Pfizer Faces New Patent Lawsuit Over Covid Vaccine
While the pandemic may seem over, intellectual property disputes over vaccine technology seem far from it. On April 4, Arbutus Biopharma and Genevant Sciences GmbH sued Pfizer and its German partner BioNTech for patent infringement of the technology used to deliver the Covid-19 vaccine.[1]
Arbutus filed the suit alleging that Pfizer infringed on five of its patents for lipid nanoparticle (“LNP”) technology that helps deliver mRNA into human cells.[2] MRNA vaccine technology had become so advanced by the start of the pandemic, that Pfizer and Moderna generated mRNA vaccines in a matter of days once scientists had fully sequenced Covid’s viral genome.[3] In these vaccines, mRNA molecules provide instructions to the cells to build proteins found in the Covid virus, triggering an immune response that produces antibodies.[4]
In its complaint, Arbutus argues that the most difficult part of creating a successful mRNA vaccine is figuring out how to deliver the mRNA molecules to the cells.[5] Arbutus alleges that because mRNA molecules are fragile in the body, scientists searched for decades to find a delivery system that could protect the mRNA long enough so that it safely and effectively enter cells.[6] To address this issue, Arbutus claims their scientists engineered new LNP technology which uses fat-like molecules called lipids to encapsulate and protect the mRNA from degradation and assists with entry into the cell.[7] Now, Arbutus claims Pfizer and BioNTech used their patented LNP technology to produce Covid vaccines without a license.[8]
Pfizer responded to news about Arbutus’ complaint by stating it “will vigorously defend against the allegations of the lawsuit.”[9] Pfizer claims that the LNP technology used in their Covid vaccines was developed by another company named Acuitas Therapeutics, which is a private biotechnology company that specializes in LNPs.[10] Acuitas filed a suit last March against Arbutus seeking a judgment that Pfizer’s vaccine does not infringe on Arbutus’ patents.[11]
Many individuals and research initiatives played a role in developing LNP technology.[12] Modern LNPs have their origins in research done on simpler systems called liposomes which are hollow, lipid spheres consisting of two or three types of lipids.[13] Researchers found liposomes offered promising results for use in cancer medications, but soon turned their attention to whether lipids could be used to deliver nucleic acids such as DNA or RNA to cells.[14] During the late 1990s and early 2000s, scientists at Inex Pharmaceuticals made breakthroughs in lipid technology and an Inex spin-off named Protiva Biotherapeutics discovered a new way to manufacture LNPs.[15] Genevant has its origins in Protiva.[16] Moreover, the CEO of Acuitas, the company which Pfizer claims to have taken the LNP technology from, used to work at Inex.[17] The history of LNP development is complicated and surprisingly interconnected, which may prove an obstacle in Arbutus and Genevant’s suit.
Arbutus also has a pending lawsuit against Moderna which similarly alleges that Moderna infringed on Arbutus’ LNP patents.[18] Moderna responded to the suit by stating its covid vaccine is a product of their own mRNA research and development, “including creation of our own proprietary lipid nanoparticle delivery technology.”[19] Moderna became more vulnerable to a patent infringement suit from Arbutus after losing an appeal in December 2021 when the Federal Circuit upheld two of Arbutus’ patents.[20]
In both of its suits against Pfizer and Moderna, Arbutus seeks reasonable royalties on all infringing sales.[21] A royalty on the vaccines could result in a massive monetary award for Arbutus and Genevant. Pfizer made $37.8 billion in 2022 alone on its Covid vaccine.[22]
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