API and IP Newsletter
Content
FDA approvals in the month of June 2021.
General information.
The U.S. Needs to Reimagine Its Pharma Supply Chain.
Almac, PILA PHARMA Enter API Manufacturing Pact
Intellectual Property.
FDA approvals in month of June 2021
Below are the approvals for the month of June. We will be covering the chemistry of small molecules in this and subsequent Newsletters.
This week let us look at chemistry of Finerenone.
Finerenone
The example 30 A in WO2008104306A2 is the representative example for Finerenone.
General information
The U.S. Needs to Reimagine Its Pharma Supply Chain
The global over-reliance on China and India for APIs, the precursor key starting materials (KSMs) required to produce them, and essential medicines is especially worrisome. An estimated 80% of the world’s APIs come from China, India, and a handful of other foreign countries. U.S. dependence on these limited sources hit home when India imposed an export ban on medicines during the pandemic. (Read more)
Almac, PILA PHARMA Enter API Manufacturing Pact
Almac Sciences will manufacture XEN-D0501, a highly selective and very potent small molecule TRPV1 antagonist, from its global headquarters in Northern Ireland. The TRPV1 target was previously in development by Bayer and Xention/Ario Pharma and has demonstrated applications across pain and inflammatory diseases and possibly in diabetes.
PILA acquired XEN-D0501 in March 2016. (Read more)
Intellectual Property
GSK vs Teva on Skinny label or Cave-out issues
Section viii carve outs
What is Section viii carve outs in the US?
The statute (21 U.S.C. § 355(j)(2)(A)(viii)) allows the generic sponsor to remove or “carve out” the protected indication or other protected condition of use from the product labelling, and submit a “section viii” statement explaining that the applicant does not seek approval for the protected use.
Though the statue looks simple, the issues related to section viii carve-outs remain unresolved in the context of the small molecules. In February 2020, The FDA issued draft guidance which makes it explicitly clear that carve-outs are indeed permissible for biosimilars.
This is the case of Carvedilol and GSK’s patent reissued in 2008, related to treatment of congestive heart failure using carvedilol.
In lower court, Teva argued that it could not be found to have induced infringement because the patented use was carved out on the skinny label.
The lower Court held that GSK failed to prove Teva caused the direct infringement.
GSK appealed. On appeal, GSK argued that Teva promotes its generic product as being the same as the branded product.
In October, a three-judge CAFC panel decided in favour of GSK.
The appeal court was to review the case "en banc," which means the court's entire complement of 12 judges was to hear arguments.
This will be an interesting case to follow, and it would pave the way for generics to carve out labels and subsequently market their products. News was here.
On 05 August 2021, the appeal court confirmed the earlier verdict. The implications could be significant. Going forward, this decision could create considerable risks for generic companies using skinny labels. The potential carve-out could be more difficult for any generic company to execute.
News is 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.
