Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 1 of 12 PageID #: 1781
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`Exhibit D
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 1 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 2 of 12 PageID #: 1782
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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.,
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`
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`Defendants.
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`Plaintiffs,
`
`v.
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`C.A. No. _________
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`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna” or the “Com-
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`pany”), by and through their attorneys, hereby allege for their patent infringement Complaint
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`against Defendants Pfizer Inc. (“Pfizer”), BioNTech SE, BioNTech Manufacturing GmbH, and
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`BioNTech US Inc. (“BioNTech US,” together with BioNTech SE and BioNTech Manufacturing
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`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.
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`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.
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`Since Moderna’s founding in 2010 in Cambridge, Massachusetts, the Company has been singu-
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`larly focused on making mRNA medicines a reality through substantial investment and years of
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`research and development.
`
`1
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 18 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 3 of 12 PageID #: 1783
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`60.
`
`The ’574 patent claims Moderna’s mRNA platform technology, which utilizes
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`mRNA encoding for a polypeptide that comprises a modified uracil, including 1-methylpseudour-
`
`idine, in a lipid nanoparticle formulation. The ’574 patent claims both methods of producing a
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`polypeptide of interest and pharmaceutical compositions.
`
`61. Moderna practices the ’574 patent through its Spikevax® vaccine, and Moderna
`
`marks Spikevax® with a reference to its patent marking website (https://www.modernatx.com/pa-
`
`tents [https://perma.cc/B6AG-6URD]), which identifies the ’574 patent for Spikevax®.
`
`B.
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`62.
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`Coronavirus Vaccines
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`Before COVID-19 first emerged, Moderna made significant breakthroughs in the
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`development of coronavirus vaccines. Coronaviruses are a class of viruses that are enveloped in
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`a protein shell that is covered on the surface by a “spike” protein. A coronavirus spike protein
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`allows the virus to attach to and infect host cells.
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`63. When another coronavirus, MERS, first emerged in the mid-2010s, Moderna care-
`
`fully studied, designed and tested a vaccine for MERS. The MERS vaccine that Moderna devel-
`
`oped was based on mRNA encoding for the virus’s spike protein. However, coronavirus spike
`
`proteins are large molecules, and no one had previously developed an mRNA vaccine targeting an
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`antigen protein of that size before.
`
`64. Moderna was the first to discover that using mRNA encoding for a full-length coro-
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`navirus spike protein in a lipid nanoparticle formulation was highly effective at producing neutral-
`
`izing antibodies to the coronavirus. Moderna’s research showed that its coronavirus vaccine pro-
`
`duced neutralizing antibodies that prevented infection and confirmed that targeting the spike pro-
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`tein was a successful vaccine design that could be applied to other coronaviruses. Moderna’s ’600
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`and ’127 patents describe and claim the results of that research.
`
`18
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 19 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 4 of 12 PageID #: 1784
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`65. When COVID-19 first emerged, this prior research allowed Moderna to design a
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`vaccine for SARS-CoV-2 in record time. Moderna used the coronavirus vaccine design described
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`and claimed in the ’600 and ’127 patents to develop an mRNA vaccine for COVID-19 by using
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`mRNA encoding for the full-length spike protein for SARS-CoV-2 in a lipid nanoparticle formu-
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`lation. Although Pfizer and BioNTech initially considered alternative vaccine designs, they ulti-
`
`mately chose to follow Moderna’s path of using mRNA encoding for the full-length spike protein
`
`of SARS-CoV-2—the exact same design used in Moderna’s Spikevax®.
`
`66.
`
`The ’600 patent is titled “Betacoronavirus mRNA vaccine.” The ’600 patent names
`
`as inventors Moderna scientists Giuseppe Ciaramella and Sunny Himansu. The ’600 patent claims
`
`priority to provisional patent applications filed in October 2015 and a PCT application filed on
`
`October 21, 2016. The ’600 patent issued on July 7, 2020, and is assigned to Moderna. A true
`
`and correct copy of the ’600 patent is attached as Exhibit 2.
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`67.
`
`The ’600 patent claims compositions comprising mRNA comprising an open read-
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`ing frame encoding a betacoronavirus S protein or S protein subunit formulated in a lipid nanopar-
`
`ticle.
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`68. Moderna practices the ’600 patent through its Spikevax® vaccine, and Moderna
`
`marks Spikevax® with a reference to its patent marking website (https://www.modernatx.com/pa-
`
`tents [https://perma.cc/B6AG-6URD]), which identifies the ’600 patent for Spikevax®.
`
`69.
`
`The ’127 patent is titled “Betacoronavirus mRNA vaccine.” The ’127 patent names
`
`as inventors Moderna scientists Giuseppe Ciaramella and Sunny Himansu. The ’127 patent claims
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`priority to provisional patent applications filed in October 2015 and a PCT application filed on
`
`October 21, 2016. The ’127 patent issued on March 2, 2021, and is assigned to Moderna. A true
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`and correct copy of the ’127 patent is attached as Exhibit 3.
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`19
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 20 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 5 of 12 PageID #: 1785
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`70.
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`The ’127 patent claims methods of administering to a subject mRNA comprising
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`an open reading frame encoding a betacoronavirus S protein or S protein subunit formulated in a
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`lipid nanoparticle to induce in the subject an immune response to the S protein or S protein subunit,
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`wherein the lipid nanoparticle comprises certain specified percentages of ionizable cationic lipid,
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`neutral lipid, cholesterol, and PEG-modified lipid.
`
`71.
`
`The administration of Moderna’s Spikevax® in accordance with its approved pack-
`
`age insert practices the methods claimed in the ’127 patent.
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`PFIZER AND BIONTECH’S COVID-19 VACCINE
`
`72.
`
`Prior to the emergence of COVID-19, Pfizer and BioNTech had begun researching
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`an mRNA vaccine for influenza, but lacked Moderna’s expertise in developing mRNA vaccines
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`for coronaviruses and other infectious diseases. Indeed, BioNTech’s CEO, Uğur Şahin, had stated
`
`that infectious disease targets were “not a priority” for his company before COVID-19.9 Upon
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`information and belief, Pfizer lacked any candidates in clinical trials using mRNA technology
`
`before COVID-19, and BioNTech did not have any such candidates in clinical trials for infectious
`
`diseases.10 By contrast, Moderna had six mRNA candidates for infectious diseases in clinical trials
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`by the time COVID-19 arrived.
`
`
`Asher Mullard, COVID-19 Vaccine Success Enables a Bolder Vision for mRNA Cancer
`9
`Vaccines, Says BioNTech CEO, 20 Nature Revs.: Drug Discovery 500 (June 17, 2021), available
`at https://www.nature.com/articles/d41573-021-00110-x (“[Q.] Prior to the pandemic, your first
`priority was cancer therapies. How much will you now focus on infectious disease vaccines? [A.]
`We were always
`interested
`in
`infectious diseases, but
`they were not a priority.”)
`[https://perma.cc/GV6C-UD74].
`10
`BioNTech, Fourth Quarter and Full Year 2019 Corporate Update and Financial Results
`10-11 (Mar. 31, 2020), https://investors.biontech.de/static-files/a718a9ec-53cd-42b6-a6e0-
`8dd21ca4d907.
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`20
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 25 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 6 of 12 PageID #: 1786
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`duction at Pfizer’s facility in Andover, Massachusetts “to support the continued supply of Co-
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`mirnaty in the European Union.”14 Pfizer and BioNTech have also made clear that they intend to
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`sell additional booster doses of Comirnaty®. For example, on March 29, 2022, the FDA author-
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`ized certain people to receive a second booster dose of Pfizer and BioNTech’s COVID-19 vac-
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`cine.15 Pfizer and BioNTech actively promote the use of booster doses for their COVID-19 vac-
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`cine, including through their website for Comirnaty®: https://www.comirnaty.com/booster-dose/
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`[https://perma.cc/7WHG-LZ3B].
`
`82.
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`In the face of that ongoing infringement, Moderna filed this lawsuit so that it may
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`obtain fair compensation for Pfizer and BioNTech’s continued use of Moderna’s patented tech-
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`nologies. That fair compensation will translate into an opportunity for Moderna to reinvest in its
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`leading mRNA platform that allowed both Moderna and Pfizer/BioNTech to address the COVID-
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`19 pandemic. Indeed, were Pfizer and BioNTech allowed to freely copy Moderna’s patented tech-
`
`nology for their own benefit, the next generation of biotech startups would lose their ability to rely
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`on the patent system that is the bedrock upon which future medicines will be discovered.
`
`COUNT I – INFRINGEMENT OF THE ’574 PATENT
`
`83. Moderna incorporates each of the above paragraphs 1-82 as though fully set forth
`
`herein.
`
`
`European Medicines Agency, Increase in Manufacturing Capacity for COVID-19 Vac-
`14
`cines from Janssen, Moderna, and BioNTech/Pfizer (Dec. 16, 2021), https://www.ema.eu-
`ropa.eu/en/news/increase-manufacturing-capacity-covid-19-vaccines-janssen-moderna-biontech-
`pfizer [https://perma.cc/43DL-YXK9].
`15
`Pfizer, Inc., Press Release, Pfizer and BioNTech Receive Expanded U.S. Emergency Use
`Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and
`Older (Mar. 29, 2022), https://www.pfizer.com/news/press-release/press-release-detail/pfizer-
`and-biontech-receive-expanded-us-emergency-use [https://perma.cc/BRL9-NX8P].
`
`25
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`84.
`
`Upon information and belief, Defendants have directly infringed and continue to
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`directly infringe one or more of the claims of the ’574 patent, either literally or under the doctrine
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`of equivalents, by making, using, selling, offering for sale, and/or importing Comirnaty® in the
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`United States and in this District without authority, in violation of 35 U.S.C. § 271(a).
`
`85.
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`Upon information and belief, the use of Comirnaty® in accordance with its ap-
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`proved package insert and/or emergency use authorization infringes one or more of the claims of
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`the ’574 patent. Defendants have induced infringement and continue to induce infringement of
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`one or more of the claims of the ’574 patent, either literally or under the doctrine of equivalents,
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`by encouraging others, including but not limited to healthcare providers and patients, to make and
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`use Comirnaty® in the United States and in this District in a manner that would directly infringe
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`the ’574 patent. Defendants have intentionally encouraged and will continue to intentionally en-
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`courage acts of direct infringement by others, including but not limited to healthcare providers and
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`patients, with knowledge of the ’574 patent and with knowledge that their acts are encouraging
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`infringement, in violation of 35 U.S.C. § 271(b).
`
`86.
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`Upon information and belief, Comirnaty® constitutes a material part of the inven-
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`tion of one or more claims of the ’574 patent and is not a staple article or commodity of commerce
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`suitable for substantial noninfringing use. Defendants have contributorily infringed and continue
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`to contributorily infringe one or more of the claims of the ’574 patent, either literally or under the
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`doctrine of equivalents, by promoting the making and use of Comirnaty® in accordance with its
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`approved package insert and/or emergency use authorization in the United States and in this Dis-
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`trict by others, including but not limited to healthcare providers and patients, and knowing that
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`Comirnaty® is especially made or especially adapted for use to infringe the ’574 patent, in viola-
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`tion of 35 U.S.C. § 271(c).
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`87.
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`Upon information and belief, Defendants have infringed or will infringe one or
`
`more of the claims of the ’574 patent, either literally or under the doctrine of equivalents, in vio-
`
`lation of 35 U.S.C. § 271(f), including by supplying the global market for Comirnaty® with com-
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`ponents, such as mRNA, manufactured in the United States.
`
`88.
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`Comirnaty® satisfies each and every element of one or more claims of the ’574
`
`patent. Defendants’ actions with respect to Comirnaty® have infringed, induced infringement, or
`
`contributorily infringed at least claims 1-4 and 6-10 of the ’574 patent.
`
`89.
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`For example, claim 2 of the ’574 patent is representative and recites:
`
`A pharmaceutical composition comprising:
`
`a plurality of lipid nanoparticles comprising a cationic li-
`pid, a sterol, and a PEG-lipid,
`
`wherein the lipid nanoparticles comprise an mRNA encod-
`ing a polypeptide,
`
`wherein the mRNA comprises one or more uridines, one or
`more cytidines, one or more adenosines, and one or more
`guanosines and wherein substantially all uridines are modi-
`fied uridines.
`
`90.
`
`Comirnaty® is a pharmaceutical composition comprising a plurality of lipid nano-
`
`particles comprising a cationic lipid, a sterol, and a PEG-lipid, wherein the lipid nanoparticles
`
`comprise an mRNA encoding a polypeptide, wherein the mRNA comprises one or more uridines,
`
`one or more cytidines, one or more adenosines, and one or more guanosines and wherein substan-
`
`tially all uridines are modified uridines.
`
`91.
`
`For example, Section 12 of the package insert for Comirnaty® states that “[t]he
`
`nucleoside-modified mRNA in COMIRNATY is formulated in lipid particles, which enable de-
`
`livery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen.” Section
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`11 of the package insert for Comirnaty® states that “[e]ach 0.3 mL dose of the COMIRNATY . . .
`
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`109. Comirnaty® satisfies each and every element of one or more claims of the ’600
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`patent. Defendants’ actions with respect to Comirnaty® have infringed, induced infringement, or
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`contributorily infringed at least claims 1-2, 4-6, 8-12, 16-17, 20-21, and 26 of the ’600 patent.
`
`110. For example, claim 1 of the ’600 patent is representative and recites:
`
`A composition, comprising:
`
`a messenger ribonucleic acid (mRNA) comprising an open
`reading frame encoding a betacoronavirus (BetaCoV) S
`protein or S protein subunit
`
`formulated in a lipid nanoparticle.
`
`111. Comirnaty® is a composition comprising a messenger ribonucleic acid (mRNA)
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`comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein
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`subunit formulated in a lipid nanoparticle.
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`112. For example, Section 11 of the package insert for Comirnaty® states that “[e]ach
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`0.3 mL dose of COMIRNATY . . . contains 30 mcg of a nucleoside-modified messenger RNA
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`(mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.” Ex. 7 at 19. Section 12 of
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`the package insert for Comirnaty® states that “[t]he nucleoside-modified mRNA in COMIRNATY
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`is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow ex-
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`pression of the SARS-CoV-2 S antigen.” Ex. 7 at 20. The “SARS-CoV-2 S antigen” encoded by
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`the mRNA in Comirnaty® is a betacoronavirus S protein.
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`113. Defendants promote the use of Comirnaty® to infringe one or more claims of the
`
`’600 patent. For example, Sections 1 and 2 of the package insert for Comirnaty® instruct how to
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`use the vaccine.
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`114. Defendants further promote the use of Comirnaty® booster shots to infringe one or
`
`more claims of the ’600 patent. For example, among other things, Pfizer and BioNTech maintain
`
`32
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`Case 1:22-cv-11378 Document 1 Filed 08/26/22 Page 35 of 39Case 1:22-cv-00252-MSG Document 133-4 Filed 09/27/23 Page 10 of 12 PageID #: 1790
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`to contributorily infringe one or more of the claims of the ’127 patent, either literally or under the
`
`doctrine of equivalents, by promoting the making and use of Comirnaty® in accordance with its
`
`approved package insert and/or emergency use authorization in the United States and in this Dis-
`
`trict by others, including but not limited to healthcare providers and patients, and knowing that
`
`Comirnaty® is especially made or especially adapted for use to infringe the ’127 patent, in viola-
`
`tion of 35 U.S.C. § 271(c).
`
`126. Upon information and belief, Defendants have infringed or will infringe one or
`
`more of the claims of the ’127 patent, either literally or under the doctrine of equivalents, in vio-
`
`lation of 35 U.S.C. § 271(f), including by supplying the global market for Comirnaty® with com-
`
`ponents, such as mRNA, manufactured in the United States.
`
`127. The use of Comirnaty® as instructed in its package insert satisfies each and every
`
`element of one or more claims of the ’127 patent. Upon information and belief, Defendants and
`
`others, including but not limited to healthcare providers and patients, have used Comirnaty® in
`
`the United States and in this District as instructed in Comirnaty®’s package insert to practice the
`
`methods claimed in the ’127 patent. Defendants’ actions with respect to Comirnaty® have in-
`
`fringed, induced infringement, or contributorily infringed at least claims 1-3, 6-9, 11-13, 17-18,
`
`and 20 of the ’127 patent.
`
`128. For example, claim 1 of the ’127 patent is representative and recites:
`
`A method comprising administering to a subject
`
`a messenger ribonucleic acid (mRNA) comprising an open
`reading frame encoding a betacoronavirus (BetaCoV) S
`protein or S protein subunit
`
`formulated in a lipid nanoparticle
`
`in an effective amount to induce in the subject an immune
`response to the BetaCoV S protein or S protein subunit
`
`35
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`wherein the lipid nanoparticle comprises 20-60 mol% ion-
`izable cationic lipid, 5-25 mol% neutral lipid, 25-55 mol%
`cholesterol, and 0.5-15 mol% PEG-modified lipid.
`
`129. The use of Comirnaty® as instructed in its package insert is a method comprising
`
`administering to a subject a messenger ribonucleic acid (mRNA) comprising an open reading
`
`frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid
`
`nanoparticle in an effective amount to induce in the subject an immune response to the BetaCoV
`
`S protein or S protein subunit wherein the lipid nanoparticle comprises 20-60 mol% ionizable
`
`cationic lipid, 5-25 mol% neutral lipid, 25-55 mol% cholesterol, and 0.5-15 mol% PEG-modified
`
`lipid.
`
`130. For example, Section 2.2 of the package insert for Comirnaty® instructs users to
`
`“[a]dminister a single 0.3 mL dose of COMIRNATY intramuscularly.” Ex. 7 at 6. Section 11 of
`
`the package insert for Comirnaty® states that “[e]ach 0.3 mL dose of COMIRNATY . . . contains
`
`30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycopro-
`
`tein SARS-CoV-2.” Ex. 7 at 19. Section 12 of the package insert for Comirnaty® states that “[t]he
`
`nucleoside-modified mRNA in COMIRNATY is formulated in lipid particles, which enable de-
`
`livery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen.” Ex. 7 at
`
`20. The “SARS-CoV-2 S antigen” encoded by the mRNA in Comirnaty® is a betacoronavirus S
`
`protein. Section 12 of the package insert for Comirnaty® further states that “[t]he vaccine elicits
`
`an immune response to the S antigen, which protects against COVID-19.” Id. Section 11 of the
`
`package insert for Comirnaty® further states that “[e]ach 0.3 mL dose of the COMIRNATY . . .
`
`also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-
`
`6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetam-
`
`ide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potas-
`
`36
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`e.
`
`A declaration that this is an exceptional case and an award to Moderna of its attor-
`
`neys’ fees, costs, and expenses, pursuant to 35 U.S.C. § 285; and
`
`f.
`
`Such other relief as this Court may deem just and proper, except Moderna does not
`
`seek injunctive relief against Comirnaty®.
`
`DEMAND FOR JURY TRIAL
`
`Moderna respectfully requests a trial by jury on all issues so triable in accordance with
`
`Rule 38 of the Federal Rules of Civil Procedure.
`
`
`
`Date: August 26, 2022
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`/s/ William F. Lee
`William F. Lee (BBO# 291960)
`Emily R. Whelan (BBO# 646982)
`Kevin S. Prussia (BBO# 666813)
`Andrew J. Danford (BBO# 672342)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`william.lee@wilmerhale.com
`emily.whelan@wilmerhale.com
`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`Amy K. Wigmore (BBO# 629275)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`(202) 663-6000
`amy.wigmore@wilmerhale.com
`
`Counsel for Plaintiffs ModernaTX, Inc. and
`Moderna US, Inc.
`
`39
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`