India’s IPR protection weak: US

India on US Priority Watch List, should provide stronger protection against unfair commercial use of drug data, says US.

The US government has urged India to take effective action to ensure stronger protection intellectual property rights including unfair commercial use of data submitted by drug makers to obtain marketing approval for drug products in India.

The US continues to “urge India to improve its IPR regime by providing stronger protection for copyrights and patents, as well as effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical and agrochemical products,” stated an annual report on IPR protection by US trading partners placing India among the 10 countries in Priority Watch List.

The US Priority Watch List is the list of trading partners that do not provide an adequate level of intellectual property rights (IPR) protection or enforcement.

Global innovator drug makers have been strongly demanding protection of their drug data submitted to the authorities from possible leakage to generic companies, who are eagerly waiting to use the information to make generic (copy-cat) version of their drugs. The drug giants, they develop and launch new drugs, have also been expressing concern about the inadequate protection of the data generated during drug trails in Indian settings. Their fear is centred on India’s decades long history which used to respect only the process of making drug and not the product, throwing open the patented products to Indian generic makers to copy.

India’s IP regime began to change at the beginning of the year 2005, when the country reversed it stand and announced a new patent act that started respecting product patent, following its obligations to WTO.

Since January 2005, India’s patent environs started changing for the better. India has made several steps to improve the IP protection with considerable results.

While noting that India has made progress on improving its IPR infrastructure, including through the modernisation of its IP offices and the introduction of an e-filing system for trademark and patent applications, the report said, US “remains concerned about weak IPR protection and enforcement in India”.

The US government also wanted India to enact legislation in the near term to strengthen its copyright laws and implement the provisions of the World Intellectual Property Organisation (WIPO) treaties and improve its IPR enforcement system by enacting effective optical disc legislation to combat optical disc piracy.

Piracy and counterfeiting, including of pharmaceuticals, remain a serious problem in India, the report said. India’s criminal IPR enforcement regime remains weak.

The report also urged the need for the imposition of deterrent-level sentences like police action against those engaged in manufacturing, distributing, or selling pirated and counterfeit goods, and expeditious judicial dispositions for IPR infringement

Besides India and China, Russia, Algeria, Argentina, Canada, Chile, Indonesia, Israel, Pakistan, Thailand, and Venezuela have been placed on the Priority Watch List and “will be the subject of particularly intense engagement through bilateral discussion during the coming year”.

“If we and our trading partners are not vigilant in protecting and enforcing intellectual property rights, they can vanish just as quickly,” a trade official said.

India has made progress on improving its IPR infrastructure, including through the modernisation of its IP offices and the introduction of an e-filing system for trademark and patent applications, the report said.

However, the report said US “remains concerned about weak IPR protection and enforcement in India”.

The US continues to “urge India to improve its IPR regime by providing stronger protection for copyrights and patents, as well as effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical and agrochemical products”.

US stands ready to work with India on these issues during the coming year, the reports.

The US also wanted India to enact legislation in the near term to strengthen its copyright laws and implement the provisions of the World Intellectual Property Organisation (WIPO) treaties and improve its IPR enforcement system by enacting effective optical disc legislation to combat optical disc piracy.

Piracy and counterfeiting, including of pharmaceuticals, remain a serious problem in India, the report said. India’s criminal IPR enforcement regime remains weak.

Police action against those engaged in manufacturing, distributing, or selling pirated and counterfeit goods, and expeditious judicial dispositions for IPR infringement and imposition of deterrent-level sentences, is needed.

As counterfeit medicines are a serious problem in India, the US is encouraged by the recent passage of the Drugs and Cosmetics (Amendment) Act 2008 that will increase penalties for spurious and adulterated pharmaceuticals, the report said.

Urging India to strengthen its IPR regime

The report also highlights “the prominence of IPR concerns with respect to China and Russia, despite some evidence of improvement in both countries”.

Of late, following reports that India is a possible hub for fake drugs, Indian government has brought in some new legislations.

A new Drugs & Cosmetics Amendment Bill with stringent provisions such as a maximum penalty of life imprisonment and a fine of not less than Rs 10 lakh for those engaged in manufacturing spurious and fake drugs was passed by the Parliament in November 2008. The new law  also prescribe punishments for the trade. The law has provision of making the offences cognizable and non-bailable.

Similarly, India is also proposing to implement laws to punish clinical research firms, if they are found breaching the standard practices and rules for testing new drugs in humans, with severe penalties including 10 years of imprisonment and cancellation of licence.