API and IP Newsletter
Contents
FDA approvals in October 2020.
General information.
Micro Labs to set up API facility near Bengaluru with INR 476 Cr investment
Healthcare Pharma going all out
Intellectual Property.
AstraZeneca in legal fight with 12 drug makers over diabetic drug Dapagliflozin.
FDA approvals in October 2020
Remdesivir:
A lot has been discussed about Remdesivir in the last six months. We will keep our discussions confined to the chemistry of Remdesivir. The process is described in example 12 in WO2016069825A1 and example 4 WO 2017/184668, compound 9. Attached here and here.
Example 4. (2S)-2-ethylbutyl 2-((((2R,3S,4R,5R)-5-(4-aminopyrrolo[l,2-firi,2,41triazin- 7-yl)-5-cvano-3,4-dihvdroxytetrahydrofuran-2- yl)methoxy)(phenoxy)phosphorylamino) propanoate (Compound 9)
The second-generation synthesis of Remdesivir is reported here. The second-generation synthesis is far better improvement in terms of scalability, it yields Sp isomer in 69% yield (SN2 type inversion) and stereoselectivity bypassing the bottleneck of inconsistent yields and chiral separation.
Most of these processes are patented by Gilead, however, these patent families in quick search, were not found to have Indian equivalents. This legal status to be checked very thoroughly but prima facie, it appears these processes could be used freely in India. These are patent families in 2015, 2016 and 2017, perhaps for Ebola, Gilead thought then, since Ebola is not going to be big market in India there is no point in validating patent applications in India. But word of caution here, one must check legal status of these applications via law firm or writing to patent offices and ensure there is no equivalent in India before any business decision.
General information
Micro Labs to set up API facility near Bengaluru with INR 476 Cr investment
The Karnataka government has cleared the proposal of Micro Labs Limited to set up an active pharmaceutical ingredient (API) unit near Bengaluru with an investment of INR 476 crore and employ 767 people. (Read more)
Healthcare Pharma going all out
Healthcare Pharmaceuticals Ltd (HPL) is going to invest about Tk 220 crore ($25.68 million) to establish large-scale active pharmaceutical ingredient (API) and formulation facilities to meet their growing demand in Bangladesh. The company will produce API and formulated pharma products at the new manufacturing units to be established on 30 acres of land at the Bangabandhu Sheikh Mujib Shilpa Nagar (BSMSN) in Chattogram. (Read more)
Intellectual Property
AstraZeneca in legal fight with 12 drug makers over diabetic drug Dapagliflozin
This is classic case of Genus vs specific claim. Two patents-in-suit are IN 205147 (Genus patent - expired on 02 October 2020) & IN 235625 (specific patent – in force, expiration on 15 May 2023).
Natco launched at risk, the generic version of Dapagliflozin in March 2020. AstraZeneca sued Natco after the launch and in its response, Natco said it has stopped the production and sale of a generic version of dapagliflozin till December 31, 2020, and given the difficulty to recall the products it has already sold, the company they gave a bank guarantee for Rs 3 crore that can be encashed by AstraZeneca in case of a Court verdict in favour of AstraZeneca.
The story became complicated when on 02 October 2020, many other generics launched in India after expiration of patent with genus claim. AstraZeneca moved the court for preliminary injunction (PI) and court denied PI. Court opined, injunctive factors such as balance of convenience, irreparable harm & public interest, etc. are in favour of generic companies (defendants), but, asked generic companies to place on record the details, quantum, and value of drug manufactured and sold. The Gxs via their affidavits will also undertake to pay damages as and when called upon to do so by the Court. (Read more)
In general, once a product in launched by Gx, it is extremely difficult to seek PI from the Courts in India. Validity of IN 235625 would determine fate of the other generics’ who have launched at the risk on 02 October 2020. That case would go on, and as per one of the news articles, hearing is scheduled in December 2020 (This needs to be confirmed).
Now about the two patents and claims. You could be a judge!
IN 205147 Claims (Expired on 02 October 2020):
IN 235625 claims specific dapagliflozin:
You could answer following questions to opine whether IN 235625 is valid.
1.) Whether Dapagliflozin claimed in IN 235625 is anticipated based on Markush structure in IN 205147?
2.) Dapagliflozin individualized in IN 205147?
3.) Wouldn’t there be millions of compounds in IN 205147 Markush structure and Dapagliflozin is just one of those millions of compounds?
4.) One must conduct undue experimentation to arrive at dapagliflozin from IN 205147?
Very broadly, if your answers to first two questions is NO and for 3rd and 4th answers are YES then there is reasonable chance that IN 235625 would be valid. But patent law is never so simple. We must wait for the Court’s decision.
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.
