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 molecule approvals every month. with more emphasis on the latter. Other aspects of the drugs, such as mechanism of action, method of use, method of administration etc. are generally not covered.
Melphalan flufenamide:
Melphalan flufenamide is a peptidase enhanced cytotoxic (PEnC) that exerts a targeted delivery of Melphalan. Brand name, PEPAXTO, the drug approved in combination with Dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma.
HCl salt, L-Melphalanyl-L-p-fluorophenylalanine ethyl ester hydrochloride reported in WO 2001/096367 in example 1, compound J1 as white crystals. NMR is reported.
Equivalent of this family are not yet listed in OB. Mostly US6992207B2, would be listed in OB. Assuming 5 years PTE, the expiration of this composition of matter patent in US would be in 2027.
GVK Bioscience has imported 4-Fluorophenylalanine as per import export database and there is a high likelihood that GVK is developing Melphalan flufenamide API.
Fosdenopterin:
WO 2012/112922 (Alexion) family describes the process of synthesis of Fosdenopterin.
API requirement must be very small. Processes reported in this patent family filed by the innovator, isolation of API is by using preparative HPLC.
General information
Novartis' Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first
A slate of other generics makers filed ANDA on September 12, 2016. And now, unless the court tells the FDA to accept Sandoz's September 7 ANDA application, it will be vying for market space alongside 20 other generic applicants when Aubagio generics launch in 2023. Sanofi has sold a rheumatoid arthritis drug, Arava, whose active ingredient is leflunomide. That ingredient is metabolized in the body to become teriflunomide (Aubagio). (Read more)
By April 28 decide on 2 TB drugs, Bombay HC tells Centre
Bombay high court asked the Centre to decide by April 28 on a representation made last November for ‘compulsory licenses’ to import two patented life-saving anti-TB drugs Bedaquiline and Delamanid. (Read more)
Intellectual Property
Decision on patenting computer simulations in Europe G 1/19
This is the decision by EBA. The European Patent Office has an "Enlarged Board of Appeal" (EBA) is fundamentally a legal instance in charge of deciding on question of Law, not question of Facts. Very few cases are decided by EBA.
Examining Division at the EPO refused to grant patent application EP 1546 948 due to lack of inventive step.
There were three fundamental questions of Law in front of EBA. They are summarised below.
1. In the assessment of inventive step, can the computer-implemented simulation of a technical system or process solve a technical problem?
2. If the answer to the first question is yes, what are the relevant criteria for assessing the inventive step.
3. What are the answers to the first and second questions if the computer-implemented simulation is claimed as part of a design process, in particular for verifying a design?
EBA decision this week does not rule out patenting computer simulations in Europe. This decision would have implication in our pharmaceutical patenting also and many patent attorneys would be innovative henceforth to protect interests of their clients. Many claims related to computer simulations would be drafted and examined by European patent offices.
News 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.
