To give an example, just a few years ago the failure rate for new Alzheimer’s drugs was around 99.6%. It should also be borne in mind that there is no guarantee of success during research and development of a drug, so that in a worst-case scenario the billions invested are lost. Recent studies put the average development costs of a single drug at between USD $1.3–2.8 billion. Patents as an incentive for time-consuming and costly research and developmentĪnother risk that a government-initiated limitation of patent protection would entail becomes clear when one considers how complex and cost-intensive the development of drugs is. For one thing, the manufacturing process is significantly more expensive and complex than that for the established vector vaccines for another, the vaccines (apart from CureVac’s vaccine candidate CVnCoV) are extremely susceptible to temperature fluctuations and mostly require a constant temperature of up to -80° Celsius.ĭue to the unique challenges of manufacturing COVID-19 vaccines, it cannot be assumed that a patent release alone will result in previously inexperienced producers around the world suddenly being able to produce clean and safe vaccines. The importance of manufacturing know-how applies even more regarding the mRNA technology on which the vaccines from, e.g., BioNTech/Pfizer, Moderna and CureVac are based. The latter requires a high level of knowledge, experience and technological infrastructure if the result is to be clean and safe vaccines. However, this assumption fails to recognize that an authorization to manufacture is not the same as an ability to manufacture. Vaccine production requires know-how and infrastructure Since patent rights to COVID-19 vaccines give the patent holder an exclusive right to manufacture the vaccine, one might conclude that a limitation of patent protection, whether through a waiver, compulsory license, or order of use, would lead to an increase in the supply of vaccine. The transposition into national law by the individual member states required after a corresponding WTO decision is likely to take additional time. For this reason, the announcement by the Biden administration is already regarded by many as a rather symbolic step. Given the divided opinion within the member states, this is not surprising and it is not expected that a consensus will be reached soon. administration, the necessary consensus for a WTO decision regarding an international waiver or limitation of patent protection has not been reached so far.
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The compulsory license can also be granted with subject or time limitations.Īlthough the debate has gained momentum with the announcement by the U.S. If the grant of a compulsory license is ordered by the individual member state, the licensee is thereby authorized to use the patented invention while being obliged to pay an appropriate license fee. This possibility was expanded with the provision of Article 31bis, introduced in 2017. 1, 4, 5 and 7) as envisaged in the original Indian-South African joint proposal, the TRIPS Agreement itself provides for measures to allow the use of third-party patents in certain exceptional cases.Īrticle 31 of the TRIPS Agreement allows member states to grant compulsory licenses to third parties for certain patents that could be used to produce patent-protected vaccines, subject to various conditions, including in the event of a national emergency. In addition to a complete “waiver” of patent protection, i.e., a suspension of all regulations on industrial property rights (TRIPS II, Sec.