API and IP Newsletter

 

Contents

• DMFs filed in December 2020. 

• General information. 

• Ahead Of Tata Deal, BigBasket Sues ‘Daily Basket’ For Trademark Infringement 

• Q&A With Dr. Reddy’s Anjum Swaroop. 

• Intellectual Property. 

DMFs filed in December 2020

We had covered only a part of DMFs filed by Indian companies in earlier Newsletters. Since many were filed in December, we are covering a few more DMFs in this Newsletter.

HOLDER	SUBJECT	SIDVIM Comments
ALEMBIC PHARMACEUTICALS LTD	THEOPHYLLINE USP	Several ANDAs, and only DMF! This is an old compound and a very smart selection by Alembic.
INNOVARE LABS PRIVATE LTD	TENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)	DMF for intermediate.
GRANULES INDIA LTD	VIGABATRIN, USP	About half a dozen DMFs already. DRL has 180 days exclusivity starting from February 2021. Commercial business would start for these API suppliers soon. Granules would be a second source.
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	VALSARTAN	Lots of issues with Valsartan API in the recent past. Some companies have to change processes to make product devoid of NDMA. Biophore exploring a business opportunity here.
METROCHEM API PRIVATE LTD	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	Old API
OPTIMUS DRUGS PRIVATE LTD	MESALAMINE	Several DMFs and several ANDA filers. Optimus would be one among them.
SOLARA ACTIVE PHARMA SCIENCES LTD	MEBENDAZOLE USP	Discontinued for human use. This must be for veterinary use and VMF. Huge market for pets and livestock against internal parasites. Not many VMFs for Mebendazole.
OPTIMUS DRUGS PRIVATE LTD	ZILEUTON	8 DMFs and many ANDA filers.
MSN LIFE SCIENCES PRIVATE LTD	FAVIPIRAVIR	Lot of noise about Favipiravir. MSN is the only second company to file DMF.
METROCHEM API PRIVATE LTD	OZENOXACIN	The second Indian company to file DMF. Compound patent would expire in 2021 but many composition patents could be able protect the product. Circumvention of composition patents could be challenging for Gxs for launches. NCE-1 date will be in November 2021 and few F2F could be expected. Smart selection by Metrochem.
OPTIMUS DRUGS PRIVATE LTD	LINEZOLID	Vanilla generic product, several DMFs. Unless there is a cost advantage, Optimus would find it very hard to enter as a second source.
LUPIN LTD	DEUTETRABENAZINE	First DMF. There would not be many DMFs. Deutetrabenazine is a deuterated form of tetrabenazine. It seems Lupin has developed competency to develop and manufacture deuterated compounds at commercial scale!
CADILA HEALTHCARE LTD	RIFAXIMIN (PROCESS-II)	Several DMFs.
AURO PEPTIDES LTD	GLATIRAMER ACETATE	Three other Indian DMFs are active, but very difficult to manufacture API and low cost supplier could find it easy to register as a second source.
CIPLA LTD	DASATINIB (A)	Several suppliers. Cipla could have developed API for own ANDA?
SUN PHARMACEUTICAL INDUSTRIES LTD	NILOTINIB BUTANEDISULFONATE	Five DMFs exists, Sun could be using it for captive consumption. Launch looks difficult before 2024.
HETERO LABS LTD	ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (AS 20.94%W/W OF ESOMEPRAZOLE)	DR pellets
METROCHEM API PRIVATE LTD	LANSOPRAZOLE USP	Vanilla generic product
HETERO DRUGS LTD	ALLOPURINOL	Old product. Half dozen DMFs active, this indicates a new trend, the companies like Hetero are seeing business opportunities in old molecules too!

General information

Ahead Of Tata Deal, BigBasket Sues ‘Daily Basket’ For Trademark Infringement 

BigBasket legal team sent a ‘cease and desist letter’ to Coimbatore-based Daily Basket for trademark infringement (Read more) 

Q&A With Dr. Reddy’s Anjum Swaroop

One thing is certain: the industry and the world will be better prepared for the next global pandemic. There has been a huge uptake in digital technology that has in many respects increased connectivity within and among companies. We are also seeing unprecedented levels of collaboration within the industry that I expect to continue. (Read more)  

Intellectual Property 

AstraZeneca vs Mylan Symbicort patent litigation in district Court of West Virginia 

Mylan filed ANDA and challenged AstraZeneca’s patents protecting Symbicort (Budesonide/ Formoterol) in the US.

Symbicort worldwide sale is USD 2 bn. Symbicort is a pressurised metered-dose inhaler (pMDI). In the US, Symbicort is only approved for use in a pMDI. 

In January 2020, AstraZeneca entered an agreement with Prasco LLC to distribute an authorised-generic version of Symbicort in the US. 

OB listed patent and patents are as below and patents in suit are marked in yellow:

Patent No	Patent Expiration	Drug Product	Patent Use Code	Submission Date
7587988	04/10/2026	DP
7587988*PED	10/10/2026
7759328	01/29/2023	DP	U-2001   U-2002   U-2122
7759328*PED	07/29/2023
7967011	08/11/2021	DP
7967011*PED	02/11/2022
8143239	01/29/2023	DP	U-2001   U-2002   U-2122
8143239*PED	07/29/2023
8387615	03/26/2027	DP
8387615*PED	09/26/2027
8528545	10/16/2028	DP		10/09/2013
8528545*PED	04/16/2029
8575137	01/29/2023	DP	U-2001   U-2002   U-2122	12/04/2013
8575137*PED	07/29/2023
8616196	04/07/2029	DP		01/29/2014
8616196*PED	10/07/2029
8875699	11/10/2024	DP		12/12/2014
8875699*PED	05/10/2025
10166247	01/29/2023	DP	U-2001   U-2002   U-2122	01/07/2019
10166247*PED	07/29/2023

These patents broadly cover composition (pMDI) containing Budesonide and Formoterol along with excipients such as HFA 227, PVP K25 and PEG-1000 with certain concentrations.

Prior art cited:

1.)   Mistry

Mistry contemplated numerous medicaments that may be dispersed in a propellant mixture, including drugs such as sodium cromoglycate, nedocromil sodium, inhaled steroids like budesonide, bronchodilators like salbutamol, reproterol, and formoterol, anticholinergics, and combinations of two or more agents.

2.)   Rogueda

Rogueda disclosed several medicines, excipients, and lubricants that could be included in pMDIs.   Rogueda performed tests to compare his invention containing polar fluorinated molecules to several “control” formulations. Control 3 and Control 9 in Rogueda are relevant to the patents-in-suit.

Rogueda found that samples prepared with HFA 134a were on average better than the ones prepared with HFA 227.

AstraZeneca argued that, had a person of ordinary skill in the art (POSA) relied on Mistry’s disclosures alone, the sheer number of potential formulations would have exceeded 2,560,000!

Second prior art (Rogueda) taught away from the claimed invention because the combinations closest to the claimed formulation were unsuitable/inferior. 

Hence, there is no obvious to select option in prior art at the priority date. There were neither predictable solutions, nor was there a reasonable expectation of success. 

Analysing these prior arts, Court opined POSA would not have had a reasonable expectation of success in creating a stable Budesonide/ Formoterol pMDI using HFA 227, PVP K25, and PEG-1000. 

The Court decided in favour of AstraZeneca. Details 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.