In our previous article, we discussed the patent litigation landscape relating to the mRNA components of mRNA vaccines. In this article, we look at the patent litigation relating to the molecules that package and transport mRNA into cells where it is translated to produce the antigen.
Patent litigation landscape in relation to lipid nanoparticles for RNA Vaccines
Many systems have been developed for nucleic acid delivery, including lipids, lipid-like materials, polymers and protein derivatives. Lipid based particles are a type of delivery system used to encapsulate and protect genetic material. Various lipid nanoparticle (LNP) formulations have been developed commercially over the years. LNPs encapsulating small molecules, siRNA and other therapeutic agents have been approved by the EMA and FDA since in the mid-1990s.
LNPs comprise several different types of lipids at varying ratios. For example, both Moderna’s Spikevax® and Pfizer’s/BioNTech’s Comirnaty® COVID-19 vaccines use LNP formulations consisting of 4 different lipids: an ionizable lipid, a neutral phospholipid (e.g. DPSC), cholesterol, and a PEG lipid (e.g. PEG-2000-DMG).
Several pending litigations in the US currently revolve around the LNPs used in the mRNA vaccines or specific components of the LNPs. For example, Alnylam has sued Pfizer/BioNTech and Moderna1 for infringement of patents that they assert encompass the ionizable lipids used in Spikevax® and Comirnaty®. It is interesting that the patents that allegedly encompass these lipids were only granted after Spikevax® and Comirnaty® were commercialized. Additionally, Alnylam’s LNP-encapsulated siRNA product Onpattro® was developed using an in-licensed LNP system containing the cationic lipid MC3 (owned by Arbutus). However, Alnylam developed several ionizable lipids in-house and holds patents to LNPs comprising such lipids with biodegradable groups.
Two rival LNP platform providers, Acuitus and Arbutus, are involved in legal disputes with each other and Moderna and Pfizer/BioNTech over IP relating to LNP technology. Arbutus holds many patents relating to the LNP-nucleic acid formulations generally, with the LNPs defined by ratios of the lipids in the particles. These patents have been asserted against Moderna and Pfizer/BioNTech2. Moderna has attempted to challenge several of the Arbutus-owned patents with varying levels of success3. Moderna has also included patents to SARS-COV-2 vaccines defining components of the LNP carrier against Pfizer/BioNTech in their litigations4.
Implications for freedom-to-operate analyses and patent strategies
Like many technologies, the patent landscape as it relates to LNPs is complex and crowded. The current litigations show the need to consider components in isolation, e.g., ionizable lipids, as well as a part of a larger whole, e.g., a LNP or a mRNA vaccine. The litigation also shows risks that can arise when claims of pending patent families are adjusted during prosecution to encompass a competitor. These risks can be mitigated by performing careful freedom to operate (FTO) searching.
From a patentee’s point of view, the current litigations also show the benefit of reviewing your own patent portfolios to determine if they encompass a competitor’s technology or if there is an opportunity to tailor any pending applications to encompass a competitor’s technology.