending, whether the suit or proceeding commenced before or after the filing of the application to amend.
(2) Every application for leave to amend an application for a patent [or a complete specification or any document related thereto] under this section shall state the nature of the proposed amendment, and shall give full particulars of the reasons for which the application is made.
(3) Any application for leave to amend an application for a patent or a complete specification or a document relating thereto under this section made after the acceptance of the complete specification and the nature of the proposed amendment may be advertised in the Official Gazette if the amendment, in the opinion of the Controller, is substantive.
(4) Where an application is advertised under sub-section (3), any person interested may, within the prescribed period after the advertisement thereof, give notice to the Controller of opposition thereto; and where such a notice is given within the period aforesaid, the Controller shall notify the person by whom the application under this section is made and shall give to that person and to the opponent an opportunity to be heard before he decides the case. [No changes made vide the 2002 Amendment Act]
(5) An amendment under this section of a complete specification may be, or include, an amendment of the priority date of a claim.
[No changes made vide the 2002 Amendment Act]
(6) The provisions of this section shall be without prejudice to the right of an applicant for a patent to amend his specification or any document related thereto to comply with the directions of the Controller issued before the acceptance of the complete specification along with other documents filed by the applicant or in the course of proceedings in opposition to the grant of a patent.
57. Amendment of application and specification [or any document related thereto] before Controller.
(1) Subject to the provisions of Section 59, the Controller may, upon application made under this section in the prescribed manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification [or any document related thereto] to be amended subject to such conditions, if any, as the Controller thinks fit:
Provided that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification [or any document related thereto] under this section while any suit before a court for the infringement of the patent or any proceeding before the High Court for the revocation of the patent is pending, whether the suit or proceeding commenced before or after the filing of the application to amend. [No change made between the 2002 and 2005 Amendments]
(2) Every application for leave to amend an application for a patent [or a complete specification or any document related thereto] under this section shall state the nature of the proposed amendment, and shall give full particulars of the reasons for which the application is made. [No changes made between the 2002 and 2005 Amendments]
(3) Any application for leave to amend an application for a patent or a complete specification or a document related thereto under this section made after the grant of patent and the nature of the proposed amendment may be published.
(4) Where an application is [published] under sub-section (3), any person interested may, within the prescribed period after the [publication] thereof, give notice to the Controller of opposition thereto; and where such a notice is given within the period aforesaid, the Controller shall notify the person by whom the application under this section is made and shall give to that person and to the opponent an opportunity to be heard before he decides the case.
(5) An amendment under this section of a complete specification may be, or include, an amendment of the priority date of a claim. [No changes made to (5) since its enactment]
(6) The provisions of this section shall be without prejudice to the right of an applicant for a patent to amend his specification or any other document related thereto to comply with the directions of the Controller issued before the grant of a patent.
Section 117A of the Patents Act, 1970
Section 117A as enacted
Section 117A, as amended by the 2002 Amendment Act
Section 117A, as amended by the 2005 Amendment Act
Section 117A, as it stands now, vide the 2021 Tribunal Reforms Act
Came into force in the year of 2002. The provision was not present in the original Act.
117-A. Appeals to Appellate Board. (1) Save as otherwise expressly provided in sub-section (2), no appeal shall lie from any decision, order or direction made or issued under this Act by the Central Government, or from any act or order of the Controller for the purpose of giving effect to any such decision, order or direction.
(2) An appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government under Section 15, Section 16, Section 17, Section 18, Section 19, Section 20, Section 25, Section 27, Section 28, Section 51, Section 54, Section 57, Section 60, Section 61, Section 63, Section 66, sub-section (3) of Section 69, Section 78, sub-sections (1) to (5) of Section 84, Section 85, Section 88, Section 91, Section 92 and Section 94.
(3) Every appeal under this section shall be in the prescribed form and shall be verified in such manner as may be prescribed and shall be accompanied by a copy of the decision, order or direction appealed against and by such fees as may be prescribed.
(4) Every appeal shall be made within three months from the date of the decision, order or direction, as the case may be, of the Controller or the Central Government or within such further time as the Appellate Board may, in accordance with the rules made by it, allow.
117-A. Appeals to Appellate Board. (1) Save as otherwise expressly provided in sub-section (2), no appeal shall lie from any decision, order or direction made or issued under this Act by the Central Government, or from any act or order of the Controller for the purpose of giving effect to any such decision, order or direction. [No changes brought about by the 2005 Amendment]
(2) An appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government under Section 15, Section 16, Section 17, Section 18, Section 19, Section 20, [sub-section (4) of Section 25, Section 28,] Section 51, Section 54, Section 57, Section 60, Section 61, Section 63, Section 66, sub-section (3) of Section 69, Section 78, sub-sections (1) to (5) of Section 84, Section 85, Section 88, Section 91, Section 92 and Section 94.
(3) Every appeal under this section shall be in the prescribed form and shall be verified in such manner as may be prescribed and shall be accompanied by a copy of the decision, order or direction appealed against and by such fees as may be prescribed. [No changes brought about by the 2005 Amendment]
(4) Every appeal shall be made within three months from the date of the decision, order or direction, as the case may be, of the Controller or the Central Government or within such further time as the Appellate Board may, in accordance with the rules made by it, allow.
[No changes brought about by the 2005 Amendment]
117-A. Appeals to High Court-
(1) Save as otherwise expressly provided in sub-section (2), no appeal shall lie from any decision, order or direction made or issued under this Act by the Central Government, or from any act or order of the Controller for the purpose of giving effect to any such decision, order or direction.
(2) An appeal shall lie to the [High Court] from any decision, order or direction of the Controller or Central Government under Section 15, Section 16, Section 17, Section 18, Section 19, Section 20, [sub-section (4) of Section 25, Section 28,] Section 51, Section 54, Section 57, Section 60, Section 61, Section 63, Section 66, sub-section (3) of Section 69, Section 78, sub-sections (1) to (5) of Section 84, Section 85, Section 88, Section 91, Section 92 and Section 94.
(3) Every appeal under this section shall be in the prescribed form and shall be verified in such manner as may be prescribed and shall be accompanied by a copy of the decision, order or direction appealed against and by such fees as may be prescribed. [No changes brought about in this section vide the 2021 Act]
(4) Every appeal shall be made within three months from the date of the decision, order or direction, as the case may be, of the Controller or the Central Government or within such further time as the [High Court] may, in accordance with the rules made by it allow.
D. CONTENTIONS OF NOVARTIS
12. Assailing the view taken by the learned Single Judge, Mr. Singh, learned counsel, addressed the following submissions on the appeal. It was the submission of Mr. Singh that the facts surrounding the consideration and disposal of the patent application is a stark and glaring example of how the PGO opportunity was abused by the respondents. The appellant contends that the opponents connived with each other so as to inordinately delay the grant of the patent and which fact is evident from the timing of the filing of each PGO aimed at ensuring that the opposition proceedings do not ever reach a point of conclusion. According to Mr. Singh, the adoption of such a device by serial opponents violates the very ethos underlying Section 43 of the Act and thus frustrating the legislative command of expeditious grant. Mr. Singh highlighted the fact that the filing of serial oppositions led to the grant being delayed by more than 16 years when computed from the time when the application was originally made. The torturous process has led to more than 16 years out of the maximum term of 20 years that a patent could have enjoyed in terms of Section 53 of the Act having been spent in prosecution proceedings before the Controller. Mr. Singh submitted that despite the long and protracted PGO proceedings, the grant has ultimately come to be set aside by the judgment impugned and that too on grounds which are wholly untenable.
13. Since the decision rendered by the learned Single Judge essentially proceeds on a finding that the proceedings as undertaken by the Controller were in violation of the principles of natural justice, we deem it apposite to note the following submissions that were addressed by Mr. Singh in this regard. Mr. Singh at the outset submitted that the learned Judge has clearly erred in upholding the challenge that was raised by NATCO and has failed to bear in mind the scheme of the Act and the Patents Rules, 20037. It was submitted that the learned Single Judge has proceeded on the premise that when an opposition is filed, the examination and opposition proceedings merge and thus conferring a right upon an opponent to be accorded audience even in proceedings which may have originated pursuant to a directive framed by the Controller based on an independent examination of the patent application in terms of Sections 14 and 15 of the Act.
14. According to learned counsel, the interpretation as placed by the learned Single Judge on the scheme of Sections 12 to 15 of the Act read along with Rules 24B, 28 and 28A is clearly erroneous and fails to bear in mind the statutory distinction which stands constructed between the examination procedure regulated by the aforenoted provisions on the one hand and Section 25(1) of the Act read along with Rule 55 and which governs the opposition procedure on the other.
15. It was submitted that the learned Single Judge also failed to bear in consideration the deleterious effect that would ensue in case a protracted pre-grant opposition procedure were to unfold. According to learned counsel, according a judicial imprimatur to such a process would clearly violate the legislative intent underlying Sections 43 and 53 of the Act. Mr. Singh submitting that the rights that may be claimed by an opponent at the pre grant stage were lucidly enunciated by a learned Judge of the Court in UCB Farchim Sa Vs. Cipla Ltd. & Ors.8 where the following pertinent observations came to be rendered: –
13. In the first instance a distinction has to be drawn between a pre-grant opposition and a post-grant opposition. While a pre-grant opposition can be filed under Section 25(1) of the Patents Act at any time after the publication of the patent application but before the grant of a patent, a post-grant opposition under Section 25(2) of the Patents Act has to be filed before the expiry of one year from the date of the publication of the grant of patent. A second significant difference, after the amendment of 2005, is that a pre-grant opposition can be filed by any person whereas a post-grant opposition under Section 25(2) can be filed only by any person interested. It may be noticed that the application for revocation of a patent in terms of Section 64 of the Patents Act can also to be filed only by any person interested. In other words, the post-grant opposition and the application for revocation cannot be filed by just about any person who is not shown to be a person who is interested. A third significant difference is that the representation at the stage of pre-grant is considered by the Controller himself. Rule 55 of the Patents Rules requires the Controller to consider the statement and evidence filed by the applicant and thereafter either refuse to grant the patent or require the complete specification to be amended to his satisfaction. Of course, in that event notice will be given to the applicant for grant of patent who can file his reply and evidence. This Court finds merit in the contention that the pre-grant opposition is in fact in aid of the examination of the patent application by the Controller. The procedure is however different aspect as far as the post-grant opposition is concerned. There in terms of Section 25(3), the Controller has to constitute an Opposition Board consisting of such officers as he may determine and refer to such Opposition Board the notice of opposition along with other documents for its examination and recommendations. After receiving the recommendations of the Opposition Board, the Controller gives the patentee and the opponent an opportunity of being heard. The Controller then takes a decision to maintain, amend or revoke the patent. The fourth major difference between the pre-grant and the post-grant opposition is that while in terms of Section 117A an appeal to the IPAB is maintainable against the order of the Controller in a post-grant opposition under Section 25(4) of the Patents Act, an appeal has not been expressly been made available against an order made under Section 25(1) of the Patents Act.
14. There are two possible situations arising from the order passed by the Controller in a pre-grant opposition. Where the pre-grant opposition is rejected, the aggrieved person would obviously be the person who has filed the pre-grant opposition. Where the Controller accepts the pre-grant opposition and therefore refuses the grant of patent or suggests amendments which are then not carried out by the applicant resulting in the refusal of the grant of patent, the aggrieved person obviously would be the applicant for the patent. Where the pre-grant opposition is rejected and patent is granted
15. In the first eventuality, where the pre-grant opposition is rejected, it is apparent from the decision in J. Mitra and from a reading of Section 25 with Section 117A that as long as the person who has filed that opposition happens to be a person interested, he would, after 1st January, 2005 [the date with effect from which Section 25 (2) came into force although the provision was introduced only on 4th April, 2005] have the remedy of filing a post-grant opposition. He can, after 2nd April, 2007, also file an application before the IPAB under Section 64 of the Patents Act for revocation of the patent. In other words, as explained by the Supreme Court in J. Mitra & Co. as long as that person is able to show that he is a person interested, he is not without a remedy after his pre-grant opposition is rejected. He in fact has two remedies. Even if his post-grant opposition is rejected, he can thereafter file an appeal to the IPAB under Section 117A. Against the decision of the IPAB in either event he will have the remedy of seeking judicial review in accordance with law by filing a petition in the High Court. At this juncture it may be notice