List of Global mRNA Vaccine Patents

Author: Zhang Yan

The outbreak of the new crown epidemic has made mRNA vaccines the most popular and profitable drug in the past two years.

In 1961, the biologist Brenner et al.

Another key to the success of mRNA vaccines is the delivery technology

Canadian biochemist Professor Pieter Cullis and his team, known as the "father of LNP technology", have been working on the use of LNP technology to deliver nucleic acid drugs since the late 1990s (the nucleic acid drug Patisiran using this technology has been listed) , from 2012, they turned to exploring the opportunities of LNP delivery system in mRNA-based drugs, and now Professor Cullis' company, Acuitas, holds several patents related to LNP technology

The mRNA vaccines currently under development are mainly divided into two categories, one is a non-replicating type (also called "traditional type"), and the other is a self-amplifying type.

Since the development and production of non-replicating mRNA vaccines are relatively less difficult, most of the mRNA vaccines currently under development are non-replicating mRNA vaccines

So what is the global competition for mRNA vaccine research and development so far? Through the analysis of the global new drug database of the medical cube, it is found that Moderna and BioNTech rank first and second in the world with 30 and 20 products under development, respectively.

The global epidemic of new crowns has also brought great changes to the research and development of mRNA vaccine indications and targets

With the development of mRNA vaccine technology, the application of related technology patents has also hit new highs in the past ten years

Source: Medicine Rubik's Cube NextPat Patent Database

Globally, Curevac holds the most patent filings, followed by Moderna and BioNTech

Source: Medicine Rubik's Cube NextPat Patent Database

At present, two mRNA vaccines for the treatment of new crowns have been launched, one of which is Elasomeran (code-named mRNA-1273) developed by Moderna, which has been officially launched in Japan and Europe, and has obtained emergency use authorization in the United States.

Source: Medicine Rubik's Cube NextPat Patent Database

Among them, US2021228707A1 is a patent application related to the marketed mRNA-1273

In addition to this patent, Moderna has also disclosed a patent to protect the use of mRNA-1273 in the treatment of new crown infection - WO2021159130A2, and a patent to supplement the protection of the structure of mRNA-1273 - WO2021159040A2

Another officially launched mRNA vaccine is Tozinameran (code BNT162b2) developed by BioNTech and Pfizer.

Source: Medicine Rubik's Cube NextPat Patent Database

In addition to their own patent applications, Moderna and BioNTech have both obtained the non-exclusive license of Penn's US8278036B patent, which is one of the most important patents in the mRNA field.

There are still some controversies about the replacement of pseudouridine.

In addition to the above-mentioned key patents, there are also many important patent applications in other technical fields related to mRNA vaccines, such as capping or poly(A) tail modification technology; self-amplification technology; sequence or codon optimization; nucleotide modification; delivery Technology, etc.
, please refer to our live broadcast for related patents
.

There are many patented technologies involved in mRNA vaccines, and it is inevitable that many disputes will arise due to intellectual property issues.
At present, companies are actively seeking to obtain patent licenses, and at the same time, they are constantly trying to invalidate the patents of competitors
.

Source: Medicine Rubik's Cube NextPat Patent Database

Moderna is currently taking the initiative to file an Inter-Party Reexamination (IPR) request with the United States Patent and Trademark Office (USPTO) for four patents of CureVac and Arbutus.
Among them, CureVac's US8383340B protects the purification method of preparative mRNA, and the patent has been successfully invalidated.

.
The other three patents are all patents related to LNP delivery technology of Arbutus company, namely US9364435B, US9404127B and US8058069B.
At present, the US9364435B patent has been partially invalidated, the US9404127B patent has been successfully invalidated, and the US8058069B patent remains valid
.
Judging from the current ruling, Arbutus can initiate a patent infringement lawsuit against Moderna on this basis, or require Moderna to pay a certain patent license fee
.
However, Moderna has always insisted that it is not the LNP technology of Arbutus, but the delivery technology developed by itself.
This dispute is still ongoing
.

Moderna is also at stalemate with NIH over the issue of the inventor of the mRNA vaccine.
The two sides have close cooperation in the research and development of the core sequence of the mRNA vaccine, while Moderna only uses the company's Scientists were listed as inventors and three NIH scientists were excluded, which aroused NIH dissatisfaction
.
Moderna's claim: While working with NIH to complete the sequence, they had an independent team advance the work in parallel with NIH and independently designed the exact same sequence as the NIH team, and the two teams just "exchanged ideas" at the end
.

Moderna may also infringe NIH patent US10960070B, which provides a universal solution to the highly immunogenic prefusion conformational stability of the coronavirus spike protein, which is expected to expire in 2037 and is currently licensed to several pharmaceutical company
.
Although Moderna's mRNA vaccine does not meet the limitations of any of the patent claims, and does not directly infringe these claims by manufacturing or selling mRNA vaccines
.
However, once injected into a human patient, the mRNA-1273 vaccine instructs the subject's body to produce the spike protein, which then confers immunity
.
This pattern of fact may constitute an induced infringement of claims covering the spike protein
.
Although NIH did not initiate a patent infringement lawsuit against Moderna, the patent provided a powerful bargaining chip for the US government and Moderna to negotiate on the distribution and pricing of mRNA vaccines
.
In March 2021, Fauci and other scientists jointly sent a letter to the government, calling for the patent to be licensed to Moderna to facilitate wider access to the vaccine worldwide
.

BioNTech itself faces less risk of patent infringement.
So far, only Allele has filed a lawsuit against BioNTech (Pfizer) for using its company's yellow-green fluorescent protein in mRNA vaccine research.
"Terms defense, the lawsuit is currently pending in the Southern District Court of California and has not yet been closed
.

BioNTech took the initiative to file opposition requests to the European Patent Office for several patents of Moderna and CureVac.
All of these patents are key patents related to mRNA research and development.
It is worth noting that these patents have the same family in China, which are worthwhile.
Chinese R&D companies pay more attention
.

Source: Medicine Rubik's Cube NextPat Patent Database

Because mRNA vaccines have brought huge economic benefits to research and development companies, the patent layout of each company is as dense as a spider web, but during the new crown epidemic, intellectual property barriers have also had a certain negative impact on global medical manufacturing and supply
.
In view of this, South Africa and India submitted proposals to the WTO for exemption from TRIPS obligations in early 2020, requiring WTO members to waive four categories of intellectual property rights before the majority of the world's population is vaccinated: patents, copyrights, designs, and future patents under the TRIPS Agreement.
public information
.

The TRIPS Council held a preliminary discussion on this proposal in October 2020.
100 countries welcomed or fully supported the proposal, with only a small number of countries or regions remaining, including: Australia, Brazil, Canada, the European Union, Japan, Norway, Switzerland, Britain and the United States rejected the proposal
.
The objections are mainly concentrated in three aspects: First, these measures will be detrimental to the innovation of the pharmaceutical industry
.
Second, the existing flexibilities in the TRIPS Agreement are sufficient to address vaccine access issues, so there is no need to waive the TRIPS obligation
.
Third, developed countries argue that there is no shortage of COVID-19-related medical products and that existing arrangements such as the COVAX mechanism are sufficient to facilitate access
.
In 2021, the Biden administration agreed to renegotiate the proposal, and the EU responded again, but this in itself did not make a substantial contribution to the TRIPS exemption proposal
.

At present, the proposal has not been agreed on a global scale, and the global patent problem still exists.
We welcome everyone to share their thoughts with us on the TRIPS obligation exemption proposal.
Do you think that during the epidemic, is there any need for patents to exist?