Patent Litigation over PFE/MRNA Vaccines
Mar 17, 2022 15:36:40 GMT
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Post by icemandios on Mar 17, 2022 15:36:40 GMT
Alnylam seeks compensation from Moderna and Pfizer in suits over patented delivery of their Covid-19 vaccines
Zachary Brennan
Senior Editor
RNAi therapeutics juggernaut Alnylam Pharmaceuticals on Thursday announced that it’s suing and seeking money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which have been integral to the way both companies’ mRNA vaccines work.
The suits, filed in the Delaware district court, both seek “fair compensation for use of its technology” but “no less than a reasonable royalty.” And if successful, the biotech will dip into two of the richest revenue streams the biopharma industry has ever seen.
The suits explain how Alnylam scientists more than a decade ago invented this new class of non-natural lipid nanoparticles, comprising a cationic (or positively charged) lipid with biodegradable groups that has proved critical for the Covid-19 vaccines and several marketed RNA therapies.
These so-called LNPs can protect the delicate RNA until it’s delivered to the cell, and then they’re metabolized and eliminated from the body.
In the case of Pfizer, the suit notes that every one of the company’s Covid-19 vaccines contains this infringing cationic lipid, known as ALC-0315.
How does Alynylam know that its patents have been infringed? The company explains how ALC-0315’s chemical name is ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), and the prescribing information for Pfizer’s Covid vaccine Comirnaty states that each dose contains that same chemical, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate).
For Moderna, although the company claims to have its own “proprietary lipid-nanoparticle-delivery system,” Alnylam said it “relies on the patented Alnylam LNP Technology” and that the “biodegradability of Moderna’s lipid system employs the patented Alnylam LNP Technology.”
The suit also explains how, prior to the pandemic, about a decade ago, Alnylam and Moderna began discussing a way for Moderna to license some of Alnylam’s IP.
In Feb. 2014, Moderna and Alnylam entered into a confidentiality agreement, allowing Alnylam to share secrets with top Moderna execs, including a “detailed PowerPoint disclosing Alnylam’s LNP Technology and how those LNPs could be used for developing RNA-based pharmaceuticals. Alnylam further disclosed valuable rodent and non-human primate pharmacology experiments that showed superior in vivo elimination of its biodegradable LNPs, while also showing superior potency,” the suit alleges.
Meanwhile, for years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. And Arbutus and another company recently sued Moderna for infringing on their patent on a lipid nanoparticle platform that they also said was crucial to the delivery of Moderna’s widely-used vaccine.
Alnylam is no stranger to lawsuits itself. The company tackled Dicerna in court, claiming the RNAi rival had essentially purloined some of its trade secrets by hiring a group of ex-Sirna scientists. Dicerna agreed to pay about $25 million in cash and stock to settle the litigation.
Zachary Brennan
Senior Editor
RNAi therapeutics juggernaut Alnylam Pharmaceuticals on Thursday announced that it’s suing and seeking money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which have been integral to the way both companies’ mRNA vaccines work.
The suits, filed in the Delaware district court, both seek “fair compensation for use of its technology” but “no less than a reasonable royalty.” And if successful, the biotech will dip into two of the richest revenue streams the biopharma industry has ever seen.
The suits explain how Alnylam scientists more than a decade ago invented this new class of non-natural lipid nanoparticles, comprising a cationic (or positively charged) lipid with biodegradable groups that has proved critical for the Covid-19 vaccines and several marketed RNA therapies.
These so-called LNPs can protect the delicate RNA until it’s delivered to the cell, and then they’re metabolized and eliminated from the body.
In the case of Pfizer, the suit notes that every one of the company’s Covid-19 vaccines contains this infringing cationic lipid, known as ALC-0315.
How does Alynylam know that its patents have been infringed? The company explains how ALC-0315’s chemical name is ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), and the prescribing information for Pfizer’s Covid vaccine Comirnaty states that each dose contains that same chemical, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate).
For Moderna, although the company claims to have its own “proprietary lipid-nanoparticle-delivery system,” Alnylam said it “relies on the patented Alnylam LNP Technology” and that the “biodegradability of Moderna’s lipid system employs the patented Alnylam LNP Technology.”
The suit also explains how, prior to the pandemic, about a decade ago, Alnylam and Moderna began discussing a way for Moderna to license some of Alnylam’s IP.
In Feb. 2014, Moderna and Alnylam entered into a confidentiality agreement, allowing Alnylam to share secrets with top Moderna execs, including a “detailed PowerPoint disclosing Alnylam’s LNP Technology and how those LNPs could be used for developing RNA-based pharmaceuticals. Alnylam further disclosed valuable rodent and non-human primate pharmacology experiments that showed superior in vivo elimination of its biodegradable LNPs, while also showing superior potency,” the suit alleges.
Meanwhile, for years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. And Arbutus and another company recently sued Moderna for infringing on their patent on a lipid nanoparticle platform that they also said was crucial to the delivery of Moderna’s widely-used vaccine.
Alnylam is no stranger to lawsuits itself. The company tackled Dicerna in court, claiming the RNAi rival had essentially purloined some of its trade secrets by hiring a group of ex-Sirna scientists. Dicerna agreed to pay about $25 million in cash and stock to settle the litigation.