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`IN THE UNITED STATES DISTRICT COURT FOR THE
`DISTRICT OF MASSACHUSETTS
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`MODERNATX, INC. and MODERNA US,
`INC.,
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`PFIZER INC., BIONTECH SE, BION-
`TECH MANUFACTURING GMBH, and
`BIONTECH US INC.,
`
`
`
`
`Defendants.
`
`Plaintiffs,
`
`v.
`
`C.A. No. _________
`
`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna” or the “Com-
`
`pany”), by and through their attorneys, hereby allege for their patent infringement Complaint
`
`against Defendants Pfizer Inc. (“Pfizer”), BioNTech SE, BioNTech Manufacturing GmbH, and
`
`BioNTech US Inc. (“BioNTech US,” together with BioNTech SE and BioNTech Manufacturing
`
`GmbH, “BioNTech”) as follows:
`
`NATURE OF THE CASE
`A. Moderna Was Founded in 2010 on the Promise of Developing mRNA Tech-
`nology to Create a New Generation of Transformative Medicines
`
`1.
`
`Just twelve years ago, messenger RNA (“mRNA”) medicines were a new and un-
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`proven technology. Although many doubted that this technology could ever be used to treat or
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`prevent disease, Moderna recognized early on that it had great potential to improve patients’ lives.
`
`Since Moderna’s founding in 2010 in Cambridge, Massachusetts, the Company has been singu-
`
`larly focused on making mRNA medicines a reality through substantial investment and years of
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`research and development.
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`1
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`
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 2 of 39
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`2.
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`Moderna embodies the American ethos of innovation. Its founders are scientists
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`who challenged the status quo and took a chance on developing this unproven technology to treat
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`and prevent some of the deadliest diseases and medical conditions. They came together to create
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`Moderna, a name created from combining “modified” and “RNA.” Throughout its history,
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`Moderna has prioritized science above all else, with a focus on helping patients who do not have
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`other options.
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`3.
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`Over the past twelve years, Moderna has worked diligently in its laboratories to
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`pioneer several fundamental breakthroughs in the field of mRNA technology. These discoveries
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`span all aspects of mRNA medicines—from the characteristics and design of the mRNA itself and
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`the protein it encodes, to the technologies to deliver mRNA to patients safely and effectively.
`
`4.
`
`Built on that research, Moderna is developing medicines that could treat and pre-
`
`vent a wide range of diseases—from infectious diseases like influenza and HIV, to autoimmune
`
`and cardiovascular diseases and rare forms of cancer.
`
`5.
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`Part of Moderna’s foundational research in this area included advancing the solu-
`
`tion to one of the fundamental challenges with mRNA medicines—namely that the body’s own
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`immune system can recognize mRNA as a foreign substance and attack it. In 2010, Moderna
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`scientists began studying new chemical modifications to the mRNA that could better avoid pro-
`
`voking an immune response. That work led to the discovery that mRNA molecules with a specific
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`modification in which uridine is replaced with 1-methylpseudouridine were surprisingly superior
`
`to other chemically-modified mRNAs. A former top vaccine official at the U.S. Food and Drug
`
`2
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 3 of 39
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`Administration (“FDA”) was recently quoted as saying that the chemical change Moderna pio-
`
`neered is “the most important thing that people have done with mRNA vaccines.”1
`
`6.
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`Moderna scientists then studied how to deliver that chemically-modified mRNA to
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`cells in the body. In 2011, they tested whether chemically-modified mRNAs could be delivered
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`to cells when formulated in a lipid nanoparticle. These experiments showed for the first time that
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`cells could successfully express the protein encoded by 1-methylpseudouridine modified mRNA
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`when formulated in a lipid nanoparticle. After those successful experiments, Moderna began using
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`1-methylpseudouridine modified mRNA in a lipid nanoparticle formulation as the foundation of
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`its mRNA platform.
`
`7.
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`In 2014, around the time that a coronavirus that caused “Middle East Respiratory
`
`Syndrome” or “MERS” first emerged, Moderna created a division that was focused exclusively on
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`developing mRNA vaccines for infectious disease. In 2015, Company scientists developed an
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`mRNA vaccine for MERS, which encoded for the full-length spike protein of the MERS corona-
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`virus in a lipid nanoparticle. Animal challenge studies showed that the new vaccine successfully
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`resulted in the production of neutralizing antibodies and prevented MERS infection. Those exper-
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`imental results provided proof of concept that mRNA encoding for the full-length spike protein in
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`a lipid nanoparticle could be used successfully to prevent coronavirus infection.
`
`8.
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`To protect Moderna’s substantial investment of time and resources in developing
`
`its innovations, Moderna sought and obtained patents protecting the inventions underlying its
`
`mRNA platform and disease-specific vaccine designs, including for coronaviruses. These patents
`
`were filed between 2011 and 2016.
`
`
`Jon Cohen, New Crop of mRNA Vaccines Aim for Accessibility, 376 Science 120, 121
`1
`(2022), available at https://www.science.org/doi/epdf/10.1126/science.abq3935
`[https://perma.cc/JBM9-9FLH].
`
`3
`
`
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 4 of 39
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`9.
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`As a company that had no commercial products at the time, these patents were
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`among Moderna’s most valuable business assets and enabled Moderna, as a startup biotech com-
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`pany, to attract investors who could help the Company fulfill its promise and bring its technologies
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`to patients. Indeed, Pfizer’s CEO, Albert Bourla, has stated that patents are crucial to “small bio-
`
`tech innovators that are totally dependent on accessing capital from investors who invest only on
`
`the premise that their intellectual property will be protected.”2
`
`B. Moderna Was Uniquely Prepared to Respond to the COVID-19 Pandemic
`Based on Its Existing mRNA Platform and Coronavirus Vaccine Work on
`MERS
`
`10. When the COVID-19 pandemic struck, Moderna had already conducted a decade
`
`of foundational research in the area of mRNA medicines, including specifically on coronaviruses,
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`and was uniquely positioned to respond to the crisis.
`
`11.
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`Following Moderna’s initial patented discoveries, the Company began partnering
`
`in 2017 with scientists at the National Institutes of Health (“NIH”) to further develop its MERS
`
`vaccine. This experience partnering with the NIH would later prove vital in quickly responding
`
`to the COVID-19 pandemic.
`
`12. Moderna was not planning to bring its first product to market—a vaccine for moth-
`
`ers that could prevent birth defects—until the mid-2020s. Prior to COVID-19, almost all of
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`Moderna’s employees worked in research and development. But when it became clear that the
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`virus that causes COVID-19 had the potential to create a pandemic, Moderna answered the call.
`
`For a company as small as Moderna, with fewer than 1,000 employees at the time, this was no
`
`small feat. Nor was it one that came without risk. Moderna diverted resources away from other
`
`
`(May 7, 2021),
`to Pfizer Employees
`from Albert Bourla
`Open Letter
`2
`https://www.pfizer.com/news/articles/why_pfizer_opposes_the_trips_intellectual_prop-
`erty_waiver_for_covid_19_vaccines [https://perma.cc/6HSM-QDM5].
`
`4
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 5 of 39
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`projects and hired and built new teams in order to take on the challenge presented by COVID-19.
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`Moderna also issued new stock to raise the funds it would need to manufacture the vaccine. The
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`Company took all of these actions because Moderna had done the research and believed that its
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`mRNA platform could take on this new coronavirus.
`
`13.
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`As a result, in early 2020, Moderna was able to quickly leverage its existing mRNA
`
`technology to address the crisis. With its partnership with the U.S. government and in particular
`
`the NIH, the Company was able to develop a COVID-19 vaccine that was ready to test in clinical
`
`trials within a matter of weeks.
`
`14. While others were predicting that vaccine development could take years,
`
`Moderna’s COVID-19 vaccine was first administered by the NIH in clinical trials on March 16,
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`2020, just two months after the genetic sequence for the virus that causes COVID-19 was pub-
`
`lished. See, e.g., infra ¶¶ 48-50.
`
`15.
`
`Regulatory authorities set a bar by which to measure COVID-19 vaccines, requiring
`
`that they be at least 50% effective in preventing infection. On November 16, 2020, less than a
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`year after COVID had first been identified, Moderna blew away those expectations and was able
`
`to show that its vaccine was 94% effective against infection by the strain of the COVID virus then
`
`circulating. Other companies using more traditional technology were not able to submit their data
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`until much later and fell short of the bar Moderna had set. Some even abandoned their efforts at a
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`vaccine altogether. Without mRNA vaccines and Moderna’s technology, many more months and
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`lives might have been lost.
`
`16.
`
`The FDA authorized the use of Moderna’s COVID-19 vaccine, which is now mar-
`
`keted under the name Spikevax®, in individuals 18 years of age and older under an emergency
`
`5
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 6 of 39
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`use authorization on December 18, 2020, and the FDA fully approved Spikevax® for use in that
`
`population on January 31, 2022.
`
`C.
`
`Pfizer and BioNTech Followed the Trail Moderna Blazed for mRNA Vaccines
`and Copied Moderna’s Innovations Without Ever Requesting a License
`
`17.
`
`Pfizer and BioNTech also developed an mRNA vaccine for COVID-19, marketed
`
`under the brand name Comirnaty®. As explained more fully below, the Pfizer/BioNTech vaccine
`
`uses the technology Moderna developed and patented.
`
`18. When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of
`
`experience with developing mRNA vaccines for coronaviruses. Upon information and belief, be-
`
`fore the emergence of COVID-19, unlike Moderna, neither Pfizer nor BioNTech had ever devel-
`
`oped an mRNA vaccine for a coronavirus.
`
`19.
`
`Pfizer and BioNTech started with a number of different options when they consid-
`
`ered how to design their vaccine. In fact, they took four different candidates into clinical testing,
`
`including options that would have steered clear of Moderna’s innovative path by using unmodified
`
`mRNA. See, e.g., infra ¶¶ 73-74. Ultimately, however, Pfizer and BioNTech discarded those
`
`alternatives and copied Moderna’s patented technology. See, e.g., infra ¶¶ 75-76.
`
`20.
`
`And they did so knowing that they were following Moderna’s lead. Pfizer’s CEO,
`
`Albert Bourla, acknowledged that the vaccine design Pfizer and BioNTech ultimately chose to
`
`pursue uses “the entire spike protein, which . . . Moderna is using.” Ex. 4, Transcript of Goldman
`
`Sachs Virtual 41st Annual Global Healthcare Conference at 3 (June 9, 2020).
`
`21.
`
`Pfizer and BioNTech copied two critical features of Moderna’s patented mRNA
`
`technology platform. First, out of numerous possible choices, they decided to make the exact same
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`chemical modification to their mRNA that Moderna scientists first developed years earlier, and
`
`which the Company patented and uses in Spikevax®. Second, and again despite having many
`
`6
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 7 of 39
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`different options, the Pfizer and BioNTech vaccine encoded for the exact same type of coronavirus
`
`protein (i.e., the full-length spike protein), which is the coronavirus vaccine design that Moderna
`
`had pioneered based off its earlier work on coronaviruses and which the company patented and
`
`uses in Spikevax®. The Moderna inventions that Pfizer and BioNTech chose to copy were foun-
`
`dational for the success of their vaccine.
`
`D. Moderna Is the Only Vaccine Manufacturer to Have Made a Global Commit-
`ment to Intellectual Property Never Being a Barrier to COVID-19 Vaccine
`Access
`
`22.
`
`Given the unprecedented challenges of the COVID-19 pandemic, Moderna volun-
`
`tarily pledged on October 8, 2020 that, “while the pandemic continues, Moderna will not enforce
`
`our COVID-19 related patents against those making vaccines intended to combat the pandemic.”3
`
`Moderna refrained from asserting its patents earlier so as not to distract from efforts to bring the
`
`pandemic to an end as quickly as possible.
`
`23.
`
`By early 2022, however, the collective fight against COVID-19 had entered a new
`
`endemic phase and vaccine supply was no longer a barrier to access in many parts of the world,
`
`including the United States. In view of these developments, Moderna announced on March 7,
`
`2022, that it expected companies such as Pfizer and BioNTech to respect Moderna’s intellectual
`
`
`Press Release, Moderna, Inc., Statement by Moderna on Intellectual Property Matters dur-
`3
`ing the COVID-19 Pandemic (Oct. 8, 2020), https://investors.modernatx.com/Statements--Per-
`spectives/Statements--Perspectives-Details/2020/Statement-by-Moderna-on-Intellectual-Prop-
`erty-Matters-during-the-COVID-19-Pandemic/default.aspx
`(emphasis
`added)
`[https://perma.cc/EMU7-9JAT].
`
`7
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 8 of 39
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`property and would consider a commercially-reasonable license should they request one.4 This
`
`announcement was widely publicized, including through coverage in The Wall Street Journal.5
`
`Critically, however, and to further its belief that intellectual property should never be a barrier to
`
`access, as part of this announcement, Moderna committed to never enforce its patents for any
`
`COVID-19 vaccine used in the 92 low- and middle-income countries in the Gavi COVAX Ad-
`
`vance Market Commitment (“AMC”). This includes any product manufactured outside the AMC-
`
`92 countries, such as the World Health Organization’s project in South Africa, with respect to
`
`COVID-19 vaccines destined for and used in the AMC-92 countries. Although they have contin-
`
`ued to use Moderna’s intellectual property, Pfizer and BioNTech have not reached out to Moderna
`
`to discuss a license.
`
`E. Moderna Brings This Action to Protect the Company’s mRNA Technology
`Platform and Ensure its Innovations Are Respected
`
`24.
`
`Despite recognizing the importance of patents to innovators such as Moderna,
`
`Pfizer and BioNTech have copied Moderna’s intellectual property and have continued to use
`
`Moderna’s inventions without permission.
`
`25. Moderna therefore brings this lawsuit to protect the mRNA technology platform it
`
`innovated, invested in, and patented and to ensure that intellectual property is respected.
`
`26.
`
`In non-AMC 92 countries, where vaccine supply is no longer a barrier to access,
`
`Moderna expects Pfizer and BioNTech to stop infringing the Company’s intellectual property.
`
`Compensating Moderna with monetary damages for using its patented technology will enable the
`
`
`Press Release, Moderna, Inc., Moderna’s Updated Patent Pledge (Mar. 7. 2022), https://in-
`4
`vestors.modernatx.com/Statements--Perspectives/Statements--Perspectives-Details/2022/Moder-
`nas-Updated-Patent-Pledge/default.aspx [https://perma.cc/R7KP-74FJ].
`5
`See Peter Loftus, Moderna Signals It May Enforce Covid-19 Vaccine Patents in Wealthy
`Nations, Wall Street J., (Mar. 7, 2022, 7:33 PM), https://www.wsj.com/articles/moderna-signals-
`it-may-enforce-covid-19-vaccine-patents-in-wealthy-nations-11646699609
`[https://perma.cc/CC7N-2JPS].
`
`8
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 9 of 39
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`Company to continue investing in its mRNA technology platform so that it can develop medicines
`
`that can treat and prevent a wide range of diseases.
`
`27.
`
`This lawsuit is based on three patents that claim priority to applications filed be-
`
`tween 2011 and 2016 covering Moderna’s foundational intellectual property, and the Company is
`
`seeking damages for revenue Pfizer and BioNTech derived from sales in the United States that are
`
`not subject to 28 U.S.C. § 1498 and from its domestic manufacture for supply to non-AMC 92
`
`countries outside the United States.
`
`28.
`
`This lawsuit does not relate to any patent rights generated during Moderna and
`
`NIH’s collaboration to combat COVID-19. In addition, in recognition of the need for ensuring
`
`access to these critical vaccines, this lawsuit is narrowly drawn in terms of the relief it seeks.
`
`Moderna is not seeking an injunction: it is not seeking to remove Comirnaty® from the market or
`
`to prevent its future sale. Consistent with Moderna’s patent pledge, Moderna is not seeking dam-
`
`ages for activities occurring before March 8, 2022. And Moderna is not seeking damages related
`
`to Pfizer and BioNTech’s sales to the 92 low- and middle-income countries in the Gavi COVAX
`
`Advance Market Commitment.
`
`PARTIES
`
`29. ModernaTX, Inc. (“ModernaTX”) is a corporation organized and existing under the
`
`laws of Delaware, having its principal place of business at 200 Technology Square, Suite 300,
`
`Cambridge, MA 02139. ModernaTX is a wholly-owned subsidiary of Moderna, Inc. ModernaTX
`
`is the owner by assignment of the patents asserted in this litigation.
`
`30. Moderna US, Inc. (“Moderna US”) is a corporation organized and existing under
`
`the laws of Delaware, having its principal place of business at 200 Technology Square, Suite 300,
`
`Cambridge, MA 02139. Moderna US is a wholly-owned subsidiary of Moderna, Inc. Moderna
`
`9
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 10 of 39
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`US is the exclusive licensee of the patents asserted in this litigation, and Moderna US sells
`
`Spikevax® in the United States.
`
`31. Moderna is a pioneer in the field of mRNA medicines. Since its founding in 2010,
`
`Moderna has through years of research and development created the most advanced platform for
`
`mRNA medicines in the world. In addition to Spikevax®, Moderna has a pipeline of several dozen
`
`mRNA vaccines and therapeutic medicines for a wide range of diseases.
`
`32.
`
`Upon information and belief, Pfizer is a corporation organized and existing under
`
`the laws of Delaware, with its principal place of business at 235 East 42nd Street, New York, NY
`
`10017. Pfizer has regular and established places of business at 1 Portland Street, Cambridge, MA
`
`02139 and 1 Burtt Road, Andover, MA 01810.
`
`33.
`
`Upon information and belief, BioNTech SE is a corporation organized and existing
`
`under the laws of Germany, with its principal place of business at An der Goldgrube 12, Mainz,
`
`55131 Germany.
`
`34.
`
`Upon information and belief, BioNTech Manufacturing GmbH, a wholly-owned
`
`subsidiary of BioNTech SE, is a limited liability company organized and existing under the laws
`
`of Germany, with its principal place of business at An der Goldgrube 12, Mainz, 55131 Germany.
`
`BioNTech Manufacturing GmbH is the Biologics License Application (“BLA”) holder for Co-
`
`mirnaty® in the United States.
`
`35.
`
`Upon information and belief, BioNTech US, a wholly-owned subsidiary of BioN-
`
`Tech SE, is a corporation organized and existing under the laws of Delaware, with its principal
`
`place of business at 40 Erie St., Suite 110, Cambridge, MA 02139. BioNTech US’s office in
`
`10
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 11 of 39
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`Cambridge, MA serves as BioNTech’s North American headquarters.6 BioNTech US is BioN-
`
`Tech’s agent for service of process in the United States.7
`
`36.
`
`Upon information and belief, Pfizer and BioNTech together developed and com-
`
`mercialize Comirnaty®.
`
`JURISDICTION AND VENUE
`
`37.
`
`This is an action for patent infringement arising under the patent laws of the United
`
`States, 35 U.S.C. § 1, et. seq. This Court has jurisdiction over the subject matter of this action
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`38.
`
`This Court has personal jurisdiction over Defendants because of their systematic
`
`and continuous contacts with Massachusetts. For example, both Pfizer and BioNTech regularly
`
`conduct business within Massachusetts, including at Pfizer’s facilities located at 1 Portland Street,
`
`Cambridge, MA 02139 and 1 Burtt Road, Andover, MA 01810, and at BioNTech’s facility located
`
`at 40 Erie St, Suite 110, Cambridge, MA 02139, which serves as BioNTech US’s North American
`
`headquarters. Both Pfizer and BioNTech have specifically directed their business activities mak-
`
`ing and selling Comirnaty® to Massachusetts, including by manufacturing the mRNA drug sub-
`
`stance for Comirnaty® at Pfizer’s facility in Andover, Massachusetts. Defendants’ actions that
`
`give rise to personal jurisdiction further include, but are not limited to: making, using, selling, and
`
`offering for sale Comirnaty® in Massachusetts; knowing and intending that Comirnaty® would
`
`be used in Massachusetts; deriving substantial revenue from the use of Comirnaty® in Massachu-
`
`setts; and expecting their infringing actions to have consequences in Massachusetts.
`
`
`See, e.g., BioNTech SE, Annual Report (Form 20-F) 179, F-12 (Mar. 30, 2021), available
`6
`at https://investors.biontech.de/static-files/e862a8ea-5d90-4672-acfb-34de57b58806.
`7
`See, e.g., BioNTech SE, Annual Report (Form 20-F) 81 (Mar. 30, 2022), available at
`https://investors.biontech.de/static-files/50d0cafc-b2c1-4392-a495-d252f84be105.
`
`11
`
`
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 12 of 39
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`39.
`
`Pfizer and BioNTech have also purposefully availed themselves of the benefits and
`
`protections of the courts in Massachusetts, including by initiating litigation relating to Comirnaty®
`
`before this Court. See BioNTech SE v. CureVac AG, C.A. No. 22-11202 (D. Mass.) (filed July 25,
`
`2022).
`
`40.
`
`Venue is proper as to BioNTech SE and BioNTech Manufacturing GmbH in this
`
`District pursuant to, inter alia, 28 U.S.C. § 1391(c)(3).
`
`41.
`
`Venue also is proper as to all Defendants in this District under 28 U.S.C. § 1400(b).
`
`Both Pfizer and BioNTech have regular and established places of business in this District, includ-
`
`ing Pfizer’s facilities located at 1 Portland Street, Cambridge, MA 02139 and 1 Burtt Road, And-
`
`over, MA 01810, and at BioNTech’s facility located at 40 Erie St, Suite 110, Cambridge, MA
`
`02139, which serves as the North American headquarters for BioNTech. Defendants have com-
`
`mitted acts of infringement and, upon information and belief, will commit further acts of infringe-
`
`ment in Massachusetts.
`
`
`
`MODERNA’S PIONEERING WORK ON mRNA MEDICINES
`
`42.
`
`Long before COVID-19 first emerged, Moderna recognized that mRNA had the
`
`potential to revolutionize the field of medicine. mRNA is a molecule that instructs cells to make
`
`particular proteins. Unlike traditional vaccines and therapeutics, mRNA medicines harness the
`
`body’s own cellular machinery to make proteins themselves that can treat or prevent disease.
`
`mRNA medicines use a specific nucleotide sequence to encode instructions to make the exact
`
`protein needed for a particular disease. This makes mRNA medicines a powerful tool that can be
`
`programmed to target specific diseases. However, before Moderna began its research, nobody had
`
`figured out how to make or use mRNA medicines successfully. Moderna was founded in 2010
`
`with the sole focus on solving those challenges to make mRNA medicines a reality for patients.
`
`12
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 13 of 39
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`43.
`
`Along the way, Moderna encountered many technical challenges as it attempted to
`
`develop an entirely new way to treat and prevent disease. The problems that Moderna faced started
`
`with the mRNA itself. mRNA is an unstable molecule that is quickly destroyed inside the body.
`
`Moderna scientists had to develop novel ways to stabilize mRNA by modifying its chemical struc-
`
`ture so that it could be used in vaccines and therapeutics. Moderna also optimized its mRNA
`
`platform to make it more effective at producing the proteins needed to fight and prevent disease.
`
`And Moderna developed new techniques for manufacturing mRNA medicines so that they could
`
`be made on a large scale. All told, Moderna invested billions of dollars over the course of nearly
`
`a decade of research to develop an mRNA platform that could be applied across a variety of ther-
`
`apeutic and prophylactic applications.
`
`44. Moderna was also at the forefront of applying its mRNA medicines to new diseases
`
`as they emerged. For example, Moderna had previously developed an mRNA vaccine against a
`
`coronavirus that caused Middle Eastern Respiratory Syndrome, or “MERS.” Through that work
`
`on MERS, Moderna demonstrated the effectiveness of mRNA vaccines to prevent coronavirus
`
`infection and developed a template that could be used for vaccines against future coronaviruses.
`
`MODERNA’S COVID-19 VACCINE
`
`45. When COVID-19 first emerged, nobody was better positioned to respond than
`
`Moderna. Moderna had already developed the world’s most advanced platform for mRNA medi-
`
`cines. And Moderna had experience developing mRNA vaccines to prior coronaviruses through
`
`its research on MERS.
`
`46.
`
`Unlike Pfizer and BioNTech, Moderna did not struggle with different approaches
`
`before designing its COVID-19 vaccine. Instead, working from its research completed years ear-
`
`lier, Moderna knew how to design an effective COVID-19 vaccine and was able to respond rapidly
`
`13
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 14 of 39
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`with a vaccine specifically targeting COVID-19 in early 2020 when reports of COVID-19 first
`
`began to emerge from China.
`
`47. Moderna partnered with leading scientists from the NIH to test and develop
`
`Moderna’s COVID-19 vaccine. The NIH had access to laboratories to conduct pre-clinical testing
`
`of Moderna’s COVID-19 vaccine, including through challenge studies demonstrating the ability
`
`of Moderna’s new vaccine to prevent COVID-19 infection. Moderna and the NIH also met regu-
`
`larly to develop a clinical trial strategy to evaluate the safety and efficacy of Moderna’s COVID-
`
`19 vaccine.
`
`48.
`
`The genomic sequence for SARS-CoV-2 was first published on January 11, 2020,
`
`and, within a matter of days, Moderna took that information to create an mRNA sequence encoding
`
`for the virus’s spike protein. The first clinical batch of Moderna’s COVID-19 vaccine was manu-
`
`factured on February 7, 2020—just four weeks after the genome sequence for SARS-CoV-2 was
`
`published. Moderna provided clinical samples to its partners at the NIH. Moderna and the NIH
`
`then worked together to conduct clinical trials of Moderna’s vaccine on an expedited basis.
`
`49. Moderna’s new mRNA technology dramatically changed the pace of vaccine de-
`
`velopment. While other leading pharmaceutical companies thought that it could take “several
`
`years” or more before a vaccine would be ready, Moderna’s CEO, Stéphane Bancel, predicted in
`
`March 2020 that Moderna could have its vaccine in Phase II and III clinical trials in just a “few
`
`months.”8
`
`
`See Remarks by President Trump and Members of the Coronavirus Task Force in Meeting
`8
`with Pharmaceutical Companies (Mar. 2, 2020), https://trumpwhitehouse.archives.gov/briefings-
`statements/remarks-president-trump-members-coronavirus-task-force-meeting-pharmaceutical-
`companies/
`[https://web.archive.org/web/20200303160403/https://www.whitehouse.gov/brief-
`ingsstatements/remarks-president-trump-members-coronavirus-task-force-meeting-pharmaceuti-
`cal-companies/].
`
`14
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 15 of 39
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`50.
`
`He was right. Spikevax® has had a significant effect in preventing infections,
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`transmission, hospitalizations, and deaths resulting from COVID-19. Spikevax® was approved
`
`for clinical trials on March 4, 2020 and became the first COVID-19 vaccine candidate to enter
`
`Phase I clinical trials in humans in the United States. On March 16, 2020, the first participant in
`
`the Phase I study of Spikevax® was dosed, with a Phase II trial beginning in May 2020 and a
`
`Phase III trial in July 2020. Those clinical trials showed that Spikevax® was 94% effective at
`
`preventing a COVID-19 infection from the original coronavirus strain after completing a two-dose
`
`regimen, and it remained 93% effective six months after administration.
`
`51.
`
`The FDA authorized the use of Spikevax® in individuals 18 years of age and older
`
`under an emergency use authorization on December 18, 2020, and the FDA fully approved
`
`Spikevax® for use in that population on January 31, 2022.
`
`52.
`
`On October 20, 2021, the FDA expanded its emergency use authorization for
`
`Moderna’s COVID-19 vaccine to permit the administration of a booster dose in certain individuals
`
`who previously completed their primary two-dose regimen with Moderna’s COVID-19 vaccine.
`
`On November 19, 2021, the FDA amended its emergency use authorization to permit individuals
`
`to receive a booster dose of Moderna’s COVID-19 vaccine six months after completion of their
`
`primary dosing regimen with any FDA-authorized or approved COVID-19 vaccine. After the
`
`Omicron variant of COVID-19 emerged, the FDA on January 7, 2022 shortened the dosing interval
`
`for a booster dose of Moderna’s COVID-19 vaccine to five months after the completion of the
`
`individual’s primary vaccination series. On March 29, 2022, the FDA expanded Moderna’s emer-
`
`gency use authorization to permit the administration of a second booster dose to individuals 50
`
`years of age and older and to immunocompromised individuals 18 years of age and older. On June
`
`15
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 16 of 39
`
`17, 2022, the FDA expanded Moderna’s emergency use authorization to permit the use of
`
`Moderna’s COVID-19 vaccine in children six months and older.
`
`53. Moderna has supplied the United States with over 299 million doses of Moderna’s
`
`COVID-19 vaccine, and over 77 million people in the United States have received a complete
`
`primary vaccine series with Moderna’s COVID-19 vaccine to date.
`
`MODERNA’S PATENTS
`
`54.
`
`The success of Spikevax® is a result of the groundbreaking innovations that
`
`Moderna made in the years before COVID-19 first emerged. Moderna has sought to protect its
`
`substantial investment in research and development by obtaining patents that cover its inventions.
`
`Three of those patents are at issue here: U.S. Patent Nos. 10,898,574 (the “’574 patent”),
`
`10,702,600 (the “’600 patent”), and 10,933,127 (the “’127 patent”) (collectively, the “Asserted
`
`Patents”).
`
`A. Moderna’s mRNA Platform Technology
`
`55. mRNA is a molecule that typically is composed of four different nucleosides: aden-
`
`osine, guanosine, cytidine, and uridine. The nucleoside sequence in an mRNA molecule provides
`
`instructions that cells use to create particular proteins.
`
`56.
`
`One of the early challenges that Moderna faced in developing mRNA medicines
`
`was that administering them to people can result in the body’s own immune system attacking the
`
`mRNA molecule. This immune response destroys the mRNA before it can have its intended effect.
`
`To solve that problem, Moderna studied numerous different potential chemical modifications to
`
`the mRNA molecule itself to disguise the mRNA from the body’s immune system. By substituting
`
`one of the typical nucleosides in mRNA with a chemically-modified version, Moderna hoped that
`
`it could prevent the body’s immune system from recognizing and destroying the mRNA molecule.
`
`16
`
`
`
`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 17 of 39
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`While certain chemical modifications had been tested before, Moderna set out to improve upon
`
`that work to identify the best chemical modifications to use in an mRNA vaccine.
`
`57. Moderna’s scientists made the groundbreaking discovery that replacing uridine in
`
`the mRNA molecule with 1-methylpseudouridine resulted in surprisingly superior protein produc-
`
`tion—a severalfold increase over chemically-modified mRNAs studied before—with a signifi-
`
`cantly reduced immune response against the mRNA itself. Moderna further discovered that pack-
`
`aging that chemically-modified mRNA in a lipid nanoparticle formulation allowed for the efficient
`
`delivery of the mRNA to cells.
`
`58.
`
`This work became the foundation of Moderna’s mRNA platform. Moderna’s ’574
`
`patent describes and claims the results of that research. Moderna’s early discovery captured in the
`
`’574 patent has been critical to the success of mRNA vacc