By Albert Su, Partner of Formosan Brothers, Attorneys-at-Law

Recently on the news, there was a voice of concern that using a comparison between domestic vaccines and original manufacturer of foreign vaccines as the basis for granting emergency use authorization (“EUA”) for domestic vaccines might be suspect of patent infringement upon the foreign vaccines. Such a concern seems to have misunderstood the principle of patent infringement comparison.

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To determine if a patent has been infringed, one needs to first identify the content and claims of the patent, and which act or product that is suspect of infringement.

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Generally speaking, a patent of original manufacturer vaccine may include the vaccine’s ingredients or proportions, the manufacturing methods, the indications or mechanism of action, etc. If the vaccine is sold, manufactured, or used without the consent of the original pharmaceutical company, it might constitute infringement upon the original manufacturer’s patent. However, conducting data analysis on the vaccine receivers’ blood serum has nothing to do with the vaccine, and could not have been included in the claims of the original manufacturer’s vaccine patent.

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According to the information released by the Ministry of Health and Welfare, the evaluation standard for Taiwan’s domestic COVID-19 vaccines is the study method of immune-bridging, that is, comparing the number of serum neutralizing antibodies 28 days after the second dose who were vaccinated of the domestic vaccines to those who were vaccinated of the AstraZeneca vaccine in adult trial subjects under 65 years old. The data for the AstraZeneca group are taken from the blood serum analysis of 200 medical staff at Taoyuan Hospital of the Ministry of Health and Welfare who have received two doses of the AstraZeneca vaccine.

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Here we have two acts involved. One is the act of vaccinating the AstraZeneca vaccine. Since the AstraZeneca vaccine was provided by the original manufacturer, the act of vaccinating would not constitute infringement. The second part is the act of obtaining blood serum from those who received the vaccine and conducting an antibody analysis on the serum. Since drawing blood requires the consent of the person being drawn and such blood serum data do not belong to the vaccine manufacturer, in addition, the blood serum analysis data have nothing to do with the ingredients, manufacturing methods or indication of the vaccine, it is not likely that such an act would infringe upon the original manufacturer’s vaccine patent.

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Moreover, in patent defense, the defense arguments of “doctrine of exhaustion” and “experimental use exemption” have been through much discussion and interpretation in patent law. Discussions include the subjects of domestic exhaustion and foreign exhaustion, and cases regarding drug patent linkage that whether or not generic drug manufacturers as defendants can allege experimental use exemption, which we can spend more time to discuss. Since the immune-bridging method involves analysis on the blood serum of vaccinated people, not the sale, manufacture, or administration of vaccines, in principle, it has nothing to do with the vaccine patent of the original manufacturer. As such, there seems to be no need to bring up the discussion on “doctrine of exhaustion” and “experimental use exemption.”

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Patent infringement determination is a highly professional task. When encountering patent infringement disputes, one should fully consult with professionals to protect one’s rights.

(This article was published in the Expert’s Commentary Column of the Commercial Times：https://view.ctee.com.tw/legal/30387.html）

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