infoJustice

In the ongoing debate over intellectual property (IP), access, innovation and COVID-19, numerous references have been made to high profile instances in which patents and other forms of IP have been perceived as barriers to the research, development, manufacture or supply of products necessary to respond to the pandemic.  This short post (which is derived from a longer article forthcoming in the Utah Law Review) collects and summarizes many of these instances for comparison and analysis.

• In February 2020, the Wuhan Institute of Virology announced that it had filed a patent application claiming the use of Gilead Sciences’ experimental antiviral drug remdesivir to treat COVID-19. The announcement caused significant controversy, given that the Wuhan Institute did not develop the drug and its effectiveness against COVID-19 was still unproven. Gilead’s own patents on the drug also caused controversy, prompting thirty state attorneys general to request that the NIH exercise its march-in rights under the Bayh-Dole Act to authorize additional manufacturers to meet predicted demand for the drug.
• In March 2020, two engineers in Brescia, Italy, a region that was particularly hard-hit by the pandemic, used a desktop 3D printer to fabricate replacement valves for more than a hundred ventilator machines used at a local hospital. Early news reports claimed that a ventilator manufacturer threatened to sue the engineers for infringing patents covering the valves. While the existence of the threat and the patents themselves remains murky, the incident sparked a flurry of commentary regarding the risks that volunteers and hospitals could face from patents.
• Later in March, patent assertion entity (PAE) Labrador Diagnostics sued French firm bioMérieux and its Utah-based subsidiary BioFire Diagnostics for patent infringement. Labrador alleged that diagnostic kits being developed for COVID-19 infringed patents that it had acquired from defunct blood testing company Theranos (Case No. 1:20-cv-00348 (D. Del., filed March 9, 2020)). News of the lawsuit sparked a wave of negative publicity that quickly persuaded Labrador’s parent company, Fortress Investments, to end the lawsuit and offer royalty-free licenses to anyone conducting COVID-19 testing.
• On April 1, Kentucky governor Andy Beshear publicly called on 3M Corporation to grant broad access to more than 400 patents covering “N95” respirators used by healthcare and other individuals at high risk of infection.  Beshear was responding to severe shortages of such protective equipment in his state, which he and others attributed to patents that prevented firms other than 3M from manufacturing them.  He is reported to have urged 3M to license its patents to “the nation” as its “patriotic duty” in a time of national crisis.
• Beginning in April, another PAE, Swirlate IP, brought patent infringement suits against a more than a dozen manufacturers of products including ventilators and blood glucose monitors. The asserted patent covered wireless communications technology and was originally owned by Panasonic.
• In July, Vancouver-based AbCellera Biologics sued rival Berkeley Lights for the infringement of eight patents originally issued to the University of British Columbia. In the suit, AbCellera sought an injunction to prevent Berkeley from selling its Beacon Optofluidic System, which is being used for the discovery and development of antibodies against COVID-19.
• From the earliest weeks of the pandemic, patents were also perceived as hindering research efforts relating to COVID-19.  As one senior molecular biology researcher recalled during a recent symposium:

[F]rom the first moment we started having these [COVID-19] meetings there were discussions of patents. There were discussions of things that we couldn’t do because they were patented; there were discussions of things where we didn’t know if we could do them, if they were valid things that we could use to pursue strategies to deal with the pandemic because of patents. And even more astonishingly to me, there were already discussions about patenting the things that were going to happen in these COVID labs.

• Finally, in the crucial area of vaccine research, it soon became apparent that a patent “gold rush” was on.  One news report in May 2020 announced “Virus Researchers Race to File Patents …”, long before any vaccine candidate was close to approval. Echoing concerns over the inaccessibility of patented vaccine technologies during the SARS and Ebola outbreaks, the WHO urged governments and the private sector to make patents broadly available in the fight against COVID-19.

These examples indicate that specter of patent liability and litigation manifested itself from the early days of the pandemic in areas ranging from basic research and vaccine development to the manufacture, supply and distribution of medical supplies and equipment.