In yet another patent infringement battles in India, Swiss drug maker Novartis has taken Indian biotech firm Biocon to court on anti-diabetes drug.
Novartis has sued Biocon in Delhi HC for patent infringement on Galvus, chemical name Vildagliptin, in an attempt to block generic versions and has got interim relief reports CNBC TV18's Archana Shukla.
Now Novartis's case stems from the fact that Biocon has received approval from the Indian drug controller for its generic version of Vildagliptin.
Novartis argued that Galvus is a novel molecule and patent protected in India and its basic compound patent expires in 2019. Hence any possible launch by Biocon would infringe on Novartis' patent.
In a statement to CNBC TV18, Novartis said, "On 27 March, 2014 Novartis has filed infringement proceedings, seeking an injunction against Biocon Limited at the Delhi High Court for infringement of the Indian basic compound patent (expiry 2019) covering and claiming the novel molecule Vildagliptin."
Based on the arguments the Delhi High court ordered that Biocon cannot commercially manufacture, sell or export Vildagliptin till the next court hearing. However, Biocon could manufacture Vildagliptin for in-house research purposes.
Galvus or Vildagliptin, is a DPP4 inhibitor class of drugs used to treat type-2 diabetes.
This is Novartis' second patent infringement battle on Glavus. First being against Wockhardt who also had requisite approvals from CDSCO since May 2013 to sell a generic version and Wockhardt was preparing to launch. It was just last month that based on a Novartis plea the Delhi High Court issued an injunction against Wockhardt.
In another legal tussle, Wockhardt has challenged the validity of the patent on Galvus & that case is simultaneously proceeding at the Indian Patent Appellate Tribunal (IPAB).
The legal tussles becomes significant for Novartis as Galvus is the biggest brand in DPP4 inhibitor class of drugs in India clocking roughly Rs 200 crore annual sales alone. Besides this Novartis also has a co-marketing tie-up with USV to sell cheaper versions of Galvus under a different brand name in the tier 2-3 towns.
This category of anti-diabetes drugs called DPP4 is gaining traction in the 3000 crore rupees diabetes drug market in India. And with small and big drug firms getting requisite approvals there has been a race to sell cheaper versions of this class of drugs.
Novartis said, "A robust and predictable intellectual property (IP) system is an essential pillar of an innovative life science industry. IP systems protect the investments into research and development of new products that will improve the quality of life for patients."
US drug firm Merck with its drug Sitagliptin, brand name Januvia, competes closely with Novartis among other drug makers in this space.
Exactly a year back Merck had sued Glenmark for patent infringement for launching generic version of Merck's Januvia & Janumet. While the Delhi High Court in this case had not giving an interim injunction and hence Glenmark continues to sell its copies in the market. The arguments of the Merck vs Glenmark case are over and the Delhi High Court is yet to release its order.
Biocon stock price
On April 03, 2014, at 09:24 hrs Biocon was quoting at Rs 434.00, down Rs 5.5, or 1.25 percent. The 52-week high of the share was Rs 497.40 and the 52-week low was Rs 264.45.
The company's trailing 12-month (TTM) EPS was at Rs 14.01 per share as per the quarter ended December 2013. The stock's price-to-earnings (P/E) ratio was 30.98. The latest book value of the company is Rs 110.34 per share. At current value, the price-to-book value of the company is 3.93.
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