2021 Year in Review: COVID-19
COVID-19 remained an area of rapid innovation in 2021. Regulators continued rapid approval of new drugs, vaccines and diagnostics. Their work involves careful balancing of safety, efficacy and speed.
Development and approval of vaccines was the key story that came to fruition in late 2020. The past year was about getting behind covid vaccine innovators to ensure increased deployment.
A big public health and innovation story of 2021 was the increased deployment of diagnostics for screening people that may have COVID-19. The FDA has now authorized over 400 COVID-19 related tests and collection kits. Beneath the veneer of simplicity in operation is the integration of a myriad of different technologies. Patents help provide a link that helps differentiate new technologies and provide a return on the cost of test kit innovation and development. Potentially patentable aspects may include high-tech aspects of diagnostic systems, such as analysis methods or high throughput processing. The invention may also be in the chemistry, such as better ways of colorimetric detection of nucleic acid amplification.
Patent Pools
There was some success in getting technology into patent pools in 2021. A focus of life sciences patent pools is to encourage patent licensing to third-world countries. The UN-supported Medicines Patent Pool (MPP) got rights to two potential covid breakthrough drugs. One drug was Pfizer’s PF-07321332, which is administered in combination with a low dose of ritonavir, a repurposed HIV antiviral drug. Pfizer signed on with the MPP to grant non-exclusive sublicenses for the new drug to certain generic manufacturers. This step was done voluntarily by Pfizer. It followed on the heels of a similar deal in October 2021, between Merck and MPP, which involved the licensing of Merck’s COVID-19 antiviral drug, molnupiravir (see the licence here). The MPP deals will make the drugs available to 95 countries, covering 53% of the world’s population.
The MPP also picked up a diagnostic test for licensing. The Spanish National Research Council (CSIC; Consejo Superior de Investigaciones Científicas) provided the MPP with rights to a COVID-19 diagnostic technology. The CSIC is a public research institute that holds patent rights in its diagnostic technology. Its COVID-19 test detects the presence of anti-SARS-CoV-2 antibodies in the blood.
Canadian Intellectual Property Office
The Canadian Intellectual Property Office (CIPO) has provided limited opportunities for expedited examination for patent applications and trademarks. Expedited review of patent applications is available to small entity applicants only, which is a small percentage of filings. Expedited trademark review is available for applications covering certain goods and services related to the COVID-19 pandemic.
Vaccine Patent Waiver
The potential vaccine patent waiver at the WHO continues to make slow progress. In the meantime, Moderna has promised not to assert its patents during the pandemic. There has been criticism of whether the waiver goes far enough. Technology transfer to Africa to enable future biomanufacturing of mRNA vaccines is ramping up, with WHO support. Public domain vaccines based on older technologies are also becoming available.
Public Health Management
There continue to be many issues around COVID-19 public health management. It remains a challenge for governments to roll out public health responses quickly, and manage privacy issues. This was seen, for example, with vaccine passports in 2021. Life sciences companies also need to be aware of carefully managing compliance with consumer and health privacy rules.
Counterfeiting remains a risk to public health and safety, as personal protective equipment, diagnostic kits, pharmaceuticals and vaccines all remain subject to rampant rip-offs. Brand owners need to be aware of the marketplace, and the risks that counterfeiting poses to safety and the goodwill of their business.
