API and IP Newsletter

 

Contents

 

• Analysis of USDMFs filed in the month of August 2020. 

• General information. 

• Latest news on IP and coronavirus in Europe. 

• Bulk drugs park may attract INR 11,100 Cr. 

• Intellectual Property. 

• Basmati battle: Pakistan fights Indian bid for EU recognition of rice.

• Bolar exemption does not apply to offering to sell patented drugs 

Analysis of USDMFs filed in the month of August 2020 

Out of 46 DMFs filed in the month of August by various API companies, as usual about 50% were filed by Indian generic companies. More details and our views about each filing are provided in the table below.

Sr	HOLDER	SUBJECT	SIDVIM Comments
1	PHARMARESOURCES (KAIYUAN) CO LTD	TICAGRELOR	Several DMFs for Ticagrelor. Export price is currently ranging from $ 3,000-5,000/Kg. This should come down significantly in near future.
2	SOLARA A PHARMA SCIENCES LTD	DIPYRIDAMOLE USP	Many active DMFs. Companies are exporting to Europe and other regulated markets @ around $ 150-200/Kg)
3	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	FAVIPIRAVIR	Biophore seem to be first to file DMF in US. Presently prices vary between $ 4,000-10,000/Kg but this would change soon.
4	METROCHEM API PRIVATE LTD	VONOPRAZAN FUMARATE	More than dozen DMFs
5	MAITHRI DRUGS PRIVATE LTD	DEUTETRABENAZINE	Many DMFs
6	SHILPA MEDICARE LTD	PRUCALOPRIDE SUCCINATE	Only two other DMFs. 2018 approval in US and one can expect many F2Fs in 2022. Prucalopride was approved for medical use in the European Union in 2009, in Canada in 2011, in Israel in 2014, and in the United States in December 2018. Metrochem filed DMF in this quarter. Many more DMFs could be expected in next quarters.
7	GLOBAL CALCIUM PRIVATE LTD	MINOXIDIL USP	Very old product and only two other active DMFs! It could be commercial reason, but one needs to investigate reasons for lack of sufficient active DMFs.
8	SHILPA MEDICARE LTD	VARENICLINE TARTRATE	Many DMFs, generic launches possible soon.
9	SWATI SPENTOSE PRIVATE LTD	GRANISETRON HYDROCHLORIDE USP	Many DMFs, many ANDA filers. No information of prices of commercial supply, some companies are exporting $ 60K to 70 K /Kg. But brief look at RMs, it is possible that prices would drop substantially after Gx entries.
10	UNICHEM LABORATORIES LTD	QUETIAPINE FUMARATE (QPT PROCESS)	Many Gx.
11	INNOVARE LABS PRIVATE LTD	PREGABALIN USP	Too many DMFs, many ANDA filers, Export Prices are ranging from $90-200 depending upon markets and quantities
12	METROCHEM API PRIVATE LTD	PRUCALOPRIDE SUCCINATE	Only two other DMFs, Old molecule, 2018 approval, good candidate for NCE-1 filing in 2022. Small development quantities are being exported at very high price ranging from $15K to 55 K/Kg. Shilpa Medicare too filed DMF in this quarter. Many more DMFs could be expected in next quarters.
13	CKD BIO CORP	PERAMIVIR HYDRATE	CKD is Korean company. Only DMF holder. Generic entry possible in 2023. Appears to be challenging chemistry starting from key RM ((-)-2-Azabicyclo[2.2.1]hept-5-en-3-one), which is  produced by an enzymatic route.
14	AUROBINDO PHARMA LTD	TENOFOVIR ALAFENAMIDE FUMARATE	Generic launch possible in 2025. Many DMFs already available. There could be many ANDA filers with PIV certificate soon.
15	GLAND PHARMA LTD	EDARAVONE	Relatively small product to treat ALS and too many DMF filers.
16	KOPRAN RESEARCH LABORATORIES LTD	METOPROLOL SUCCINATE	Many DMFs
17	MICRO LABS LTD	AMINOCAPROIC ACID USP	7-8 DMFs and 3-4 ANDA approvals.
18	MACSEN DRUGS	METHYLENE BLUE USP	Very interesting DMF filing by this Rajasthan based company. There is only one other active DMF for methylene blue. This could be potential treatment for COVID and product could be in demand.
19	MAITHRI LABORATORIES PRIVATE LTD	PYRIDOSTIGMINE BROMIDE USP	This is a very good product selection by MSN, only other one DMF active. There are 4-5 ANDA filers.
20	AUROBINDO PHARMA LTD	ESLICARBAZEPINE ACETATE	Too many DMFs, Gx entry possible by middle of 2021.
21	ACEBRIGHT INDIA PHARMA PRIVATE LTD	TENOFOVIR ALAFENAMIDE FUMARATE [DRUG SUBSTANCE (NON-STERILE)].	Generic launch possible in 2025 and too many DMFs
22	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	NELARABINE	Interestingly Biophore is the only DMF filer. At first glance it appears that chemistry, though not complicated, it could be challenging to handle. One reaction step is at -70 degree centigrade and very low yields and one has to deal with 4 chiral centers.
23	SWATI SPENTOSE PRIVATE LTD	MELATONIN USP	Many DMFs, old product. With approvals in sleep disorders sales could pick up.
24	AURO PEPTIDES LTD	DEGARELIX	A subsidy of Aurobindo for peptide synthesis, generic launch possible in 2021 but there is only one other active DMF. Good products for companies who are specialized in peptide synthesis.

General information

Latest news on IP and coronavirus in Europe

President of the EPO, Antonio Campinos, has announced the extension of a pilot project for oral proceedings until 15 September 2021. (Read more)

Bulk drugs park may attract INR 11,100 Cr.

State government body Gujarat Industrial Development Corporation (GIDC) is aggressively pursuing the bulk drugs park project at Jambusar in Bharuch District and expects an investment of INR 11,100 Cr. (~ $1.5 bn). (Read more)

Intellectual Property

Basmati battle: Pakistan fights Indian bid for EU recognition of rice

This week we could not find any interesting case which would typically involve novelty or inventive step arguments. Generally, in novelty or inventive step discussions, science is involved which makes us think.

This week, we look at a case on India’s application to the EU claiming “Basmati Rice” under Geographical Indication status.

GI status is used to mark a product out to consumers as having “qualities, reputation or characteristics relating to its place of origin”. In Europe, products such as Parma ham, champagne and stilton cheese have such a status, allowing producers from the respective regions to charge higher prices.

Pakistan’s government has vowed to “vehemently” oppose an application by India for the long-grain aromatic rice to be recognised by the EU as being grown exclusively in specific regions of the Indian subcontinent.

A formal objection is expected before the EU’s December deadline.

Since 2006, the EU has applied zero tariffs on rice imported into the bloc that has been authenticated by either Pakistani or Indian authorities as genuine basmati.

About two-thirds of basmati imports to the EU are from India and the rest from its northern neighbour. Pakistan’s exports of basmati rice to the EU have more than doubled in the last three years whereas India’s exports have been shrinking owing to a failure of its producers to meet increasingly strict EU standards on the use of pesticides.

The granting of GI status solely to Indian basmati rice would be a hammer blow to Pakistani exporters. (Read more)

 

Bolar exemption does not apply to offering to sell patented drugs

On 26 April 2020 (world IP day), the China National Intellectual Property Administration (CNIPA) released details of 10 exemplary patent administrative enforcement cases from 2019.

One selected case concerned a patent infringement dispute relating to the anti-tumour drug sorafenib, which has been selected for its significance in respect of the application of the Bolar exemption.

The Shanghai IP Office clarified that the Bolar exemption does not apply to offering to sell a patented drug, which is expected to deter some opportunistic generic drug manufacturers seeking to monetise patented drugs before their expiration.

(Read more)

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.