Case 2:23-cv-00222-JKW-DEM Document 252 Filed 03/29/24 Page 1 of 123 PageID# 9730
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`Norfolk Division
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`
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`Civil Action No. 2:23-cv-0222 (JKW-DEM)
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`JURY TRIAL DEMANDED
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`BioNTech SE, BioNTech Manufacturing
`GmbH, and Pfizer Inc.,
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`
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`CureVac SE (f/k/a CureVac AG),
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`
`
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`Plaintiffs and Counter Defendants,
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`v.
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`Defendant and Counter Claimant,
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`and
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`CureVac Manufacturing GmbH,
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`Counter Claimant.
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`BIONTECH AND PFIZER’S SECOND AMENDED COUNTERCLAIMS AND
`ANSWER TO CUREVAC’S FIRST AMENDED COUNTERCLAIMS
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`COUNTERCLAIMS
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`Pursuant to this Court’s Order (ECF No. 240), without admitting any of the allegations of
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`CureVac SE and CureVac Manufacturing GmbH (collectively, “CureVac” or “Defendants”)
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`other than those expressly admitted herein, and without prejudice to the right of BioNTech SE
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`and BioNTech Manufacturing GmbH (collectively, “BioNTech”) and Pfizer Inc. (“Pfizer” and,
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`together with BioNTech, “Plaintiffs”) to plead additional counterclaims as the facts of the matter
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`warrant, BioNTech and Pfizer assert the following counterclaims against CureVac.
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`INTRODUCTION
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`1.
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`This action involves Plaintiffs’ and Defendants’ respective independent efforts to
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`develop vaccines to combat the COVID-19 pandemic. Plaintiffs’ Comirnaty® was the world’s
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`first mRNA vaccine approved for public use, deployed in record time, and proved to be effective
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`in preventing severe disease, hospitalization, and death from the COVID-19 pandemic. BioNTech
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`worked tirelessly to create the mRNA vaccine after years of research and development of mRNA
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`technology, collaborating with Pfizer to bring the vaccine through regulatory approval and
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`distribution to combat this global pandemic. All of the investment and work paid off—BioNTech
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`and Pfizer successfully developed an mRNA vaccine, proved its efficacy, established global
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`manufacturing and supply chains, and gained regulatory approval. Their efforts played a vital role
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`in managing the global COVID-19 crisis.
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`2.
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`CureVac also tried to develop a vaccine to help the fight against COVID-19. Unlike
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`BioNTech and Pfizer, CureVac was unsuccessful. Presumably using its alleged patented
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`technology, CureVac’s vaccine was an unsuccessful treatment and lacked sufficient efficacy for
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`regulatory approval.
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`3.
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`Failing to supply a useful vaccine, CureVac now attempts to profit from BioNTech
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`and Pfizer’s success through allegations of patent infringement. BioNTech and Pfizer, however,
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`developed their Comirnaty® vaccine without any contribution from CureVac’s alleged mRNA
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`technology—which is why BioNTech and Pfizer brought this declaratory judgment action—
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`instead relying on innovations from their own scientists and coordination with the global scientific
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`community. CureVac played no part in Comirnaty®’s stunning success.
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`COMIRNATY® WAS BUILT ON DECADES OF PLAINTIFFS’
`AND THEIR PARTNERS’ FOUNDATIONAL RESEARCH—NOT CUREVAC’S
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`4.
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`Comirnaty® was the first-approved vaccine utilizing messenger RNA (“mRNA”)
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`technology. If efficacious, an mRNA vaccine works by introducing into a person mRNA that
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`instructs the body to make a certain protein, such as a piece of a virus that the vaccine seeks to
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`protect against. When that protein is made, or “expressed,” by a person’s cells, that person’s
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`immune system can recognize the protein as foreign and develop an immune response to it. If that
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`person is later infected with the actual virus itself, his or her immune system is ready to protect
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`2
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`against or minimize the severity of the viral infection. This is unlike previously approved
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`non-mRNA vaccines, developed before the COVID-19 pandemic, such as weakened or inactivated
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`viruses injected into the patient.
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`5.
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`Scientists have known since the 1970s that mRNA has the potential to be
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`administered as a therapeutic to translate a protein that may treat or prevent disease in humans. By
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`the 1990s, researchers demonstrated that mRNA administered as a therapeutic could be used to
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`elicit antiviral immune responses in animal models, e.g., encoding proteins expressed by cancer
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`cells to induce an immune response.
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`6.
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`One vexing problem encountered by researchers, however, was that synthetic
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`mRNA can trigger proteins that result in a non-antigen-specific immune response, such as
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`activation of toll-like receptors. This can lead to an undesirable reaction in the body, such as
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`inflammation. Despite this, Dr. Katalin Karikó (a BioNTech scientist and professor at the
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`University of Pennsylvania), was convinced that mRNA structures could be used to instruct cells
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`to make their own therapeutic proteins.1
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`7.
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`In the mid-2000s, after years of painstaking research, Dr. Karikó and Dr. Drew
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`Weissman made a key breakthrough while they were both at the University of Pennsylvania: they
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`discovered that certain chemical modifications to RNA nucleosides could reduce or eliminate the
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`inflammatory reaction. They showed that the unmodified mRNA that they expressed induced an
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`1 As Dr. Anthony Fauci acknowledged, Dr. Karikó “was, in a positive sense, kind of obsessed with
`the concept of messenger RNA.” (D.I. 104, Ex. 1 at 1.) Despite her tenacity, Dr. Karikó struggled
`to stay afloat in academia, as she sought—and was denied—grant after grant to pursue ideas that
`seemed wild and fanciful to many in the academic community. (Id. at 1-2.) As one of her
`colleagues explained, “[w]hen your idea is against the conventional wisdom that makes sense to
`the star chamber, it is very hard to break out.” (Id. at 1.) Yet, Dr. Karikó’s focus and drive never
`wavered. Her genius was a “willingness to accept failure and keep trying, and her ability to answer
`questions people were not smart enough to ask.” (Id. at 3.)
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`3
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`immune response, while the control—called transfer RNA (“tRNA”), an intermediary molecule
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`used during protein translation that links the mRNA and the amino acid sequence of proteins—did
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`not. In particular, they discovered that a class of nucleotides called pseudouridines found in tRNA
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`allowed it to evade the cell’s internal immune response.
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`8.
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`This led Drs. Karikó and Weissman to investigate the idea of modifying uridines in
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`mRNA with naturally occurring pseudouridines found in tRNA, including 1-methylpseudouridine.
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`They discovered that the uridine modification helped synthetic mRNA evade the body’s innate
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`immune system. Drs. Karikó and Weissman published their insights in a series of research papers,
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`including a seminal 2005 paper titled “Suppression of RNA Recognition by Toll-like Receptors:
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`The Impact of Nucleoside Modification and the Evolutionary Origin of RNA.” (D.I. 104, Ex. 2.)2
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`9.
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`Drs. Karikó and Weissman presented their ideas to pharmaceutical companies and
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`venture capitalists. At first, no one was interested. As Dr. Weissman later recounted, “[w]e were
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`screaming a lot, but no one would listen.” (D.I. 104, Ex. 1 at 4.) BioNTech, however, took notice
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`of Drs. Karikó and Weissman’s work and began funding Dr. Karikó’s laboratory. (Id.) In 2013,
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`Dr. Karikó joined BioNTech full-time as a senior vice president.
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`10.
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`Drs. Karikó and Weissman’s discovery that modified mRNA nucleosides could
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`evade the cell’s internal immune response was the critical innovation behind the only fully
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`2 Drs. Karikó and Weissman patented their groundbreaking discovery by submitting, in 2005,
`Provisional Patent Application No. 60/710,164 titled “RNA Containing Modified Nucleosides and
`Methods of Use Thereof.” (D.I. 104, Ex. 3.) The ’164 application describes how “[t]his invention
`provides RNA . . . comprising pseudouridine or a modified nucleoside” and expressly identifies
`N1-methyl-pseudouridine. (D.I. 104, Ex. 3 at 1, 14.) The ’164 application further “provides
`methods of reducing the immunogenicity of RNA” by using mRNA with pseudouridine
`nucleotides. (Id. at 1.) The U.S. Patent Office eventually granted U.S. Patent No. 8,691,966 (“the
`’966 patent”) to Drs. Karikó and Weissman, which claims priority to the ’164 application. (D.I.
`104, Ex. 4.) The ’966 patent expressly claims mRNA comprising “a modified nucleoside selected
`from the group consisting of (i) 1-methypseudouridine (m1Ψ) and (ii) pseudouridine (Ψ).” (D.I.
`104, Ex. 4 at claim 1.)
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`4
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`approved mRNA COVID-19 vaccines, BioNTech and Pfizer’s Comirnaty® and Moderna’s
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`Spikevax®. Moderna’s co-founder, Derrick Rossi, recognized this discovery as “fundamental to
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`this entire field” of mRNA vaccines and therapeutics. (D.I. 104, Ex. 5 at 2.) In Dr. Rossi’s
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`estimation, Drs. Karikó and Weissman’s work will “earn them a Nobel Prize because it really is
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`what allows these mRNA vaccines and any mRNA therapeutic down the road” (id.), and
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`Moderna’s co-founder reiterated that, “[i]f anyone asks [him] whom to vote for some day down
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`the line, [he] would put them front and center” (D.I. 104, Ex. 6 at 7). According to Dr. Rossi, Drs.
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`Karikó and Weissman’s “fundamental discovery is going to go into medicines that help the world.”
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`(Id.) In fact, Moderna backed up Dr. Rossi’s belief with its pocketbook by taking a license from
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`the University of Pennsylvania’s successor-in-interest, Cellscript, LLC so it could practice patents
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`embodying Drs. Karikó and Weissman’s “fundamental discovery,” including patents disclosing
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`the modified uridine that Moderna’s mRNA vaccine uses. (Id.; D.I. 104, Ex. 7.)
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`11.
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`For their discovery, Drs. Karikó and Weissman have been honored on several
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`occasions by institutions such as the Columbia University Irving Medical Center and the European
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`Patent Office for their “trailblazing” work, which “laid the foundation for the creation of [an]
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`incredibly effective COVID-19 vaccine[.]” (Exs. 8, 9; see also Exs. 10 and 11.) Drs. Karikó and
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`Weissman have also been presented with many other awards, such as the Princess of Asturias
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`Award, the Albany Medical Center Prize in Medicine and Biomedical Research, the 2022
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`Breakthrough Prize in Life Sciences, and the 2021 Lasker Award—America’s top biomedical
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`research prize. (D.I. 104, Exs. 10, 12, 13, 14, 15, and 16.)
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`12.
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`Dr. Karikó’s continued research on modified mRNA at BioNTech included
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`determining that an mRNA vaccine could elicit antibodies against the Zika virus. In 2017, Dr.
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`Karikó co-authored a paper in Nature (the “2017 Nature Paper”) demonstrating that “a single low-
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`dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside modified mRNA
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`(mRNA-LNP) encoding the pre-membrane and envelope glycoproteins of a strain from the Zika
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`Outbreak in 2013 elicited potent and durable neutralizing antibody responses” in animal models.
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`(D.I. 104, Ex. 17 at 1.) The mRNA vaccine developed by BioNTech and the University of
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`Pennsylvania against the Zika virus used mRNA that contained the modified nucleoside
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`1-methylpseudouridine, which is the same modified nucleoside that would later be used in
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`Comirnaty®. (Id. at 2–3.)
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`13.
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`BioNTech’s development work included additional discoveries as part of its mRNA
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`platform. For example, by 2014, scientists at BioNTech created the disrupted poly(A) tail that
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`would later be used in Comirnaty®. (See, e.g., D.I. 104, Ex. 18.) BioNTech’s development work
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`also involved collaborations with various partners. For example, by 2017, Acuitas Therapeutics,
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`Inc. (“Acuitas”) and BioNTech were collaborating on the development of mRNA therapeutic
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`products using Acuitas’ technology as a delivery system. During this time, Acuitas painstakingly
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`engineered a microscopic sphere of fats called a lipid nanoparticle (“LNP”) that can envelop and
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`protect the mRNA. These LNPs allow the mRNA to cross the membrane of a human cell and then
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`release the mRNA payload so it can be used to create the proteins that can potentially generate a
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`protective immune response. BioNTech licensed LNPs from Acuitas for use with mRNA
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`therapeutic products.
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`14.
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`BioNTech’s scientists, including Dr. Karikó, demonstrated that modified mRNA
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`vaccines successfully conferred immunity against HIV, Zika, and influenza viruses in animal
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`models; and published these results in the Journal of Experimental Medicine (the “2018 JEM
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`Paper”). (See D.I. 105, Ex. 19.) The 2018 JEM Paper recognized that BioNTech’s mRNA vaccine
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`platform has the “advantages of a favorable safety profile, potentially inexpensive manufacturing,
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`and the capacity for rapid development in emerging epidemics.” (Id. at 1580 (emphasis added).)
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`15.
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`That same year, Pfizer and BioNTech partnered to develop an mRNA-based
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`vaccine for influenza. As part of the agreement, BioNTech and Pfizer would jointly conduct
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`research and development to advance mRNA-based flu vaccines. In announcing the collaboration,
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`the head of Pfizer’s vaccine research and development unit, Dr. Kathrin Jansen, noted that
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`“[i]nnovative vaccine approaches are urgently needed to provide improved protection against
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`seasonal flu, and to respond rapidly and in quantity to pandemic influenza threats.” (D.I. 105,
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`Ex. 20 at 1 (emphasis added).) Dr. Jansen further emphasized that “mRNA vaccines offer a novel
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`approach to code for any protein or multiple proteins, and the potential to manufacture higher
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`potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines.” (Id.)
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`16.
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`In December 2019, SARS-CoV-2 was reported in Wuhan, China. When this novel
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`coronavirus emerged, BioNTech was well-positioned to respond rapidly by constructing a vaccine
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`around its existing modified mRNA platform, which had already been tested against viruses such
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`as HIV, Zika, and influenza. Leveraging decades of foundational research, BioNTech rapidly
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`identified several candidates for clinical testing as mRNA-based vaccines to protect against
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`COVID-19.
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`17.
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`By early 2020, soon after the genetic sequence for SARS-CoV-2 (the virus that
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`causes COVID-19) was published, BioNTech and its development partner Pfizer initiated “Project
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`Lightspeed,” an accelerated vaccine development program to fight COVID-19. BioNTech and
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`Pfizer’s COVID-19 vaccine development program leveraged BioNTech’s experience and
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`expertise with mRNA technologies, as well as the work of other partners, including Acuitas and
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`the National Institutes of Health (“NIH”).
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`18.
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`For example, BioNTech developed
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`innovative, proprietary mRNA-based
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`technologies to achieve effective translational performance and direction of the immune response.
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`BioNTech also leveraged its prior work with Acuitas on LNP technology and used Acuitas lipids
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`ALC-315 and ALC-159. Further, BioNTech licensed and incorporated the work of NIH scientists
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`relating to a particular modification to the sequence of the coronavirus spike protein (i.e., the
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`protein structures covering the exterior of the SARS-CoV-2 virus), which causes the modified
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`spike protein to be locked in a certain configuration. (See, e.g., D.I. 105, Ex. 21.) This
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`configuration allows the modified spike protein to be recognized more easily by human cells and
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`elicit a more robust bodily response that results in immunity.
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`19. With the benefit of its prior development work for its mRNA platform, BioNTech
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`rapidly developed and performed numerous toxicological and pharmacological studies to
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`determine the safety and efficacy of the Comirnaty® vaccine. For example, BioNTech’s studies
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`showed, inter alia, that the vaccine is highly immunogenic in animal models and provided the
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`confirmation needed to move quickly into Phase 1 clinical studies.
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`20.
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`BioNTech partnered with Pfizer on
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`the development, clinical
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`testing,
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`manufacturing, distribution, and regulatory approval of the Comirnaty® vaccine. (See D.I. 1,
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`Exhibit 6.) By March 2020, when the World Health Organization (“WHO”) declared the COVID-
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`19 outbreak a global pandemic, Pfizer and BioNTech had already begun their collaborative effort.
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`21.
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`Clinical trials of the Comirnaty® vaccine began in late April 2020, with preliminary
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`results demonstrating its safety and efficacy published within six months. This rapid development
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`and start of clinical trials of product candidates was not a chance event, the result of sudden
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`inspiration, or copying someone else’s work. It was the result of the relentless work by dedicated
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`scientists and the vision of BioNTech and Pfizer working together.
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`22.
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`On May 5, 2020, BioNTech and Pfizer announced that the first participants had
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`been dosed in the United States in the Phase 1/2 clinical trial for their vaccine, codenamed
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`BNT162, designed to determine safety and efficacy against COVID-19. (See D.I. 1, Exhibit 9.)
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`After attaining promising Phase 1/2 clinical study results, on July 27, 2020, BioNTech and Pfizer
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`began a Phase 2/3 study on their Comirnaty® vaccine. (See D.I. 1, Exhibit 12.) The pivotal Phase
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`3 study was conducted on a global scale—encompassing more than 44,000 patients—to continue
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`determining its safety and efficacy in humans. (See D.I. 1, Exhibit 8.)
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`23. Meanwhile, Pfizer was also working on the logistics and infrastructure needed to
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`successfully manufacture and distribute the Comirnaty® vaccine. Pfizer leveraged its extensive
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`manufacturing network to produce an approved COVID-19 vaccine as quickly as possible for those
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`most in need in the United States.
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`24.
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`In November 2020, the Comirnaty® vaccine was shown to have met all the primary
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`efficacy endpoints in a Phase 3 clinical trial, demonstrating an “efficacy rate of 95% (p < 0.0001)
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`in participants without prior SARS-CoV-2 infection (first primary objective) and in participants
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`with and without prior SARS-CoV-2 infection (second primary objective),” as measured from
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`seven days after the second dose of the vaccine. (See D.I. 1, Exhibit 13.)
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`25.
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`On November 20, 2020, Pfizer, on behalf of itself and BioNTech, submitted the
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`clinical trial data as part of an Emergency Use Authorization (“EUA”) request to the Food and
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`Drug Administration (“FDA”) for administering the Comirnaty® vaccine to people 16 years of age
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`and older.
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`26.
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`On December 11, 2020, the FDA granted the first EUA for a COVID-19 vaccine
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`to Pfizer and BioNTech’s Comirnaty® vaccine with vaccinations rolling out immediately
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`thereafter,3 completing the fastest development of a vaccine in history.
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`27.
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`Based on a comprehensive data package and real-world results demonstrating
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`overwhelming safety and efficacy, on August 23, 2021, the FDA granted full approval of the
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`Comirnaty® vaccine for individuals 16 years of age and older. In late 2021 and early 2022, the
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`FDA amended its emergency use authorization for Comirnaty® to permit administration of a
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`booster dose in certain individuals after completing their primary two-dose series with an FDA-
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`authorized or approved COVID-19 vaccine, including Comirnaty®. The Comirnaty® vaccine was
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`both the first mRNA drug product and the first COVID-19 vaccine to receive full FDA approval.
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`BioNTech Manufacturing GmbH is the Biologics License Application holder for Comirnaty® in
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`the United States.
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`28.
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`Since receiving the first EUA from the FDA, Comirnaty® vaccine has contributed
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`to saving at least 14 million lives that otherwise may have been lost due to the pandemic. (See
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`D.I. 1, Exhibit 16.) Furthermore, widespread vaccination of populations with Comirnaty® vaccine
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`allowed jurisdictions worldwide, including Virginia, to remove restrictions on movement, easing
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`the economic and social burdens countless individuals suffered during forced isolation.
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`3 FDA Memorandum, Emergency Use Authorization (“EUA”) for an Unapproved Product
`Review (Dec. 11, 2020), https://www.fda.gov/media/144416/download; Press Release, FDA,
`FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization
`for First COVID-19 Vaccine (Dec. 11, 2020),
`https://www.fda.gov/newsevents/pressannouncements/fda-takes-key-action-fight-against-covid-
`19-issuing-emergency-useauthorization-first-covid-19.
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`CUREVAC NOW SEEKS TO PROFIT FROM
`PFIZER AND BIONTECH’S VACCINE AFTER ITS OWN VACCINE FAILED
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`29.
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`Like BioNTech and Pfizer, CureVac also tried to develop a vaccine containing
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`mRNA packaged in an LNP to fight the COVID-19 pandemic. Unlike BioNTech and Pfizer,
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`however, CureVac failed to create an mRNA vaccine against COVID-19 that induced a sufficient
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`protective immune response.
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`30.
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`Upon information and belief, on or about June 16, 2021, a pivotal Phase 2b/3
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`clinical trial showed that CureVac’s COVID-19 vaccine candidate, “CVnCoV,” had an interim
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`vaccine efficacy of about 47% against COVID-19 of any severity, which did not meet the pre-
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`specified statistical success criteria. (See D.I. 1, Exhibit 4.)
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`31.
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`Upon information and belief, an earlier Phase 1 study of CVnCoV showed that
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`serum levels of so-called neutralizing antibodies, which prevent the virus from binding to cells,
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`were relatively low in vaccine recipients compared with people who were naturally infected with
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`SARS-CoV-2.
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`32.
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`Upon information and belief, after failing to develop its own effective COVID-19
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`vaccine, CureVac set its sights on profiting off BioNTech and Pfizer’s Comirnaty® vaccine through
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`baseless allegations of patent infringement. In its Counterclaims, CureVac improperly attempts to
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`inflate its scientific contributions to the field of mRNA therapeutics. For example, CureVac
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`alleges that its “discoveries span all aspects of mRNA medicines, including methods to stabilize
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`mRNA, to modify it, to manufacture it on a commercial scale, to increase the yield of the protein
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`it encodes, and to formulate it for safe and effective administration to patients.” (D.I. 106 at ¶ 4.)
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`Despite all of these “discoveries,” and CureVac’s allegation that it “was the first company in the
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`world to harness mRNA for medical purposes” (D.I. 106 at ¶ 3), when the global community called
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`for a COVID-19 vaccine, CureVac was unable to provide one.
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`33.
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`CureVac also alleges that, “[w]hen the COVID-19 pandemic struck, CureVac
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`scientists leveraged their resources and expertise to find the optimal mRNA sequence encoding
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`the full-length COVID-19 spike protein and packaged that mRNA in the LNP that resulted from
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`CureVac’s selection and validation process in the human rabies vaccine trial.” (D.I. 106 at ¶ 26.)
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`CureVac did not discover the sequence of the SARS-CoV-2 spike protein, despite citing it in U.S.
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`Patent Nos. 11,241,493 (“the ’493 patent”), 11,471,525 (“the ’525 patent”), 11,576,966 (“the ’966
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`patent”), and 11,596,686 (“the ’686 patent”); that information was publicly available before
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`February 2020. (See, e.g., D.I. 105, Exs. 22 and 23.) Likewise, CureVac did not discover the basic
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`idea of an mRNA vaccine to elicit an immune response against a specific viral antigen or the
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`particular modification to the sequence of a coronavirus spike protein that stabilizes the spike
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`protein, which allows it to be used effectively as an mRNA vaccine antigen. Instead, NIH
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`scientists described the specific spike protein sequence modification. (See, e.g., D.I. 105, Ex. 21.)
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`34.
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`CureVac also did not create the LNP in which the mRNA is packaged because that
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`was done by Acuitas and disclosed publicly prior to the filing of CureVac’s patents in suit. (See,
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`e.g., D.I. 105, Exs. 24-26.) Moreover, Acuitas has an ownership interest in the ’493, ’525, ’966,
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`and ’686 patents (collectively, the “’493 Patent Family”). CureVac lacks standing to assert the
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`’493 Patent Family against BioNTech and Pfizer because Acuitas has not and would not consent
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`to join in an infringement lawsuit by one business partner, CureVac, against its other business
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`partner, BioNTech. (See, e.g., D.I. 136 at 7.)
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`35.
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`CureVac also alleges that it “discovered that increasing the proportions of
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`guanosine and cytidine nucleosides in an mRNA stabilizes the molecule and results in an increased
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`expression of the protein it encodes.” (D.I. 106 at ¶ 19.) This is incorrect. U.S. Patent
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`No. 11,135,312 (“the ’312 patent”) does not disclose the stabilization of any mRNA or increased
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`12
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`expression of any protein. Regardless, codon optimization of viral nucleic acid coding sequences
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`for increasing expression in mammalian cells over the wild type virus was known years before
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`CureVac’s patent applications were filed. (See, e.g., D.I. 105, Exs. 27-29.)
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`36.
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`CureVac’s broad allegations demonstrate that CureVac is not attempting to protect
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`a specific composition, but rather seeks to preempt others from using prior art methods that were
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`known and practiced by scientists before CureVac’s applications were filed. (D.I. 106 at ¶ 19.)
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`CureVac should not be permitted to monopolize an entire class of alleged inventions by claiming
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`them according to their function (e.g., the stabilization of any mRNA or enhanced expression of
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`any protein), especially where its patent specification does not even show that claimed function.
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`37.
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`CureVac further asserts that it “discovered that modifying one of [mRNA’s]
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`untranslated regions, composed of sequential adenosine nucleotides at one end of the mRNA (often
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`called ‘polyA’), results in a substantial increase in the amount of protein expressed by the cell or
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`organism.” (D.I. 106 at ¶ 21.) But again, this concept of modifying mRNA using “polyA,” as
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`CureVac attempts to claim in U.S. Patent Nos. 11,149,278 (“the ’278 patent”), 11,286,492 (“the
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`’492 patent”), and 11,345,920 (“the ’920 patent”) (see D.I. 106 at ¶ 21), is broad and was
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`previously known in the art (see, e.g. D.I. 104, Ex. 18; D.I. 105, Exs. 30 and 31). Also, upon
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`information and belief, the U.S. Government has certain rights, including “have made” rights, in
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`the asserted patents, including at least the ’278, ’492 and ’920, patents.
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`38.
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`CureVac also alleges that it “developed new methods to purify the mRNA, as well
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`as the DNA template which encodes the mRNA, using a technique called Tangential Flow
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`Filtration (‘TFF’).” (D.I. 106 at ¶ 23.) Once again, this is not true. The prior art reveals that the
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`use of TFF was known to purify nucleic acids, including plasmid DNA and RNA, before the
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`applications leading to U.S. Patent Nos. 10,760,070 (“the ’070 patent”) and 11,667,910 (“the ’910
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`patent”) were filed. (See, e.g., D.I. 105, Exs. 32-36.) Also, upon information and belief, the U.S.
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`Government has certain rights, including “have made” rights, in the asserted patents, including at
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`least the ’070 and ’910 patents.
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`39.
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`Upon information and belief, CureVac sought to broaden its patent portfolio
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`beyond what it actually invented, in an effort to collect and leverage well known and fundamental
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`research discoveries made by others for its own financial gain.
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`40.
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`For these reasons, and as set forth more fully in these Counterclaims and Answer
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`to Counterclaims, BioNTech and Pfizer deny CureVac’s allegations, deny that CureVac is entitled
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`to any relief, and seek the relief described below.
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`PARTIES
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`41.
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`BioNTech SE is a company organized and existing under the laws of Germany,
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`having a principal place of business at An der Goldgrube 12, D-55131 Mainz, Germany.
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`42.
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`BioNTech Manufacturing is a company organized and existing under the laws of
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`Germany, having a principal place of business at An der Goldgrube 12, D-55131 Mainz, Germany.
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`43.
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`44.
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`BioNTech Manufacturing is a wholly owned subsidiary of BioNTech SE.
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`Pfizer is a corporation organized and existing under the laws of the State of
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`Delaware, with its principal place of business at 66 Hudson Blvd E, New York, NY 10001-2192,
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`USA.
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`45.
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`Upon information and belief, CureVac SE is a corporation organized and existing
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`under the laws of Germany, having a place of business at Friedrich-Miescher-Straße 15, 72076
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`Tübingen, Germany.
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`46.
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`Upon information and belief, CureVac Manufacturing GmbH is a corporation
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`organized and existing under the laws of Germany, having a place of business at Friedrich-
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`Miescher-Straße 15, 72076 Tübingen, Germany. CureVac Manufacturing GmbH is a
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`wholly-owned subsidiary of CureVac N.V.
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`JURISDICTION AND VENUE
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`47.
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`BioNTech and Pfizer seek a declaratory judgment pursuant to 28 U.S.C. §§ 2201
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`and 2202. The Court has jurisdiction over these Counterclaims pursuant to 28 U.S.C. §§ 1331 and
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`1338(a).
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`48.
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`Venue is proper under 28 U.S.C. §§ 1391 and 1400(b), and by CureVac’s choice
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`of forum.
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`49.
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`This action is based upon an actual controversy between the parties arising from
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`allegations of infringement of the ’312, ’278, ’492, ’920, ’070, ’910, ’493, ’525, ’966, and ’686
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`patents.
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`COUNT I - DECLARATION OF INVALIDITY OF THE ’312 PATENT
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`50.
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`Pfizer and BioNTech reallege and incorporate by reference paragraphs 1 through
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`49 of its Counterclaims as if fully set forth herein.
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`51.
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`As set forth above, and in particular, in paragraphs 32, 35-36, and 39, the claims of
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`the ’312 patent are invalid for failure to satisfy one or more of the provisions set forth in 35 U.S.C.
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`§§ 100 et seq., including, without limitation, the requirements of 35 U.S.C. §§ 102, 103, 112,
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`and/or any other judicially created requirements for patentability and enforceability of patents,
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`such as obviousness-type double patenting, and/or in view of the defenses recognized in 35 U.S.C.
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`§ 282.
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`52. Without limitation, the claims of the ’312 patent are anticipated and/or obvious
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`based on prior art, including but not limited to, prior art described above in paragraph 35.
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`53.
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`In addition, the claims of the ’312 patent are not adequately described, defined,
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`and/or enabled across the full scope of the claims.
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`COUNT II - DECLARATION OF INVALIDITY OF THE ’278 PATENT
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`54.
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`Pfizer and BioNTech reallege and incorporate by reference paragraphs 1 through
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`49 of its Counterclaims as if fully set forth herein.
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`55.
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`As set forth above, and in particular, in paragraphs 32, 37 and 39, the claims of the
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`’278 patent are invalid for failure to satisfy one or more of the provisions set forth in 35 U.S.C. §§
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`100 et seq., including, without limitation, the requirements of 35 U.S.C. §§ 102, 103, 112, and/or
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`any other judicially created requirements for patentability and enforceability of patents, such as
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`obviousness-type double patenting, and/or in view of the defenses recognized in 35 U.S.C. § 282.
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`56. Without limitation, the claims of the ’278 patent are anticipated and/or obvious
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`based on prior art, including but not limited to, prior art described above in paragraph 37.
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`57.
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`In addition, the claims of the ’278 patent are not adequately described, defined,
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`and/or enabled across the full scope of the claims.
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`COUNT III - DECLARATION OF INVALIDITY OF THE ’492 PATENT
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`58.
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`Pfizer and BioNTech reallege and incorporate by reference paragraphs 1 through
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`49 of its Counterclaims as if fully set forth herein.
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`59.
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`As set forth above, and in particular, in paragrap