Fixing Pre grants: Will the EAC suggestion to fix time limit help?

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Recently, the Economic Times reported that the Economic Advisory Council to the Prime Minister (EAC) suggested two ways to fast track the process of granting patents. First, it suggested hiring more examiners, an issue we have previously raised alarm about here and here. However, it’s the second suggestion, to limit the timeline for filing pre-grant opposition to 6 months, which has been making quite a few rounds in the media  (see for instance here and here). These suggestions were apparently made by the EAC in a presentation to its stakeholders which include the Department of Promotion of Industry and Internal Trade and Niti Ayog. I was not able to locate a primary source for these though.

The demand for changing the existing pre-grant opposition mechanism has been age old in India.  As highlighted by MSF in its comment on the suggestion, in early 2000s the pharma industry pushed hard to dilute the pre-grant opposition process in India, while the domestic legislation was undergoing amendment to comply with TRIPS. The reason for this suggestion by the EAC is to address the delays in the patent examination system. But is this a viable solution? Or is the solution trying to fit into a problem?? 

Of course, pre-grant oppositions have their own set of issues, and  no time cap on pre grant oppositions may seem like another one. In the past, the now defunct IPAB and the Bombay High Court adopted a strenuous approach by narrowly interpreting and reading unwarranted qualifications within the meaning of “any person” under Section 25 (1) (pre-grant opposition provision) in an attempt to overcome the delays in the examination process occurring out of pre-grant oppositions. However, as critiqued by Swaraj and Varsha here and here, such an interpretation may not only be bad in law but also that these delays are not one sided and rather emit out of the flawed examination system as a whole. Has there been a clear examination of where the delays arise from? Whether pre-grants, or patent office adjudication, or amendments by the applicant, delays in filing, or other reasons? Swaraj and I have raised questions on this in the past.  

The Delhi High Court in the recently adjudicated Natco Pharma Ltd. V. UoI (July 2022), highlighted the issue of delayed examinations and expressly held that blame cannot be chalked around a single reason or factor for this. While identifying the contributions in the delay by pre-grant oppositions, the court decided to look a little further and identified the multiple amendments by the applicant consequent to each objection and thus adding to the delay in the process. Noting this the court directed that the pre-grant opponent must be informed of the amendments taking place in the application to keep it updated. (para. 19). 

In its comment, MSF  identifies two instances whereby the ‘no time cap on opposition’ approach has actually proved to be beneficial in addressing the wider public health concerns by highlighting the evergreening attempts by the patentees. First, it talks about how pre-grant opposition to Johnson and Johnson’s evergreening patent application on new DR-TB drug bedaquiline was filed years after the application and thus was crucial to bring to light the fact that the subject matter was not novel (longtime readers will remember the series of hard hitting posts here and here, by Prashant on the extremely problematic advocacy of this as a wonder drug). Second, MSF’s own pre grant opposition to Pfizer’s PCV-13 vaccine’s patent application(s) years after the application (something Swati covered here for us). In doing so, the commentary makes an important point that applicants may deliberately conceal the international non proprietary names (INN) of the drugs behind vague and unclear terms and thus digging into them, assessing the novelty and concerning antitrust issues therein eats up a lot of time. Thus, fixation of 6 months to wrap this assessment up and file a maintainable opposition becomes somewhat of a herculean task.   

Therefore, merely fixing a specific time limit, without considering the practices and challenges to file the pre-grant opposition (presumably along the lines of foreign practices) is perhaps not the right choice. Furthermore, this one glove fits all mentality falls flat on its face when the inspirations i.e. countries with higher number of patents start complaining themselves of substandard patents (see here, courtesy the MSF commentary) owing to increasing applications. With India’s own track record on granting a potentially embarrassingly high number of erred patents in the past, proposal to shorten an aiding mechanism thereby making it more difficult to use, is nowhere a solution. It is pertinent to note that pre-grant opposition has been one of the most important and perhaps frequently used TRIPS flexibility in the IP regimes globally. The Delhi High Court in M/S Ucb Farchim Sa vs M/S Cipla Ltd. & Ors have expressly identified them to be an aid in the examination process. And thus the proposal to dilute it, under the garb of improving the mechanism must come backed up with some sound rationale and empirical evidence for it or else it will only add on to the pile of problems in the Indian patent eco-system.

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