14.04.2020
April 14, 2020
The World Health Organisation (WHO) is launching drug ingredient tests to find a combination that is effective against symptoms caused by the coronavirus (COVID-19). Even though the known drug ingredients tested are patented, active international cooperation signals that the finished medicine will end up in widespread distribution. Even if cracks appear in the cooperation at some point, distribution would be guaranteed by a compulsory licence, says Kolster’s European Patent Attorney Krister Karlsson.
The World Health Organisation (WHO) announced the launch of global tests to determine the impact and effectiveness of four drug ingredient combinations against coronavirus symptoms. The known drug ingredients used in the tests, remdesivir, lopinavir, and ritonavir, were originally developed for other purposes, such as against malaria, HIV, and Ebola.
“For example, the rights to the lopinavir-ritonavir combination used in the tests belong to the US pharmaceutical company AbbVie. AbbVie has stated that if the tests result in a viable coronavirus medicine, it does not intend to take advantage of its patent protection. So the company will make the drug resulting from the tests available for free use”, says head of the chemistry team and European Patent Attorney Krister Karlsson.
The purpose of the tests is to determine whether the known drug ingredients would be effective against the coronavirus and at what dosages.
“Since the properties of the drug ingredients and their potential side effects are already known, these tests are a matter of months, when it can normally take a decade to test completely new drug ingredients.”
Unprecedented global cooperation
“The WHO and other health authorities have stepped up the dissemination of information and research results as well as advocated freedom of access to scientific publications and tests. The scientific community is openly sharing coronavirus information with one another, and competition among vaccine developers has been replaced by a sense of community”, Karlsson says.
Drug ingredient patents are often granted for widespread use, such as for the manufacture of AIDS and HIV medicines in developing countries. However, the international cooperation in the development of the coronavirus vaccine and drug ingredients is special, even in the field of medicine.
“Such a broad and strong international consensus on both the sharing of information and making the finished drug widely available is quite unique.”
Compulsory licence if the worst comes to the worst
“Pharmaceutical companies benefit from the widest possible spread of a developed drug. It would therefore be strange if a pharmaceutical company or holder of a vaccine patent prohibited others from using the finished vaccine as widely as possible or restrict the availability of the product itself”, Karlsson says.
Patent law provides for a situation where a company obtains exclusive rights to a vaccine without a desire for its widespread distribution or licensing. In cases of overriding public interest, the court may issue a compulsory licence on a country-specific basis.
“Compulsory licence is invoked especially in the case of drug ingredients. If the owner of a patented vaccine does not agree to grant a licence to manufacture the protected vaccine elsewhere, authorisation can be obtained by court order”, Karlsson says.
Israel has already introduced a compulsory licence for the ritonavir-lopinavir drug combination used in the WHO’s drug ingredient testing. Proactive measures to make the coronavirus vaccine available have been taken in other countries as well, such as Chile and Ecuador. The countries have checked possibilities for a compulsory licence from the authorities.
“Still, I believe that AbbVie’s outlook of releasing patents for free use is the prevailing mindset and approach when it comes to the coronavirus vaccine. It is not in anyone’s interest for a pharmaceutical company to hold on to its patent rights to a drug ingredient too tightly”, says Krister Karlsson.
Krister Karlsson
Associate Partner, Head of Biotech & Chemistry, European Patent Attorney
krister.karlsson@kolster.com
+358 44 236 5676
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