Indian pharma companies, especially smaller ones, can look forward to a cheaper patent-filing and litigation process in the US.
The US Government is planning a variety of measures in this regard including reduction in documentation and cutting down the time span for the process, Ms Teresa Stanek Rea, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the US Patent and Trademark Office told Business Line here on Friday.
As the incidence of litigation is higher in patents, efforts were also on to engage specialised judges to hasten the judicial process in places like New Jersey where many pharma companies are located, she said.
As litigation was inevitable in patents, the expenses could be brought down. There was also an increase in out of court settlement of patent disputes as litigation cost are very high. “Ninety per cent of patent litigation is settled outside the court,” the US official said.
The approximate cost for filing a US patent, if not under litigation, is upwards of $20,000. From filing to approval it takes over two years.
On Indian patent regime, Ms Rea said there was a greater need to ensure data protection in areas like biosimilars and biologics.
“Over 50 per cent of new drugs being approved by the US Food and Drug Administration are in biologics,” she added.
India occupies second position in number of patent approvals from US among Brazil, Russia, India and China.
“The rate of innovation here is rapidly expanding in India. It is very important global market, especially in pharma and healthcare because of a long history of talent,” Ms Rea said.
China has the highest number of patents being filed in the US and there is a Government scheme to extend financial assistance.
PRIOR ART
A digital database of traditional knowledge/use of various products provided to the US by India was useful in taking a decision on existence of prior art (an important criteria to grant a patent) in traditional products, she said.
“In some of the products, we are not aware of prior art. The data needs to be constantly updated,” she added.