Compulsory licensing to help patients & players, says Natco

Hyderabad-based Natco Pharmaceuticals is making a first-of-its kind effort to get a compulsory licence (CL) for the generic version of Bayer’s liver and kidney cancer drug, Nexavar, in India, alongside pursuing opportunities in the generic pharmaceutical markets. The CL process, which is allowed under Indian laws for drugs launched after 1995, will open major opportunities for Indian companies once the first decision on the application is taken, Rajeev Nannapaneni, Natco’s chief operating officer, tells  DNA in an interview. Excerpts:

What is the status of the CL application you had filed?
One hearing is already over. One more hearing is expected to happen this month. We don’t want to speculate on either the outcome or anything related to the issue.

You have taken an unusual path for taking an MNC head on…
It is unusual, but the law in the country provides for that under the clause of unaffordability. We have applied for such a licence on a drug called sorafenib (generic Nexavar). This is for treatment of liver and kidney cancer. The innovator price of this drug is at `2.8 lakh (per month) and we are offering it at `8,900. We are trying to do something different from what most people have done. We are asking the Indian authorities to issue compulsory licence on pharmaceutical products that were launched after 1995. Nobody has tried this so far in India.

What happens once the decision is out?
Its success will open the doors to all post-1995 drugs. This actually creates new market for domestic pharma companies, which otherwise did not exist. The opportunity is going to be huge. There are many molecules in this category in cancer and diabetes categories. I don’t want to give away the names for strategic reasons.

If your application goes through, what are the areas you would work on?
In India, we are first working on oncology. If you look at the pricing of the available products, they are not affordable. Even if one has an insurance cover, no insurance plan would pay a patient Rs2.8 lakh per month towards the treatment. Typical to India, many patients pay from their pocket for the treatment and the drugs. So, if you do not have money, you will not be able to get the treatment.

How is the CL process in other countries?
Compulsory licences are generally being issued for HIV products in Africa, South America and Asia. Even for cancer, in one or two circumstances in Brazil and Thailand, CLs were issued. However, the number of such issuances is more in HIV.

What are the issues in pursuing a CL in India?
The problem with exploring CL is that nobody has so far gone through the process. Take our case. We started on it a year ago and we are still in the early stages of the process. Definitely, the process is lengthy and there is an element of uncertainty in it. Everyone is looking for a precedent. Once the precedent is set, it will open doors for everyone.

What does that mean to you?
Other than offering a great benefit to the society, this means good business for the companies getting it.

Does the process cost as much as it costs for a patent challenge in the US?
It is obviously going to cost much less than a similar process in the US. But the numbers are also much less here. A good launch in India is not going to give you $100 million.

Will you get some sort of exclusivity if your application goes through?
I am not sure. But even if the first guy succeeds in getting the CL, others will have to go through the same process by filing an application and getting it approved. So, it gives a semi-exclusivity of sorts to the first guy. Since we are the first one to try it out, we are also waiting for the standards to be set. Regardless of whether Natco succeeds in it or not, it is good for the industry. It is also good for the patients since they are going to benefit the most.

What are the chances of others following you?
Personally speaking, once a CL decision is made, at least 10-15 companies will come in to file similar applications. But remember, that would happen only after a decision is made on the application that is pending.