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Roche Products (India) Pvt Ltd & Ors vs Drugs Controller General Of India And ... on 25 April, 2016

168. This Court in Bayer Corporation and another v. Union of India and Others, (2010 (43) PTC 12 (Del) (DB)), has rightly held that Appendix IA to Schedule Y of the Drugs Rules applies to generic versions of a patented drug. The manufacturer of a generic version of a patented drug is only required to satisfy defendant No.1 that its drug is bioavailable and bioequivalent to the patented drug (as required under Appendix IA).
Delhi High Court Cites 81 - Cited by 1 - M Singh - Full Document

Genentech Inc And Others vs Drugs Controller General Of India And ... on 25 April, 2016

113. This Court in Bayer Corporation and another v. Union of India and Others (2010 (43) PTC 12 (Del) (DB)) has rightly held that Appendix IA to Schedule Y of the Drugs Rules applies to generic versions of a patented drug. The manufacturer of a generic version of a patented drug is only required to satisfy defendant No. 1 that its drug is bioavailable and bioequivalent to the patented drug (as required under Appendix IA).
Delhi High Court Cites 49 - Cited by 1 - M Singh - Full Document

F. Hoffmann-La Roche Ag & Anr vs Biophore India Pharmaceuticals ... on 28 March, 2024

6. Mr. Singh, representing the Defendant, before commencement of the hearing, on instructions states that the Defendant has neither manufactured nor sold any commercial/ non-commercial quantity of Risdiplam in India or anywhere else. He states that presently, the Defendant is using Risdiplam only for the purposes of research, as permissible under Section 107A of the Patents Act, 1970 ["Act"], in terms of the guidelines laid down in Bayer Corporation & Anr. v. Union of India & Ors.1. Mr. Singh further places 1 2019 SCC OnLine Del 8209 This is a digitally signed order.
Delhi High Court - Orders Cites 3 - Cited by 0 - S Narula - Full Document
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