According to news dated May 5, the US Government (USTR – The Office of the United States Trade Representative) has issued a statement that “We support the temporary waiver of patents on vaccines to increase the international supply of COVID-19 vaccines.” In response, the WHO praised the US decision, but the EU opposes the waiver of patents. In particular, Germany issued a statement on the 6th, saying that “It is the production capacity and high quality level that hinders vaccine production, not the issue of patents.” France initially supported the United States, but later stated that “Patent issues are not a high priority in vaccine supply,” and there is some stagnation. On the other hand, it is reported that India and South Africa have requested the WTO to temporarily exclude patent rights on COVID-19 at this time. The pharmaceutical industry is uniformly opposed to a “temporary waiver of patent rights.”
The composition of this discussion is similar to what I once saw at WIPO. At WIPO, there is a forum called the SCP (Standing Committee of Patents) as a place to discuss patent issues around the world. This forum is a “meeting of professional practitioners on patents”, and the PLT (WIPO’s Patent Law Treaty) was once established through discussions in this forum. After that, discussions were held on “substantive patent harmonization”, but due to disagreements between developed and developing countries, further such discussion was tentatively abandoned at the SCP. “Patents and Health”, which at first glance seems to be completely unrelated to patent practitioners, was proposed by developing countries in 2011 and then established as one of the agenda item.
At that time, there was the issue from national health perspective of developing countries that the supply of AIDS-related drugs to developing countries was insufficient. There was also a political point of view that “the harmonization of the patent system from the view point of developing countries is troublesome since the hurdle of the patentability is set by the developed countries”, so it was, in-effect, an “anti-patent harmonization” movement.
Regarding the “Patent and Health” issue, the seminars and lectures were held within the SCP by the WIPO secretariat. At that time, I attended the SCP many times as a representative of a Japanese private organization. What impressed me was the invitation of Ms. Margaret Chan, Secretary-General of WHO to the SCP seminar. At the seminar, she gave a speech on “Patents and Health” from the standpoint of the WHO. In it, Ms. Chan said, “We do not think that patents impede the supply of medicines. The patent system and health problems are separate issues.” This is different from the present WHO position on this issue.
In a panel discussion at another SCP seminar, a director of Pfizer of the United States was an invited panelist. He said that it takes time and a large amount of up-front investment in research work to manufacture chemicals. If patents are suspended after chemicals are developed, the necessary profits from selling the chemicals cannot be obtained, and fewer pharmaceutical companies will be established. He and the panelists from the developing country reach some consensus, but were never on the same wavelength.
I think there is a possibility that this issue, including that of the COVID-19 vaccine at this time, is basically being discussed from a political and emotional point of view. That is, “Is the existence of patents really hindering the supply of drugs? If such hindrance is a fact, in what situations is it hindering it? The extraction of the basic issue of “is it actually occurring in any countries?” has not been clarified as far as I know, I don’t remember hearing any empirical, concrete claims or proof on these points from the representatives of the developing countries in the discussion at SCP.
As reported in newspapers, even if a person skilled in the art reads the patent specification of a drug patent, it is impossible to manufacture the drug immediately, and a if a “compulsory license” that limits the validity of the patent is set, it will not be possible to supply the drug promptly unless the appropriate manufacturing facility, researchers, and supply system are complete in those countries. This is the reality.
The effect of a patent is enormous because it is an exclusive right, and sometimes it has a great impact on the international community. However, the emotional and political perspectives should be eliminated when this issue being discussed. There should be positive and constructive discussions for the health and happiness of all people of the world.