Mumbai-based oral & injectable contraceptive maker Famy Care was sued in a US court,along with partner Mylan Labs, by the largest generic company Teva last week for alleged infringement of Teva?s patent for oral contraceptive pills Seasonique and LoSeasonique.
Along with Famy Care, another Indian firm, Lupin was also sued by Teva for alleged infringement of the contraceptive pills two months back. Famy Care was in the news recently for its proposed dilution of 15% stake to Baring Private Equity for $40 million.
Famy Care is a major producer of instra uterine device like Copper-T and oral birth control pills such as Mala-D. The company also makes various contraception products such as injectables, tubal rings and emergency contraceptives, catering to the $7.5 billion global market for women reproductive health products. Ashutosh Taparia, MD, Famy Care did not respond to the queries from FE.
In 2008, Mylan Labs, one of the largest global generic drug manufacturers, had formed a strategic alliance with Famy Care to enter the US contraceptive market with jointly filing abbreviated new drug application (ANDA) for approval to launch at least 22 new oral contraceptives with the US Food and Drug Administration (FDA).
Two separate suits were filed against Famy Care in the US court of New Jersey by Teva Women?s Health, Inc for alleged infringement of its patent for LoSeasonique (oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology, and Seasonique. Both Seasonique and LoSeasonique are combination of ethinylestradiol (estrogen) and levonorgestrel differing only in dose amount.
Teva said, ?Mylan Pharma, the US agent for Famy Care, notified that Famy care had submitted an ANDA to the US FDA seeking approval to manufacture, sell and distribute our Seasonique contraceptive product. By filing ANDA, intending to sell the product before patent expiry, Famy Care infringes patent of both the drugs.?