Last week we blogged about two post-grant oppositions against Novo Nordisk’s patent that have been pending for eight years. While the Delhi High Court (single judge) directed the Controller to finally hear and decide the matter by September 30, 2022, Sandeep Rathod in his comment here, pointed out that the patentee appealed the Single Judge decision before a Division Bench. It appears that this appeal was then withdrawn by the patentee midway while arguing! Sandeep has also written about post-grant oppositions in India here.
Image from here
In this post, we reflect on post grant opposition timelines and procedures followed by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO). Knowledge of comparative law is valuable as it enables countries to meet their own needs by learning from varied experiences of other national systems. While other systems may also have flaws and suffer from delays, inspiration can be drawn from advantageous aspects of each such system. And surely, the time to act is now, in however small a way. “For if we do act now, we don’t have to wait for some grand utopian future, as the future is an infinite succession of presents.” Even small changes in the way oppositions are conducted could go a long way in reducing timelines.
Before 2016, it appears that the average duration to decide post-grant oppositions, at the first instance, at the EPO was 34 months (nearly 3 years). However, post 2016, the EPO announced its decision to reduce timelines to 15 months (at least for straightforward oppositions) from the opposition date. Different stages of the opposition process are put in place keeping this overall timeline in mind. While some timelines are fixed, other timelines may be flexible.
Broadly, stages and timelines are as follows (here): (a) nine months from grant to file the opposition, (b) review of opposition for formalities by the formalities officer – usually two months given to the opponent to remedy deficiencies / file additional material, (c) four months for the patentee to respond, (d) a month or two (this is not clear / may be flexible) for the Opposition Division* to consider the opposition, come up with its preliminary opinion and fix a date for the hearing, (e) six months to prepare for hearing (and two months before the date of hearing for parties to file additional material), (f) one to six months for the written decision. Extension of time is given only in exceptional situations and is assumed to be difficult to get. Cumulatively (b) to (f) comes up to around 15 to 22 months. The Guidelines for Examination lay down these broad timelines (here, here).
*The Opposition Division consists of three technically qualified members. Unlike in India, the examiner who took part in the grant process can be a member of the Opposition Division. Due to this, some have characterised post grant oppositions before the EPO has ‘enhanced examinations’ rather than litigations.
Unlike the EU, the US has a statutorily prescribed timeline within which post-grant reviews (which is a time-bound inter partes review mechanism) are required to be decided. The America Invents Act, 2011 stipulates an aggressive timeline of 12 months (one year) from the date of institution of post grant review (with a six months extension available) for the final decision.
Broadly, the process works as follows (here, here): (a) nine months from grant to file the opposition, (b) within three months of notification of the opposition, the patentee may file a preliminary response (this response is optional), (c) within three months from the patentee’s response / due date to respond, the Patent Trial and Appeal Board (Board)* will determine whether or not to institute a trial (and identify on a claim by claim basis how the trial will proceed). If a trial is instituted, the Board will enter a Scheduling Order that sets due dates for the proceeding. For example, the patentee may be given three months for discovery and response, after which, the opponent may be given three months for discovery and its reply. And another one month may then be provided for the patentee to respond. An initial conference call is held with the parties to determine whether any adjustments to the schedule are required – depending on the complexity of the case. The Board is required to conduct the trial in a streamlined manner within the outer timeline of 12 to 18 months. As pointed out in the comments section by Ayushman to my previous post here, the USPTO trial practice guidelines encourage the use of conference calls to raise and resolve issues and provides guidelines for this.
* The Board consists of administrative patent judges (with legal and scientific qualifications) and not examiners.
Unlike the US, there is no statutorily prescribed outer timeline for completion of post-grant oppositions. However, similar to the EPO, courts have time and again directed the Patent Office to complete post-grant oppositions within 12 to 18 months.
While this outer timeline is prescribed by case law, the Patent Rules lay down stage-wise timelines: (a) one year from grant to file post grant opposition, (b) patentee has two months to reply along with evidence, (c) the opponent then has one month to file evidence in response to the patentee’s evidence, (d) the Opposition Board then has three months to provide its recommendations to the Controller, (e) the Controller can then schedule a hearing by providing not less than 10 days notice. Further evidence can be filed only with approval from the Controller and in no case after a hearing date is fixed (except for a new publication as per Rule 62(4)). Timelines for responses can be extended by a month with leave of the Controller.
If the rules are followed strictly (with no extensions) it appears that opposition decisions should be made as fast as 8 to 10 months. Maybe these timelines and rigid processes need to be revisited since oppositions, in reality, are taking 8 years and not 8 months.
While there is a need to change and streamline processes, changes should be crafted carefully. The intention of the law which seeks to maintain a fine balance between competing interests of patentees, generic companies and the public should not be forgotten. Keeping this in mind, some preliminary thoughts below:
Case management techniques such as issuing a scheduling order, early in the opposition process, as done by the USPTO could help streamline oppositions. A schedule for the proceeding should be fixed upfront for both the parties to agree to / make adjustments. Once the schedule is decided (which should also be done in a time bound manner), the Controller should ensure that extensions are given only in exceptional situations and keeping the 12-18 month timeframe in mind.
The role and involvement of the Opposition Board requires consideration. It cannot be a mere spectator, issuing delayed recommendations and being detached from the process. Since the recommendations of the Opposition Board form a crucial part of the material to be considered by the Controller, its involvement and participation in the process should be on-going. The Opposition Division at the EPO is actively involved in the opposition process – invites parties as often as necessary to clarify the substance of the case, file observations etc. All this – within the timeline required to issue its opinion.
A longer notice period for hearing along with a deadline to file additional evidence (similar to that offered by the EPO) could enable parties to prepare better and reduce the possibility of delays due to additional evidence.
To increase transparency, the patent office should be required to make available data describing the length of time between institution of and issuance of a final decision for each post grant opposition (also required in the US).
House-keeping issues such as using efficient and organised document management systems can go a long way in establishing order in post-grant proceedings. Currently, there is no semblance of order or logic in the way files are named, uploaded or categorised which only adds to the chaos and confusion.
Hiring experienced patent officers will also help fast-track matters.
The Economic Advisory Council to the PM has recently suggested some controversial changes to the pre-grant opposition process but nothing has been said about post-grant opposition mechanisms.