By HU Yuanqiong – Advocates of access to medicines movement would not feel unfamiliar with the issue of patent evergreening on chemical medicines while monopoly could get prolonged through applying for multiple patents on small changes of the same medicine. The similar tricks have also been practiced on other medical products, such as vaccines. As a traditional public health intervention, vaccines have been costing more money in recent years when a couple of newer generation of products are exhausting governments’ budgets largely due to their monopoly situations. Recent researches have suggested that patent thicket and evergreening, among others, have played an instrumental role.
However, the newly launched report by World Intellectual Property Organization (WIPO) Global Challenges division (herein the WIPO report) has concluded with several contestable remarks and downplayed the role of patent in hindering vaccine competition.
Firstly, the WIPO report has either overstated or overlooked the role of patent in the context of vaccine access and innovation.
On one hand, it states that the control derived from patent ‘can help ensure vaccine quality and safety’ [Page 19 of the WIPO report]. It seems peculiar to read such overstatement, because it is commonly known that it is rather good manufacture practice standards and government regulations that can ensure quality and safety of any medical products including vaccines. Patent, on another hand, is governed by different legal framework and criteria.
On another hand, it holds the view that ‘the various forms of IP rights have not posed a significant barrier to the manufacture and distribution of vaccines’ [page 22 of the WIPO report]. Literature in recent years have however increasingly demonstrated the detrimental effect of IP, especially patent, on delaying competition in vaccine market.
A recent report published by Medicins sans Frontieres (MSF) suggests that new generation of vaccines are prone to high concentration of patent evergreening. One such example is a composition patent applied by Pfizer on its 13-valent pneumococcal conjugate vaccine (PCV-13 vaccine) concerns comprising more serotypes to a PCV vaccine based on obvious technologies known for vaccine producers. It is under disputes in multiple jurisdictions including India, South Korea, US and Europe. The broad patent, if granted without national law scrutiny, could effectively block follow-on developers to launch their own version of PCV-13.
Composition patent is only one possible barrier, while other types of patent applications could hinder launching or using the vaccine even if competitors could produce a follow-on alternative of the vaccine. For instance, blockage may occur when the targeted age groups for the concerned vaccine have been covered by patent. Blockage may also occur when patent may cover the specific vaccination schedule which turned to be the common schedule that many national immunization programmes would follow. Since patent has been applied for at nearly every step of vaccine development, production and use, monopoly of originator companies could be extended from starting material, to the actual product and the final clinical use.
Other literature also holds the similar view that the trend of expansive use of patents in new vaccine development field have posed an increasing thread to competition.
It is therefore oversimplification for the WIPO report to conclude that patent plays only insignificant role in the lack of competition in the current vaccine market.
The lack of closer looking at the excessive patenting behaviour has led to somewhat lax recommendations of the WIPO report on how IP related hurdles could be addressed.
Especially, the very core problems of evergreening and the role of government have been overlooked.
Applying patentability criteria that could restrict expansive claims, and easing public scrutiny mechanism such as patent opposition procedures, are among the critical measures that national patent laws should consider. Claims concerning age groups or vaccine dose regimens, for instance, could be systematically rejected upon strict patentability. Procedural safeguards such as pre-grant and post-grant oppositions, could also increase public scrutiny on excessive practices.
Moreover, the WIPO report seems have a research problem leading to its disapproval attitude towards the use of compulsory license on vaccines. [See page 22 of the WIPO report]
There are some logical and factual issues. Firstly, it argues that ‘compulsory license has never been used on vaccines’ It is a weak argument. As an integral part of patent law, compulsory license is applicable for all types of products and technologies. Lacking the first case cannot be used as a logic to dismiss the possibility and legitimacy of using it in the future.
Second, the report argues that using a compulsory license may not be helpful because know-how, commonly used in vaccine production, may not be included. On this note, it dismissed the essence of compulsory license as an important legal and public policy tool, that can be deployed with broad discretion in its content. Know-how certainly can be and has been subject to compulsory license in the past. For instances, literature have suggested that know-how has been included in several compulsory licenses issued in the US, alongside patent and other needed technological information.
In addition, there are some citation problems. Concluding the discussion of compulsory license, the WIPO report cited the United National High-Level Panel on Access to Medicines report (UNHLP report) that compulsory license could dissuade manufacturers to invest and develop new technologies. Tracking the reference of this citation will lead us to Page 23 of UNHLP report, where such opinion was included in a particular literature reviewed. To the contrary of this original literature, UNHLP report has rather recommended that countries should adapt expedited procedures of compulsory license to facilitate access to medicines. There is a conventional distinction between original literature reviewed and the actual discussion of a research work. Using citation in this manner has distorted the actual recommendation by the UNHLP report concerning compulsory license. It is misleading.
WIPO needs to retreat this report to give a more professional analysis on the concrete patent barriers facing the new vaccine market, and the legal and policy tools that countries could use in tackling evergreening practices.
