COVID-19 and Intellectual Property 2020 Year in Review
January 28, 2021
By Noel Courage and Jennie Yum
The year 2020 was one that will not be soon forgotten, even though many of us may wish to forget! There were many interesting issues and bright spots involving R&D, innovation and IP. We will review some of the highlights in this article.
Contracts / Licensing
In 2020, we saw tremendous progress in the areas of chemistry, biotechnology, high technology and mechanical innovations, led by international collaborations to solve COVID-19 issues. There was an urgency to these collaborations, however, even in these situations, good IP practices must be maintained. There were key considerations to be aware of in collaborations with others on patentable inventions. For example, due diligence on commercial partners, the scope of IP, the necessity of properly identifying inventors, tying up ownership with assignments, as well as having properly drafted R&D agreements and carefully-considered terms.
On the flip side, while most efforts towards COVID-19 were cooperative, we also saw hoarding and piracy of personal protective equipment (“PPE”) as countries grappled with shortages. Two types of attempted PPE piracy posed the greatest dangers and needed to be minimized, i) unduly restricting or prohibiting export, and ii) redirection of exports in transit. Intensive and proactive diplomacy was, and is, the best way to ensure that PPE keep moving fairly to where they are needed most. The export restriction issue is surfacing again in the context of vaccines, with Europe considering reducing export.
Companies typically protected their IP, as usual, while commentators discussed the role of IP in helping or hindering the COVID-19 response. It is indeed possible to fully protect IP, and thereafter to facilitate sharing by either openly making IP available or doing a controlled IP license for COVID-19. There are various ways in which IP can be shared – via patent pools, licensed access to IP, or by simply enabling others to make copies by publishing design specifications. As an example, the drug manufacturer, Gilead, was the IP owner of the only drug (remdesivir) that, as of May 2020, had been authorized by the FDA on an emergency use basis to treat COVID-19. Gilead opted for an aggressive and fast IP licensing model to roll-out its drug internationally. This case study illustrates the intricacies of commercializing an invention against a backdrop of heavy public interest.
Counterfeit or Substandard Goods
The COVID-19 pandemic exposed weaknesses in the medical device supply chain. PPE and medical devices, such as diagnostic test components and ventilators, were in short supply, forcing governments and hospitals to urgently source product from new suppliers and distributors with very little time to properly vet them. The result: some good product, but also numerous reports of low quality, underperforming, or even contaminated product. There are possible avenues for buyers to use their contracts for recourse against sellers of substandard goods. There are typically specific provisions in a sales contract relating to fulfillment (performance) of the contract and product quality, and not meeting these requirements would be a breach of the contract.
The urgent need for PPE for combatting COVID-19 also led to a sharp rise in counterfeit products. Buyers needed to move quickly to acquire this equipment, but there was also a heightened need for vigilance due to sellers engaging in false marking of certifications, counterfeiting and fraud. Not only were quality control and counterfeiting serious concerns, but in some cases the goods simply never materialized. There are specific contractual issues and remedies to deal with suppliers that cannot, or choose not to, deliver. Of course, none of these replace the need for basic contractual due diligence prior to entering into any agreement.
Patent, design and trademark rights also allow IP owners to potentially block low quality and counterfeit copies of their product. The Canadian Intellectual Property Office (“CIPO”) recently announced a mechanism for expedited examination of trademark applications covering COVID-related goods or services, which will greatly improve the ability of trademark owners to enforce their rights. Expedited review of patent applications is also available in Canada and the US for certain regulated medical products.
R&D – New IP / Collaborations / Retooling
The COVID-19 pandemic encouraged many positive outcomes as Canadian companies and researchers mobilized to find ways to combat the disease and pave the way for economic recovery:
- In response to the medical supply shortage, companies retooled existing technology or goods to produce supplies such as hand sanitizer, masks, face shields, and gowns, as well as parts for ventilators and other medical devices. Funding for retooling initiatives and research relating to COVID-19 are available from the government.
- Collaborations were also on the rise, some focusing on medical treatments and software tools (e.g., to track disease spread), others on basic supplies, such as manufacturing PPE.
- There have been significant innovations in COVID-19 diagnostics IP – demand for a rapid and reliable method of detecting the virus meant that testing capabilities evolved rapidly as companies focused on developing better and faster diagnostics. Nucleic acid and antibody tests for COVID-19 may become the new normal as we seek to reopen the economy.
- Clinical trials and research labs that were initially shuttered as part of efforts to curb the spread of COVID-19, reopened under new guidelines and enhanced safety protocols which will ensure that scientific advancement can continue safely in the future (and, hopefully, with less need for interruption).
Data / IT / Artificial Intelligence (“AI”)
Good quality data leads to better science, public health policy and IP. With the rise of COVID-19, we saw firsthand the dangers of incomplete or bad scientific data which allowed ill-informed dogma to perpetuate (such as the claims of anti-maskers, or claims that drug X was an effective prevention method or treatment for COVID despite lack of testing and evidence of efficacy). There is a need for the scientific community and government leaders to make significant efforts to communicate scientific data to the public to counteract misinformation – which can spread easily during times of heightened stress such as a global pandemic.
COVID also brought to light many gaps in the reporting of healthcare data in Canada. Most of the country was, and is still, hanging on daily provincial data about new coronavirus cases, which appears to be the only publicly available information. This data was initially only a small snapshot of the kind of information that researchers and healthcare providers need to make informed and educated decisions. The data has improved over time. There remains a need to adapt to data requirements, for example to diagnose and track new variants of the novel coronavirus. As well, a COVID-19 immunity task force recently indicated that it was having difficulty accessing sufficient data on antibody immunity sampling for its work. Another hot issue in data is that the collection and disclosure of data must comply with privacy legislation. Privacy law balances patient protection against the need for public health authorities to generate and share data.
This past year, we also saw healthcare artificial intelligence (“AI”) solutions enter the spotlight as people turned to the power of AI to model the spread of infectious disease, to make decisions on allocation of healthcare resources and treatment options. However, the common denominator for all AI is that they need to be fed as much data as available to develop solutions (i.e., AI needs good, reliable data and lots of it!). It is critical for governments to collect comprehensive data and make it available to their AI collaborators and the general public, to the fullest extent possible.
A common thread in the above issues has been the ability of science to adapt and scale to meet new challenges. While there are many areas for improvements, the overall level of effort and accomplishment in 2020 has been remarkable in helping to turn the tide against COVID-19.
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