Posts

Showing posts from November, 2024

API and IP Newsletter

Image
  Contents FDA approvals in October 2024: 505 (b) (2). General information Commission fines Teva €462.6 million over misuse of the patent system FDA Approves Minocycline Hydrochloride Extended-Release Capsules for Individuals with Rosacea Intellectual Property Unilever Vs Henkel AG FDA approvals in October 2024: 505 (b) (2).  We follow 505(b)(2) approvals on the FDA website.  The 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without repeating all the drug development work done for an innovative drug.  A 505(b)(2) applicant may rely on the FDA’s findings of safety and/or effectiveness for a listed drug only to the extent that the proposed product in the 505(b)(2) application shares characteristics (e.g., active ingredient, dosage form, route of administration, strength, indication, or other conditions of use) in common with the relied-upon listed drug/drugs. In 2019, the FDA published guidelines for the industry on whether an applicant sh

API and IP Newsletter

Image
  Contents Patent applications by Emcure Pharmaceuticals General information Daiichi-Singh brothers dispute: Delhi HC orders auctioning of Fortis trademark Delhi High Court reinstates Injunction stopping sale of Zydus’ Sigrima Intellectual Property T 3253/19 (Compositions containing borate-polyol complexes / NOVARTIS) 07-10-2024 Patent applications by Emcure Pharmaceuticals We follow patent filings by Indian companies. This week, we followed patent applications filed by Emcure Pharmaceutical. Public domain information shows that about 15 of Emcure’s patent applications have been published in the last five years. This assessment does not evaluate the strength of Emcure's IP or determine its legal status. However, it could provide an idea of the Emcure Development Centre's direction. What types of products are under development at Emcure?  One must understand that there will be an 18-month lag. Patent applications are generally published 18 months after the priority date.