(Intellectual Property Rights Division) v. DY CONTROLLER OF PATENTS AND DESIGNS & Ors.

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 2 28th April 2006 The International (PCT) Application number PCT/U2006/116764 deriving priority applications was filed 10th October The National phase application under Section 7(1A) was 2007 entered India and patent application number 3865/KOLNP/2007 was assigned to it. 4 Sr. No. Date Event 3 4 5 6 7 8 9 18th July 2008 Indian Patent Application 3865/KOLNP/2007 was published. 22nd April 2009 Appellants request examination 3865/KOLNP/2007 27th February The respondent No. 1 examined the patent 2012 application 2012 and issued the First Examination Report (FER) 30th August 2012 The appellants filed response to the First Examination Report issued by the respondent No. 1 issued on 27th February 2012. 16th October The respondent No. I issued the subsequent examination 2012 report (SER). 13th February Appellants filed response to the subsequent examination 2013 report (SER) and amended claims 1 to 9, filed with SER response 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 13 3rd February Third pre-grant opposition was filed by the respondent No. 2016 4, Mr. Sanjeev Sharma (Opponent-3) 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- 5 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 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. 6 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 7 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 8 of 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. 9 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 10 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. 11

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 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.)