Opinions and Editorials

Mar. 23, 2020

IAM: In the Fight Against the Coronavirus Outbreak, Life Sciences Companies Need Certainty in 101 by James Edwards

The novel coronavirus that originated in Wuhan, China, has now swept the globe. Its rapid spread, which has reached pandemic levels, has sparked a worldwide effort  of medical research and development to address this contagion. COVID-19 has not only affected our daily lives and health, but has disrupted commerce, trade, financial markets, industry and more.  Staying home is in; large gatherings are out.

In the R&D battle to beat COVID-19, established and early-stage pharmaceutical and biotechnology companies have joined universities and government agencies such as the National Institutes of Health and the Biomedical Advanced Research and Development Authority. They are working on diagnostic tests, therapeutics and vaccines. They are developing new antiviral medicines and immunotherapies. They are testing whether diagnostics and therapeutics originally invented for other viruses might be safe and efficacious for this coronavirus.

Drug innovators are making progress at remarkable speed. COVID-19 emerged in December 2019 and within about one month, scientists had genetically sequenced the virus. While at best a drug or vaccine is expected to reach the market in 12 to 18 months, having many companies working on it increases the prospects of earlier success. Clinicaltrials.gov shows about 80 clinical trials underway for tests, treatments and vaccines for various coronaviruses.

The US Food & Drug Administration (FDA) has issued new guidance allowing clinical labs and commercial manufacturers the emergency use of new lab-developed, in vitro diagnostic tests for COVID-19.  This move should help to counter the virus’s rapid spread by speeding up access to reliable testing across the United States. Labs and drugmakers are working on molecular, antigen detection and serological diagnostics, some under FDA emergency use terms and others under state authorisation.

This can-do, hands-on public health effort is certainly inspiring. But there’s some unfinished business that could stall this work. To wit: What if the state of affairs regarding patent-eligible subject matter disrupts the progress toward coronavirus tests, treatments and vaccines?