The Indian Pharmaceutical Alliance, which consists of 20 pharmaceutical companies which collectively account for about 85 per cent of private sector investment on pharmaceutical research and development in India, has appealed to the USTR to remove India from the USTR Priority Watch List.

In its submission to the USTR for 2018 Special 301 Review, the Alliance has in its support cited several actions taken by the Indian government for improving the IPR environment and enforcement in the country. In the submission, it has also addressed all major concerns expressed by PhRMA and BIO relating to IPR environment in India, including IPR environment, reducing patent backlog, enforcement, litigation, compulsory licensing and other concerns.

Arguing a case for reviewing the continuance of India on the Priority Watch List, the Alliance said that the administrative improvements in patent issue and enforcement demonstrated in 2015 and 2016 have been sustained and accelerated in 2017. Adequate examiners are now in place and the pace of examination of patents has noticeably improved. Trademark examination time has been drastically reduced to one month.

“We are not aware of abusive patent opposition proceedings or material disadvantage to US companies because of patent oppositions. We are not aware of denial of timely injunctions in 2016 and 2017 before the launch of a follow-on generic when a patent for the product is in force and the patented product is in the market.  There been no grant of compulsory license in the last five years nor any revocation of patents under Section 66. We have shown that Section 3(d) of the Patents Act only limits secondary patents that do not enhance efficacy and typically result in ‘evergreening’. We have also shown that Section 3(d) and Hatch-Waxman provisions are not dissimilar in terms of outcomes. Therefore, Section 3(d) ought not to be of concern”, it said.

It further stated, “We continue to be unclear about the extent of adverse impact of the lack of data exclusivity for US companies. Though general assertions have been made, no specifics have been provided in past submissions by US companies. We do not expect that the impact, if any, will be significant as products without patent protection that outlasts data exclusivity are unlikely to be launched in India for commercial reasons. We submit that in the absence of such data, no cognizance should be taken of apprehensions and speculation about possible or potential adverse impacts”.

The Alliance further said that the administrative burden cast on US companies by reporting requirements prescribed under the Patents Act is not significant enough to warrant notice by the USTR.  The apprehensions and concerns of the US pharmaceutical industry have figured prominently in the Special 301 Reports of past years and have likely been the major reason for the placement of India on the Priority Watch List. It is now clear that substantial and consistent progress has been made by India and overall, Indian laws relating to patents and their application do not deny adequate and effective protection of IPR; nor do they deny fair and equitable market access to the US pharmaceutical industry which relies on intellectual property protection.

“We urge the USTR to consider the removal of India from the Priority Watch List. It would be encouraging recognition of the strides that India has made in promoting, protecting and enforcing IPR and sustain its forward momentum”, the Alliance's Secretary General D G Shah said in the submission.