Copies of patented cancer drugs ahead?

Hope floats for liver and kidney cancer patients who find the available patented medication unaffordable, out of reach.
The Mumbai Patent Office will shortly decide whether or not to allow production of the generic version of Nexavar, or sorafenib tosylate.

The drug is sold by German drugmaker Bayer at a whopping Rs280,428 a month. Granted a patent in 2008, it is the only brand of sorafenib legally allowed for sale in the country.

However, two years ago, Mumbai-based Cipla launched at-risk generic sorafenib for Rs28,000 for a month’s treatment, following which Bayer filed an infringement suit against it.

An at-risk launch is when a generic manufacturer challenges the validity of an existing patent.

Meanwhile, Hyderabad-based Natco Pharma requested Bayer for a licence to manufacture the generic version and sell at a more affordable Rs8,880 per month.

But the German firm turned down the request, and Natco applied for a compulsory licence last August in the Patent Office.
With the hearing getting concluded at the Patent Office last week, a decision is expected shortly.

If granted, the compulsory licence would allow Natco to legally sell the generic (it already has manufacturing and marketing approval from the drugs controller), while paying royalties on sale to Bayer.
According to experts, compulsory licensing is a flexibility provided in the Trips (Trade Related aspects of Intellectual Property Rights) agreement of the World Trade Organisation, of which India is a signatory, and can be applied when the patented drug is unaffordable or unavailable.

“Rs280,428 per month is an incredible amount for most Indians. And the medication has to be taken lifelong. This makes it a clear case for compulsory licensing, as the drug is unaffordable,” said a healthcare and patent law expert.

Estimates suggest liver and kidney cancers affect around 30,000 Indians every year, with 24,000 succumbing to them every year. Over 1 lakh Indians are suffering from the two cancers.
The patent expert said that since 2005, when the product patent regime rolled out, several important drugs with stupendous prices have been granted patents (see table).

“Generic versions are needed to bring prices down,” he said.
According to the expert, compulsory licensing has been granted in the past by not just poor countries like Cameroon, Mozambique, Zimbabwe and Ghana, but also by several developed and developing countries (see table).

However, the Organization of Pharmaceutical Producers of India, the lobby of MNC drugmakers, feels that for innovator companies, the ability to recoup the value of their products through patents is vital if they have to continue research and development.

The Trips agreement says as much. According to it, granting a compulsory licence does not tear apart the patent, as the patent owner still has rights and gets royalties on sale.