April 4, 2013 | By Márcio Barra
Last tuesday, Merck issued a lawsuit with the Delhi High Court against the Indian generic drug maker Glenmark, who launched last week generic versions of Merck’s diabetes blockbuster’s Januvia and Janumet (a class of products known as Gliptins, or hypoglycemic drugs). MSD Pharma, Merck’s indian unit, holds an Indian patent on the active ingredient in Januvia, sitagliptin, which is combined with Metformin in Janumet.
Although MSD Pharma’s patent is still a ways off from expiration, Glenmark went ahead launched generic versions of the two drugs. MSD’s stated that it was disappointed with the generic drug maker decision to launch generics of still in-patent products.
“Glenmark is a responsible company and has launched the products after due diligence and research,” said Glenmark in a statement to Reuters.
Now, according the Indian law, the launch of these two generics for drugs still under patent is legal. Under the Drugs and Cosmetics Act of India, a company can apply for market approval a generic copy of a patented drug four years after the innovator launch. So, even if a patent exists, as long as the innovator has been for sale for four years, a generic can be launched in India.
Januvia goes for sale at nearly 1,300 rupees ($23.92) for a monthly dose, while the generic copy goes up with a 20% discount face the innovator. The price of the drug is a odd factor that may indicate that India is extending its compulsory licence agreements beyond expensive cancer drugs, as Januvia does not carry an expensive price tag.
This news follows last Monday’s news that the India’s Supreme Court has rejected a plea by Novartis to patent an updated version of its cancer drug, Glivec, on the grounds this version was only slightly different from the old, allowing Indian generic drug maker to continue to produce generic copies of this drug. For more information, read this excellent article from Derek lowe over at SeekingAlpha.