China Desk Newsletter - 问题需要解决–创新的时代 Problems call for solutions – a time of innovation
Extraordinary times call for extraordinary measures. Throughout history, crises have motivated for innovation. They have challenged mankind to rethink our approach and how to solve problems we are faced with. In an attempt to fight the 1800 century fatal smallpox disease, the British doctor Edward Jenner started using cowpox virus against the disease in 1798. This early effort of vaccination was the starting point of the eradication of smallpox – a disease which last occurred naturally in October 1977 and was certified eradicated globally by the World Health Organization (WHO) in 1980. In comparison, the disease caused approximately 400,000 European casualties each year during the 1800 century.
Nitrogen fixation discovered in 1918 was invented as a result of the work done by the German chemist Fritz Haber. He is known as the father of chemical weapons, but won the Nobel Prize for the development of the ammonia-synthesis process, creating a new class of fertilizers instrumental to the green revolution.
Although accidentally discovered in 1928 by Alexander Fleming, medical application and mass production of penicillin first unfolded and played a paramount role during World War II. In 1942, the first patient was treated for streptococcal sepsis with penicillin produced by Merck & Co, thanks to important research work done by Fleming and later Howard Florey and Ernst Boris Chain, for which the three of them shared the Nobel Prize in 1945. As a direct result of intense research and manufacturing innovation work carried out during World War II, from June 1945 over 646 billion units of penicillin were being produced per year.
Moving to today, the Corona Virus Disease 19 (COVID-19), caused by the new coronavirus SARS-CoV-2, has challenged our society across a vast spectre. Extraordinary measures have been implemented in a global attempt to flatten the curve and hinder the spread of the disease. One example of many measures taken, is the U.S. Food & Drug Administration's (FDA) 24 hours expeditious issuance 12 March 2020 of an Emergency Use Authorization (EUA) for emergency use of the Roche's cobas SARS-CoV-2 test for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical or epidemiological criteria. EUA authority allows FDA to help strengthen the public's health protections against chemical, biological, radiological and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under the Federal Food, Drug, and Cosmetic Act, the FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
As COVID-19 is a new disease not previously known in humans, there are as of today no approved vaccine against the disease. Medicine agencies across the world are therefor in ongoing dialogue with scientists and pharmaceutical companies in pursue of an effective vaccine. This includes the European Medicines Agency (EMA), which Norway is associated with. EMA has adopted a separate and expeditious grant procedure for incoming applications for approval of vaccines and other pharmaceuticals applicable for the treatment and prevention against COVID-19. A market authorization (MA) recommended by EMA and approved by the EU Commission will be valid for all EEA countries, Norway included.
The first clinical trials for a COVID-19 vaccine starts now in March 2020 and several studies are planned. Though it may take several months before any vaccine candidate is tested in a larger scale, the medicine agencies seem ready to act and issue an MA as soon as we have an adequate solution of the ongoing extraordinary medicinal and pharmaceutical innovation.
The problem-solution approach is a fundamental principle in European patent law. So, in a time of distress, do not disperse; solving and overcoming problems lies in our DNA – both as human beings and as patent lawyers.