API and IP Newsletter
Contents
FDA approvals in March 2021.
General information.
Collaboration to encourage US adoption of continuous manufacturing.
Delhi HC Restrains Eris Lifesciences from Infringing Novartis Sacubitril, Valsartan FDC.
Intellectual Property.
Kibow Biotech Vs La Renon (Madras HC decision)
FDA approvals in March 2021
In coming weeks we will provide information about FDA approvals in March 2021.
We will concentrate on small molecules and that too mainly from synthesis of small molecules. We will not cover mechanism of action and other details of the molecule.
This week we will cover synthesis of ponesimod
This API process is disclosed in WO 2005054215 A1
1. WO2005054215A1 discloses compound in example 86. NMR is reported. This family could be considered as basic (composition of matter) patent family and could be extended in US and Europe approximately till 2029.
2. WO2008062376A2: Discloses improved process, intermediate is disclosed in example 16.
3. WO2010046835A1: Relates to crystalline forms.
4. WO2014027330A1: Relates to industrial process. This process patent will be valid till 2033 in Europe and US would extend much beyond patent term extension on basic patent. So, lot of scope for process chemists to design around process patents, file new applications for polymorphs!
5. WO2019060147A1: Application filed by Teva relates to new crystalline forms. The priority date of this PCT application is in September 2017. Teva must have started working on this molecule 5 years before its approval!!
General information
Collaboration to encourage US adoption of continuous manufacturing
USP and Phlow have built a new laboratory to develop test methods and standards to facilitate broader. adoption of continuous manufacturing in the US. News here.
Delhi HC Restrains Eris Lifesciences from Infringing Novartis Sacubitril, Valsartan FDC
News(here)
Intellectual Property
Kibow Biotech Vs La Renon (Madras HC decision)
Let us first understand what cannot be patented in India. Section 3 of Indian Patent Act defines what are not inventions. In this section 3, Section 3 (e) states, a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not considered as an invention.
However admixtures could be considered as inventions proviso, functional interaction between the components achieves a combined technical effect which is greater than the sum of the technical effects of the individual components.
Here is a case Kibow Biotech (Philadelphia based company and exclusive licensee Centaur Pharmaceuticals ) vs La Renon (Ahmedabad)
Kibow’s patent IN 224100 relates to Compositions for augmenting kidney function using probiotic Streptococcus. Kilbow argued that La Renon’s products Cudo Forte and Probigress, infringe their patent and sought injunction. Court granted the injunction. The matter went before the appellate board (IPAB).
IPAB denied La Renon’s challenge and upheld Kibow’s patent. La Renon then sought a review of this ruling before the Madras high court, which confirmed IPAB decision.
The Court opined that Kibow’s efforts in identifying the probiotic among plethora of other bacterium and determining the required quantity for forming the colony requires research; and to identify this probiotic, numerous others would have been tested and rejected. The Court therefore observed that the present invention cannot be regarded as a mere admixture or a “discovery made overnight.”
This case could have impact on many cases related to famous section 3 (d) in pharmaceutical litigations. Where Markush claim is cited to invalidate specific compound claim. In chemical inventions also, one would require do lot of research, to identify specific moiety with substantial activity, numerous others would have been tested and rejected.
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.
