It is the strategy to go after niche and difficult-to-make products, that catapulted Hyderabad-based drug maker Natco Pharma onto the national healthcare landscape.
Run by a management that assiduously keeps a low-profile, the 30-odd-year-old company though, has been at the fore-front of key patent-related litigation.
From being part of the legal challenge on Novartis’ blood-cancer drug Glivec, which in itself is a high-profile case, to its latest success in getting the country’s first compulsory licence (CL) on Bayer’s kidney cancer drug Nexavar, the spotlight is clearly on Natco.
A CL is a provision under the amended patent regime in the country and it allows a company to make a similar version of an innovative medicine, on payment of royalty to the innovator company.
In fact, on Monday, an appeals board further endorsed the Patent Office’s decision to grant Natco a CL to make the inexpensive version of Bayer’s Nexavar. By getting the licence on Nexavar, the estimated Rs 680-crore company was able to introduce its version of the medicine in the market at about Rs 9,000 a month, while Bayer’s drug cost about Rs 2.8 lakh a month.
Top brass
At the helm of the company, spear-heading Natco’s research initiative is Chairman and Managing Director V.C. Nannapaneni, and heading strategy and new initiatives is his son, 35-year-old Rajeev Nannapaneni, Vice-Chairman and Chief Executive Officer.
The company has been going after patent challenges in the US as well, so in that sense the Glivec and Nexavar challenges are not unique, a company top-official says, unwilling to be quoted. The high-profile nature of the above mentioned local litigation, both being a first-time of sorts under the amended patent regime, has made people notice Natco only now, he adds.
The Glivec case is the first patent-related case, after India amended its patent regime in 2005. Besides the Cancer Patients Aid Association, Natco is one of the key participants in this case, poised for a judgment at present. Patents give the innovator a 20-year monopoly to make and sell a product, medicines in this case. And the concern is that patents could lead to monopolies in the market that price the medicine beyond the reach of the patient.
Expensive process
It is not easy for generic drug companies to pursue such litigation that is both expensive and time-consuming. Besides companies have alliances with multinationals, so are unable to work with them and fight them, says the official.
But Natco’s alliance partners are not worried, he adds, since they are generic-drug makers, possibly challenging innovators in other global markets.
The latest decisions on the CL would open doors for other domestic companies to try and tread the same path. Such challenges are important, the official says, as it brings in competition when a lower priced medicine is marketed, and that is good for access. Besides, it is not possible to go after every patented drug. The Nexavar case will go into appeals, so the story is not over, he adds.