With the COVID-19 pandemic rapidly depleting medical equipment and supplies and triggering a global race for a treatment or vaccine, there is growing concern to ensure that patent rights are not an obstacle. The Federal Opposition has already called upon the Government to invoke rarely used ‘Crown use’ patent provisions to help Australia respond to the health emergency.
Following a letter to the Industry Minister Karen Andrews, last Monday Shadow industry minister Brendan O’Connor called on the Government to consider its ability to invoke Crown use to deal with the COVID-19 pandemic in Parliament:
“The government will need to detail how Crown use of patents may be invoked, particularly for use for repurposed manufacturing businesses, to address shortages of essential goods impacted by disrupted supply chains.”
COVID-19 and access to patented inventions
As foreshadowed in our article published last year, prescient amendments to the Patents Act 1990 relating to Government and private third party access to patented inventions passed Parliament and became law only weeks ago. Access by the Government (and those authorised by the Government) is referred to as ‘Crown use’. The ‘compulsory licensing regime’ enables access by third parties. These provisions are largely untested.
There are recent reports of offers by businesses and industries across a range of sectors to assist in the response to COVID-19 (some proactively offering their patented technology for free). There are also reports of businesses engaging cooperatively in research and development activities. These responses underscore the scale of the emergency we are facing.
Nevertheless, there are a number of considerations specific to the COVID-19 pandemic that make it particularly apt for the Crown use and/or compulsory licensing provisions to be engaged. They include:
- the potentially devastating economic consequences that could follow if the rate of infection does not abate in spite of social isolation / lockdown measures;
- the health emergency that may unfold if lifesaving medical equipment or medicines cannot meet demand;
- the immense pressure to restore depleted supplies of personal protective equipment;
- demand pressures if a vaccine is developed which would require expedited and super scaled production; and
- the general lack of a diverse range of local manufacturing businesses (Australia is a net importer of personal protective equipment, medications and medical equipment). In this regard it is noteworthy that on 18 March 2020, the Commonwealth Department of Industry, Science, Energy and Resources issued a request for information for the domestic production capability of medical personal protective equipment (PPE). The medical PPE listed in the request for information included surgical gowns, gloves and googles.
Each of these considerations could very quickly lead to a situation where the public good could justify a Federal, State of Territory Government taking steps to authorise the exploitation of patented technology or drugs or requests for access by third parties.
It is noteworthy that corresponding provisions have already started to be invoked in other countries. For example, Israel has authorised the importation of generic version of AbbVie’s HIV drug Kaletra (a drug that is being studied as a potential treatment for COVID-19).
Crown use, compulsory licences and the public interest
As outlined in our previous article, during emergencies the Crown Use provisions give the Government (Federal or State/Territory) powerful rights to immediately (and without consent of the patent owner) commence exploiting a patented invention for the provision of a service that the Government has the primary responsibility for providing or funding. It is hard to imagine an emergency more pressing than the COVID-19 pandemic.
The compulsory licensing regime enables the Court to allow a third party to use patented technology without the patent owner’s consent where the demand for the technology is not being met on reasonable terms, the patentee has declined to authorise the third party to use the technology and it is in the public interest for the third party to have access to the patented technology.
For example, the Australian Government could authorise the production of COVID-19 diagnostic test kits that are the subject of an Australian patent owned by a third-party without having to consult with or obtain the consent of that third party.
As companies and universities undertake very significant research in the race to identify or develop a vaccine or treatments for COVID-19, we are likely to see attempts made to obtain patent protection. So far it has been reported that the Wuhan Institute of Virology filed a patent application in China in respect of the use of a known pharmaceutical product (used to treat Ebola) for the treatment of COVID-19. In the unlikely event that rights are asserted by a patent owner over a vaccine or treatment in a manner that is inconsistent with the public interest, the Crown Use provisions could be invoked.
Finally, if a patent owner sought to assert rights in a way that was inimical to the public interest by bringing patent infringement proceedings against the Government or a third party, the Court would consider the impact on the public in deciding whether to prevent any ongoing use of patented technology. It is important to emphasise that the public interest is (following the most recent amendments to the Act) recognised as one of the objects of the Act:
“The object of this Act is to provide a patent system in Australia that promotes economic wellbeing through technological innovation and the transfer and dissemination of technology. In doing so, the patent system balances over time the interests of producers, owners and users of technology and the public.”
The COVID-19 pandemic may well require governments and businesses to urgently access patented technology to avert either health or economic catastrophe. They should be aware of the avenues that are available to obtain access, including those available without the patent owner’s consent.
Equally, patent owners will need to be mindful of the regimes that apply in these unusual circumstances and carefully consider how they will respond to both requests for access and any unauthorised use of patented technology by government or third parties.
This publication is introductory in nature. Its content is current at the date of publication. It does not constitute legal advice and should not be relied upon as such. You should always obtain legal advice based on your specific circumstances before taking any action relating to matters covered by this publication. Some information may have been obtained from external sources, and we cannot guarantee the accuracy or currency of any such information.