New crown vaccine "leader" Moderna key patent case lost
2021-12-11 13:01:36
According to relevant channels, Moderna, the "leader" of Xinguan vaccine, lost in a key patent case for mRNA vaccine research and development. The Federal Circuit Court confirmed the earlier ruling of the patent approval and appeal board (ptab) and rejected Moderna's request to withdraw the two patents of Canadian pharmaceutical company arbutus "435" and "069". This means that Moderna may face patent infringement litigation in the future, delay the research and development of the new crown vaccine mrna-1273, or pay a certain patent license fee to arbutus to share the sales revenue of the new crown vaccine.
LNP patent dispute
The patent dispute between Moderna and arbutus mainly focuses on "lipid nanoparticle (LNP)", that is, the carrier delivery technology adopted by mRNA vaccine.
Exogenous mRNA is very fragile and easy to be degraded by enzymes, so it is difficult to enter cells to play a role. Therefore, it needs a "protective device" to deliver it to cells, and LNP has been proved to be effective in delivering mRNA, drugs, vaccines, etc. LNP can wrap mRNA and simulate human low density lipoprotein (LDLs), which is ingested into human body through endogenous pathway, so as to play a role in specific cells. Therefore, without LNP delivery technology, relevant drugs will not be able to enter the human body safely, and the technical route of mRNA and human gene editing will not be opened.
According to the report of Forbes in tracing the source of mRNA vaccine delivery technology: a struggle about science, patent and wealth, the results of Forbes' investigation for several months show that the Canadian biochemist Ian MacLachlan has made the greatest contribution to the delivery technology. After MacLachlan left its company, CEO changed its name to Arbutus, and decided to focus on cooperative development of hepatitis B drugs. However, he retained the patent ownership of the four lipid delivery system.
In 2012, acuitas obtained the license for LNP technology from arbutus, and soon afterwards, acuitas transferred the delivery technology to Moderna so that the latter can use it to develop mRNA influenza vaccine.
In 2016, arbutus learned that acuitas had licensed LNP technology to Moderna, but according to the licensing agreement at that time, acuitas only had the right to use and sublicense LNP technology in "antisense" and "gene therapy", and there were strict restrictions on sublicense. Therefore, arbutus initiated a lawsuit against acuitas. Acuitas denied violating any agreement and also filed a lawsuit.
Arbutus finally won the lawsuit, and in 2017, the court issued a temporary injunction to block acuitas's technology license.
In 2018, arbutus and acuitas reached a settlement. Arbutus finally terminated the license to acuitas and limited the use of lipid nanoparticles of arbutus for Moderna transmission to the candidate vaccines of four identified viruses (respiratory virus RSV, influenza A, Zika virus and chikungya virus), but did not include mRNA vaccine, At the same time, Moderna can no longer use this technology to develop other products.
At the same time, in order to prevent such incidents from happening again, arbutus also established a joint venture, Geneva Sciences, to specifically master the intellectual property and commercialization rights related to tetralipid delivery technology. It is worth mentioning that a few months after the establishment of Geneva science, biontech reached an agreement with it to apply the delivery technology to biontech's five existing mRNA cancer projects.
Moderna, aware of the huge impact of the settlement on the company, immediately began to challenge the three LNP key patents "127", "435" and "069" of arbutus, and sought to cancel the relevant patent protection from the patent trial and appeal board ptab of the U.S. patent and Trademark Office. Moderna said it had developed its own LNP delivery system and no longer needed arbutus technology. However, arbutus insists that it is difficult for Moderna to develop effective LNP technology without the help of arbutus patent.
In fact, according to Forbes' report, the regulatory documents submitted by Moderna show that its vaccine does use the same four lipids as MacLachlan delivery technology, but one of them is patented by the company, and its use proportion is "slightly changed".
In July 2020, ptab finally determined that "127" was invalid, maintained that "069" remained valid, "435" some claims were invalid, and other claims remained valid.
After that, Moderna filed an appeal challenging the review results of ptab. In December 2021, the Federal Circuit Court confirmed ptab's ruling and Moderna lost the case.
