IPSA Updates 7: COVID-19’s Patent Woes?

Contributed by: Lenon ONG of the IPSA Core Team

Edited by: Benjamin HO of the IPSA Core Team

Photo by: Volodymyr Hryshchenko

On 11 March 2020, the World Health Organisation declared COVID-19 a global pandemic, spurring drug-makers around the world to develop vaccines to meet the global need for a solution to the pandemic. As the race to find a vaccine for COVID-19 intensifies, compulsory licensing of its patent has become a hot topic in the intellectual property realm.

Just three months later, on 23 June 2020, a Chinese state-owned developer authorised a COVID-19 vaccine candidate in the United Arab Emirates (“UAE”) to conduct phase three human clinical trials. These clinical trials were approved by the UAE’s Ministry of Health and Prevention during a teleconference; this is also the first overseas clinical trial for a Chinese-grown vaccine. [1]

However, speed is not everything, as French drug-maker Sanofi SA eyes the approval of COVID-19 vaccine by first half of 2021. [2] Sanofi’s Chief Executive, Paul Hudson, said that the firsts in this race for a vaccine are not assured of securing victory. “There are companies moving faster, but let us be brutally clear, speed has three downsides. They are using existing work, in many cases done for SARS; it is likely not to be as efficacious; and there is no guarantee on supply in large volumes,” Hudson said. The probability of success for Sanofi is “higher than anybody else,” the Chief Executive said.

Existing patent protections

To date, most of the promising COVID-19 treatments being tested in clinical trials already have patents attached to them. These are, for example:

  • Favipiravir (used to treat influenza);
  • The combination of lopinavir and ritonavir (sold under the brand name Kaletra® to treat HIV/Aids); and
  • Remdesvir (a medicine developed for Ebola by the biotechnology company Gilead). [3]

However, depending on the specific drug(s) approved in the fight against COVID-19, intellectual property protections may inflate the price and limit the accessibility of vaccines and treatments due to the monopolising effect of patents.

COVID-19: Voluntary waiver of patent rights by private organisations

Fortunately, in response to the global need for a cure, several private organisations have voluntarily waived their patent protection rights. [4]

To this end, several major pharmaceutical and biotechnology companies that are currently developing candidate COVID-19 vaccines or treatments have also pledged to share or waive exclusivities in relation to their patentable inventions. For instance, pharmaceutical company AbbVie announced that it will not enforce its patent rights for Kaletra® medicine. Intel, IBM and Hewlett Packard Enterprise, which are founding members of the Open COVID Pledge, have also pledged to grant non-exclusive licences to their extensive portfolio of patents to COVID-19 researchers and scientists until one year after the World Health Organisation (WHO) declares the pandemic to have ended or 1 January 2023, whichever is earlier. [5]

Universities and research institutions such as Cambridge, Oxford, Harvard, Stanford, Yale, and the Innovative Genomics Institute have also pledged to adopt similar approaches through initiatives such as the COVID-19 Technology Access Framework. [6]

On the governmental front, there is a push for pharmaceutical companies to engage in collaborative research. One salient example is the Costa Rican government which urged companies to voluntarily pool the necessary intellectual property for companies to collaborate on treatment research. This follows the model created by the Medicines Patent Pool, a United Nations-backed public health organisation, [7] established in response to treating HIV, hepatitis C and tuberculosis. Patent licences will be granted to manufacturers under such an initiative, allowing companies to manufacture drugs despite not owning the necessary patents.

Compulsory licensing: when “voluntary” falls short

Compulsory licensing is “an action of a government forcing an exclusive holder of a right to grant the use of that right to other upon the terms decided by the government”. [8] Governments may also suspend patents on a product in times of emergency or in the public interest through the compulsory licensing of patents. This allows governments to grant itself, and third parties, the right to use a patent and manufacture a patented drug without the consent of the patent holder, thereby ensuring equal and affordable access to COVID-19 treatment worldwide.

To this end, several countries – Canada, France, and Germany to name a few – have amended or passed new legislation in light of the COVID-19 pandemic to provide for compulsory licensing. [9] Israel was the first country to approve a compulsory licence for importing generics of AbbVie’s patented Kaletra ® medicine from India for use in the treatment of COVID-19. [10]

Reviewing the legal position in Singapore

In Singapore, section 55 of the Patents Act (Cap 221, Rev Ed 2005) (the “Patents Act”) relates to compulsory licenses, and any interested person (including the Singapore Government) may apply to the court for the grant of a licence under a patent on the ground that the grant of the licence is necessary to remedy an anti-competitive practice. Sections 56 to 62 of the Patents Act also allow the Singapore Government and any party authorised in writing by the Government to facilitate the use of patentable treatments in COVID-19 patients.

Section 56 of the Patents Act allows the Government and any party authorised in writing by the Government to do anything in relation to a patented invention:

(a) for a public non-commercial purpose, or

(b) for or during a national emergency or other circumstances of extreme urgency, without such acts amounting to an infringement of the patent.

These acts should be limited to the supply of the patented invention predominantly in Singapore. [11]

Moreover, the Patents Act explicitly allows the Government and any party authorised in writing by the Government to import any relevant health product, and do anything in relation to any relevant health product so imported, for or during a national emergency or other circumstances of extreme urgency, where the Government has given the Council for TRIPS a relevant notification in relation to the relevant health product. [12] However, this right under section 56 to use a relevant health product which is imported under section 56(1A) does not include a right to export the relevant health product. [13]

The current COVID-19 crisis is likely to qualify as a situation of national emergency or a circumstance of extreme urgency. Although the Patents Act itself does not expressly define these terms, the Declaration on the TRIPS Agreement and Public Health provides each member country the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. [14]

Final Thoughts

There is no doubt that patents spur innovation; the patent is a key instrument to promote the research and development of new products. Yet, patents on essential pharmaceutical products may drive prices high, thereby limiting access to such drugs to those with sufficient purchasing power. On the other hand, some may argue that the lack of patent protections will inhibit access to essential drugs because the monopoly provided to pharmaceutical companies through patent protection enables them to recover costs of research and development, and to finance further research and development projects. [15]

Compulsory licensing is therefore a necessary evil. While a violation of the rights of the patent holder (with appropriate monetary compensation), this violation avoids any potential misuse of monopoly right and protects a basic human right to health. Compulsory licensing balances the rights of patent owners and the greater societal good; neither is a full patent protection granted, nor is it denied altogether.

Many unprecedented legal measures have been rolled out in Singapore in the past few months, from the mandatory wearing of masks in public to the imposition of “circuit breaker” legislation for persons flouting safe distancing measures. It is assuring to know that Singapore’s Patents Act facilitates the wide use of a viable vaccine in light of the current public health crisis, and does not act as a hurdle in this trying time.

Editorial endnote: Challenging and uncertain times lie ahead, and everyone should always remain vigilant and stay updated with the news. From the IPSA team, stay safe and healthy!

———————————————————-

[1] Global Times, published 24 June 2020, online: https://www.globaltimes.cn/content/1192598.shtml, accessed 27 June 2020.

[2] Matthias Blamont, Reuters, published 23 June 2020, online: https://www.reuters.com/article/health-coronavirus-sanofi-vaccine/sanofi-eyes-approval-of-covid-19-vaccine-by-first-half-of-2021-idUSL8N2DZ4FE, accessed 27 June 2020.

[3] Samantha Silver, Lindsay Maclean, Kennedys, published 14 May 2020, online: https://www.kennedyslaw.com/thought-leadership/article/covid-19-vaccine-development-and-compulsory-licensing, accessed 27 June 2020.

[4] Ibid.

[5] Tan Tee Jim, The Straits Times, published 28 May 2020, online: https://www.straitstimes.com/opinion/will-global-ip-system-block-access-to-vaccine, accessed 27 June 2020.

[6] Ibid.

[7] Medicines Patent Pool, online: https://medicinespatentpool.org/, accessed 27 June 2020.

[8] T. Jain, “Compulsory licenses under trips and its obligations for member countries,” ICFAI Journal of Intellectual Property Rights, vol. 8, no. 1, 2009.

[9] Deriş Patents and Trademarks Agency, Lexology, published 11 May 2020, online: https://www.lexology.com/library/detail.aspx?g=e6792b09-1420-4dd0-bed1-5c241d29effd, accessed 27 June 2020.

[10] Ibid.

[11] Section 60(1)(c) of the Patents Act.

[12] Section 56(1A) of the Patents Act.

[13] Section 60(1A) of the Patents Act.

[14] World Trade Organization, DOHA WTO MINISTERIAL 2001: TRIPS WT/MIN(01)/DEC/2, adopted on 14 November 2001, online: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm, accessed 27 June 2020.

[15] J. Matthews, “Renewing healthy competition and why abuses of the trips article 31 standards are most damaging to the united states healthcare industry,” Business, Entrepreneurship and the Law, vol. 7, 2010.

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