BackGlenmark faces patent infringement lawsuit for cancer drug in US
Glenmark sued by Cephalon for patent infringement after it sought approval to sell a cheaper copy the drug in the US
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Mumbai: Glenmark Pharmaceuticals Ltd said on Tuesday that Cephalon Inc., the patent holder of cancer drug Treanda, had sued the company for patent infringement after it sought approval to sell a cheaper copy of the drug in the US.
Cephalon filed the suit at the Delaware district court in the US.
Glenmark has applied to the US Food and Drug Administration (FDA) seeking marketing approval for its generic version of the post-chemotherapy drug bendamustine hydrochloride, which had sales of at least $659 million in the first three quarters of 2013 in the US.
Cephalon, a subsidiary of world’s largest generic drug maker Teva Pharmaceutical Industries Ltd since it was acquired by the latter in a $6.8 billion deal in May 2011, sued Glenmark last week under the Hatch-Waxman Act of the US that allows generic companies to seek marketing approval for copies of patented drugs.
Under the Act, it is the responsibility of generic drug maker to prove it isn’t infringing on a patent. Hence, an infringement law suit by the patent holder will either force Glenmark to reveal its non-infringing technology or block the entry of the generic version of the leukaemia drug.
“There are other generic applications, which were filed earlier, also pending with the FDA for bendamustine, so Glenmark doesn’t expect a first-to-file opportunity for this drug in the US," said a Glenmark executive on Tuesday. The executive didn’t want to be named.
A first-to-file opportunity is a market exclusivity allowed to a generic drug maker, that first files the application for a cheaper copy of patented product.
Teva, which also sells a liquid variant of Treanda in addition to the powder form originally launched by Cephalon, is aiming to create a large portfolio of cancer drugs through Cephalon. Treanda is the lead drug under this portfolio at present.
Glenmark filed an abbreviated new drug application, or ANDA, with the US FDA for this new cancer drug from its Argentina injectable facility. An ANDA is filed with the FDA seeking approval for a generic version of a patented drug.
“If Glenmark proves that its technology doesn’t infringe the Cephalon patent, it can successfully launch the product in the growing oncology market in the US. But it will prove an at-risk launch for the Indian company in case it is successful to get an approval from the FDA before the law suit is concluded," said a sector analyst with a foreign brokerage, declining to be identified.
An at-risk launch is always a risky option as the generic drug maker may end up paying a huge compensation to the patent holder if a court later rules that it infringed the patent.
The patent for Treanda in the US was issued in May 2013 and will expire only in March 2029.
In a similar case earlier, India’s Sun Pharmaceutical Industries Ltd and Teva, which launched a copy of US drug maker Wyeth Inc.’s anti-acid reflux medicine Protonix (pantoprazole) through an at-risk route prior to the expiry of the original patent, had to pay $2.5 billion as compensation.
On BSE, the patent challenge didn’t affect Glenmark’s shares much. The stock was trading 0.01% higher at ₹ 532.10 at 3.30pm on Tuesday, while the Sensex was trading 0.14% higher at 21,173.53 points.
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