Tracking off-patent drugs

Multi-country, multi-language search with online alerts

Service will help companies get their product launch date right

Will help make the process litigation-free

Domestic generic drug makers that will start chasing overseas markets when many original products go off patent in the next three to four now have their jobs made somewhat easier.

A new multi-country, multi-language patent sifting service will help these companies get their product launch date right and litigation-free, according to Dr Kalyan C. Kankanala, co-founder and Chief Knowledge Officer of Brain League IP Services.

Multiple layers

The Bangalore-based company has added this search service — Patent Expiry Service — to its range of intellectual property-related solutions. According to Dr Kankanala, pharma innovators build many layers of intellectual protections around their inventions – as product, process, package, and so on.

Each patent expires at different dates in different countries. Generic players entering that space could land themselves in expensive law suits – upwards of $5 million (Rs 25 crore) - if the patent details are not fully known.

It is also not easy for a generic company planning a new conquest to verify all these. “Pharma is a high-stake game. Some 200-300 generic products are being launched each year. Many companies with an in-house capability also want a third opinion,” he told Business Line.

The industry is beginning to realise the legal risks, he said. Brain League is offering advice on the issue to 10 companies in Brazil, Ukraine, Taiwan, China and Malaysia. A bio-sciences team of eight employees, including four Ph.Ds, scours categories using a handful of licensed software. “Most companies don't have the bandwidth or the human resources to perform such patent searches in-house. There are language barriers in the case of Spanish, Portuguese, Chinese and Korean patents. You need local attorneys to help you but not every country has such resources,” he said.

Generic companies target emerging and less-regulated markets of Latin America, Africa, Central Asian or CIS countries and South-East Asia, where information on patents is not easy to get. Translations of such highly technical documents make searches five to six times more expensive. The pharma industry has estimated that between 2009 and 2015, drugs worth at least $200 billion will go off patent. Indian industry leads the pack of global generic exporters. According to Dr Kankanala, around 200 domestic companies are likely to be readying their generics baskets for an overseas splash.

Using the new service, companies can get information by country, product or by expiry dates, as also online alerts on the status of their projects and track deadlines.

Planning ahead

Patent search itself could be a huge market worth Rs 300-500 crore. Brain League has identified 500-600 Indian companies as prospective clients. Expanding generic companies need to plan two years ahead of rollout, he added.