Glenmark Takes On Remogliflozin Infringers In India
Executive Summary
Alleged infringers of the patent on remogliflozin are facing legal heat in India from Glenmark, in an ongoing case where copies of the product were apparently offered for sale including via third-party trading sites.
Glenmark Pharmaceuticals Ltd. has moved decisively to fend off alleged attempts by certain local firms in India to infringe on the local patents for its licensed diabetes therapy remogliflozin etabonate, which has had strong run in the country since its launch earlier this year.
Mumbai-based Glenmark had earlier this year moved the Delhi High Court and secured a restraining order against some companies, believed to include Triveni Chemicals and Avanscure Lifesciences Pvt Ltd, among others, that have allegedly been offering for sale the patented sodium glucose co-transporter-2 (SGLT2) inhibitor on third-party trading sites or through related entities.
Some of the firms charged with alleged infringement by Glenmark have, however, since filed an application to set aside the ex-parte court order, with the case now expected to be listed in the Delhi High Court later this month.
Glenmark said that it will take the "necessary legal action against any individual or organization" attempting to infringe its intellectual property. “We consider protecting our intellectual property a critical aspect of our business,” the company told Scrip. The firms facing infringement charges could not immediately be reached for their comments on the case.
Case Specifics
The Delhi High Court had, in February this year, restrained the defendants and all those acting for and on their behalf from “using, making, selling, distributing, advertising, exporting, offering for sale, or in any other manner, directly or indirectly, dealing in any product” that infringes the subject matter of Indian Patent Nos. IN 2226624 and IN 243093 pertaining to remogliflozin .
Both patents are held by the Japanese firm Kissei Pharmaceutical Co. Ltd. and have been licensed to BrightHaven Ventures LLC, which in turn has a licensing deal with Glenmark.
Case details indicated that, when contacted by Glenmark’s investigator, one of the allegedly infringing parties was “willing to supply” the patented compound, though the representative said that the product was not in stock and the firm would check for its availability with a sister concern that also offers the product for sale on certain third-party sites.
Remogliflozin’s Strong Run
While most of the challengers appear to be lesser known small firms, industry experts expect Glenmark to keep a sharp eye on such “irritants”, given the strong commercial strides remogliflozin has made since it hit the Indian market earlier this year.
Glenmark’s remogliflozin (marketed as Remo and Remozen) was introduced with a sharp price advantage; it was launched at a daily treatment cost of INR25 ($0.35; INR12.50 per tablet) - around half the cost of other SGLT2 inhibitors such as canagliflozin, dapagliflozin and empagliflozin in India at the time. (Also see "Glenmark’s Remogliflozin Hopes To Shake Up Indian SGLT2i Market" - Scrip, 1 May, 2019.)
Sales of remogliflozin were already tracking at around INR20m per month less than two months from launch, as per IQVIA June 2019 data and Glenmark during its first-quarter FY2020 earnings call last month maintained that the product was one of the successful launches for its India business. Further, just released numbers from the market research agency AIOCD AWACS show that the Indian SGLT2 market is valued at INR8.72bn (+53%) as per moving annual total data for August, with remogliflozin notching INR96m in sales value.
Glenmark has also sealed a co-marketing alliance with Indian peer Torrent Pharmaceuticals Ltd. for remogliflozin and hopes to close one more such deal in the second quarter. (Also see "Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation" - Generics Bulletin, 22 Aug, 2019.)
The Indian diabetes segment, especially DPP-4 inhibitors, has seen a series of patent infringement-related cases over the past few years, including those pertaining to Merck & Co. Inc.'s Januvia (sitagliptin) and Novartis AG’s Galvus (vildagliptin). The Swiss multinational continues to be engaged in a high-profile suit pertaining to vildagliptin against latest challenger Natco Pharma Ltd.. (Also see "Merck Wards Off More Januvia Infringers In India" - Scrip, 9 Nov, 2015.)