Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine

CureVac NV

26/08/2022 13:00

By Daniel Trotta
    Aug 26 (Reuters) - Moderna is suing Pfizer and its German
partner BioNTech for patent infringement in the development of
the first COVID-19 vaccine approved in the United States,
alleging they copied technology that Moderna developed years
before the pandemic.
    The lawsuit, which seeks undetermined monetary damages, was
being filed in U.S. District Court in Massachusetts and the
Regional Court of Dusseldorf in Germany, Moderna said in a news
release on Friday.
    "We are filing these lawsuits to protect the innovative mRNA
technology platform that we pioneered, invested billions of
dollars in creating, and patented during the decade preceding
the COVID-19 pandemic," Moderna Chief Executive Stephane Bancel
said in the statement.
    Moderna Inc  MRNA.O , on its own, and the partnership of
Pfizer Inc  PFE.N  and BioNTech SE  22UAy.DE  were two of the
first groups to develop a vaccine for the novel coronavirus.
    Just a decade old, Moderna, based in Cambridge,
Massachusetts, had been an innovator in the messenger RNA (mRNA)
vaccine technology that enabled the unprecedented speed in
developing the COVID-19 vaccine.
    An approval process that previously took years was completed
in months, thanks largely to the breakthrough in mRNA vaccines,
which teach human cells how to make a protein that will trigger
an immune response.
    Germany-based BioNTech had also been working in this field
when it partnered with the U.S. pharma giant Pfizer. 
    The U.S. Food and Drug Administration granted emergency use
authorization for the COVID-19 vaccine first to Pfizer/BioNTech
in December 2020, then one week later to Moderna. 
    Moderna alleges Pfizer/BioNTech, without permission, copied
mRNA technology that Moderna had patented between 2010 and 2016,
well before COVID-19 emerged in 2019 and exploded into global
consciousness in early 2020.
    Early in the pandemic, Moderna said it would not enforce its
COVID-19 patents to help others develop their own vaccines,
particularly for low- and middle-income countries. But in March
2022 Moderna said it expected companies such as Pfizer and
BioNTech to respect its intellectual property rights. It said it
would not seek damages for any activity before March 8, 2022. 
    Patent litigation is not uncommon in the early stages of new
technology.
    Pfizer and BioNTech are already facing multiple lawsuits
from other companies who say the partnership's vaccine infringes
on their patents. Pfizer/BioNTech have said they will defend
their patents vigorously.
    Germany's CureVac  5cv.DE , for instance, also filed a
lawsuit against BioNTech in Germany in July. BioNTech responded
in a statement that its work was original.
    Moderna has also been sued for patent infringement in the
United States and has an ongoing dispute with the U.S. National
Institutes of Health over rights to mRNA technology.
    In Friday's statement, Moderna said Pfizer/BioNTech
appropriated two types of intellectual property.
    One involved an mRNA structure that Moderna says its
scientists began developing in 2010 and were the first to
validate in human trials in 2015.
    "Pfizer and BioNTech took four different vaccine candidates
into clinical testing, which included options that would have
steered clear of Moderna's innovative path. Pfizer and BioNTech,
however, ultimately decided to proceed with a vaccine that has
the same exact mRNA chemical modification to its vaccine,"
Moderna said in its statement. 
    The second alleged infringement involves the coding of a
full-length spike protein that Moderna says its scientists
developed while creating a vaccine for the coronavirus that
causes Middle East Respiratory Syndrome (MERS).
    Although the MERS vaccine never went to market, its
development helped Moderna rapidly roll out its COVID-19
vaccine.

 (Reporting by Daniel Trotta; editing by Caroline Humer and
Edwina Gibbs)
 ((daniel.trotta@reuters.com;))