API and IP Newsletter
Contents
- FDA approvals in first quarter 2022
- General information
- Pharma industry to grow 8-10% in FY22; growth momentum likely to moderate in FY'23: ICRA
- Dr Reddy's Inks $61 Million Deal to Acquire Cidmus Brand in India from Novartis
- Intellectual Property
FDA approvals in first quarter 2022
In Sidvim we analyse FDA approvals. Time to time we have published individual approvals of small molecules, details of chemistry, sourcing information, our educated guesses about development by generic companies etc.
Summary is in the below table. It is interesting to note 50% approvals are of large molecules. Industry is moving from Chemistry to Biology!
General information
Pharma industry to grow 8-10% in FY22; growth momentum likely to moderate in FY'23: ICRA
Revenues for ICRA’s sample set of 21 Indian pharmaceutical companies is estimated to grow at 8-10 percent in FY2022; and moderate to 6-8 percent in FY2023, partly attributable to the high base of FY2022.
The operating profit margin for the sample set stood at 21.7 percent in Q3 FY2022 and 23.2 percent in 9M FY2022, in line with the corresponding period of the previous fiscal.
News here.
Dr Reddy's Inks $61 Million Deal To Acquire Cidmus Brand In India From Novartis
Dr. Reddy's Laboratories announced on Friday that it has struck a deal with Novartis AG to purchase the Cidmus cardiovascular medication brand in India for $61 million (about Rs 463 crore). Dr Reddy's will be assigned and transferred the Cidmus trademark in India from Novartis AG for a fee of $61 million, according to a regulatory filing by the Hyderabad-based pharmaceutical company.
The Cidmus brand will be assigned to a pharmaceutical composition that contains a combination of Valsartan and Sacubitril (now patented by Novartis) and is intended for heart failure patients with a reduced ejection fraction, according to the company. The tablets come in three different strengths. Cidmus recorded sales of Rs 136.4 crore in India for the most recent twelve months ending in February 2022, according to IQVIA MAT data.
News here.
Intellectual Property
Delhi HC’s interim order issued in favor of Novartis and directed Eris to deposit a sum of Rs.5 crores with Registrar General of the Court
The three suits have been filed by Novartis against Eris Lifesciens (Eris), Windlas Biotech (Windlas) and Chhabra Healthcare (Chabbra).
The three suits have been filed to seek permanent injunction restraining the infringement of Indian Patent No.IN229051, the suit patent relates to a pharmaceutical composition consisting of Valsartan or a pharmaceutically acceptable salt thereof, and Sacubitril or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. The said pharmaceutical preparation is used in the treatment of cardiovascular disease.
Earlier suit was filed by Novartis, against one MSN Laboratories Pvt. Ltd. (MSN) before the Telangana High Court, seeking permanent injunction restraining the infringement of the same patent. In the said suit, both the parties are directed to maintain status-quo on 26th February, 2021.
Eris challenged and argued that before the status quo order was granted and after the transfer of the suit to this Court, Eris has manufactured certain quantity of sacubitril finish formulations. They have expiry dates and unless said stock is disposed of, grave prejudice will be caused to Eris.
Eris therefore submitted that they may be permitted to sell the said quantity of drug. Having regard to this submission, Eris was permitted to sell the quantity of drugs already manufactured before the status quo order was granted by this Court. However, Eris shall maintain account of the details of quantity of drugs already manufactured, sold in pursuant to this order and the sale proceeds. Eris shall furnish the details to Novartis and shall also file an affidavit to that effect in the suit.
As directed by the Telangana Court and this Court, an affidavit was filed by Eris. The said affidavit disclosed the quantum of purchase made from MSN Laboratories which states that the Zayo product is a Crystalline Form S [Valsartan and Sacubitril].
Eris received sacubitril stocks from Windlas and MSN.
Novartis stated this is an illegal modus operandi been adopted by MSN, ERIS and Windlas, only with an intent to circumvent the injunction order passed by the Telangana High Court as also the status quo orders in the present suits.
Novartis submitted that product information literature of the product ‘ZAYO’, which was available in the market, clearly showed that the product was manufactured by MSN Laboratories as the said literature refers to MSN Laboratories. If the products were manufactured by Windlas, the question of MSN Laboratories being mentioned in the product information literature, would not have arisen.
Novartis further submitted based on market data that only a small percentage of the large stocks manufactured by Windlas has been sold in the market as of April, 2021.
Eris ought not to be allowed to violate the status quo orders by selling such a huge quantum of products in violation of Novartis’ rights in the suit patent.
The details of stocks available with Chhabra was also presented to the court, which was marketed by Eris.
Novartis requested to Court, ERIS ought to be directed to withdraw the said stock from the distributors, which is in market even after the order of Telangana Court and this Court.
Eris arguments
Eris raised two submissions. The first submission was that the products being marketed by ERIS are supramolecular forms of the combination of Valsartan and Sacubitril, and the suit patent does not cover the supramolecular complexes of the combination of Sacubitril and Valsartan.
Second, Eris submitted that earlier order passed against Eris covers MSN products. The said order did not cover any products manufactured by Windlas. All the products which are available with ERIS are of February 2021 i.e., prior to 26th February 2021, and hence, there is no violation of the injunction.
Thus, the products that are being sold are not covered by the injunction. It is further submitted that the order dated 26th February 2021 passed by the Telangana High Court permitted sale of all the products manufactured prior to order dated 11th December 2020. In view of both orders, the products would not be covered by the injunction.
Novartis insisted that all the products ought to be recalled at this stage and the details of the distributors ought to be disclosed to the Novartis. However, almost one year has passed since the affidavit dated 17th May 2021 giving IQVIA data, was placed on record.
This Court considered the following factors –
The suit patent is itself due to expire in January 2023.
The affidavit giving the IQVIA data is more than ten months old.
The medicines are for cardiovascular disease which may be needed by many patients.
Recall from distributors or retailers would be an extremely cumbersome exercise and may result in panic.
Even if the exercise is undertaken, owing to the sheer number of distributors and chemists to whom the products may have been disbursed, directing recall is not a viable option.
Hence the Court said
ERIS cannot be allowed to go completely scot-free. Some measures would have to be taken to secure Novartis interest, especially since recall from distributors is not a viable option, at this stage.
There shall be an interim injunction restraining all alleged infringers in these matters from manufacturing, selling, offering for sale any pharmaceutical preparations which are a combination of Sacubitril and Valsartan, either in tablet form or any other form, either packaged as strips or in bottles/containers, and from infringing the Patent IN’051 of Novartis, in any manner whatsoever.
In view of the stocks, which were clearly marketed by Eris Lifesciences Limited post the passing of the earlier order, Eris Lifesciences Limited is directed to deposit a sum of Rs.5 crores with the worthy Registrar General of this Court.
The Court listed next activities and will announced further hearing dates.
