API and IP Newsletter
Contents
FDA approvals in December: Part I
General information.
Home maker Shubhangitai Patil receives patent for Ragi Walnut Soup recipe.
Drugmakers raise prices 3.3% in the New Year
Intellectual Property.
Ibrutinib Compound patent in India.
FDA approvals in December: Part I
The objective of this write-up is to deep dive in synthetically manufactured APIs. This week, in the API Newsletter, we would cover two such APIs:
1.) Vibegron
2.) Relugolix
Vibergron:
Compound 14 in WO2011043942A1 is Vibegron. A process details could be found on page no. 42 and 43 of WO2011043942A1.
A composition of matter patent family could be WO2009124166A1. Vibegron is individualized in claim 7 of WO2009124166A1. Assuming composition of matter patent would be subjected to Patent Term Extensions in key jurisdictions, one could use processes in WO 2011 patent family. No process claims are seen in some of the equivalents of WO 2011 family. However, all these aspects to be studied very carefully, and strategies to be finalized with the help of patent department after detailed analysis of the patent landscape.
Jubilant, Laurus and Sai are importing oxazolidine derivatives, could be working on Vibegron API.
Relugolix:
There are several patent families by Takeda relate to Relugolix. Composition of matter patent is WO 2004/067535. Among other relevant families, WO 2010/026993 relates to pharmaceutical compositions containing, Relugolix, WO 2014/051164 relates to processes and crystalline forms of Relugolix. WO 2016/136849 relates to a solid preparation. In short, there is lot of IP around.
GVK, Sai, TCG Lifesciences are importing chloropyridazine derivatives makes it clear that these companies are active in Relugolix.
General information
Home maker Shubhangitai Patil receives patent for Ragi Walnut Soup recipe.
A 52-year-old Pune based home-maker, Shubhangi Patil has been granted a patent by the Office of Controller General of Patents, Designs & Trade Marks, for her unique recipe of ragi (finger millet) walnut soup.
This is to be evaluated for Section 3(e) requirements of Indian patent Act and I am sure there would be many stalwarts in Indian Patent Acts, who would be commenting on the grant of this patent. Section 3 (e) has been bothering Patent attorneys and agents defending Pharmaceutical patents a lot. (Read more)
Drug makers raise prices 3.3% in the New Year
GlaxoSmithKline PLC and Sanofi SA are among the companies that raised the prices of hundreds of drugs by an average of 3.3%, according to a new analysis.
Pfizer Inc., which has a large portfolio of products, led the way with the most increases, raising prices by 5% or less on more than 200 products. (Read more)
Intellectual Property
There are not many Courts working over holidays, not for IP cases for sure. We take the opportunity to summarize few of our earlier cases covered.
Ibrutinib Compound patent in India
We had circulated our views on Ibrutinib case in early July.
Patent was revoked in post grant opposition and Patentee appealed in IPAB for revocation of the Controller’s decision.
We had a view that Controller had erred in his understanding of science and analysis of prior art. IPAB confirmed our view on 29 September and revoked the controller’s decision. Patent is reinstated. It should be valid till 2026.
Sidvim LifeSciences Private Limited posted on LinkedIn
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.
