A recent proposal (IP/C/W/669) calls for a waiver for all World Trade Organisation members of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in relation to the "prevention, containment or treatment" of COVID-19. This article discusses some of the limitations of the proposed waiver in the context of improved access to COVID-19 vaccines.

Trade secrets

There are many aspects of biological medicines such as vaccines that may qualify as confidential information – including:

  • technical information, formulae and specifications relating to processes, systems and products developed by the proprietor, including for production, formulation, filling or vialing and administration of the biological medicine;
  • training and instruction manuals and demonstrations;
  • unregistered designs;
  • computer source code;
  • database information;
  • samples and other materials;
  • information relating to logistics, distribution and supply; and
  • information relating to raw materials.

Such confidential information would typically be protected by the holder or possessor of the information (ie, the originator company of the biological medicine) using various mechanisms (eg, via company policies, contractual obligations and access limitation).

It is important to consider the following:

[TRIPS] only creates obligations of governments to pass laws supporting intellectual property rights of various kinds: patents, copyrights, designs, trademarks, and trade secrets. It doesn't affect the private ownership of those rights. That's an important distinction, especially for trade secrets (or 'undisclosed information' as it's called in TRIPS), because unlike the other 'registered' rights, it doesn't depend on a government grant. It just requires a legal system that enforces confidentiality.(1)

In other words, it is unlikely that a company can be forced to hand over its trade secrets by way of a TRIPS waiver. Possibly, if a company's trade secrets were misappropriated and used by a third party without authorisation in respect of waiver subject matter, the government might refuse to grant an order enforcing the company's rights. However, it remains to be seen whether this mechanism is likely to be used.

Patents

It is also important to consider that patent specifications do not usually include the 'secret sauce' for production of a medicament, particularly in the field of complex biological medicines such as vaccines. This is not always because the patent applicant wishes to keep this information secret; in many cases, the processes and systems are too complex to provide a written description in detail and there is an assumption that a person skilled in the art who reads the application would have sufficient understanding based on the description to be able to perform the invention claimed. However, even with the support of a patentee to provide the technical know-how relating to the materials and processes for the production of biological medicines, this can be a lengthy and challenging operation for a third-party collaborator.

Compulsory licences

Where compulsory licences are granted that order the transfer of technology in the form of confidential information relating to the patented subject matter which is the subject of the compulsory licence, the question remains how governments can ensure the full disclosure of such information to the licensee. It seems that unless originator companies of biological medicines are willing to voluntarily provide this undisclosed information and full technical support, the TRIPS waiver becomes fairly meaningless in a case where rapid access to vaccines is necessary, such as in the context of the COVID-19 pandemic.

Comment

The issues discussed above are in addition to the possibly more pertinent issues that are stalling access to COVID-19 vaccines in developing countries, including:

  • the cost and availability of raw materials;
  • the capacity and number of vaccine manufacturing facilities capable of producing the quantities of quality vaccine required for the global population; and
  • the logistical complexities of providing vaccines to the populace requiring vaccination, particularly where many people live in remote or rural locations and where the vaccines require a cold chain, in some cases of -70°C, to remain viable.

In all likelihood, should IP rights be targeted by a TRIPS waiver in regard to COVID-19 vaccines, reliance of large vaccine originator companies on the maintenance of trade secrets will become all the more prevalent. Unlike in the case of pharmaceuticals, which are chemical molecules that can be relatively simple to manufacture, it is likely to be relatively difficult for governments to extract all of the requisite information and technical support for technology transfer to a third-party manufacturer to produce and distribute complex vaccines on the basis of a TRIPS waiver or compulsory licence, particularly on a rapid scale such as is needed for COVID-19.

Without the voluntary cooperation of vaccine originator companies, a significant or rapid increase in the production of vaccines by third-party manufacturers is unlikely.

Endnotes

(1) James Pooley, IP Watchdog, 25 May 2021.