COVID-19 Testing Device Manufacturers Sued

Labrador Diagnostics LLC filed a lawsuit earlier this month in the District of Delaware against a manufacturer, bioMerieux and it’s subsidiary BioFire, for patent infringement in a medical testing device used for COVID-19 testing using a patent formerly owned by Theranos.

Mark Lemley, director of the Stanford Law School Program in Law, Science, and Technology tweeted “this could be the most tone-deaf IP suit in history.” The company later backtracked their statement in response to bad publicity.

After originally asking the court for an injunction to stop BioFire from using the technology, Labrador Diagnostics announced on Tuesday they would offer royalty-free licenses for use in COVID-19 tests. “Labrador fully supports efforts to assess and ultimately end this pandemic and hopes that more tests will be created, disseminated, and used to quickly and effectively protect our communities through its offer of a royalty-free license during the current crisis.” They said they wanted to make it clear the complaint was not directed at COVID-19 testing but instead on activities over the past 6 years and they were unaware the technology was being used to develop tests for COVID-19 until BioFire issued a press release two days after the suit was filed.

Labrador is a shell company owned by Fortress Investment Group and backed by SoftBank, according to The Verge. Labrador Diagnostics LLC is represented by Farnan.

The patents, United States Patent 8,283,155, and 10,533,994 which are owned by Labrador, relate “generally to ‘the field of medical devices,’ including ‘portable medical devices that allow real-time detection of analytes from a biological fluid.’” According to the complaint, the products FilmArray 2.0, FilmArray EZ, and FilmArray Torch devices operate using the technology in the copyright.

“Defendant BioFire submitted FilmArray pouches, to be used in conjunction with the FilmArray 2.0, FilmArray EZ, and/or FilmArray Torch as part of the FilmArray System in an infringing manner, to the FDA for FDA clearance,” the complaint states.

Theranos, the original owner of the patent, did not get a similar machine to work according to Ars Technica, but they were able to secure patent protection. BioFire was able to create a version of the technology that works and COVID-19 has been added to the pathogens the device can detect.

The 155 patent “describes a generic architecture for a machine that automates testing for the presence of substances in bodily fluids. In the system described by the patent, an operator inserts a ‘test device’(which contains both the bodily fluid to be tested and the reactants required to perform the test) into a ‘reader device.’ The reader device then triggers the necessary chemical reactions to perform the test and reports the results. Theranos’ patent isn’t limited to any specific bodily fluid, reactants, or testing protocol,” the Arstechnica article explains.

Although Labrador is allowing the use of the patents for COVID-19 testing, they are still proceeding with the lawsuit at this time.