“Will the world end after COVID-19? I feel pity for the idea of sharing patent rights.”

26 Dec 2022
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WHO's resolution to share patents for COVID-19 medicine-vaccine results from lack of understanding the patent system.


SARS-CoV2. When will Corona-19, a more familiar expression, come to an end? As an ordinary person and not an infectious disease expert, we vaguely expected it to end in the spring when flowers bloom, but now we are forced to adapt to a world where non-contact is becoming the new normal. However, ironically, a pandemic like COVID-19 is also an opportunity for pharmaceutical companies.

In February this year when COVID-19 was in early stages, we had presented an opinion that the invention of diagnostic field would follow first. In fact, the diagnostic-related companies in Korea took a great active part, which, combined with the clever quarantine strategies of the Korea Centers for Disease Control and Prevention and medical staff, became an opportunity to change the world's view of Korea.

In the meantime, it was thought that the merit of developing a medicine or vaccine would drop considerably if COVID-19 ends within a short time like SARS in 2003 and MERS in 2015 (in reality, vaccines for SARS and MERS have not yet been released). Unfortunately, COVID-19 is still tormenting us, and the world's eyes are shifting from the realm of diagnosis to the realm of treatment or prevention.

Remdesivir from Gilead Sciences in the United States has been approved as a medicine for COVID-19 in the United States and other countries, and it is understood that special imports of remdesivir are planned in Korea. In addition, Avigan (avifavir) for Fujifilm in Japan was recently approved in Russia as a medicine for COVID-19. Both remdesivir and avifavir are known substances which were developed as Ebola virus medicines, but they were developed at an unusual speed through a drug repositioning strategy. In Korea, several companies including Bukwang Pharm (levovir; HBV medicine), Shinpoong Pharm (piramax; malaria medicine), and Ilyang Pharm (supect; CML medicine) seem to be implementing drug repositioning strategies. On the other hand, Celltrion developed new antibodies derived from national projects and has success to launch Regkirona.

Vaccines are slower than medicines in development. Although there is an imbalance in supply and demand, various vaccine products have been developed and administered.

Meanwhile, the debates over whether a COVID-19 medicine or vaccine belongs to public goods are growing. World Health Organization (WHO) adopted a resolution to share patent rights for medicines or vaccines for COVID-19 at the World Health Assembly (WHA) on May 18 and May 19, and on May 29, launched 'C-TAP' (COVID-19 Technology Access Pool) to follow up on the above resolution.

The United States and China have opposite responses to the above resolution of the WHO. The United States argues that innovation is possible only when intellectual property rights for drugs are acknowledged, whereas China intends to provide a medicine or a vaccine for COVID-19 as public goods for the world.

Although it is said that worldwide natural disasters which no one could have predicted occurred, WHO has never shown reliable results in its initial prediction and response. From the standpoint of WHO, which should treat already infected patients and protect with vaccines the general public trembling with fear, it is appropriate to prepare measures for stable supply of medicines or vaccines in the future.

In addition, while medically advanced countries including the United States and Europe have less difficulties in securing medicines or vaccines, infectious diseases like COVID-19 may be more fatal to poor countries including African countries, therefore the purpose of WHO resolution to smoothly supply medicines or vaccines to these countries is deeply understood.

However, as a person engaged in the patent industry, the methodology of patent sharing in the resolution adopted by WHO raises some objections. Looking more closely into the contents of the resolution, it adopts a manner in which any country or company that developed a COVID-19 medicine or vaccine should transfer intellectual property rights thereof voluntarily to WHO and supply it at a low license fee.

It is questionable whether WHO is inducing voluntary waiver of intellectual property rights by referring to AbbVie's recent waiver of Kaletra patent (it may be AbbVie's PR strategy, the decision to waive the patent right at the time when Kaletra was not approved as a medicine was a questionable and hasty decision).

Let’s imagine a time when there is no incentive for a COVID-19 medicine or vaccine. Do you think pharmaceutical companies would be eager to develop a medicine or a vaccine when a natural disaster comparable to COVID-19 occurs in the future unless they are charitable organizations like UNICEF? The efforts and costs put in by pharmaceutical companies should be entitled for fair compensation.

As expected, both domestic and foreign pharmaceutical companies are opposing. Pascal Soriot, CEO of AstraZeneca, said, “There are essentially no incentives for innovation unless intellectual property is protected,” and Albert Bulla, CEO of Pfizer, also bellowed, “The idea of patent sharing is absurd at this point.” I also believe that the resolution of WHO stems from lack of understanding the patent system.

In the past, World Trade Organization (WTO) agreed to be able to exercise a compulsory license in cases of “national emergency or urgent situation” in the Trade-Related Intellectual Property Rights Agreement (TRIP).

This was also reflected in the Patent Act in Korea, which provides 1) expropriation of patent rights (Article 106 of the Patent Act), 2) license of a patented invention by the government, etc. (Article 106-2 of the Patent Act), and 3) establishment of a compulsory license (Article 107 of the Patent Act), etc. In particular, Article 107 of the Patent Act specifies, “If there is a need to license a patented invention for exporting drugs (including active ingredients necessary for the production of drugs and diagnostic kits necessary for the use of drugs) to countries which intend to import such drugs to treat diseases threatening the health of many nationals”, it is possible to establish a compulsory license, which seems to be a clause well fit for COVID 19.

As long as there is an agreement already discussed in the existing consultative body as mentioned above, and a regulation reflecting this is in the patent laws of WTO member countries, WHO should not attempt to take in patent rights by making new rules now. Medicines or vaccines can be used as public goods after ensuring the incentive of patents to countries and companies with capabilities to develop medicines or vaccines and paying a fair price.

I don't think the world will end with COVID-19. We will have to be prepared for post COVID-19. No one knows when and how new COVID-19 virus, new Ebola virus, or entirely new and unknown virus will emerge.

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