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30 May 2023Big PharmaSarah Speight

Moderna and Pfizer face fresh suits over COVID-19 vaccine

A US biotech is accusing the pair of infringing several of its “foundational” lipid particle patents | Pfizer and BioNTech accused plaintiff in earlier suit of antitrust in a dispute over one of the patents at issue.

Biotech firm Alnylam Pharmaceuticals has sued Moderna and Pfizer alleging infringement of a clutch of patents that it says are essential to the mRNA-based COVID vaccines.

The company first sued the two COVID-19 manufacturers last March, claiming infringement of one of its patents (US patent 11,246,933)—both of which the defendants deny.

It has now accused Moderna of infringing three further patents, and Pfizer of infringing four, in two lawsuits filed on Friday May 26 in the US District Court for the District of Delaware.

Alnylam, founded in 2002, invented a “breakthrough” class of protonatable biodegradable lipids used to form lipid particles that carry and deliver RNA-based vaccines safely into the human body.

The Massachusetts-based company claims that its lipid particle technology is “foundational” to the success of the messenger RNA (mRNA)-based COVID vaccines, both of which were developed by Moderna and Pfizer.

Pfizer reaped $37.8 billion in sales of its COVID-19 vaccine Comirnaty in 2022, while Moderna earned $18.4 billion from its vaccine Spikevax, according to Reuters.

Lipid particle technology

In its complaint, Alnylam alleged that Moderna’s COVID-19 vaccine infringes three of the patents that protect this lipid particle technology (US patents 11,590,229, 11,633,479, and 11,633,480).

Infringement of the ‘229 patent, said Alnylam, is via Moderna’s use of its patented lipid particles; while the ’479 and ’480 patents are allegedly being infringed through Moderna’s use of SM102, a protonatable biodegradable lipid formulated into lipid particles.

According to Alnylam, Moderna has been aware of its lipid particle technology since at least early 2014, when the two companies entered into a business discussion regarding a licence to Alnylam technology, including the lipid particle technology.

In a parallel suit, Alnylam accused Pfizer of infringing the same three patents as above, but with different claims, as well as a fourth patent (US patent 11,612,657).

It said that Pfizer’s use of ALC-0315, a lipid compound used in its COVID-19 vaccine, infringes the ’479 and ’480 patents.

Alnylam also accused Pfizer of infringing the ’657 and ’229 patents through the use of its patented lipid particles, which comprise four lipids—one of which is the ALC-0315.

In both lawsuits, Alnylam is seeking compensation, although it is not seeking injunctive relief against such use.

Separately, Alnylam sued Pfizer and BioNtech in May last year over the ‘933 patent, but the defendants counter-claimed, arguing that Alnylam was misusing the patent and that its “conduct in seeking to licence and enforce the ’933 patent…was an attempt to seek an improper economic benefit”.

The two most recent complaints are among a swath of patent lawsuits filed by biotech firms over COVID-19 vaccines, including a dispute between Moderna and Arbutus Biopharma; and a suit brought by Moderna against Pfizer and its German partner BioNTech.

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