FDA to grant licence to Chinese-owned Advion for COVID-19 diagnostic patent
The US Food and Drug Administration (FDA) will today announce that it plans to grant a Chinese-owned testing company an exclusive worldwide licence for a US government-owned patent covering a diagnostic test for the rapid detection of COVID-19.
According to the Federal Register notice which is dated 9th November and due to be published today, 13th November, the FDA is “contemplating” giving the royalty-bearing licence to Advion, a New York-based life sciences company owned by Beijing Bohui Innovation Biotechnology Company. Both companies develop and manufacture diagnostic systems.
The patent at the centre of the FDA’s considerations, “Direct impact ionization (DII) mass spectrometry” ( patent number 8,704,169), was filed in October 2011 and granted in April 2014. Rights to the patent have been assigned to the US government.
The patent’s abstract reads: “Disclosed is a mass spectrometer for analysing a sample that has or is suspected of having microorganisms. The disclosed mass spectrometer has been uniquely configured to include a sample platform which functions as a counter electrode or discharge electrode and a surface to provide the sample to be analysed.”
Mass spectrometry is an analytical testing technique which measures the mass-to-charge ratio of ions in a sample.
The FDA said that the prospective territory of the exclusive licence “may be worldwide and in fields of use that may be limited to manufacturer and commercialisation of a field-deployable mass spectrometer diagnostic for the rapid detection of SARS, SARS-CoV-2 and other viruses, bacteria and bacterial serovar, and drug impurities”.
If granted, the exclusive licence will be royalty bearing.
According to the notice the prospective exclusive licence may be granted unless, within 15 days of the date listed on the notice, the FDA receives evidence that the grant of the licence would not be consistent with the relevant laws governing the licensing of government-owned inventions.
The public are invited to file comments or objections in response to the notice.
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