9. Proposed Guidelines Create Uncertainty

The proposed Guidelines will generate significant uncertainty.

(a) Section 5.1.6.8 states that “the notice shall be acknowledged by the patent owner or patent licensee and PRH NDP within seven (7) days”. But what happens if the patent owner or patent licensee delays in providing acknowledgement or does not provide any acknowledgement?

(b) Section 5.2.2 states that “Failure to notify NPRA within the stipulated timeframe may result in appropriate administrative action under the applicable regulatory framework”. There is no clarity on what the administrative actions will be.

(c)The Guidelines do not provide clarity on whether the patent information provided by the Category 2 applicants will be made publicly available even though in Section 2 of the Guidelines, it is claimed that it will be a “transparent administrative mechanism”. Yet, there is no clarity which aspects will be transparent.

(d) The Guidelines might also have an impact on fast-track registration pathways presently provided by NPRA e.g. a generic approved under priority review procedure presently expects to be approved within 100 working days and the generic facilitated registration pathway under ASEAN Joint Assessment Procedure, has an approval timeframe of 60 days. There is little clarity on how this will be managed.

(e) There is also the possibility that a PRH NDP or the patent holder/licensee may seek to trigger back to-back suspension of the regulatory process, by continuously updating its patent list (which the Guidelines allow). For example, towards the end of the first 12-month suspension, a PRH NDP or the patent holder/licensee adds more patents to the list, triggering 45 day notification and another 12-month suspension. Such as scenario has happened in other countries implementing similar systems; how will this scenario be managed by NPRA?