API and IP Newsletter

 

Contents

• Analysis of patent applications of Divi’s Laboratories. 

• General information. 

• DOJ Says Three Generic Drug Companies Resolve Price-Fixing Allegations. 

• Welsh scientist makes potential $539m fortune from biotech flotation in US. 

• Intellectual Property. 

• T 2360/18 (Storage-stable formuation of paracetamol/Neogen N.V.) of 20.9.2021. 

 

Analysis of patent applications of Divi’s Laboratories

Divis is not well-known for development capabilities or for state of art development centers. As per public domain information, development budget of Divis is much lower than peers. We tried to analyse patent portfolio of Divis, and here are our observations. 

Publication Number	Title	Publication Date	Sidvim Comments
US10781170B1	Making brivaracetam used to treat epilepsy involves reacting amino-oxoethyl-hexanoic acid with chlorinating agent, reacting chloroamino-2-oxoethyl hexanoic acid with sodium hydroxide and converting reaction product to brivaracetam	2020-09-22	This is logical extension for Divis. They are very strong in Levetiracetam, and now working on brivaracetam. The approval is in 2016, Lupin, Cadila, Micro have already filed DMFs, Divis must not be far behind.
US10399926B1	Preparing gabapentin comprises reacting spirocyclohexane-1,9'-(diazabicyclo-(3.3.1)nonane)-2',4',6',8'-tetraone with an alkali and converting 1,1-cyclohexane diacetic acid monoamide to gabapentin by Hofmann reaction using alkali hypohalite	2019-09-03	Divis is one of the biggest player in Gabapentin. Such an old molecule, but it is interesting to note Divis is working on the process of gabapentin to improve its cost.
IN 202141018775A	Preparing molnupiravir, antiviral drug under investigation for treatment of Covid-19, comprises reacting 2-3-isopropylidene cytidine with isobutyric anhydride in the presence of base to obtain 5Msobutyric ester having an amide impurity	2021-05-07	Molnupiravir going to be new block buster, every Indian company is working and generating IP for molnupiravir  which is in Phase -III.
IN329761B	Mono phenyl tenofovir preparation involves reacting tenofovir with diphenyl phosphonate in presence of suitable base to give mono phenyl tenofovir, where suitable base is triethylamine, triethyl amine or dimethyl amino pyridine	2020-01-24	This is N-1 stage for tenofovir. Monophenyl tenofovir is further converted into tenofovir alafenamide. Divis is working on life cycle management project of tenofovir.
IN 201741044376A	Improved process for preparing free base of pimavanserin, comprises e.g. reacting 1-(methylpiperidinyl)-fluorobenzylamine with urea in acetic acid and reacting resultant with isobutoxy benzaldehyde in presence of titanium tetraisopropoxide	2018-02-09	Six others filed DMFs so far for Pimavanserin. Divis will file DMF soon.

Conclusions:

1.      Divis is filing patent applications for old products and one can term them as life cycle management projects. Divis is trying to maintain cost leadership position in old molecules.

2.      Few new molecules are under development portfolio.

3.      As expected, based on their development budget, there are not many patent applications, and Divis is far behind the competitors in terms of IP creation.

General information

DOJ Says Three Generic Drug Companies Resolve Price-Fixing Allegations

The DOJ (US Justice Department) said Taro Pharmaceuticals USA Inc., Sandoz Inc. and Apotex Corp. agreed to pay a total of $447.2 million. 

The government alleged that between 2013 and 2015, all three companies paid and received compensation prohibited by the Anti-Kickback Statute through arrangements on price, supply and allocation of customers with other pharmaceutical manufacturers for some generic drugs manufactured by the companies.

News here.

 

Welsh scientist makes potential $539m fortune from biotech flotation in US

After nearly a decade working at the US drug giant Pfizer, followed by five years at the University of Dundee where he researched applying data mining and machine learning to the pharmaceutical industry, Hopkins set up Exscientia in 2012.

The company has just floated in New York with a market value of $2.9bn. It sold 13.9m shares at $22 apiece to raise $304.7m on Friday, spurning a London listing. The shares soared 32% to $29 in early trading on their Nasdaq debut, valuing the company at $3.7bn.

The share price surge has given Hopkins, 49, honorary chair of medicinal informatics at Dundee University’s School of Life Sciences, a paper fortune of $539m.

News here.

Intellectual Property

T 2360/18 (Storage-stable formuation of paracetamol/Neogen N.V.) of 20.9.2021 

Neogen NV is an out-licensing pharmaceutical company, based in Belgium (Brussels)  

They are part of the Alter Pharma Group, with a focus on the development, manufacturing, and distribution of pharmaceutical products. 

As per their website they offer Paracetamol, solution for infusion, 10 mg/mL, is indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever. 

European patent EP2464332 was issued to Neogen with a set of 15 claims 

Independent claim 1 (claim 12 is also an independent claim which is not part of this write-up) as granted read as follows: 

Claim 1

A liquid formulation that is stable to oxidation and that is based on paracetamol in an aqueous solvent obtainable by the following steps:

i) dissolving in a reaction vessel paracetamol in an aqueous solvent having a temperature between 65°C and 95°C, and having pH between 5.0 and 6.0

ii) cooling the solution so formed to a temperature equal to or above 35°C and below 40°C under an atmosphere of nitrogen,

iii) adding cysteine hydrochloride and sodium hydroxide simultaneously to the solution without stirring,

iv) closing the reaction vessel and stirring the solution of step iii) in a nitrogen atmosphere.

The opposition division (1st instance) revoked patent. According to the opposition division claims regarded as not novel over prior art “Rote Liste 2005 Arzneimittelverzeichnis fur Deutschland, 05 166”

This write-up is on Appellate board decision. The appeal lies from the decision of the opposition division (1st instance) to revoke the patent. 

In EPO, one can file Auxiliary Request (AR). In fact, one can file several ARs at EPO. This AR is nothing, but an auxiliary claim set which is filed at the same time as the main claims which are being pursued. The auxiliary request is considered only if the EPO deem the main request claims to be unallowable.

In this case Patentee Neogen filed four ARs. 

The auxiliary request IV was limited to the process claims, revised independent claim is as follows. 

New claim1: 

Method to produce a liquid formulation that is stable to oxidation and that is based on paracetamol in an aqueous solvent, comprising the steps of:

i) dissolving paracetamol in an aqueous solvent having a temperature between 65°C and 95°C, and having pH between 5.0 and 6.0 in a reaction vessel

ii) replacing the remaining air in the vessel by an inert gas, such as nitrogen, and cooling the solution so formed to a temperature equal to or above 35°C and below 40°C,

iii) adding cysteine hydrochloride and sodium hydroxide simultaneously to the solution without stirring, and

iv) closing the reaction vessel and stirring the solution of step iii) in a nitrogen atmosphere. 

The arguments of the patentee with new Auxiliary request summarized as follows:

1.  The new claim is related to a method for producing a stable paracetamol formulation.

2.  These method claims had not been opposed by the opponent.

3.  The said request (AR-IV) was also not challenged by the opponent in their submission in the appeal proceedings. 

Consequently, in the absence of any objections by the opponent the Board decided to maintain the patent in amended form based on the revised process claims.

Decision 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.