COVID-19 Vaccine: What Are the Legal Considerations?

The COVID-19 virus has had a pervasive impact on almost all aspects of life in 2020. As a result, there are many organisations racing to develop an effective COVID-19 vaccine. Correspondingly, many people are likely to want to get the vaccine when it comes out. However, intellectual property law may provide some barriers to getting access to COVID-19 vaccines. This guide will explore the potential intellectual property factors at play upon the vaccine’s release.

How does intellectual property connect to COVID-19 vaccines?

In general, intellectual property law seeks to protect creative work. For example, one form of this protection is the patent. Patents protect creative work, specifically inventions, by giving inventors the legal right to prevent others from manufacturing, using, or selling that invention. This protection provides the inventor with the opportunity to properly profit from their hard work. However, patents do not automatically protect all inventions. In order to receive protection, you must submit a successful application for a patent. It is also important to note that the protection of patents do not last indefinitely. In Australia, for example, a standard patent protects the invention up to 20 years after the filing of the application.

Patents can protect newly developed vaccines since they are a form of creative work. In fact, in Australia, vaccines may qualify for an extended duration of standard protection as a pharmaceutical substance.

Given the desirability of effective COVID-19 vaccines, organisations that are successful in developing one are likely to want to patent the vaccine in order to profit from it. However, this might cause problems to the effective rollout of COVID-19 vaccines as organisations that insist on enforcing their strict legal rights under patents would limit the availability of the vaccine. The scarcity of the vaccine may also drive prices up. Evidently, this could cause harm to public health and confidence in the management of public authorities.

How can intellectual property law resolve this problem?

While the usual rules surrounding 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 organisation wants to manufacture and distribute the vaccine, it can try to negotiate a license with the patent holder so that it has a legal right to do so. However, if the patent holder refuses to grant a license, the organisation may apply to the Federal Court of Australia (FCA) for an order to grant a compulsory license. Importantly, the FCA may not make an order for the licensing of the vaccine unless certain conditions exist:

  • the demand in Australia for the vaccine is not being met on reasonable terms
  • the order is essential to meet the demand
  • the applicant for the order has made reasonable attempts to negotiate an agreement with the patent holder but has not succeeded
  • taking into account the benefits for the pubic in meeting the demand, the commercial costs and benefits to the applicant and the patent holder in granting the order, and any other relevant matters, especially those relating to competition and innovation, it is in the public interest to make the order

Therefore, if the availability of the vaccine is limited due to patenting, compulsory licensing arrangements may help resolve the issue.

International considerations

Other ways of addressing the issue may exist beyond Australia. While IP Australia administers patent rights within Australia, the Council for Trade Related Aspects of Intellectual Property Rights (TRIPS) administers the Agreement on TRIPS internationally. Countries may make (and some have already made) proposals to the Council to relax intellectual property rights surrounding COVID-19 vaccines. While the Council may discuss such proposals, the likelihood of a successful proposal or compromise is questionable.

So, now what?

It is good to understand your legal rights surrounding COVID-19. However, it is impossible to predict the exact legal scenario that might exist before the vaccine is released. Nonetheless, it can be comforting to know that Australians are unlikely to have issues accessing vaccines caused by patenting.

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