What does it mean if the United States abandons the new crown vaccine patent?

On May 5, US Eastern Time, the US government stated that in order to end the epidemic, it would actively participate in the written negotiations of the World Trade Organization (WTO) and support the cancellation of the protection of intellectual property rights for the new crown vaccine.

Xiao Youdan, a researcher at the Institute of Strategic Consulting of the Chinese Academy of Sciences, said that this decision was based on a "diplomatic position," with no administrative or legal effects, and more of a moral pressure.

How effective is this US statement? What is the specific meaning of abandoning the intellectual property protection of the new crown vaccine? To what extent can it solve the current global vaccine shortage? In this regard, "Intellectuals" interviewed many experts in the field of vaccines and intellectual property rights.

On May 5, US Eastern Time, the US government under Biden announced its support for the cancellation of intellectual property protection for the new crown vaccine.

Although the US government "strongly supports the protection of intellectual property rights, but in order to end the epidemic and support the cancellation of the protection of the new crown vaccine (intellectual property)," US Trade Representative Katherine Tai said, "We will actively participate in the World Trade Organization (WTO).

At present, many countries are facing the problem of vaccine shortage.

Beginning last year, developing countries such as India and South Africa have asked for the opening of new crown vaccine patents[2], and UN human rights experts have also condemned the monopoly of pharmaceutical companies[3] and called for exemption from intellectual property rules, believing that this is the key to repelling the new crown .

This issue is also being discussed continuously within the US government.

The Director-General of the World Health Organization (WHO) Tedros Adhanom praised this statement, calling it a "milestone moment" [5].

However, this statement was opposed by some countries such as Germany [7].

Some American politicians worry that the cancellation of patent authorization will benefit China.

This is not good news for pharmaceutical companies that rely on vaccine technology to make a profit.

How effective is this statement? What is the specific meaning of abandoning the intellectual property protection of the new crown vaccine? To what extent can it solve the current global vaccine shortage problem? "Intellectuals" interviewed a number of experts in the field of vaccine research and development and intellectual property rights.

Many experts believe that relying on the cancellation of patent protection cannot effectively solve the problem of vaccine shortage in the short term.

What is the significance of canceling vaccine patent protection?

Pharmaceutical companies apply for patents for their vaccine technology, essentially protecting technological innovation.

Since the content of the patent itself is public, and everyone will be able to see it after a certain period of time, what is the point of canceling patent protection for vaccines?

Intellectual property expert and patent attorney Zhao Youbin explained that the holder of the patent has the right to charge the party who uses the patent or prohibit its use.
In other words, if an institution uses a certain patented technology, the pharmaceutical company holding the patent can require the institution to pay fees through litigation, or prohibit the institution from using the patent.

Therefore, Zhao Youbin believes that the essence of canceling the protection of vaccine patents is to cancel the prohibition or charging rights of vaccine patent companies.
The patented technology that originally required paid authorization can be used for free after the protection is cancelled.

The U.
S.
states that it intends to "force" pharmaceutical companies to act

Xiao Youdan, a researcher at the Institute of Strategic Consulting of the Chinese Academy of Sciences, said that this decision was based on a "diplomatic position," with no administrative or legal effects, and more of a moral pressure.

"Externally, the US government's position is to support the WTO system to temporarily suspend part of the (intellectual property protection) agreement for a period of time in response to the new crown epidemic," he said.
"At home, the Biden government is telling American pharmaceutical companies.
If it does not solve this problem by itself, the federal government may also take measures.
"

This statement by the United States is one month earlier than the formal meeting of the WTO to discuss patent exemption in June.
This is not accidental.

Zhao Youbin introduced that patent rights are private rights and are the property of enterprises or private individuals.
The US government cannot directly announce the cancellation.
He explained that the current "support for cancellation" proposed by the US government refers to its support for the amendment of relevant international agreements under the WTO framework.

At present, each country has its own independent patent application system, and the patents applied for in the country take effect within that country.
The patent system between countries is connected through two main agreements: the "Paris Convention for the Protection of Industrial Property"[11] and the "Patent Cooperation Treaty (PCT)"[12].

In addition, under the WTO system, the Agreement on Trade-Related Intellectual Property Rights (TRIPS) requires member states to protect the intellectual property rights of other member states with a protection standard not lower than their own intellectual property rights.
The patent rights part refer to the Paris Convention "carried out.
Signing the TRIPS Agreement is a mandatory requirement for WTO entry, that is, 164 member states have participated in this agreement.
[13]

"According to the TRIPS rules, (vaccine companies) can prohibit other countries from producing related vaccines or charge licensing fees.
The so-called abandonment of patents now means that this rule is not required, or a special clause is added to it to allow countries to abandon the patent protection of the new crown vaccine.
"Zhao Youbin said.

The TRIPS agreement protects intellectual property rights on an international scale, but there are also criticisms that it is not conducive to developing countries' access to medicines or enabling developed countries to obtain high profits.

In 2001, in order to provide more countries with better access to AIDS treatment drugs, WTO member states passed a "Doha Declaration", which made “flexible handling” on the basis of recognition of the TRIPS Agreement, allowing governments of various countries to impose compulsory treatment during public health crises.
Issuing a patent license.
[14]

Under the new crown epidemic, the TRIPS agreement has also been challenged.

In October 2020, India and South Africa proposed in a TRIPS Council of the WTO that in order to deal with the new crown epidemic, some obligations in the TRIPS agreement should be exempted for a limited time and some patent rights should be used free of charge[15].
According to a report from China Business News, WTO member states had different opinions on the proposal at the time: the least developed and developing economies supported the proposal; most developed countries, including the United States, expressed opposition and believed that intellectual property rights would be weakened.
Protection and law enforcement will be detrimental to the global fight against the epidemic; some member states such as China welcome the proposal, but need to further clarify the economic problems that may arise [16].

This proposal has undergone many deliberations after October, but the countries have not reached an agreement.
The next official TRIPS board of directors is scheduled for June 8-9.
The US government's statement this time actually turned to support the proposals of India and South Africa.

In addition to international pressure, the U.
S.
government and pharmaceutical companies are also facing domestic pressure to liberalize drug patents.
Xiao Youdan introduced that from February 2020 to the present, the dispute over whether the intellectual property rights of the new crown vaccine should be liberalized has not ceased in the United States.

"Biden's statement is to tell the pharmaceutical company that I cannot bear the international public opinion and domestic moral pressure.
" Xiao Youdan said.
"This is actually forcing pharmaceutical companies to negotiate, whether it is opening up or lowering the threshold, forcing pharmaceutical companies to make concessions in the production process and vaccine pricing.
If you don't solve this problem yourself, the federal government will also It may take measures, such as supporting compulsory licenses.
"

Xiao Youdan said that in terms of institutional arrangements, there are some domestic laws in the United States that support the government in requisitioning patents in emergency situations and give patent owners as compensation.
The United States has not yet used these policy tools.

Can the cancellation of vaccine patent protection solve the problem of global vaccine shortage?

Zhao Youbin believes that the cancellation of vaccine patent protection will have a very limited impact on improving vaccine shortages.

First of all, what is a "vaccine patent" is unclear.
Take the relatively most patented mRNA vaccine as an example, "Which patents belong to mRNA vaccines is currently undefined.
"

The mRNA vaccine has undergone a complex research and development process, and its related technologies include related patents such as amplification and packaging particles.
According to "Nature" magazine statistics, there are currently at least 113 patents related to this technology, 70% of which come from the industry.
[17]

In addition, because the US government also supports the development of some vaccines, some patents, such as the amino acid substitution patents used to stabilize spike proteins in vaccine design, belong to the US government, but this proportion is not high.
[18]

Secondly, even if the WTO starts to discuss the cancellation of vaccine patent protection with the support of the United States, it will take time to form a resolution.
After the resolution is formed, each country needs to issue regulations to apply the resolution within its own laws, and these processes will take a long time.

Anthony Fauci, the Chief Medical Adviser to the President of the United States, also expressed concern about the time-consuming process in a TV interview on May 5, Eastern Time.
"The so-called'cancellation of patents' is complicated in that when you prepare By the time these technologies can be used in other countries, it may be the end of 2022 or early 2023, and many people may have already died.
" He said.
[19]

The WTO’s slow action seems to confirm this: According to WTO spokesperson Keith Rockwell (Keith Rockwell), later in May, an intellectual property group will again review the proposals made by India and South Africa.
The official TRIPS Council is still scheduled to be held in June.
[20]

More importantly, even if the patent protection is cancelled, the specific operations of companies from R&D to production are still technical secrets, and it is difficult for companies lacking actual vaccine production experience to replicate.

"When there are no intellectual property rights issues, there may be several large companies such as GlaxoSmithKline, Merck & Co.
, etc.
, which can enter this field immediately and increase supply quickly.
The technology, capital, equipment, and personnel are not necessarily qualified for the production of mRNA vaccines.
" Zhao Youbin said.

Wang Nianshuang, a scientific researcher who used to develop mRNA vaccines with Moderna in the United States, said that as far as mRNA vaccines are concerned, the technology is complicated and there are many patents.
There are generally two ways for companies to protect intellectual property rights: patent (patent) and trade secret (commercial secret).
"For many companies, the core technology is generally not written in the patent.
In other words, it is not necessary to make a complete reference to the patent.
"

Xiao Youdan also believes, “In vaccine production, even if you tell you about the patent, can you increase production capacity in a short time? Many things are not within the scope of patent protection, and they are all know-how (proprietary technology or know-how), including processes.
, The organization of production and the supply of raw materials.
"

In fact, Stephen Hoge, President of Moderna, told the Wall Street Journal as early as October 2020 that he would not be held accountable for infringement of its vaccine patents [21].
Moderna CEO Stephen Bancel (Stéphane Bancel) also said that the cancellation of patent authorization will not affect the company's business [9].

"(This statement) does not solve the substantive problem at all.
" InBev, the founder and CEO of Suzhou Aibo Biotech, said, "Tell you about the patent, but if you don't tell you the process, you still can't do it.
"

Suzhou Aibo Biology is also developing an mRNA vaccine, which is similar to the mRNA vaccine technology route developed by Pfizer and Moderna, the two major new crown vaccine providers in the United States.

"Patents were not a problem before.
" InBev said.
He believes that the technology of vaccine production is as important as the technology represented by vaccine patents.
However, in the production process, whether it is the construction of the core mRNA sequence or the production of preparations such as nanoparticles as a delivery medium, there is no way to master it without technology sharing.
.
"It's like cooking.
I know that all the ingredients don't necessarily make a dish.
If I throw everything into the pot, the dish must taste wrong.
"

For the same reason, Lisa Ouellette, a law professor at Harvard University, said that even if the patent authorization is cancelled, it will not alleviate the tightness of the vaccine supply chain.
Therefore, it will not have a significant effect on increasing the global vaccine supply in a short period of time.
In the long run, policymakers need to encourage technology sharing as quickly as possible to ensure the equitable distribution of vaccines around the world.
[twenty two]

Zhao Youbin believes that more scientific and actionable measures are needed to solve the problem of vaccine shortage.
"The more feasible measure is technical cooperation.
" He said that companies such as Pfizer and Moderna need to send technicians to use complete sets of technology to carry out technical cooperation with pharmaceutical companies in developing countries.
They provide technology, and other countries provide equipment and materials to jointly produce and set up companies or projects to produce vaccines.

A revolution in the patent system of the pharmaceutical industry?

Xiao Youdan analyzed that the discussion on the cancellation of patent protection has deeper policy connotations.

"I feel that many people are using this vaccine to make a revolution in the entire biomedical industry.
It is not a question of whether the patent system is good or bad, but to overthrow it," he said.

The long-standing tension between public health and pharmaceutical companies' patent protection for medicines is the thread behind this discussion.

Xiao Youdan said that the granting of patents for the invention of pharmaceutical products and production methods began with the TRIPS agreement.
The establishment of the drug patent system makes pharmaceutical companies tend to set up many obstacles in the implementation of drug patent licensing in order to maintain their monopoly position, leading to high drug prices.

Even in developed countries such as the United States, some drugs are expensive and cause difficulties for patients.
In 2017, 51 members of Congress submitted an open letter to the Trump administration, asking the United States to use the March-in right in the Bayh-Dole Act (note: an important U.
S.
patent bill) to reduce prescription drugs price.
[23] The right to intervene means that the federal agency has the right to require the right party to authorize the capable implementer to use the results when responding to the needs of public health and public safety.
[twenty four]

In January of this year, the National Institute of Standards and Technology (NIST) proposed a regulatory amendment to the Bayh-Dole Act, hoping to introduce a new mechanism to make medicines cheaper and more flexible in production mechanisms.
[25]

Xiao Youdan said that the first-mover advantage of pharmaceutical companies' innovation is obvious.
Whether the pharmaceutical industry does not need patent protection will be a long-term question for US policymakers.
At present, the position of the Biden administration is only an administrative position.
After the legislative and judicial organs intervene, they will surely fight each other.
Tensions in Sino-US relations have also been taken into consideration, and discussions will be more complicated.