top of page

PTAB Supports BioNTech and Pfizer in Initiating Patent Challenge against Moderna | Heavyweights Stand Their Ground, Patent Battle Over mRNA+LNP Technology Reviewed

Mar 25, 2024

BioNTech and Pfizer claim that Moderna has rewritten history, "erasing the contributions of many outstanding and dedicated scientists and placing itself as the sole protagonist." .

The COVID-19 epidemic, which is unprecedented for mankind in a century, has forced the global economy and society to press the pause button. Biotechnology companies, pharmaceutical giants, and global scientists worked together to develop a vaccine based on mRNA technology in a very short period of time, which effectively prevented the spread of the virus, especially severe cases, and ended the COVID pandemic. In such a short period of time, top scientists from all walks of life worked together and concentrated all available resources in order to defeat mankind's common enemy. In the eye of this hurricane, mRNA technology has developed in a geometric leap and entered large-scale clinical applications several years ahead of schedule. It has also brought LNP lipid nanoparticle delivery technology to the center of the stage. So far, many companies have deployed in LNP-related fields.

The advancement of technology and the widespread use of products have brought returns to the giants. According to SOMO (Research Center for Multinational Corporations) estimates, the total profit of the global COVID prevention and treatment market is close to a staggering US$90 billion in 2021 and 2022 alone. , Pfizer's COVID-19 related products alone generated $35 billion in net profits. BioNTech and Moderna each made at least $20 billion !

Behind the huge revenue scale of mRNA vaccines, major global giants will inevitably fall into chaotic patent battles. In March 2024, the PTAB expressed support for BioNTech and Pfizer's patent challenge against Moderna. Once again, the patent dispute surrounding LNP and mRNA technology has been pushed to the forefront.

Abraham Lincoln once said: The patent system has added the fuel of interest to the fire of genius. The patent system adds fuel to the fire of genius.

Among them, Moderna, Alnylam, Pfizer/BioNTech, etc. are also the main leaders. The competitive relationship between them is complicated, as can be seen in Figure 1.

The development process of the patent dispute

On August 26, 2022, Moderna filed a patent infringement lawsuit against Pfizer and BioNTech in the District Court of Massachusetts in the United States and the District Court of Dusseldorf, Germany . Moderna's lawsuit involves three patents, and there appears to be evidence that Pfizer and BioNTech illegally copied mRNA chemical modifications, specifically N1-methylpseudouracil (m1ψ) - an mRNA chemical that can avoid adverse immune reactions in the body when mRNA vaccines are produced. Retouching techniques .

In the same year, Moderna also received lawsuits from Alnylam, Arbutus and Genevan . These companies accused Moderna of selling Spikevax vaccine products that infringed on their patents and claimed compensation from them; Pfizer and BioNTech were sued by Alnylam, CureVac and Moderna, and also involved multiple Patent infringement.

In April 2023, Arbutus and Genevant filed a lawsuit against Pfizer and BioNTech in the U.S. District Court of New Jersey for infringement of five patents regarding the production and sale of the Comirnaty COVID vaccine, involving the formulation composition, production process, and delivery of mRNA-LNP. Technology and Usage. In May, Alnylam sued Pfizer and Moderna for the third time in Delaware , claiming that these companies infringed its patent rights in LNP technology.

Amid the smoke, Pfizer's drug delivery strategic partner Acuitas has further muddied the waters. Acuitas sued Arbutus and Genevant , but its lawsuit is different from other lawsuits. Acuitas filed a lawsuit for a declaratory judgment (Declaratory Judgment).

Previously, Arbutus claimed that Moderna infringed its patents, and Acuitas believed that it needed to prove through a declaratory judgment that Pfizer's vaccine did not infringe. Otherwise, Arbutus's lawsuit threatened Acuitas' ability to continue licensing its LNP technology. As a result, Acuitas is seeking declaratory judgment relief on nine patents owned by Arbutus, including the patents Arbutus is suing against Moderna, so that it does not infringe any of Arbutus's patents.

If it is still a small player, that is, the Emerging Companies & New Entrants referred to in Figure 2, it is even more dazzling. But this also shows how hot the field of LNP and mRNA is, and the future potential is still as bright as the stars and the sea, with unlimited potential.

*Figure 2 comes from ROTHWILL FIGG law firm ’s review of LNP/mRNA patent competition in September 2023

The battle between giants. Who will win the mRNA technology patent is still a mystery to this day. In March 2024, the U.S. Patent Trial and Appeal Board (PTAB) agreed to review two Moderna COVID-19 vaccine patents challenged by competitors Pfizer and BioNTech. The PTAB granted Pfizer and BioNTech’s petition to conduct inter partes review of the patents and stated that the challengers (Pfizer and BioNTech) had demonstrated a reasonable likelihood that the rights in these patents were invalid , as follows:

  1. Moderna sued Pfizer and BioNTech for infringing three of its patents.

  2. Pfizer and BioNTech argue that Moderna's patents have broad rights and are invalid due to prior technology, including a 2013 U.S. patent application and other prior technology.

  3. Moderna opposed the review, saying the same invalidity position had been raised in the district court case.

  4. However, the PTAB found the arguments put forward by Pfizer and BioNTech to be more persuasive.

  5. Moderna remains confident in the validity of its patents and is committed to continuing to protect its intellectual property.

It is foreseeable that this patent war will last for several years and will have a profound impact on the industry. This dispute also sounded the alarm for new drug delivery companies like N1 Life and provided a lesson. The teams responsible for patents and science must proactively formulate and implement effective strategies and means to protect patented technology and future business. right . N1 Life's ChARLS delivery technology can realize the selective delivery of biological macromolecules (such as mRNA, DNA, etc.) and gene editors (such as CRISPR) in the body; using innovative molecular transport technology, N1 Life can promote the innovation of drug delivery technology , accelerating the innovative research and development of all categories of drugs, and can be widely used to develop new therapies and vaccines in the field of CGT.

Delivery with broader application prospects

Technology continues to support CGT therapy

RNA-based therapies can not only regulate gene expression, but also produce therapeutic proteins or antigens that stimulate immune responses to treat a variety of disease types, including infectious diseases, cancer, immune diseases and genetic diseases.

Currently, many pharmaceutical companies around the world are developing mRNA tumor vaccines . For example, BioNTech is developing mRNA therapies for rectal cancer, melanoma and other cancers ; Moderna is teaming up with Merck to develop and sell a personalized precision cancer vaccine.

Among them, drug delivery is a key link in the development of mRNA drugs. Lipid nanoparticles (LNP) are currently the most widely used delivery carrier in the industry. They are mainly prepared from phospholipids and cholesterol and have good biocompatibility, degradability, and biosafety. But so far, LNP systems have not been able to meet all needs, such as delivering specific mRNA into target cells. Three major difficulties need to be overcome to achieve intracellular delivery: cell barriers, inclusion body escape, and intracellular immunity.

In order to solve the above problems, N1 Life independently developed ChARLS nano-delivery technology , which has now achieved organ-targeted mRNA delivery in the body and has broad application prospects in gene therapy, gene editing, cell therapy, scientific research and diagnosis and other fields . Moreover, unlike LNP technology in the smoke of gunpowder, ChARLS technology is completely independently developed by N1 Life and will not involve patent disputes.

Looking at the entire market, other companies in the industry generally use LNP technology, but it is difficult for LNP technology to truly target extrahepatic organs and has certain disadvantages in terms of cost, technology, patents, and immune safety . Many companies' LNP/mRNA products on the market focus on liver diseases. The main reason is that the drug carrier (lipid nanoparticles) naturally goes to the liver for metabolism.

In addition, current LNP/mRNA particles generally need to be stored at low temperature or after freeze-drying, and the storage time is relatively short. ChARLS technology can achieve higher stability after wrapping mRNA, so that some vaccines do not need to be stored at ultra-low temperatures, reducing supply chain and material costs.

In summary

mRNA technology, LNP technology, and other CGT technologies have brought waves of exciting breakthroughs to global biomedicine, and technological innovations are emerging one after another. However, truly practical and broad-spectrum technologies are those that can benefit mankind. The patent war between LNP and mRNA will continue after the epidemic is over, having a profound impact on the industry. At the same time, new drug delivery companies must develop effective strategies to protect intellectual property and promote technological innovation. N1 Life's ChARLS delivery technology is a solution with great potential. It can achieve organ-targeted RNA delivery in the body and avoid the worries of patent disputes through source innovation. As this technology develops, we can expect to see advances in gene therapies, improved drug efficacy, and more effective treatments for various diseases. Such innovation will promote the development of the industry and bring more hope and opportunities to human health. We will continue to pay attention to the progress of patent competition and the advancement of domestic and foreign technologies.

bottom of page