COVID-19 Vaccine: What Are the Authorized Issues?

As organizations around the world head towards the development of a COVID-19 vaccine, other legal issues may arise. Find out more here.

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The COVID-19 virus affected almost all aspects of life in 2020. As a result, there are many organizations struggling to develop an effective COVID-19 vaccine. Accordingly, when it comes out, many people are likely to want to receive the vaccine. However, intellectual property law can pose some barriers to access to COVID-19 vaccines. This guide examines the potential intellectual property factors that play a role in the vaccine release.

How does intellectual property relate to COVID-19 vaccines?

In general, intellectual property law aims to protect creative work. One form of this protection is, for example, the patent. Patents protect creative work, especially inventions, by giving inventors the legal right to prevent others from making, using, or selling this invention. This protection gives the inventor the opportunity to really benefit from his hard work. However, patents do not automatically protect all inventions. To obtain protection, you must file a successful patent application. It is also important to note that patent protection does not last indefinitely. For example, in Australia, a standard patent protects the invention for up to 20 years after the filing of the application.

Patents can protect newly developed vaccines because they are a form of creative work. In Australia, vaccines may be eligible for a longer duration of standard protection as a pharmaceutical substance.

Given the desirability of having effective COVID-19 vaccines, organizations that successfully develop one will likely want to patent the vaccine in order to benefit from it. However, this could create problems with the effective roll-out of COVID-19 vaccines, as organizations that insist on enforcing their strict legal rights under patents would limit the availability of the vaccine. The scarcity of the vaccine can also drive up prices. Obviously, this could damage public health and confidence in the administration of the authorities.

How can intellectual property law solve this problem?

While the usual rules on patents could limit the accessibility of COVID-19 vaccines, the Patents Act 1990 (Cth) and Patents Regulations 1991 (Cth) contain some measures that could fix this.

Compulsory licensing

If another organization wants to manufacture and sell the vaccine, they can try negotiating a license with the patent holder so that they have a legal right to do so. However, if the patentee refuses to grant a license, the organization can apply to the Federal Court of Australia (FCA) for a compulsory license. Importantly, the FCA may not place an order for approval of the vaccine unless certain conditions are met:

  • The demand in Australia for the vaccine is not being met on reasonable terms
  • The order is important to meet the demand
  • The applicant has made reasonable attempts to negotiate an agreement with the patentee but has not been successful
  • Taking into account the benefits to the public in meeting the demand, the commercial costs and benefits to the applicant and patentee in obtaining the contract, as well as all other relevant matters, particularly those related to competition and innovation, this is in the public interest To make order

Therefore, if the availability of the vaccine is limited due to patents, mandatory licensing agreements can help solve the problem.

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International considerations

Outside of Australia, there may be other ways to address the problem. While IP Australia manages patent rights in Australia, the Trade-Related Aspects of Intellectual Property Rights Council (TRIPS) manages the TRIPS agreement internationally. Countries can make proposals to the Council (and some have already done so) to relax intellectual property rights related to COVID-19 vaccines. While the Council can discuss such proposals, the likelihood of a successful proposal or compromise is questionable.

So what now?

It is good to understand your legal rights regarding COVID-19. However, it is impossible to predict the exact legal scenario that could exist before the vaccine is released. That said, it can be comforting to know that Australians are unlikely to have any problems accessing vaccines caused by patenting.

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