As some readers may have noticed, there was recently a report published by Hidayatullah National Law University, Raipur on patent oppositions. The report was also presented to DPIIT with suggestions on streamlining patent opposition process and enabling ease of doing business in India. We are pleased to bring to you a guest post by Sandeep K. Rathod critically assessing some key aspects of the report. Sandeep is a lawyer who comes with 2 decades of experience in pharmaceutical law, drug access and patents. Views expressed in the post are his own. [Long post ahead.]
Examining Oppositions: Time for a Deeper Look
Sandeep K. Rathod
A team from the Centre for Intellectual Property, Innovation and Technology at Hidayatullah National Law University recently released a monograph titled ‘A Study of Patent Opposition System’, available here (PDF). The main monograph forms the first 32 pages of the 180-page document. I will be focusing on the monograph, in this write-up.
Methodology, Scope and Objective of the Report(s)
My first and biggest reservation about this monograph arises from lack of information on the data and methodology used for preparing it. From the text it appears that the HNLU team relied on an underlying ‘study’ conducted by a renowned IP law firm. Neither HNLU nor the IP law firm has made the raw data available to the public nor have they clarified the basis of selecting or excluding the data that they have used for their ’study’. They also have not clarified if their data matches or aligns with data from the Indian patent office or from use of any RTIs. A connected reservation is that there is no ‘funding or conflict of interest’ declaration pertaining to the law firm or the authors of this monograph. So, for example, the public is not made aware of the funding relationship between the IP law firm and the HNLU team or whether any party exercised any editorial control or direction/ area of research.
The monograph’s preface states that the objective is to understand the patent opposition mechanism in India. In contrast, the law firm’s report which the preface also says it “mainly relied on”, titled “Ease of Doing Business” states that it “was commissioned to understand the issues faced by applicants during opposition proceedings”. It is to be emphasised here that opposition proceedings are, by definition, meant to ensure that undeserved patents don’t get granted easily. That is to say, ‘applicants’ are interested stakeholders here, and focusing on issues faced by applicants alone, just one of the many stakeholders, does not equate to understanding the patent oppositions mechanism as a whole. Further, there is no mention of who has commissioned the report. The law firm in question is renowned for patent prosecution work, including working for a number of multi-national pharmaceutical companies. In such a situation, there appears to be a clear conflict on basing an academic monograph solely on this report.
Like versus Unlike
The monograph has 2 major sections:
- Comparative analysis of patent systems across jurisdictions
- Analysis of Patent Proceedings in India and a sub-section on analysis of about 250 patent opposition proceedings that were on-going in the period 2016-2021. This sub-section focuses on the pharmaceutical and life-sciences domain.
The Comparative Analysis section almost exclusively focuses on patent practices of developed countries. India is a developing country and is a major part of the global supply chain for pharmaceutical products. To compare and seek alignment of Indian patent laws with developed country patent laws, without understanding how their governments incentivize industry, deliver and support public healthcare or how their public and private healthcare infrastructure (esp. health insurance coverage) works for their population, to me, sounds not a like-to-like comparison. One must also not forget that many of today’s developed countries had very different IP standards when they were in their ‘developing’ stage. It is unclear why this section does not look at experiences of similarly placed developing countries, or even the experiences of currently developed countries when they were developing.
While reading the European Union section, I was intrigued to see that the monograph completely omitted the ‘3rd Party Observation Procedure’ that is available to the entire public prior to the grant of a patent. This exclusion is jarring since the 3rd party observation procedure is very similar to certain parts of India’s pre-grant opposition as both proceedings are prior to grant of a patent and allow ‘any person’ to use these mechanisms. The monograph specifically states that EU does not have a system of pre-grant opposition. Hence, the statement on page 16 is incorrect. Also, the monograph completely ignores pre-grant opposition or similar practices that are prevalent in many developing countries like Malaysia, Philippines, Egypt etc.
The Abuse of Procedure Argument
The next, and the more important, section is titled ‘Opposition of Patent and Causes of Delays in India’. The monograph, which in its executive summary states that it is a non-empirical based report, emphasises several times that pre-grant opposition filings by ‘any person’ having no apparent ‘interest’ have been problematic and have led to abuse, and cites to the law firm’s report as the empirical basis of this statement (see text accompanying footnote 70 of the report).
While not saying so, the impression from the monograph appears to be that such oppositions are numerous and are an ‘alleged front’ for other interested parties (my language) and hence cause a huge burden to the system.
The monograph appears to be an attempt to paint a picture that a significant number of oppositions as those filed by fake parties or those with mala-fide intent. This is far from the truth. The monograph has focused a lot on allegedly fronted oppositions, but the monograph has not considered the extensive impact that pre-grant oppositions have had on access to pharmaceuticals for Indians and foreign citizens. The monograph does not cite a single document or study that shows that pre-grant oppositions have benefits or the actual benefits that Indians have had because of timely filing of oppositions against ‘evergreening type’ pharmaceutical patent applications. The monograph would have come across as more balanced had the authors looked at and examined the literature and arguments effectiveness and importance of oppositions in pharmaceutical applications. Timely and very strong oppositions filed by civil society/ generic companies that have resulted in entry of generic drugs in face of multiple patent applications for many drugs.
Looking at the IPO’s Data on Pre-Grant Oppositions
The above perspectives from the monograph needs examined vis-à-vis available data and literature. The Indian Patent Office (IPO) in its Annual Report for the year 2020-2021, states:
‘… a total of 52764 patent applications were published under section 11A and 583 pre-grant oppositions were filed under section 25(1) of the Patents Act, 1970, which is about 1.1% of the total published applications.’
The IPO Report gives data for last 5 years and the pre-grant oppositions filed for the period is in the range of approximately 1% of applications filed. So, the entire discussion of oppositions, their effective processing and impact on applicants as well as society is material only to this approximately 1% of the patent applications filed. That does not mean that the issue of efficiency of the opposition system is trivial since arguably, only the most important patent applications are opposed (for instance, in the life sciences category). Conversely, it is more important that the most impactful patent applications are strictly scrutinised and efficiency achieved on this front.
For professionals tracking pre-grant oppositions, some persons who regularly file oppositions across domains are known. For instance, the Dhaval Diyora case which was litigated in Bombay High Court and Ms. Sonal – who appears to file pre-grant oppositions in different fields and which oppositions are not always prosecuted thereafter. However, the key points to be noted is that the legislation has indeed specified that ‘any person’ can file a pre-grant opposition to aid in the examination process and not restricted the filing to only ‘interested’ parties. Curtailing opposition to only ‘interested’ parties would effectively mean that one round of opposition is cut-off. Even the EPO 3rd party process specifically allows straw-man observations to be filed. So, this worry on ‘fronted’ oppositions is actually focusing on the minor issue of identity, which has, as we have seen above, no real adverse impact on the patent examination process. In fact, it may well be argued, that opposition helps the examination process and results in better patent grants (Refer UCB Farchim).
When less than 1% total applications are opposed, what could be the number of such ‘allegedly fronted’ oppositions within the overall opposition tally? In this author’s study, Ms. Sonal has filed approximately 50 pre-grant opposition(s). Hazarding a guess- such ‘fronted’ oppositions from different person(s) would be, at maximum, 10% annually of this 1% (i.e. 55-60 oppositions of the 583). If the numbers are so miniscule, should these ‘fronted’ oppositions really be warranting such hue and cry, or should we discuss on how to efficiently process the balance 90% of pre-grant oppositions (and 99.9% of patent applications)? Also, not all ‘fronted oppositions’ are “fake”. Such oppositions also result in IPO refusing applications (on patentability grounds) even when the Opponent has not appeared, e.g. the IPO’s Jan 2023 decision for 3596/CHE/2012 where Ms. Sonal had filed a pre-grant opposition. We must not lose sight of the rationale for oppositions as laid down in the Ayyangar Committee Report.
At a later part of the monograph, the authors state that ‘average delay due to oppositions filed by individuals without proper credentials is approx. 114 months’. It is unclear on how the authors of the monograph (self-described as non-empirical) arrived at this number since delay in reaching a final decision in a pre-grant case (whether genuine or due to allegedly fronted oppositions) is due to a multiplicity of factors and not a single factor alone. There is no single cause for delay by a “fronted party” in a pre-grant opposition – without looking at how much delay was caused by other factors. In fact, allegedly fronted oppositions (and/ or genuine oppositions) can be processed significantly faster if the IPO runs its processes much faster (which is not happening and has been noted by authors later).
The monograph then goes to discuss the Economic Advisory Council to Prime Minister (EAC-PM) Report. However, it must be noted that not all details of the working and data used for the EAC-PM Report are in public domain and hence the report’s suggestion (upon which the monograph builds upon) to create a 6 month window for filing pre-grant oppositions from issuance of FER must be looked at, only once the EAC-PM working and underlying data is put in public domain.
The monograph then notes that the next cause of delay is to serial oppositions being filed by several parties. However, it must be noted that applicants also amend their claims during the prosecution of the application and hence an amendment of claim would impact industry competitors and hence trigger their interest in filing a pre-grant opposition. Trying to understand opposition filings (serial or otherwise) without looking at the number of claim amendments is a flawed process. An important contextual point here is that pharmaceutical companies file multiple patent applications covering one pharmaceutical drug. So, the issue of multiple oppositions, multiple patent applications and differently timed oppositions is not a straight-line discussion but should be a more of a branched decision tree type analysis.
The monograph thereafter moves to some very interesting observations on delays- viz. delay caused on account of delay in issuing a notice of opposition by the Controller and delay caused on account of delay in issuing a hearing notice for the opposition by the Controller. The monograph rightly notes multiple instances where Patent Office does not issue the original opposition notice or, more commonly, the notice for hearing of the opposition as also the constitution of opposition board (post grant opposition). A related delay is the delay caused by late delivery of final orders. These are all real-life problems which, in my view, that no stakeholder can have contradictory views upon. A lot of heartburn and ‘delay’ for all stakeholders can be avoided if the Patent Office strengthens these components –
- timely issuance of original opposition filing notice thus initiating the pre-grant process,
- timely issuance of pre-grant hearing notice,
- timely constitution of the opposition board for post-grant opposition cases and most importantly,
- timely release of final decision(s).
The monograph has rightfully discussed the above aspects on delay.
The monograph notes the point on various adjournments sought by parties and it must be pointed out that not only opponents but equally, applicants also seek adjournments. The IPO’s recent circular in this regard would help close this adjournment loop. Finally, the monograph goes on to make some suggestions in terms of possible amendments to both the Rules and the Patents Act. However, critiquing these suggestions without having access to the underlying raw data is fighting a battle without the key weapons.
While collating above thoughts on the monograph, the Delhi High Court released its decision in Natco v. Assistant Controller of Patents on 12/Jan/2023 (after the release of the Monograph). Some excerpts from this decision would be relevant to a better understanding of the patent grant process and the critical role of oppositions:
“74. … The right to oppose the grant of a patent is just as sacrosanct as the right to seek grant of a patent. The public interest involved in ensuring that patentable inventions are patented, cannot be accorded a greater degree of sanctity than the public interest involved in ensuring that the non-patentable inventions are not allowed to be patented. … In pharmaceutical patents, especially, additional care has to be taken to ensure that, by being allowed to evergreen a patent beyond its expiry, the patent holder does not keep others, who may seek to deal in the patented product, out of the market. The ultimate sufferer, in such a situation, would be the ailing public, who seek access to the product.”
Thus, the authors of the monograph completely ignore the public interest in the moderation of monopolies that patents grant, a fundamental basis of IPR theory for over a century. That to me, is the biggest lacuna of the monograph.