{"id":108,"date":"2022-11-17T08:43:00","date_gmt":"2022-11-17T03:13:00","guid":{"rendered":"https:\/\/raratheme.com\/preview\/lawyer-landing-page\/?p=108"},"modified":"2022-11-30T23:54:20","modified_gmt":"2022-11-30T18:24:20","slug":"ipo-section3d-objections","status":"publish","type":"post","link":"https:\/\/www.lexadept.com\/?p=108","title":{"rendered":"Delhi HC holds that IPO must identify”Known Substance” for raising objections under Sec 3(d)"},"content":{"rendered":"
DS Biopharma Limited v. The Controller of Patents and Designs<\/h5>\n

Prosecution history<\/strong><\/p>\n

DS Biopharma Limited has filed a patent Application (PCT NP Appln No: 201717040270) on 10\/11\/2017 titled \u201cCOMPOSITIONS COMPRISING 15 OXO EPA OR 15 OXO DGLA AND METHODS OF MAKING AND USING SAME\u201d.<\/p>\n

FER Report was issued on 05\/03\/2020 wherein the objections were raised for lack of Inventive Step u\/s 2(1)(j) (Claims 1-26), Non-patentability u\/s 3(i) (Claims 7-26) and lack of clarity and conciseness u\/s 10(5) & 10(4)(c) (Claims 2-3, 5-6).<\/p>\n

FER response was filed by the applicant on 08\/07\/2020 with claims 1-6 alone and claims 7-16 being cancelled.<\/p>\n

Hearing Notice was issued on 25\/11\/2020 with hearing scheduled on 18\/12\/2020 with objections u\/s 3 \u2013 \u201cSubject matter claimed in claim 1,4 is not Patentable u\/s\/ 3 (d) of Patents Act\u201d and a review petition was issued confirming that the objection was still outstanding.<\/p>\n

The application was rejected by the Patent Office vide the impugned order dated January 13, 2021<\/p>\n

The Appellant moved to the court stating that the hearing notice which quoted Section 3(d) did not identify the known substance. They cited the IPAB judgement of Fresenius Kabi v. Glaxo Group that for objecting under Section 3(d) the Patent Office has to identify the known substance. The appellant contended that without the identification of the known substance, it is not possible to respond to the objection and also further quoted that there is no legal obligation u\/s 3(d) to provide the efficacy, if the \u2018known substance\u2019 is not identified.<\/p>\n

Moreover, Section 3(d) objection was not made in the FER but was pointed out at a later stage in the hearing notice. The Appellant was not given sufficient time period for responding to the objection. They had hardly 23 days to respond while the appellant might have got 6 months to respond if the same 3(d) objection was pointed out earlier in the FER.<\/p>\n

IPO argued that all the prior arts (D1-D6) were already disclosed in the FER and the appellant has failed to provide the efficacy data in order to prove that the newly claimed compound has enhanced therapeutic efficacy compared to the known substance, being a derivative or new form of the known substance.<\/p>\n

Decision of the Court<\/strong><\/p>\n

The Court in its order, observed that in order to raise an objection under section 3(d), the known substance has to identified. The Patent Office has to point out the known substance and why the claimed compound seems to be a new form or derivative of the known substance. The Patent office failed to mention the known substance in the hearing notice and the burden of identifying the \u2018known substance\u2019 cannot fall on the Appellant. Also, the Appellant did not get sufficient time to respond to the 3(d) objection since this objection was raised in the hearing notice. Based on this the court ruled the impugned order of the Patent office. The court further directed the Appellant to file a response within a period of 8 weeks\u2019 time with the necessary efficacy data and the controller can decide the validity of the claims based on the response through a hearing.<\/p>\n

This decision has reinstated the IPAB judgement of Fresenius Kabi and laid a new guideline for Patent office for raising any objection under Section 3(d).<\/p>\n","protected":false},"excerpt":{"rendered":"

Patent Office should identify Known Substance for raising Sec 3(d) objections – Delhi High Court<\/p>\n","protected":false},"author":1,"featured_media":487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[30],"tags":[84,85,82,81,79,83,80],"yoast_head":"\r\nDelhi HC holds that IPO must identify"Known Substance" for raising objections under Sec 3(d) - Lexadept IP Associates<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.lexadept.com\/?p=108\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Delhi HC holds that IPO must identify"Known Substance" for raising objections under Sec 3(d) - Lexadept IP Associates\" \/>\r\n<meta property=\"og:description\" content=\"Patent Office should identify Known Substance for raising Sec 3(d) objections - 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