API and IP Newsletter

 

Contents

• Analysis of DMF filed in March 2021. 

• General information. 

• Optimus Pharma gets nod for phase 3 trials of Molnupiravir capsule. 

• Sandoz plans $183m boost to antibiotics production in Europe. 

• Intellectual Property. 

• Patents for Covid vaccines in India.  

Analysis of DMF filed in March 2021 

We analyse DMFs filed by various Indian companies in our organisation. Every quarter, the filings are published by USFDA. This week we analysed DMFs filed in the month of March 2021. There are more than 85 DMFs filed in March 2021! As expected more than 55 DMFs were filed by Indian companies. To cover all 55 DMFs in this one write-up would have been challenging and this post would have ran into several pages.  Hence, we are covering only a few DMFs this week. 

HOLDER	SUBJECT	Sidvim Comments
GLENMARK LIFE SCIENCE LTD	IRON SUCROSE	There are 15 other DMFs. Is Glenmark late?
JUBILANT GENERICS LTD	HISTAMINE DIHYDROCHLORIDE	First Indian DMF. Histamine phosphate is discontinued. It was Eli Lilly's old product. Dihydrochloride does not have an FDA approval for AML. One should investigate why companies started filing DMF for this yet to be approved product by FDA.
ALEMBIC PHARMACEUTICALS LTD	CHLORDIAZEPOXIDE HYDROCHLORIDE USP	Very old product, several dossiers in the market. Five other DMFs though three of them were filed in last two years. Business potential for API supplier to be evaluated. This must be under Narcotics Act, but needs to be checked.
ALKEM LABORATORIES LTD	AMLODIPINE BENZOATE	First DMF for benzoate salt. Alkem would be filing different salt in US, either own dossier or with the partner.
EMCURE PHARMACEUTICALS LTD	LISINOPRIL USP	Eight other DMF holders, very competitive market.
SUPRIYA LIFESCIENCE LTD	METHYLCOBALAMIN USP	Old product. First DMF filed after 10 years in US.
MSN LIFE SCIENCES PRIVATE LTD	LOSARTAN POTASSIUM USP	Many DMFs, MSN would be one among other two dozen companies.
MANKIND PHARMA LTD	SITAGLIPTIN PHOSPHATE	Could be highly cost competitive market. Every month some company is filing DMF for Sitagliptin. There are about 50 DMFs active for Sitagliptin.
SCINOPHARM TAIWAN LTD	ELAGOLIX SODIUM	Since launch is approaching, many companies must be gearing up for filing. Two DMFs filed in last two months. Many more to come soon.
SOLARA ACTIVE PHARMA SCIENCES LTD	SAFINAMIDE MESYLATE	This is 2017 approval and 10 DMFs filed already. Many companies must be eyeing on NCE-1 date.
SOLARA ACTIVE PHARMA SCIENCES LTD	MYCOPHENOLATE SODIUM USP	Not many DMFs are active for sodium salt, there are many for mofetil salt.

General information 

Optimus Pharma gets nod for phase 3 trials of Molnupiravir capsule

Drug-maker Optimus Pharma on Wednesday said it received approval of the Drugs Controller General of India (DCGI) to conduct Phase III clinical trials for Molnupiravir capsule on mild and moderate COVID-19 patients (Read more).

 

Sandoz plans $183m boost to antibiotics production in Europe

Novartis subsidiary Sandoz is set to boost its antibiotics manufacturing network in Europe by increasing capabilities in Kundl, Austria and Palafolls, Spain, with a total investment of $183m (€150m). 

Initially, the company will invest about $122 mn (€100m) to launch new manufacturing technology to produce oral amoxicillin, which is an active pharmaceutical ingredient (API) in its penicillin medicine.

In line with the network modernisation strategy, Sandoz will discontinue the production of oral APIs at its Les Franqueses site in Spain, which is to be closed in 2024 (Read more).

 

Intellectual Property

Patents for Covid vaccines in India. 

There was news last week in many leading newspapers that the Biden administration announced the United States will support temporary waiver of intellectual property rights to Covid-19 vaccines, accepting a key element of a joint proposal by India and South Africa at the WTO. 

There were many media reports covering this story. However, no news had covered how many actual patent applications are filed in India for these vaccines and what is their legal status in India. Is there any patent protection for the vaccines which are being sold (or distributed free by the Government channels) in India? We decided to investigate the matter and our findings are summarised in the below table.

Innovator	Patent family	Filing date	Indian equivalent	Comment about Patent claims filed in PCT application
Moderna	WO2017070626A2	21-Oct-16	No	Patent relates to mRNA vaccines where the betacoronavirus structural protein is spike protein (S). Patent cover Moderna’s mRNA vaccine, for numerous respiratory diseases, including the betacoronavirus (BetaCoVs), one of four coronaviruses, including MERS-CoV and SARS.
AstraZeneca	WO2012172277A1	25-May-12	IN 318021 (Granted)	Patent family relates to novel adenoviral vectors derived from a chimpanzee adenovirus, immunogenic compositions thereof and their use in medicine.
Johnson & Johnson	WO2012082918A1	14-Dec-11	IN 339862 (granted)	The patent family relates to recombinant adenovirus vectors (serotype 26 and serotype 35) encoding filovirus antigens. An AD26 vaccine for Ebola.
	US20180080010A1	27-Nov-17	7901/CHENP/2012 (Pending)	A method for producing recombinant adenovirus serotype 26 (rAd26)
Novavax	WO2004084941A1	24-Mar-04	No	Patent family relates to Matrix-M™ technology. A method of preparing an antigenic composition, comprising mixing an iscom particle and at least one live micro-organism.
Sputnik	WO2021002776A1	13-Jul-20	Not yet filed in India?	The patent family relates to Immunobiological agent for the prevention of diseases caused by severe acute respiratory syndrome virus SARS-CoV-2 based on recombinant human adenovirus serotype 5 or recombinant human adenovirus serotype 26
	RU2731342C1	22-Aug-20	Not yet filed in India?	Pharmaceutical agent for the induction of specific immunity against the severe acute respiratory syndrome virus SARS-CoV-2
	RU2731356C1	22-Aug-20	Not yet filed in India?	Expression vector containing the genome of the recombinant human adenovirus strain of the 26th serotype, in which the E1 and E3 regions are deleted, and the ORF6-Ad26 region is replaced by ORF6-Ad5
NIV/ICMR/ Bharat Biotech	Not yet published?			ICMR and NIV collaboration started in May 2020. This is basic technology, to seek patent protection for an age-old technology would be challenging. Even if patent application is filed, it would take 18 months to publish by Indian patent office.

In summary, most of vaccines are protected in India. We expect patent application would be filed for Sputnik soon in India. If Pfizer-BioNtech is approved in India, we will cover it later. At first glance, there are several patent families covering Pfizer-BioNtech vaccines. 

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.