The Gatherer - Volume 9

PANDEMICS & CROWN USE OF PATENTED TECHNOLOGY

to the patentee before exploiting the invention ( Patents Act 1990 , ss 163(3)(e)). In addition, the Act specifically addresses the economic value of the exploitation and states that a prescribed court must determine an amount of remuneration that is ‘just and reasonable’ ( Patents Act 1990, ss 165(2)), unless an agreement has otherwise been reached. To date, crown use as described above has been rarely necessary and recognised as potential treatments for COVID-19. One of them being a well- known HIV treatment, Kaletra™ which has been patented in many countries by AbbVie, a biopharmaceutical company. Due to an expected increase in demand, and the potential public backlash against anyone seen to be profiteering during these difficult times, in March 2020 AbbVie decided not to enforce their patent rights for Kaletra™, allowing generic copies to be made around the globe for the purpose of COVID-19 treatment. Other pharmaceutical and biotech companies are following in the steps of AbbVie, including Gilead Science with their new antiviral drug, Remdesivir™. Gilead Science rescinded their request for an FDA orphan drug designation for Remdesivir™, which if granted would have given them 7 year market exclusivity, albeit after facing intense criticism. rarely invoked in Australia. Will the Crown Use Provisions Even be Necessary? Few existing drugs have been

Conclusion Crown Use is one of those terms that people are aware of in some abstract sense, stored away in the recesses of our minds with other concepts like the compulsory acquisition of land and military conscription. The risks of public health institutions and/or community minded private corporations being shut out from accessing potentially life saving technology whilst either trying to manufacture life-saving medical equipment and/or develop an effective vaccine appear real at first blush. However, when looked at calmly (much easier to say now rather than when new cases were increasing exponentially), the current provisions of the Patents Act 1990 appear sufficient to address any concerns regarding whether potentially life- saving technology will be available to the public. Pleasingly, situations such as the world is presently facing in COVID-19 have a tendency to galvanise the scientific community, whether it be private or public, in a common cause, making it even less likely that provisions such as Crown Use in the Patents Act 1990 will need to be relied upon.

The Invocation of Crown Use In Australia there have been calls in parliament for the government to consider how Crown Use might be invoked to help address the myriad of issues created by the current pandemic. In times such as these isn’t it appropriate that public health institutions have unfettered access to the latest and best technology available, whether it is currently patented or not? Crown Use in the Australian Context In Australia, the Patents Act 1990 has provisions allowing a Relevant Authority (inc. a Minister of the Commonwealth or the Attorney General of a State or Territory) to exploit a patented or pending invention, without it being an infringement, for the public interest. This requires that the exploitation of the invention is an emergency or is accompanied with a written approval from the relevant authority ( Patents Act 1990, ss 163A(3)). A recent legislative amendment (enacted on 27 February 2020) prophetically captures in its scope healthcare, noting that the relative authority in the case of COVID-19 would be the Minister for Industry, Science and Technology, or the relevant State or Territory Attorney General. Despite these provisions appearing very ‘anti-patentee’, the necessary written approval can only be obtained if the relevant authority has tried for a reasonable period, but without success , to obtain the applicant or patentee’s authorisation on reasonable terms ( Patents Act 1990, ss 163(3) (a)). In fact, there’s a prescribed period of at least 14 days from when the relevant authority gives notice

If a government deems it appropriate, can they simply avail themselves of a patented technology?

The COVID-19 global pandemic is, unsurprisingly, bringing all manner of issues relating to our ability to treat and heal people into focus. One of these issues is whether the circumstances are such that governments may set aside intellectual property rights, such as patents, in the service of the greater public good. Two items of particular interest over the past two months or so, for obvious reasons, have been respirators and vaccines. Both are potentially the subject of patents, presuming they meet the legal requirements for novelty and inventiveness. Both may either already be patented or they may be new improved versions that might be eligible for patent protection. But a patent is essentially a right of exclusion. It allows a patent owner to determine who is granted access to that technology and on what terms, for a period of monopoly granted by the government, in exchange for the public disclosure of the details of the technology.

PETER CAPORN Principal

ELLEN CHA Technical Assistant

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