API and IP Newsletter

 

Contents

• Analysis of import-export of Arch Pharma. 

• General information. 

• 5 appellate tribunals to be scrapped. 

• FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021. 

• Intellectual Property. 

Analysis of import-export of Arch Pharma

This week we analysed import-export of Arch Pharma and tried to find out in which molecules Arch is investing development recourses.

We glanced patent database and discovered patents related to atorvastatin process filed by Arch. Hence, in addition to below molecules some work must have been done on atorvastatin. The below list is only indicative and detailed list is not published here.

It could be concluded that Arch is concentrating efforts on antiretrovirals, statins and few molecules which are not sold in US. Arch is looking for high value and small volume APIs? For more details see below table.

Product Name	API	Sidvim Comments
β-Nicotinamide adenine dinucleotide phosphate hydrate	Rivastigmine	Not a new molecule, about 20 DMFs active. Amneal, Matrix are selling to US and other countries at about USD 2000/Kg. Arch must be seeing good market opportunity  in the crowded market.
BOC-L-PHENYLALANINE	Bortezomib	Many DMFs active, more than 17-18! High value, small volume API.
20180503 - N-CARBOBENZOXY-S-PHENYL-L-CYSTEINE	Nelfinavir	2003 approval, and no DMF yet. Arch would be the first DMF filer?
SQ-FP026-2018152 - 4-(4-FLUOROPHENYL)-6-ISOPROPYL-2-(N-METHY - L-N-METHYLSULFONYL)AMINO)PYRIMIDINES-5-YL-METHANOL	Rosuvastatin	Old molecule, several DMFs
TRIMETHYLPYRUVIC ACID	Metribuzin  (agro)	Agrochemical intermediate for Metribuzin?
[(3R 3AS 6AR)-HYDROXYHEXAHYDROFURO[2 3-]FURANYL SUCCINIMIDY - L CARBONATE	Darunavir	Several DMFs active. But it seems Arch is concentrating on antiretrovirals, and hence it fits into their strategy?
(S)-4-CHLORO-3-HYDROXYBUTYRONITRILE	(S)-Oxiracetam (Not approved in US)	Nootropic drug. Not approved in US.
3-(3-(4-FLUOROPHENYL)-1-(1-METHYLETHYL)-1H-INDOL-02-YL)-(E)-2-PROPENAL	Fluvastatin sodium	Old molecule, 6 active DMFs. Lupin and Biocon active in India.

General information

5 appellate tribunals to be scrapped

Government promulgated an ordinance to dismantle five appellate tribunals, including intellectual property appellate board (IPAB). News here.

FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021

New Facility Fees

The notice confirms that FDA will assess and collect fees with respect to both OTC monograph drug facilities and contract manufacturing organization facilities. The fee schedule for Fiscal Year 2021 is as follows:

·       OTC monograph drug facilities (MDFs): $20,322 (increased from $14,060 in December 2020)

·   Contract manufacturing organizations (CMOs): $13,548 (increased from $9,373 in December 2020)

(here)

Intellectual Property 

CAFC defined who is POSA (Person Skilled in Art)

POSA: PHOSITA (Person Having Ordinary Skill in The Art), many use term POSITA (Person having Ordinary Skill in The Art) and the Supreme Court in US used term POSA.

In every case, invariably it is discussed who is POSA for the described art in the patent. The Court opines who should be considered as POSA for the invention. There are many case laws, provided guidance for selection of POSA.  In short, POSA is an expert in the field. However, the question arose whether such POSA could consult another expert?

Federal Circuit (CAFC) provided guidance. The Court held that a POSA may have access to and rely on experts “if in the relevant art the POSA routinely would rely on such expert assistance.” More details are 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.