Calcutta High Court
Viiv Healthcare Company And Anr vs Dy Controller Of Patents And Designs And … on 14 May, 2025
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
(Intellectual Property Rights Division)
BEFORE:
The Hon'ble Justice Ravi Krishan Kapur
IPDPTA/1/2025
IA NO: GA-COM/1/2025
VIIV HEALTHCARE COMPANY AND ANR
VS
DY CONTROLLER OF PATENTS AND DESIGNS AND ORS.
For the appellant : Ms. Archana Shankar, Advocate
Ms. Mini Agarwal, Advocate
For the Controller of Patent : Mr. Swatarup Banerjee, Advocate
Ms. Mary Dutta, Advocate
Mr. Sariful Haque, Advocate
For the respondents 2 to 5 : Mr. Anand Grover, Senior Advocate
Ms. Jhuma Sen, Advocate
Ms. Swatika Chatterjee, Advocate
Mr. Mehboob Rahaman, Advocate
For the respondent no.6 : Mr. Subhatosh Majumdar, Advocate
Ms. Mitul Dasgupta, Advocate
Ms. Amrita Majumdar, Advocate
Mr. Teesham Das, Advocate
For the respondent no.7 : Mrs. Rajeshwari, Advocate
Mr. Tahir Aj, Advocate
Mr. Paritosh Sinha Advocate.
Mr. K.K. Pandey, Advocate
Ms. Pooja Sett, Advocate
Ms. Mallika Bothra, Advocate
Judgment on : 14.05.2025
Ravi Krishan Kapur, J.:
1. This appeal has been filed under section 117A of the Indian Patents Act
1970 challenging an order dated 3 October, 2024 passed by the
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respondent no.1, Deputy Controller of Patents and Designs rejecting
Indian Patent Application No. 3865/ KOLNP/ 2007.
2. During the pendency of this appeal, in view of a settlement by and
between the appellants and the respondent no.6, the respondent no.6
had withdrawn the pre-grant opposition filed by them. Hence, the
appellant and the proceeding insofar as the respondent no.6 is
concerned stood settled on the following terms and conditions:
a) That the appellants have no objection to the making, using.
offering for sale and selling of Dolutegravir only by the
respondent no. 6 including its successors, assigns, affiliates,
subsidiaries, distributors, agents, representatives, and any
other entities under its control or acting on their behalf for the
manufacture and marketing of Dolutegravir at any future point
of time (no right to sub-license) claimed by Indian patent
application no. 3865/KOLNP/2007 in India and the appellants
would not sue the respondent no.6 for infringement should the
patent be granted to appellant upon remand.
b) That the respondent no. 6 undertakes not to make or sell
Cabotegravir at any time prior to April 28, 2026.
c) The respondent no. 6 shall withdraw and not pursue the pre-
grant opposition in relation to IN 3865/KOLNP/2007 should
the impugned order of the respondent no. 1 dated October 3,
2024 be set aside and application no. IN 3865 be remanded to
the respondent no. 1 for fresh adjudication and that said pre-
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grant opposition proceeding would not be adjudicated upon by
the respondent no. 1.
d) The respondent no. 6 shall not participate in these proceedings
and shall withdraw from all further participation.
e) The respondent no. 6 would also not institute a fresh
proceeding against the grant and subsequent to grant, till the
expiry of the patent.
In this background, this appeal has been contested by the
respondent no.1 Controller, the respondent nos.3 and 5 and the
respondent no.7.
3. Briefly, the impugned application IN 3865 relates to a “Polycyclic
Carbamoylpyridone Derivative having HIV Integrase Inhibitory Activity”.
In particular, the application for patent is directed to two new HIV
integrase inhibitors, Dolutegravir and Cabotegravir. Claims 1 to 3 are in
relation to the compound Dolutegravir and claims 4 to 6 are in relation
to the compound Cabotegravir.
4. For convenience, the relevant dates summarizing the proceedings under
the Act are set out below:
Sr. No. Date Event
1 28th April 2006 The International (PCT) Application number
PCT/U2006/116764 deriving priority from the two
applications was filed
2 10th October The National phase application under Section 7(1A) was
2007 entered in India and patent application number
3865/KOLNP/2007 was assigned to it.
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Sr. No. Date Event
3 18th July 2008 Indian Patent Application 3865/KOLNP/2007 was
published.
4 22nd April 2009 Appellants filed request for examination of the
3865/KOLNP/2007
5 27th February The respondent No. 1 examined the patent 2012 application
2012 and issued the First Examination Report (FER)
6 30th August 2012 The appellants filed response to the First Examination
Report issued by the respondent No. 1 issued on 27th
February 2012.
7 16th October The respondent No. I issued the subsequent examination
2012 report (SER).
8 13th February Appellants filed response to the subsequent examination
2013 report (SER) and amended claims 1 to 9, filed with SER
response
9 12th February The respondent No. 2, Delhi Network of HIV+ People (DNP+)
2013 (Opponent-1), filed the first Pre-Grant Opposition under
Section 25(1) read with Rule 55.
10 26th June 2013 Appellants filed reply statement to the pre-grant opposition
filed by Respondent No. 2, Delhi Network of HIV+ People
(DNP+) along with affidavit of Dr Brian John (Affidavit-
Johns-1).
11 20th December The respondent No. 3, Bengal Network of HIV+ People
2015 (BNP+ and Mr Firoz Shah) filed the second pre-grant
opposition (Opponent 2).
12 3rd February Third pre-grant opposition was filed by the respondent No.
2016 4, Mr. Sanjeev Sharma (Opponent-3)
13 4th February Appellants filed the evidence of their expert, Dr. Sheo Bux
2016 Singh (Affidavit-Dr Singh-1) and hearing was scheduled for
15th February 2016.
14 4th February Hearing u/s 25(1) in the pre-grant opposition filed the
2016 respondent No. 2 was concluded.
15 12th April 2016 Appellants filed reply statement to the second pre-grant
opposition filed by the respondent No. 3, (BNP+ and Mr
Firoz Khan, i.e, BNP+) along with affidavits of Dr Brian John
(Affidavit-Dr. Johns-2) and Dr. Sheo Bux Singh (Affidavit-Dr
Singh-2).
16 2nd May 2016 The respondent No. 3 (Opponent-2) made request for Cross-
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Sr. No. Date Event
Examination of the Appellant’s expert Dr. Brian Johns and
Dr. Sheo Bux Singh.
17 22nd July 2016 Fourth Pre-Grant Opposition under Section 25(1) was filed
by Respondent No. 5, Dr. Mira Shiva (Opponent-4)
18 13th June 2017 Appellants consented for the cross-examination of Dr Sheo
Bux Singh.
19 21st July 2017 Appellants filed reply statement against the pre-grant
opposition filed by the respondent No. 4 and 5, along with
affidavit of Dr. Sheo Bux Singh (Affidavit-Dr Singh-3) and
(Affidavit-Dr Singh-4).
20 16th August 2017 Hearing u/s 25(1) was concluded in the pre-grant
17th August 2017 opposition filed the Respondent No. 3, 4 and 5.
21 18th August 2017 Cross examination of Dr. Sheo Bux Singh was concluded on
18-Aug-2017 in the pre-grant Opposition filed by
Respondent No. 3.
22 31st October 2018 The respondent No. 6, Natco Pharma Ltd., (Opponent-5)
filed the fifth pre-grant opposition.
23 28th January Appellants filed the reply statement to the pre-grant
2019 opposition filed by the respondent No. 6, along with the
evidence of Dr Sheo Bux Singh and Dr Brian Johns filed in
the other pre-grant opposition proceedings.
24 18th March 2019 Hearing under 25(1) in respect of pre-grant opposition filed
by the respondent No 6, Natco Pharma Ltd, was concluded.
25 30th March 2019 The respondent No. 6, Natco Pharma Ltd., filed the writ
petition W.P. 7470 (W) of 2019 before Calcutta High Court
advocating the cross-examination request.
26 5th April 2019 Hearing in the Writ Petition 7470 (W) of 2019 was
concluded and order was issued.
27 14th June 2019 The respondent No. 1 issued order on the request of cross-
examination in view of the Writ Court order dated April 05,
2019
28 2nd December Sixth pre-grant opposition was filed by the respondent No. 7
2019 (Opponent-6, Sankalp Rehabilitation Trust)
29 22nd May 2020 Appellants filed the reply statement to the sixth pe-grant
opposition along with the affidavit of Dr Sheo Bux Singh
and Dr Brian Johns.
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Sr. No. Date Event 30 9th September Hearing u/s 25(1) was concluded in relation to the sixth 2020 pre-grant opposition filed by the respondent No. 7 (Opponent-6, Sankalp) was concluded 31 8th April 2024 New hearing officer, respondent No. 1, communicated the
progress of the pre-grant proceeding and invited the parties
to submit any new documents within 10 days’ time period.
32 18th April 2024 The respondent No. 6, NATCO Pharma Ltd., made a request
for fresh hearing
33 11th June 2024 The respondent No. 1. issued a hearing notice scheduling
hearing on 1st and 2nd July 2024 in the six-pre grant
opposition proceedings.
34 27th June 2024 The respondent No. 6, NATCO Pharma Ltd., filed a request
for adjournment and therefore to defer the hearing
scheduled on July 01, 2024 until the fresh writ is decided.
35 30th June 2024 The respondent No. 7, filed writ before High Court at
Calcutta against the order of the respondent No. 1 dated
June 14, 2019.
36 1st July 2024 The respondent No. 1 concluded hearing in the first pre-
grant opposition filed by the Respondent No. 2, Delhi
Network of Positive People.
37 2nd July 2024 Respondent No. 1 concluded hearing in the third pre-grant
opposition filed by the respondent No. 4, Mr Sanjeev
Sharma and hearing under Section 14.
38 15th July 2024 The respondent No. 1 concluded hearing in the second pre-
grant opposition filed by Respondent No. 3, 4 and 7
39 16th July 2024 The respondent No. 1 concluded hearing in the fifth pre-
grant opposition filed by the respondent No. 6, Natco
Pharma Ltd.
40 3rd October 2024 The Respondent No. 1 issued the impugned order refusing
the grant of patent for the Indian Patent Application,
3865/KOLNP/2007.
5. Upon the filing of the above application, several pre-grant oppositions
were filed by respondent no. 2 [Delhi Network of People Living with
HIV/AIDS(DNP+)] respondent no. 3 [Bengal Network of People Living with
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HIV/ AIDS (BNP+) and Mr. Firoz Khan, the respondent no. 4 [Mr Sanjeev
Sharma); the respondent no. 5 [Dr. Mira Shiva], the respondent no. 6
[Natco Pharma Ltd.] and the respondent no. 7 [Sankalp Rehabilitation
Trust] between the period 2013 to 2020.
6. The hearings in the pre-grant oppositions filed by the respondent No. 2
were concluded on 4 February 2016. Further hearings to the pre-grant
oppositions filed by the respondent no. 3; respondent no. 4 and
respondent no. 5 were concluded on 16 and 17 August 2017
respectively. In addition, the cross-examination of the appellant’s expert
witness, Dr. Sheo Bux Singh stood concluded on 18th August 2017.
Thereafter, hearing to the pre-grant opposition proceedings of the
respondent no. 6 and the respondent no. 7 was concluded on 18th
March 2019 and 9th September 2021 respectively.
7. In an earlier writ petition being WP 7404 of 2019, a Co-ordinate Bench of
this Court by an order dated 13 April 2019 had directed the Controller to
consider the request for cross-examination filed by the respondent no.6.
Pursuant to such direction, the respondent no.1 passed an order
refusing the application for cross-examination of the respondent no.6.
Being aggrieved by the order dated 14 June 2019, a second writ petition
was filed numbered WP 16643 of 2024 wherein, a Co-ordinate Bench
had passed the following order:
“Thus, the authority is directed to consider the opposition of
Natco Pharma Limited, without taking into account the six affidavits
filed by the experts.
It is further directed that the opposition of Natco Pharma
Limited, shall be decided on the basis of records other than those
relating to the proceedings of other objectors in which the affidavits
8of the experts had been either referred to or relied upon or
discussed.
The writ petition is accordingly disposed of.
There shall be no order as to costs.
All parties are to act on the basis of server copy of this order.”
8. A plain reading of the above order indicates that the concession by the
appellants before the Court was only limited to the opposition proceeding
filed by Natco Pharma and not in relation to any other objections which
were pending before the respondent Controller. It is significant to
mention that despite the hearing of the above application of patent being
concluded on four prior occasions by different Hearing Officers, no final
order was passed. Subsequently, the matter was transferred to a new
Hearing Officer who heard the matter on 1 July 2024, 2 July 2024, 15
July 2024 and 16 July 2024 respectively and passed the impugned
order.
9. In passing the impugned order, the respondent no.1 has interpreted the
order of the High Court dated 15 July 2024 to mean that the entire
expert evidence relied on by the appellants need not be taken into
consideration in deciding the above application for patent. In this
context, it is important to highlight that the following expert evidence
had inter-alia been relied on by the appellants before the Authorities.
a) Dr. Brian A. Johns had adduced expert evidence in the pre-
grant opposition filed by the respondent no. 2, on 26th June
2013.
b) Dr. Sheo Bux Singh had filed evidence in the opposition filed by
the respondent no. 2, on 4th February 2016.
c) Dr. Brian A. Johns (in the pre-grant opposition filed by the
respondent no. 3) filed on 12th April 2016.
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d) Dr. Sheo Bux Singh (in the pre-grant opposition filed by the
respondent no. 3) filed on 12th April 2016.
e) Dr. Sheo Bux Singh (in the pre-grant opposition filed by the
respondent no. 4) filed on 21.07.2017.
f) Dr. Sheo Bux Singh (in the pre-grant opposition filed by the
respondent no. 5) filed on 21.07.2017.
10. The impugned order has been passed on the merits of the case without
taking into consideration any of the expert evidence relied on by the
appellants. The interpretation given to the order dated 15 July 2024
passed by the Court is ex facie perverse, distorted and inherently flawed.
By the impugned order, the appellants had only conceded to the
objection of the respondent no.6 being disposed of without taking into
account the expert evidence relied on by the appellants. There was no
other concession at all which can be attributed to the appellants far less
the concession that the entirety of the expert evidence on behalf of the
appellant, ought not to be considered in adjudicating any of the pending
objections.
11. The Act and Rules framed thereunder both contemplate expert evidence
being relied on while hearing and disposal of an application for patent.
This is inbuilt and is a fundamental feature in most applications for
patent. In passing the impugned order and concluding that the subject
application for patent is not an invention or lacked inventive steps or
that there was an absence of specifications or that the specifications
were not sufficiently clear the expert evidence relied on by the appellants
was necessarily required to be considered regardless of the evidentiary
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value. This was neither the scope nor purport of the order dated 15th
July, 2024. In passing the impugned order, the Deputy Controller of
Patents has misinterpreted and misconstrued the order dated 15th July,
2024 which has resulted in a complete abdication of jurisdiction. A plain
reading of the order dated 15 July 2024 indicates that the concession of
not relying on expert evidence was only limited to the objection of the
respondent no. 6 and not to the objections of any of the other
respondents.
12. It is also a matter of some regret that the subject application for patent
had been pending for a considerable long period of time. It is worth
recollecting that the time lines under the Act are meant to ensure that no
unnecessary delays are caused during the process for grant of patent.
The Patent Office is expected to pass an order within a reasonable time
period and not to cause any unreasonable delay in the disposal of the
application. The facts of this case demonstrate that there has been an
exceptional and extraordinary delay in the disposal of the above
application. Such delay is simply not justifiable and emasculates the
very object of the Act. (Procter and Gamble Co. vs. Controller of Patents
and Designs 2023 SCC OnLine Del 7832, R.C. Sharma vs. Union of India
1976 (3) SCC 574 and BASF SE vs. Joint Controller of Patents and Designs
& Ors. IPDPTA 5 OF 2024).
13. For the above reasons the impugned order is unsustainable. The mis-
interpretation of the order dated 15 July 2024 passed in WP 16643 of
2024 (Natco Pharma Co. vs. Union of India & Ors.) is ex facie perverse,
unsustainable and vitiates the impugned order in its entirety.
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14. In such circumstances, the appeal stands allowed. In view of the peculiar
facts and circumstances of the case the following directions are passed:
(i) To issue a hearing notice within two weeks from the date of this order
and dispose of the subject application along with all objections(save
and except NATCO) within eight weeks from the date of
communication of this order.
(ii) All the documents/publication filed by the appellants in the
proceedings under Section 14 and in the pre-grant oppositions
proceedings by the respondent no. 2 to respondent no. 7 are to be
considered.
(iii) NATCO (respondent no.6) shall withdraw their opposition in terms of
the Settlement as enumerated in paragraph 2 above.
(iv) The evidence of all experts to be considered in the proceedings filed
by the remaining respondent no. 2 to 5 and the respondent no. 7
(save and except the respondent no.6).
(v) In order to obviate any apprehension of predetermination, the
Controller who had passed the impugned order shall not rehear the
matter and the subject application along with all the objections are to
be considered by any other Controller or Appropriate Hearing Officer.
(vi) With the above directions and to the above extent, IPDPTA/1/2025
stands allowed. It is made clear that there has been no final
adjudication on the merits and all questions are left open to be
decided in accordance with law.
15. With the above directions and to the above extent, IPDPTA 1 of 2025
stands allowed. Accordingly, GA-COM/1/2025 stands disposed of.
(Ravi Krishan Kapur, J.)
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