API and IP Newsletter
Contents
‘Pay ₹2 Cr to Pfizer or go to jail’: Delhi HC to Triveni Interchem director
Mesirow Institutional Investment Buys Shares of 377,099 Amphastar Pharmaceuticals, Inc.
Recent FDA approvals: Bexagliflozin
We follow small molecule approvals by USFDA and study synthesis reference, analyse very brief IP situation, try to estimate who would be the potential DMF filers in near future.
In January FDA approved Bexagliflozin.
It will be sold under the brand name Brenzavvy. It is an antidiabetic medication used to improve glycaemic control in patients with type 2 diabetes. This is developed by a small biotech company, Theracos.
Specific compound patent (and process) family: WO2010/022313
Crystalline form patent family: WO2011/153712A1
The chemical name of bexagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(2-cyclopropoxyethoxy)benzyl)phenyl)- 6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol.
Bexagliflozin is a white/off-white to pale yellow powder.
It is very slightly soluble in water and freely soluble in methanol, acetone, ethylene glycol, and propylene glycol. It is slightly soluble in heptane, cyclohexane, and toluene.
Crystalline bexagliflozin is not hygroscopic.
Each film-coated tablet would contain 20 mg of bexagliflozin and the inactive ingredients colloidal silicon dioxide, glyceryl dibehenate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and poloxamer 188.
For API synthesis one can follow example 1 in WO2011153712A1.
There must be several companies working in this API. By studying import export analysis one can notice, many companies are importing 4-bromo-1-chloro-2-(4-ethoxybenzyl)benzene, which is one of the starting material for bexagliflozin.
A glance at import of starting material of bexagliflozin one could conclude Macleods and Cadila would be ahead in development of API (and even formulation?) compared to the competition. They might file DMF soon.
As per one of the old analysis of HDFC securities it seems Theracos had tie-up with Dishman Carbogen for API supply. Details here. Status of such contract (if any) with Dishman to be studied under present circumstances.
General information
‘Pay ₹2 cr to Pfizer or go to jail’: Delhi HC to Triveni Interchem director
According to Pfizer’s lawyer Pravin Anand, Triveni Interchem Private Limited and Triveni Chemicals were found to advertise and offer ‘for sale’ generic Palbociclib in active pharmaceutical ingredient (API) form on their websites and IndiaMART (e-commerce platform), without any permission or authorisation from Pfizer.
“….the court deems it appropriate to dispose of this application by directing Kamlesh Singh, the director of Defendants 1 and 2 to pay, to the plaintiff, an amount of ₹ 2,00,00,000/- within a period of two weeks from today, failing which he shall be taken into custody and detained in a civil prison for a period of two weeks at Tihar Jail, Delhi,” the court said.
News here.
Mesirow Institutional Investment Buys Shares of 377,099 Amphastar Pharmaceuticals, Inc.
The institutional investor purchased 377,099 shares of the company's stock, valued at approximately $10,596,000. Amphastar Pharmaceuticals accounts for 1.5% of Mesirow Institutional Investment Management Inc.'s holdings, making the stock its 14th biggest position. Mesirow Institutional Investment Management Inc. owned approximately 0.77% of Amphastar Pharmaceuticals at the end of the most recent quarter.
News here.
Intellectual Property
Glenmark Pharmaceuticals ... vs Sanjeevni Medicos And Ors on 20 January, 2023
Glenmark adopted and coined the trade mark 'TELMA' - a medicinal preparation containing 'Telmisartan' used for treatment of blood pressure, which has been manufactured and marked since November 2002.
In the year-2006, 'TELMA-AM', a combination of 'Telmisartan and Amlodipine'
Glenmark submitted that in and around September 2022, they received reports of counterfeit 'TELMA' and 'TELMA-AM' products being sold in Delhi and elsewhere.
On receiving the above information and to ascertain the identity of person(s) and the extent of their involvement in manufacturing, selling and marketing of counterfeit products using Plaintiff's 'TELMA' mark, Glenmark carried out extensive survey and purchased products from different outlets.
Upon analysis of random purchases made, it was revealed that Sanjeevni Medicos, who are pharmacists, were engaging in stocking and supplying of counterfeit Telmisartan 40 mg and Amlodipine 5mg tablets under the marks 'TELMA'/ 'TELMA-AM', without authorization and approval of Glenmark.
Sanjeevni Ors have copied Glenmark’s marks and also trade dress/ get-up of 'TELMA' and 'TELMA-AM'. Sanjeevni Ors, being fully aware of Glenmark’s marks have indulged in illegal activities of manufacturing, marketing, stocking and selling such counterfeit/spurious products with the sole intention to pass off as those of Glenmark’s products.
Analytical differences in two products pointed out by Glenmark in this case. One can refer differences here in paragraph 20.
The Hon Judge granted the injunction in Glenmark’s favour.
The Court said, Glenmark could have at least notified pharmacists and healthcare professionals regarding the percolation of the counterfeit batch in the market and advising them to stop the sale of the same.
The Court further said, an injunction, at this stage, is perhaps too little, too late, when substantial damage may already have been caused by their delayed action.
The Counsel of the Glenmark pointed out that Glenmark has already submitted a complaint with the Deputy Commissioner of Police, South West, New Delhi and Joint Commissioner Police (Crime), New Delhi, and Drug Inspector, South West, New Delhi, to carry out search and seizure at Defendant's premises to curb circulation of counterfeit medicines, however, no response has been received nor any action taken on the same.
The Court issued following directions:
Sanjeevni and all persons acting for and on their behalf are restrained from manufacturing, marketing, stocking, supplying, selling and offering for sale, advertising, directly or indirectly, medicinal and pharmaceutical preparations under the trade mark - 'TELMA' and 'TELMA-AM' and/ or any other mark deceptively similar to above marks.
Sanjeevni and Ors were directed to file an affidavit within a period of two weeks giving complete address and GSTIN of source of their supplier corresponding with batch numbers.
Deputy Commissioner of Police, South West, New Delhi and Joint Commissioner Police (Crime), New Delhi are directed to submit their respective status reports with respect to the criminal complaints submitted by Glenmark
The Drug Inspector, South West District, New Delhi is directed to submit a status report within a period of one week providing therein the action taken on the complaint submitted by Glenmark.
Decision here.
