API and IP Newsletter
Contents
FDA approvals in January 2021.
General information.
FDA: Compounded Remdesivir Products Should Not Be Used.
Seqens majority owner looking to sell API maker amid record-high run in healthcare valuations: report
Intellectual Property.
Patent claims mNeonGreen technology. Granted claim in US is as follows
FDA approvals in January 2021
In this write-up, we would evaluate synthetic APIs. Last week we looked at chemistry of Cabotegravir. This week, we will understand the synthesis and potential of Vericiguat for the generic pharmaceutical industry.
Vericiguat
Composition of matter patent of Riociguat WO2003095451A1 could be considered as basic patent for Vericiguat. A couple of processes of such compounds are disclosed in patent literature. An example 1 in WO2011161099A1 shows the synthesis of Vericiguat.
Subtle structure difference between Riociguat and Vericiguat:
Alembic and MSN have already filed DMFs for Riociguat. These two companies should be able to quickly file DMFs for Vericiguat as well. Teva filed ANDA for Riociguat, and it could be assumed that there could be a possibility that the same strategy might work for them for vericiguat on NCE-1 date.
General information
FDA: Compounded Remdesivir Products Should Not Be Used
Remdesivir, marketed under the brand name Veklury, is indicated for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization in adults and paediatric patients 12 years of age and older and weighing at least 40 kg. In a safety communication, the Agency urged healthcare providers to only use the FDA-approved product as “using API forms that differ from the API in the FDA-approved drug may affect the compounded drug’s quality, including the solubility of the API in the compounded drug.” (Read more)
Seqens majority owner looking to sell API maker amid record-high run in healthcare valuations: Report
Three years after it rebranded from Novacap, Seqens, a French pharmaceutical manufacturer and ingredient supplier is reportedly being prepped for sale. (Read more)
Intellectual Property
Safe Harbour Provision in US
US10221221B2 (issued to Allele Biotechnology)
Patent claims mNeonGreen technology. Granted claim in US is as follows:
1. A non-naturally occurring isolated monomeric or dimeric lanYFP fluorescent protein comprising a polypeptide having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 1-----”
mNeonGreen is a new technology, which is a bright monomeric yellow-green fluorescent protein.As imaging moves into the super resolution era, most common fluorescent proteins, including Green Fluorescent Protein (GFP), may not possess certain characteristics beneficial for super resolution applications.
mNeonGreen was employed by Pfizer/ BioNTech for use in the ongoing vaccine trial for Covid-19 and forms a part of its regulatory submission to the USFDA.
According to Allele, many other companies and Universities licensed the technology from them, but Pfizer and BioNTech chose not to do so.
Pfizer argued Safe Harbor provision in Hatch-Waxman Act.
What is “The Safe Harbour” provision the Act? This provision allows companies to engage in infringing activities which are necessary to obtain regulatory approvals.
Allele argument revolves around mNeonGreen being a "breakthrough" artificial fluorescent, that is being used to make "the gold standard" COVID-19 assay for testing against vaccine candidates. So, it should be considered as patent infringement, if the technology is not licensed from Allele.
According to Pfizer and BioNTech, their alleged use of mNeonGreen was "reasonably related" to developing data for FDA approval, meaning they are protected by the Safe Harbor provision of the Hatch-Waxman Act. Hence it is not a patent infringement.
Court is yet to opine. Details 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.
