OIPD-5 IN THE HIGH COURT AT CALCUTTA Intellectual Property Rights Division ORIGINAL SIDE BEFORE: The Hon'ble Justice Ravi Krishan Kapur IPDAID/45/2024 [OLD NO. AID/11/2023] SIGA TECHNOLOGIES INC VS THE CONTROLLER GENERAL OF PATENTS DESIGNS AND TRADE MARK CGPDTM AND ORS. For the petitioner : Mr. Adarsh Ramanujan, Advocate. Ms. Yamini Mookherjee, Advocate. Ms. Kaushiki Roy, Advocate. Mr. Sonal Mishra, Advocate. Mr. Antriksh Mishra, Advocate. Mr. Suryaneel Das, Advocate. Ms. Garima Mehta, Advocate. For the respondents : Mr. Ranjan Bachawat, Senior Advocate. Mr. Sayan Roy Chowdhury, Advocate. Mr. Amit Kumar Nag, Advocate. Ms. Ranjabati Ray, Advocate. Ms. B. Samanta, Advocate. Ms. Ankita Jha, Advocate. Heard : 24.07.2026 Judgment : 24.07.2026 Ravi Krishan Kapur, J. 1. This appeal is directed against an order dated March 31, 2023 whereby the Controller General of Patents Designs and Trade Mark has rejected the application filed by the appellant being Application No.3206/KOLNP/2012 under section 25(1) of the Patents Act, 1970 for an invention titled “POLYMORPHIC FORMS OF ST 246 AND METHODS OF PREPARATION”. 2. The above application was filed in India on October 19, 2012 carrying an international filing date of March 23, 2011. The invention concerns an oral 2 formulation antirival drug to treat infections caused by orthopox viruses (human smallpox disease caused by the variola virus) developed by the appellant. By the impugned order, the application has been rejected under sections 2(1)(ja), 3(d) and 3(e) of the Act. 3. On January 29, 2018 an FER containing objections raised by the respondent nos.1 and 2 both substantial and procedural had been issued. The appellant had filed its reply within its amended claims within the stipulated period. On February 15, 2022 a hearing notice was issued by the respondent nos.1 and 2 on the pre-grant opposition. The hearing was held on August 10, 2022 and the parties filed their Written Submissions. 4. The primary contention raised on behalf of the appellant is in respect of a document called “Quenelle et al 2007, Efficacy of delayed treatment with ST-246 given orally against systemic orthopoxvirus infectious in mice, Antimicrobial Agents and Chemotherapy Feb; 51 (2): 689-95”. It is contended on behalf of the appellant that the same was relied on for the first time in the post hearing written submissions filed by the respondent no. 3 on August 24, 2022 without granting any opportunity to the appellant to deal with the same. The impugned order relies on the said document and this is also a procedural irregularity which vitiates the impugned order. 5. On behalf of the respondents it is fairly submitted that no opportunity has been granted to the appellant to deal with the post hearing written submissions which refer to the above document. It is further alleged that though there was reference to the said document in the records before the Controller, the respondent no.3 dealt with the same exhaustively only in the post hearing Written Submissions. 6. From the records it appear that the entire text of “Quenelle et al 2007, Efficacy of delayed treatment with ST-246 given orally against systemic orthopoxvirus infectious 3 Chemotherapy Feb; 51 (2): 689-95” was in mice, Antimicrobial Agents and not on record and had not been cited in the FER. Neither was the same cited in the opposition. On the contrary, the said document was introduced for the first time only in the post hearing written submissions. 7. In view of lack of opportunity afforded to the appellant, the impugned order has been passed in violation of the principles of natural justice. There was no opportunity afforded to the appellant to deal with “Quenelle et al 2007, Efficacy of delayed treatment with ST-246 given orally against systemic orthopoxvirus infectious in mice, Antimicrobial Agents and Chemotherapy Feb; 51 (2): 689-95” which has been referred to and relied on in the impugned order. On this limited ground, the impugned order dated March 31, 2023 is unsustainable and set aside. 8. The matter is remanded back to the Controller to be heard afresh within a period of three months from the date of communication of this order. It is made clear that there has been no expression on the merits of the application and all issues are left open for the Controller or his designate to decide in accordance with law. 9. It is clarified that this order will not prevent the adjudicating authority from taking into consideration the above cited document “Quenelle et al 2007, Efficacy of delayed treatment with ST-246 given orally against systemic orthopoxvirus infectious in mice, Antimicrobial Agents and Chemotherapy Feb; 51 (2): 689-95” after granting an opportunity to the appellant. 10. With the above directions, IPDAID/45/2024 stands disposed of. (RAVI KRISHAN KAPUR, J.) Spal/sk