API and IP Newsletter
Contents
FDA approvals in February 2021.
General information.
Novartis' Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first
By April 28 decide on 2 TB drugs, Bombay HC tells Centre.
Intellectual Property.
FDA approvals in February 2021
In this Newsletter we cover synthetic APIs, small molecules approval every month. The more emphasis on synthesis of APIs than anything else. Other aspects of the drugs, such as mechanism of action, method of use, method of administration etc. are generally not covered. Last week we covered two APIs, this week we will discuss about synthesis of Trilaciclib.
Trilacicilib
Example 91 and compound 91 (also referred to as Compound ZZ) disclosed in WO2016040858A1 refers Trilacicilib.
Jubilant Chemysis and Synzeal are importing derivatives of 1-(Aminomethyl) cyclohexanamine and 5-Bromo-2,4-dichloropyrimidine. There is high likelihood that these companies are developing Trilaciclib API.
WO2015161283A1 could be basic patent family. However, WO2016040858A1 could be equally strong, it has prior rights. This is a specific terminology especially for Europe (and for US too). It means WO2015161283A1 is filed before the date of filing or priority of WO 2016040858A1 but it was not published before filing of WO2016040858A1.
This concept is very important in patent act. One must note, in such cases the earlier application is relevant only to the assessment of the later application's novelty, not its inventive step.
General information
The FTC Is Taking a More Aggressive Approach Toward Pharmaceutical M&A
The Federal Trade Commission warned on Tuesday that it intends to “take an aggressive approach” to “anticompetitive pharmaceutical mergers,” setting off a round of warnings from analysts that biopharma deals could prove harder to accomplish in the coming years.
(here)
The Third to Tango: After Pakistan, Nepal Opposes India’s GI Application for Basmati
The author discussed the implications of Nepal joining Pakistan’s opposition to India’s application for registration of GI over Basmati in the EU. The first IP dispute between the three South Asian countries. Major reasons reported for Nepal’s opposition:
1. Basmati is grown and consumed traditionally in Nepal
2. Nepal has worked extensively with national and international scientists, since 1965, to develop different varieties of rice using local basmati landraces
3. Basmati has social and cultural ties with the Nepalese communities. News here.
Intellectual Property
Carfilzomib (Onyx Therapeutics Inc vs Cipla)
OB listed patents are as below. It is about 2 bn product in USA.
Onyx sued all Gx filers, there were 10 of those. Expect Cipla others entered into agreement with Onyx. Cipla continued to challenge validity of Onyx’s US patents US 7,417,042 and 8,207,125 (Compound Patents) expiring in 2025 and 2026 and US 7,737,112 (Formulation Patent) expiring in 2027
Trial was held in May 2019 and decision was handed down last week.
OB listed patents are as below.
Prior art:
Prior art or lead compound cited by Cipla was YU-101 (Proteolix) disclosed in the US 6,831,099 Patent.
Court said,
Cipla has not proven that the Compound Patents are invalid due to obviousness, for at least two reasons.
1. Cipla failed to meet its burden to prove that YU-101 would have been an obvious lead compound to develop as a drug product or improved molecular probe.
2. even if YU-101 were a lead compound, Cipla failed to meet its burden to show any motivation to modify YU-101’s N-terminus with a morpholino methylene with any reasonable likelihood of success.
There are many more interesting aspects to this case and for more details one can glance through the link 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.
