The Indian Pharmaceutical Alliance, which comprises of 20 pharmaceutical companies which collectively account for around 85 percent of private sector investment on development and pharmaceutical research development in India, has appealed 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 help 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 the 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 showed in 2015 and 2016 have been maintained and v in 2017.
Adequate examiners are presently set up and the pace of examination of patents has noticeably moved forward. Trademark examination time has been highly decreased to one month.
“We don’t know about offensive proceedings or material disadvantage to US organizations because of patent oppositions. We don’t know about 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 over the last five years nor any revocation of patents under Section 66. We have demonstrated that Section 3(d) of the Patents Act only limits secondary patents that don’t upgrade efficacy and typically result in ‘evergreening’. We have also demonstrated that Section 3(d) and Hatch-Waxman provisions are not unique regarding results. Therefore, Section 3(d) should not to be of concern”, it said.
It additionally stated, “We continue to be unclear about the extent of the adverse impact of the lack of exclusivity for US companies. In spite of the fact that general assertions have been made, no specifics have been significant in past products by US companies. We don’t expect that the impact, if any, will be significant as products without patent protection that outlasts information exclusivity are probably not going to be launched in India for commercial reasons. We present that without such information, no awareness should be taken of apprehensions and speculation about possible or potential adverse effects”.
The Alliance further said that the administrative burden cast on US companies by reporting requirements prescribed under the Patents Act isn’t sufficient 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 behind the placement of India on the Priority Watch List.
It is now certain that substantial and consistent progress has been made by India and overall, Indian laws relating to patents and their application don’t deny adequate and effective protection of IPR; nor do they deny reasonable and equitable market access to the US pharmaceutical industry which depends on intellectual property protection.
“We urge the USTR to consider the removal of India from the Priority Watch List. It would support recognition of the strides that India has made in advancing, protecting and implementing IPR and manage its forward momentum “, the Alliance’s Secretary General D G Shah said in the submission.