API and IP Newsletter
Contents
FDA approvals in April 2021.
This week, let us understand the chemistry of infigratinib.
WO2006000420A1, covers the compound. Example 145 discloses infigratinib.
General information.
Govt Issues Operational Guidelines For PLI Scheme For Pharmaceutical Industry.
Sun Pharma, Ferring Pharma ink pact to introduce obstetric drug in India.
Intellectual Property.
Claim construction dispute for tenofovir alafenamide.
FDA approvals in April 2021
Every month we follow approvals by USFDA and comment about processes followed to manufacture small molecule APIs.
This week, let us understand chemistry of Infigratinib.
WO2006000420A1, covers the compound. Example 145 discloses Infigratinib.
Sai life, Aurigene and couple of other companies are importing 3,5 dimethoxy aniline. Maybe they are trying to develop Infigratinib. One must note, it is not going to be easy. Use of phosgene at stage IV could dampen the enthusiasm of many companies. It would be a challenge for process chemists to develop an alternate route to avoid phosgene and still be cost competitive.
General information
Govt Issues Operational Guidelines For PLI Scheme For Pharmaceutical Industry
The Department of Pharmaceuticals has notified the 'Production Linked Incentive (PLI) Scheme for Pharmaceuticals, for which the approved outlay is Rs 15,000 crore, Ministry of Chemicals and Fertilizers said in a statement. The application window is for 60 days starting from June 2, 2021, to July 31, 2021, the statement said. (Read more)
Sun Pharma, Ferring Pharma ink pact to introduce obstetric drug in India
One of the company's wholly-owned subsidiaries has entered into a license agreement with Ferring Pharmaceuticals Pvt Ltd -- a subsidiary of Switzerland-based Ferring Pharmaceuticals -- to commercialise a room temperature stable formulation of the obstetric drug Caritec in India
Intellectual Property
Claim construction dispute for tenofovir alafenamide
Claim term of U.S. Patent Nos. 7,390,791 and 7,803,788 is construed as follows
1. “tenofovir alafenamide hemifumarate” means “a hemifumarate form of tenofovir alafenamide”
2. “tenofovir alafenamide monofumarate” means “a monofumarate form of tenofovir alafenamide”
The above claim construction was proposed by patentee Gilead. Gilead claim construction finds support in the specifications of equivalent patents, which repeatedly refer to a hemifumarate form of tenofovir alafenamide or “TAF.” Gilead could convince the Hon Judge, stating in the summary of the invention, the patents state “Described is a hemifumarate form of . . . tenofovir alafenamide”.
ANDA filers argued that a person of ordinary skill would recognize that the terms “hemifumarate” and “monofumarate” identify specific salts of TAF, anything other than specific salt is not included in the claim language.
Court said, no, the correspondence with the FDA as well as articles submitted in connection with the briefing, use the term hemifumarate to include things other than salts, such as co-crystals. Thus, the word “hemifumarate” does not necessarily imply only salt but would comprise things other than the salts.
Could accepted claim construction of Gilead. Decision here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
