The abolition of patent protection for coronavirus (COVID-19) vaccines has quickly taken centre stage in the global political debate. However, removal of patent protection will not have a decisive impact on the vaccine shortage. Instead, it would jeopardise the reliability and predictability of the patent system.
“The debate around coronavirus vaccines lacks understanding of the fact that there is no single world patent: patents are country-specific rights to prohibit, and pharmaceutical companies generally do not apply for a patent in all countries. For example, if a pharmaceutical company does not have valid COVID-19 vaccine patents in Finland, it cannot prohibit the manufacture and use of its vaccine in Finland on the grounds of patent protection”, says Marjut Honkasalo, Partner and European Patent Attorney at Kolster.
Honkasalo also points out that granting a patent is a long process.
“I believe that none of the vaccines designed specifically against COVID-19 have a patent yet, though applications are pending, of course. Granted patents related to coronavirus vaccines may apply to some parts of the vaccine, such as auxiliary substances. Those can be circumvented through development work, in which case the patents and applications are not an obstacle. The alternative is to try to obtain a licence, i.e. permission to use the protected solution. However, that does not guarantee that the vaccine is equivalent or that the medical authorities will allow the vaccine to be used without the required testing”, Honkasalo notes.
The scaling of vaccine production is therefore not held back by IP rights, but instead the bottlenecks lie in production and in the time required for the approval process of new products. Removing patent protection would not guarantee that the shortage of raw materials would be resolved or that copy manufacturers in, for example, developing countries would be able to produce products as good as the originals. In any case, products from copy manufacturers must also pass a marketing authorisation process that is expensive and takes time, but is absolutely necessary to demonstrate the safety of the vaccine.
Political destabilisation of the patent system jeopardises willingness to invest
“The patent system is the largest agreement-based system in the world. Its strength lies in predictability and a commonly shared contractual basis. It must not be scrapped for political reasons. If patent protection is weakened by political decision-making, this can affect companies’ willingness to invest and, at worst, reduce investments in product development”, says Kolster’s CEO Timo Helosuo.
Resolving crises such as COVID-19 can also be done by means other than interfering with patent protection. Pharmaceutical companies that manufacture coronavirus vaccines have offered vaccine licences free of charge to developing countries.
“Climate change is also a massive crisis, the resolution of which requires the development resources of the entire global business field. If companies have reason to suspect that climate change mitigation may be led by demanding the forced handover of related patents, this could have the exact opposite effect: reducing investment and slowing down the development of environmental technologies”, Helosuo says.
Do you wish to hear more about our views on this issue?
Timo Helosuo, CEO
timo.helosuo@kolster.com
tel. +358 40 576 1659