Merck Sharp and Dohme Corp’s.(MSD) Anti Diabetes Drug JANUVIA and JANUMET Versus Glenmark Alleged Generic Drug Zita and Zita Met
Today’s sedentary lifestyle where definition of work has changed from physical work to hours of sitting before our computers and stretching our mind’s limit to the point of exhaustion, this coupled with nations growing addiction towards fast food, no wonder India is fast becoming the diabetes capital of the world.
“The More The Merrier” for Pharma Companies as the growing Indian diabetes drug market, with the second-largest diabetic population in the world, is one of the key growth markets for companies selling anti diabetes drugs and where there is money involved, litigation follows.
After the Hon’ble Supreme Court’s judgement against Novartis, another case against alleged generic drug production comes in forefront.Merck Sharp and Dohme Corp.(MSD) filed a suit against Glenmark alleging Glenmark’s drug infringed on the patents of its products branded JANUVIA and JANUMET.
Sun Pharmaceuticals has joined MSD’s suit against Glenmark as Sun Pharmaceuticals, last year signed a license agreement with U.S.-based Merck to market the drug in India under the brand name Istavel Istamet.
MSD’s move comes a week after Glenmark Pharma launched alleged generic versions of a range of anti-diabetes products sold by the US company under the brand names Januvia and Janumet. Glenmark has branded its medicines Zita and Zita Met.
Januvia and Janumet are patented and enjoy IP protection of 20 years in India.Launched in 2008, Januvia and Janumet (the medicines are among a class of products known as Gliptins) figure among the best-selling anti-diabetic drugs in India. Gliptins drugs help to raise insulin levels, the lack of which causes the blood sugar level to go down.
MSD, in its plea, alleged that the Indian pharma company has violated its intellectual property right over its anti-diabetes medicines, Januvia and Janumet, by coming in the market with their own drugs containing the same salts.
The Delhi High Court refused to grant interim relief to Merck Sharp and Dohme (MSD) which sought a restraint on Glenmark Pharmaceuticals on manufacturing and marketing Zita and Zita-Met.
Under the Drugs and Cosmetics Act of India, a company can apply for approval to market a patented drug four years after its launch. Glenmark has used this route to get an approval to launch the drug. Under the Drugs and Cosmetics Act, state-level regulators can grant marketing approval even if a patent exists, as long as the drug has been around for four years.
A strip of seven tablets of Januvia (50 mg and 100 mg) is priced at approximately Rs 300 while Glenmark’s version costs around 30 per cent less.Obviously MSD is extremely disappointed with the decision and will consider all options, including an appeal of the decision Whereas Glenmark said it has not infringed on the patents and respects patent laws and that it launched the drug after due diligence and research.
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Courtesy:
Economic Times
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Wall Street Journal
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