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Balancing Intellectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia

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Abstract

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.

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Notes

  1. See Drug Registration Guidance Document, 2021 Version (DRGD 2021).

  2. Ibid.

  3. A specific guideline on Registration of Biologics in the DRGD provides specific explanations on vaccines and the conditions for their registration.

  4. DRGD 2021, p. 3.

  5. Ibid.

  6. Ibid., p. 4.

  7. Ibid., p. 6.

  8. Ibid., p. 3.

  9. Ibid., p. 5.

  10. Ibid., p. 6.

  11. Guidance Document & Guidelines for Vaccine Lot Release Malaysia, p. 8.

  12. Ibid., p. 9.

  13. DRGD 2021, pp. 7–10.

  14. Reg. 31, CDCR 1984.

  15. Ibid.

  16. Regulation 7(1) of CDCR 1984.

  17. DRGD Appendix 12 2021, p. 1.

  18. Ibid., p. 2.

  19. It however has to draw upon preliminary data on safety and efficacy based on at least one “well-planned Phase III clinical study” that clearly demonstrates the safety and efficacy of the product, and has been given authorization for use (via emergency use approval or any pathway equivalent to it) or has obtained marketing authorization from national regulatory authorities of country of origin or any drug control reference agencies or by World Health Organization (WHO).

  20. DRGD 2021, p.42.

  21. Preamble, TRIPS Agreement.

  22. On 6 May 2021, Biden signalled US’s support of the waiver. See [21].

  23. Article 6, TRIPS Agreement.

  24. The Malaysian patent law (Patents Act 1983) allows parallel importation as it has a provision that prevent infringement claim if the patented product is put to market with the patent owner’s consent or inter alia put to market by the patent owner, licensee or beneficiary of a compulsory licence (Patents Act 1983, Sect. 37(2)) [14]. International exhaustion is implied from the fact that the relevant provision of the Malaysian patent law is silent on the identification of the market for the purpose of parallel imports [14]. Further, international exhaustion is the choice by Malaysia because section 58A of the 1983 Act states that it is not an infringement “to import, offer for sale, sell or use” any of the following: “any patented product” or “any product obtained directly by means of the patented process or to which the patented process has been applied, which is produced by, or with the consent, conditional or otherwise, of the owner of the patent or his licensee” [15] [14]. Nevertheless, there is yet settled case law on whether parallel imports are allowed because of the opposing views of the Malaysian courts on the subject [16]. Though dealing with Malaysian trademark law rather than its patent law, one case found that Malaysian trademark law did not allow a trademark owner to control the commerce of the trademarked goods (Winthrop Products Inc. & Anor v Sun Ocean (M) Sdn Bhd & Anor [1988] 2 MLJ 317) [16]. Such case which is known as the Panadol case was viewed as an indicator that Malaysia accepted international exhaustion of trademark law [15]. Another case disallowed parallel importation of confectionery foodstuff without trademark owner’s consent on the grounds of false trade description (i.e. circumventing Malaysia’s health regulations) and unfair competition (In Re PT Garudafood Putra Putri Jaya TBK [2019] 6 CLJ 217 [HC]) [16].

  25. DRGD 2021, para. 4.1.

  26. Ibid., p. 16.

  27. DRGD 2021, Appendix 5, para. 1.

  28. The Administration of the Territory of Papua and New Guinea v Leahy (1961) 105 CLR 6; Gorringe v Calderdate Metropolitan Borough Council [2004] 2 All ER 326; Stovin v Wise [1996] AC 923.

  29. Though COVID-19 is not included in the list of infectious diseases in that Act, it can fall under the category of fall under the category of “any other life-threatening microbial infection” under the said list. See [27].

  30. Kerajaan Malaysia & Ors v Lay Kee Tee & Ors, [2009] 1 MLJ.

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  1. Faculty of Law, National University of Malaysia (UKM), Bangi, Selangor, Malaysia

    Haniff Ahamat, Hairanie Sa’ban & Nazura Abdul Manap

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Ahamat, H., Sa’ban, H. & Manap, N.A. Balancing Intellectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia. Health Care Anal 31, 196–207 (2023). https://doi.org/10.1007/s10728-023-00465-9

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