March 20, 2020
Vaccines can be patented in the same way as other drug development, and pharmaceutical applications and vaccine developers grant licences to their products to those who have the ability to pay. Kolster’s European Patent Attorney Krister Karlsson explains why it is possible to obtain exclusive rights to a vaccine – but not in the way we fear.
It raised many eyebrows when the German paper Welt am Sonntag wrote that US President Donald Trump was trying to buy exclusive rights to the coronavirus vaccine being developed by the pharmaceutical company CureVac to use it in the United States. The German government has made a counteroffer so that vaccines and medicines against the coronavirus (COVID-19) can be developed and used worldwide. According to German politicians, no country should have a monopoly on the vaccine.
The development of a coronavirus vaccine began as early as December 2019 when the first observations of infection came in from China, and according to the latest information, the testing of a vaccine developed by one company is already starting in the United States using volunteers. Vaccines are protected by patents in the same way as other drug development. Consequently, from patent law viewpoint, it is possible for a single company to obtain exclusive rights to a vaccine, and thus the opportunity to exclusively grant licences.
“The primary goal of commercial pharmaceutical companies is to take care of human health, but the second is understandably business. If, for example, the United States is able to pay more for coronavirus vaccines than a poorer country, that can lead to availability problems: the pace of vaccine production is not sufficient to meet the needs and more of them are sold to countries that can pay”, Kolster’s European Patent Attorney and head of the chemistry team Krister Karlsson says.
In practice, however, exclusivity is unlikely. Obtaining an exclusive right to an invention through patenting is too slow, as a vaccine must meet the same patenting criteria as other inventions. These include, for example, novelty and inventiveness. The number of companies competing in vaccine development also limits the venture.
“The German CureVac pharmaceutical company enticed by Trump may have come a long way in developing a coronavirus vaccine, but it is not the only operator developing such vaccines and has no exclusive rights to the product. A dozen different companies are currently working together to develop the vaccine.”
Compulsory licence circumvents the right to prohibit provided by a patent
The patent system makes it possible to apply for protection as widely as desired. In the case of vaccines, patents are most often sought with a worldwide scope. Even though a patent is essentially a right to prohibit others, it does not slow down the spread of vaccines.
“It is a utopian notion that a pharmaceutical company or holder of a vaccine patent would prohibit others from using the finished vaccine as widely as possible or restrict the availability of the product itself. The patent allows reliable information to be disseminated more quickly, preventing counterfeiting”, Karlsson says.
“Both diagnostic tests and vaccines must meet regulatory requirements, including reliability and testability, to prevent just anyone from making and selling the products without authorisation.”
Vaccine development is expensive for a company, so there is a desire for the products to be used as widely as possible, thus benefiting the business of the companies. Instead of restrictions on use, the bigger problem may lie in ensuring availability.
“We need a sufficient number of reliable companies that have the resources to manufacture vaccines and pharmaceutical products according to the strict quality criteria of the authorities. Therefore, countries that have the capacity to produce the huge volumes of product required to contain a pandemic have an advantage. A possible shortage of medications and vaccines can be attributed more to resources than exclusive rights to the product”, Karlsson says.
Patent law provides for a situation where a company obtains exclusive rights to a vaccine and does not share or license it to a sufficient extent. In cases of overriding public interest, the court may issue a compulsory licence on a country-specific basis.
“Even if the vaccine is patent protected and the patentee does not grant a licence for the production of the protected vaccine, it could be possible to, for example, obtain authorisation to manufacture the coronavirus vaccine in Finland through a court order. Compulsory licences have been used especially for drug ingredients: India, for example, has granted compulsory licences for the manufacture of HIV drugs.”
Needs to be quick, but also safe
Its global spread is what distinguishes the coronavirus from other epidemics, such as Ebola, SARS and swine flu.
“The coronavirus is heavily affecting Europe and the West. The interest in curbing it is greater than, for example, in the case of Ebola, which was considered just an African problem”, Karlsson says.
The virus causing COVID-19 is the seventh corona-type virus, so there is already a lot of existing scientific research to help in the development of pharmaceutical tests and vaccines.
“The WHO and other health authorities are advocating freedom of access to scientific publications and tests. Although several pharmaceutical companies are developing coronavirus vaccines simultaneously, instead of a competitive setting, the scientific community is openly sharing information on the virus with one another. A sense of community is emphasised rather than secrecy.”
National health is at the top of the authorities’ priority list. In the case of the coronavirus, there is a desire to act as quickly as possible, but without loosening the regulations concerning medications.
“With the narcolepsy associated with the swine flu vaccine, we learned that patience is a virtue. The coronavirus vaccine must meet the same regulations and criteria as any other vaccine. Expedited processing cannot be implemented at the expense of control and safety”, Karlsson says.