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Moderna

Controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2022

    Alnylam sues Moderna and Pfizer over lipid patent

    Lawsuit filed

    Alnylam filed lawsuits against Moderna and Pfizer in federal court in Delaware, alleging that their COVID-19 vaccines infringe its biodegradable-lipids patent. Alnylam said it was seeking monetary relief and did not want to impede vaccine sales, production or distribution. Moderna denied the allegation; Pfizer had not commented to the outlet.

    Company response

    • Denial — Moderna

      “Moderna’s LNPs do not resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s Covid-19 vaccine is specious,” the company said.

    Source excerpt

    • Alnylam alleges that the company’s FDA-approved Covid vaccine, Spikevax, uses biodegradable LNP technology that infringes on the biodegradable lipids patent.
    • The two lawsuits were filed Thursday in federal court in Delaware.
    • Alnylam did not have similar meetings with Pfizer or BioNTech, but the company claims that their FDA-approved Covid vaccine, Comirnaty, uses LNPs that infringe the same patent.
    Source

  2. 2022

    Genevant sues Moderna over vaccine-related patents

    Lawsuit filed

    Moderna faced a US patent infringement lawsuit over lipid nanoparticle technology used in its Covid-19 vaccine. Genevant claims Moderna infringed technology covered by six US patents developed by Arbutus Biopharma and licensed to Genevant; Genevant is seeking royalties. Moderna denied the allegations and said it would defend itself in court.

    Company response

    • Denial — Moderna

      Moderna denies these allegations, and will vigorously defend itself against Genevant’s claims in Court.

    Source excerpt

    • Covid-19 vaccine producer Moderna faces a patent infringement lawsuit in the US, relating to the lipid nanoparticles (LNPs) that protect the mRNA in its vaccine.
    • In a statement, Moderna said it was aware of the alleged patent infringements. ‘Moderna denies these allegations, and will vigorously defend itself against Genevant’s claims in Court.
    • The suit claims Moderna is infringing technology from six US patents, developed by Arbutus Biopharma and licensed to Genevant – a joint venture between Arbutus and Roivant Sciences.
    Source

  3. 2020

    Moderna reports vaccine documents accessed in cyberattack

    Issue disclosure

    Moderna stated that the European Medicines Agency informed it that certain documents related to pre-submission discussions about its COVID-19 vaccine candidate had been unlawfully accessed in a cyberattack on the regulator. According to Moderna, its submission did not include information identifying individual study participants. The company disclosed the notification without providing further details on the accessed documents or the attack itself.

    Moderna said the European Medicines Agency informed it that certain documents related to pre-submission discussions about its COVID-19 vaccine candidate had been unlawfully accessed in a cyberattack on the regulator. Moderna said its submission did not include information identifying individual study participants.

    Source excerpt

    • Moderna Inc has recently stated that it was informed by the official European Medicine Agency or EMA that certain documents that were related to the pre-submission talks of its own COVID-19 vaccine candidate were said to be unlawfully accessed in a cyberattack on the known medicines regulator.
    • Moderna has stated that its submission to the EMA actually did not include any information that identified certain individual study participants.
    Source