Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 1 of 32 PageID# 9879
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`Norfolk Division
`
`
`
`
`
`
`
`Plaintiffs/Counterclaim Defendants,
`
`
`
`v.
`
`BIONTECH SE, BIONTECH
`MANUFACTURING GMBH, and PFIZER,
`INC.,
`
`
`
`
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`CUREVAC SE (f/k/a CUREVAC AG),
`
`
`
`and
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`CUREVAC MANUFACTURING GMBH,
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`
`
`Defendant/Counterclaimant,
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`Counterclaimant.
`
`
`
`
`
`
`C.A. No. 2:23-cv-222-JKW-DEM
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`JURY TRIAL DEMANDED
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`CUREVAC SE AND CUREVAC MANUFACTURING GMBH’S
`ANSWER TO BIONTECH SE, BIONTECH MANUFACTURING GMBH, AND
`PFIZER, INC.'S SECOND AMENDED COUNTERCLAIMS
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 2 of 32 PageID# 9880
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`INTRODUCTION
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`1.
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`The COVID-19 pandemic was an unprecedented public-health crisis that required
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`an unprecedented response, and BioNTech and Pfizer’s Comirnaty® vaccine was, and continues
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`to be, an essential part of that response. But the story that BioNTech and Pfizer are telling this
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`Court about their development of Comirnaty® is, at best, incomplete. They say their success was
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`based on their own work (though they don’t say what that was), and that of scientists at the
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`University of Pennsylvania, the National Institutes of Health, and Acuitas Therapeutics.
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`2.
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`As will become evident in this case, the real story is that Comirnaty® is an effective
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`vaccine, and that BioNTech and Pfizer were able to quickly develop and bring it to market, because
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`it incorporates the extensive family of technologies claimed in CureVac’s patents-in-suit: the same
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`mRNA, manufactured by the same process, administered to patients in the same way, and delivered
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`to those patients’ cells using the same delivery system.
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`3.
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`But instead of respecting CureVac’s intellectual property rights (by taking a license
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`to CureVac’s COVID-19 patent portfolio), BioNTech and Pfizer filed this lawsuit, in which they
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`argue that Comirnaty® does not infringe those patents. And instead of addressing the indisputable
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`evidence of infringement in the documents discussed in and submitted with CureVac’s
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`Counterclaims, or providing any other evidence to support their assertions of non-infringement,
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`they are trying to distract the Court from the real issues by instead focusing on the work of the
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`Penn, NIH, and Acuitas scientists. To be clear, CureVac respects the work that others have done
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`in the field of mRNA therapeutics, and does not seek to detract from or diminish others’ prior
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`contributions. As history makes clear, inventors do not work in a vacuum: advances in science and
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`medicine can result from multiple scientists working to advance the field over the prior
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`contributions of other scientists.
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`4.
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`The inventions claimed in CureVac’s patents are no different: they resulted from
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`the creative and persevering work of the CureVac scientists listed as inventors on each patent, and
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`they constituted additions to, and advances over, the contributions of others. BioNTech and Pfizer
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`argue that the claims of the patents-in-suit are invalid because those contributions of other
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`scientists were disclosed in prior-art patent applications and/or scientific publications. But they
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`fail to tell the Court that CureVac submitted prior art disclosing those prior contributions to the
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`expert examiners in the Patent Office during prosecution of the patents-in-suit, and that the Patent
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`Office issued the patents-in-suit to CureVac only after thorough consideration of that prior art.
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`5.
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`BioNTech and Pfizer also ignore the indisputable fact (discussed in CureVac’s
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`Counterclaims) that their success in rapidly developing Comirnaty® resulted in large part from
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`Acuitas having improperly given them CureVac’s confidential, proprietary clinical trial data
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`proving that the Acuitas ALC-315 lipid could be used to safely and effectively deliver an mRNA
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`vaccine to humans. With that information in hand, BioNTech and Pfizer were able to rapidly pivot
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`to use that ALC-315 lipid (instead of the other Acuitas lipids they were testing) in Comirnaty®,
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`which allowed them to bring Comirnaty® to market many months before they otherwise could
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`have done so.
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`6.
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`Finally, BioNTech and Pfizer try to contrast the success of Comirnaty® against the
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`purported “failure” of CureVac’s mRNA vaccine candidate, called “CVnCoV,” in a clinical trial
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`(the “HERALD” trial). But the real story is that, contrary to BioNTech and Pfizer’s assertions that
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`it was a “failure,” CureVac’s vaccine actually met the prespecified success criteria for efficacy
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`against symptomatic COVID-19 of any severity, and for efficacy against moderate-to-severe
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`COVID-19, as defined in the protocol: it was 48% effective in preventing infection of any severity,
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`was 77% effective at preventing moderate and severe disease, and was 100% effective at
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 4 of 32 PageID# 9882
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`preventing death. This, despite the fact that it was tested when there were at least 13 different
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`variants of the SARS-CoV-2 virus circulating in the population. Given these facts, BioNTech and
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`Pfizer’s attempt to disparage CureVac’s inventions by contrasting the results of the successful
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`clinical trials of Comirnaty® (which were conducted when the original SARS-CoV-2 virus was
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`causing nearly all infections) against the results of CureVac’s successful clinical trial of its
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`COVID-19 vaccine (which were conducted much later, when at least 13 different variants of the
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`virus were causing infections) is, to say the least, both factually wrong and disingenuous.
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`7.
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`Simply put, the fact that others made contributions to this field, or that CureVac’s
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`vaccine candidate, while successful, was not brought to market, does not render the claims in the
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`patents-in-suit invalid, and it does not excuse BioNTech and Pfizer’s infringing use of CureVac’s
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`patented inventions to develop Comirnaty®.
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`8.
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`As noted above, Comirnaty continues to be an essential part of the response to the
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`COVID-19 threat. Accordingly, CureVac is not seeking an injunction that would prevent or
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`impede the production, sale, or distribution of Comirnaty®: rather, CureVac seeks only to have its
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`intellectual property rights acknowledged and respected in the form of fair compensation so that
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`CureVac can continue to invest in the further advancement of mRNA technology and the ongoing
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`development of new life-saving medicines.
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`ANSWERS TO SPECIFIC ALLEGATIONS1
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`Without admitting any of the allegations of BioNTech SE and BioNTech Manufacturing
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`GmbH (collectively, “BioNTech”) and Pfizer Inc. (“Pfizer”) (and, together with BioNTech,
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`“Plaintiffs/Counterclaim Defendants”) other than those expressly admitted herein, and without
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`1 CureVac does not reproduce the headings or footnotes from Pfizer and BioNTech’s
`Counterclaims and denies any allegations contained in those headings or footnotes.
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 5 of 32 PageID# 9883
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`prejudice to their right to plead additional claims and defenses as the facts of the matter warrant,
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`CureVac SE and CureVac Manufacturing GmbH (collectively “CureVac”) respond to the
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`counterclaims against CureVac as follows:
`
`This action involves Plaintiffs’ and Defendants’ respective independent efforts to
`1.
`develop vaccines to combat the COVID-19 pandemic. Plaintiffs’ Comirnaty® was the world’s first
`mRNA vaccine approved for public use, deployed in record time, and proved to be effective in
`preventing severe disease, hospitalization, and death from the COVID-19 pandemic. BioNTech
`worked tirelessly to create the mRNA vaccine after years of research and development of mRNA
`technology, collaborating with Pfizer to bring the vaccine through regulatory approval and
`distribution to combat this global pandemic. All of the investment and work paid off—BioNTech
`and Pfizer successfully developed an mRNA vaccine, proved its efficacy, established global
`manufacturing and supply chains, and gained regulatory approval. Their efforts played a vital role
`in managing the global COVID-19 crisis.
`
`ANSWER: CureVac admits that Comirnaty® was approved for public use under an
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`Emergency Use Authorization on December 11, 2020, and avers that one reason it was able to be
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`developed and deployed so quickly is because it incorporates the inventions claimed in CureVac’s
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`patents-in-suit, which resulted from the decades of pioneering research and development work at
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`CureVac. CureVac denies the remaining allegations in Paragraph 1.
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`CureVac also tried to develop a vaccine to help the fight against COVID-19. Unlike
`2.
`BioNTech and Pfizer, CureVac was unsuccessful. Presumably using its alleged patented
`technology, CureVac’s vaccine was an unsuccessful treatment and lacked sufficient efficacy for
`regulatory approval.
`
`ANSWER: CureVac admits that it developed an mRNA vaccine, called “CVnCoV,” to
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`help in the fight against COVID-19. CureVac avers that CVnCoV was tested in the “HERALD”
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`clinical trial; that CVnCoV was 48% effective in preventing infection of any severity across the
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`unprecedented 13 strains of the virus active at that time, was 77% effective at preventing moderate
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`and severe disease, and was 100% effective at preventing death. CureVac avers that the HERALD
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`trial met the prespecified success criteria for efficacy against symptomatic COVID-19 of any
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`severity, and for efficacy against moderate-to-severe COVID-19, as defined in the protocol.
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`CureVac denies the remaining allegations in Paragraph 2.
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 6 of 32 PageID# 9884
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`Failing to supply a useful vaccine, CureVac now attempts to profit from BioNTech
`3.
`and Pfizer’s success through allegations of patent infringement. BioNTech and Pfizer, however,
`developed their Comirnaty® vaccine without any contribution from CureVac’s alleged mRNA
`technology—which is why BioNTech and Pfizer brought this declaratory judgment action—
`instead relying on innovations from their own scientists and coordination with the global scientific
`community. CureVac played no part in Comirnaty®’s stunning success.
`
`ANSWER: CureVac denies the allegations in Paragraph 3.
`
`Comirnaty® was the first-approved vaccine utilizing messenger RNA (“mRNA”)
`4.
`technology. If efficacious, an mRNA vaccine works by introducing into a person mRNA that
`instructs the body to make a certain protein, such as a piece of a virus that the vaccine seeks to
`protect against. When that protein is made, or “expressed,” by a person’s cells, that person’s
`immune system can recognize the protein as foreign and develop an immune response to it. If that
`person is later infected with the actual virus itself, his or her immune system is ready to protect
`against or minimize the severity of the viral infection. This is unlike previously approved
`non-mRNA vaccines, developed before the COVID-19 pandemic, such as weakened or inactivated
`viruses injected into the patient.
`
`ANSWER: CureVac admits the allegations in Paragraph 4.
`
`Scientists have known since the 1970s that mRNA has the potential to be
`5.
`administered as a therapeutic to translate a protein that may treat or prevent disease in humans. By
`the 1990s, researchers demonstrated that mRNA administered as a therapeutic could be used to
`elicit antiviral immune responses in animal models, e.g., encoding proteins expressed by cancer
`cells to induce an immune response.
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`ANSWER: CureVac admits that scientists have been studying mRNA for years.
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`CureVac denies that research sufficient to create a real-world, safe, and effective mRNA vaccine
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`against COVID-19 existed prior to CureVac’s work. CureVac lacks knowledge and information
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`sufficient to form a belief as to the truth of the vague allegations in Paragraph 5, and therefore
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`denies them.
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`One vexing problem encountered by researchers, however, was that synthetic
`6.
`mRNA can trigger proteins that result in a non-antigen-specific immune response, such as
`activation of toll-like receptors. This can lead to an undesirable reaction in the body, such as
`inflammation. Despite this, Dr. Katalin Karikó (a BioNTech scientist and professor at the
`University of Pennsylvania), was convinced that mRNA structures could be used to instruct cells
`to make their own therapeutic proteins.
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`ANSWER: CureVac admits that synthetic mRNA can cause cells to produce proteins
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`that can result in a non-antigen-specific immune response, such as activation of toll-like receptors,
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 7 of 32 PageID# 9885
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`which can lead to an undesirable immune and inflammatory response in the body. CureVac lacks
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`knowledge or information sufficient to form a belief about the truth of the remaining allegations
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`in Paragraph 6, and therefore denies them.
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`In the mid-2000s, after years of painstaking research, Dr. Karikó and Dr. Drew
`7.
`Weissman made a key breakthrough while they were both at the University of Pennsylvania: they
`discovered that certain chemical modifications to RNA nucleosides could reduce or eliminate the
`inflammatory reaction. They showed that the unmodified mRNA that they expressed induced an
`immune response, while the control—called transfer RNA (“tRNA”), an intermediary molecule
`used during protein translation that links the mRNA and the amino acid sequence of proteins—did
`not. In particular, they discovered that a class of nucleotides called pseudouridines found in tRNA
`allowed it to evade the cell’s internal immune response.
`
`ANSWER: CureVac lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in Paragraph 7, and therefore denies them.
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`This led Drs. Karikó and Weissman to investigate the idea of modifying uridines in
`8.
`mRNA with naturally occurring pseudouridines found in tRNA, including 1-methylpseudouridine.
`They discovered that the uridine modification helped synthetic mRNA evade the body’s innate
`immune system. Drs. Karikó and Weissman published their insights in a series of research papers,
`including a seminal 2005 paper titled “Suppression of RNA Recognition by Toll-like Receptors:
`The Impact of Nucleoside Modification and the Evolutionary Origin of RNA.” (D.I. 104, Ex. 2.)
`
`ANSWER: CureVac admits that D.I. 104-2 states that it was authored by Katalin
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`Karikó, Michael Buckstein, Houpin Ni, and Drew Weissman; that it has the quoted title’ and that
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`it states that it was included in a volume of the journal “Immunity” dated August 2005. CureVac
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`lacks knowledge and information sufficient to form a belief as to the truth of the remaining
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`allegations in Paragraph 8, and therefore denies them.
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`Drs. Karikó and Weissman presented their ideas to pharmaceutical companies and
`9.
`venture capitalists. At first, no one was interested. As Dr. Weissman later recounted, “[w]e were
`screaming a lot, but no one would listen.” (D.I. 104, Ex. 1 at 4.) BioNTech, however, took notice
`of Drs. Karikó and Weissman’s work and began funding Dr. Karikó’s laboratory. (Id.) In 2013,
`Dr. Karikó joined BioNTech full-time as a senior vice president.
`
`ANSWER: CureVac admits that D.I. 104-1 includes the quoted language. CureVac
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`lacks knowledge and information sufficient to form a belief as to the truth of the remaining
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`allegations in Paragraph 9, and therefore denies them.
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`Drs. Karikó and Weissman’s discovery that modified mRNA nucleosides could
`10.
`evade the cell’s internal immune response was the critical innovation behind the only fully
`approved mRNA COVID-19 vaccines, BioNTech and Pfizer’s Comirnaty® and Moderna’s
`Spikevax®. Moderna’s co-founder, Derrick Rossi, recognized this discovery as “fundamental to
`this entire field” of mRNA vaccines and therapeutics. (D.I. 104, Ex. 5 at 2.) In Dr. Rossi’s
`estimation, Drs. Karikó and Weissman’s work will “earn them a Nobel Prize because it really is
`what allows these mRNA vaccines and any mRNA therapeutic down the road” (id.), and
`Moderna’s co-founder reiterated that, “[i]f anyone asks [him] whom to vote for some day down
`the line, [he] would put them front and center” (D.I. 104, Ex. 6 at 7). According to Dr. Rossi, Drs.
`Karikó and Weissman’s “fundamental discovery is going to go into medicines that help the world.”
`(Id.) In fact, Moderna backed up Dr. Rossi’s belief with its pocketbook by taking a license from
`the University of Pennsylvania’s successor-in-interest, Cellscript, LLC so it could practice patents
`embodying Drs. Karikó and Weissman’s “fundamental discovery,” including patents disclosing
`the modified uridine that Moderna’s mRNA vaccine uses. (Id.; D.I. 104, Ex. 7.)
`
`ANSWER: CureVac admits that Comirnaty® and Moderna’s Spikevax® each contain
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`mRNA in which certain uridylyl nucleosides have been replaced with 1-methylpseudouridine.
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`CureVac admits that D.I. 104-5, -6, and -7 include the quoted language. CureVac lacks knowledge
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`and information sufficient to form a belief as to the truth of the remaining allegations in Paragraph
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`10, and therefore denies them.
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`For their discovery, Drs. Karikó and Weissman have been honored on several
`11.
`occasions by institutions such as the Columbia University Irving Medical Center and the European
`Patent Office for their “trailblazing” work, which “laid the foundation for the creation of [an]
`incredibly effective COVID-19 vaccine[.]” (Exs. 8, 9; see also Exs. 10 and 11.) Drs. Karikó and
`Weissman have also been presented with many other awards, such as the Princess of Asturias
`Award, the Albany Medical Center Prize in Medicine and Biomedical Research, the 2022
`Breakthrough Prize in Life Sciences, and the 2021 Lasker Award—America’s top biomedical
`research prize. (D.I. 104, Exs. 10, 12, 13, 14, 15, and 16.)
`
`ANSWER: CureVac admits that D.I. 104-8 contains the quoted language. . CureVac
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`admits that D.I. 104-9–15 state that Drs. Karikó and Weissman received certain awards. CureVac
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`lacks knowledge and information sufficient to form a belief as to the truth of the remaining
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`allegations in Paragraph 11, and therefore denies them.
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`Dr. Karikó’s continued research on modified mRNA at BioNTech included
`12.
`determining that an mRNA vaccine could elicit antibodies against the Zika virus. In 2017, Dr.
`Karikó co-authored a paper in Nature (the “2017 Nature Paper”) demonstrating that “a single
`low-dose intradermal immunization with lipid-nanoparticle-encapsulated nucleoside modified
`mRNA (mRNA-LNP) encoding the pre-membrane and envelope glycoproteins of a strain from
`the Zika Outbreak in 2013 elicited potent and durable neutralizing antibody responses” in animal
`models. (D.I. 104, Ex. 17 at 1.) The mRNA vaccine developed by BioNTech and the University
`of Pennsylvania against the Zika virus used mRNA that contained the modified nucleoside
`1-methylpseudouridine, which is the same modified nucleoside that would later be used in
`Comirnaty®. (Id. at 2–3.)
`
`ANSWER: CureVac admits that D.I. 104-17 states that Dr. Karikó was one of thirty-
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`seven authors (and the only author listed as affiliated with BioNTech) of a letter included in a
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`volume of the journal “Nature” published in 2017, and includes the quoted language. CureVac
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`admits that D.I. 104-17 states that the anti-Zika vaccine contained 1-methylpseudouridine. Id.
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`CureVac admits that Comirnaty® contains 1-methylpseudouridine. CureVac lacks knowledge and
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`information sufficient to form a belief as to the truth of the remaining allegations in Paragraph 12,
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`and therefore denies them.
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`BioNTech’s development work included additional discoveries as part of its
`13.
`mRNA platform. For example, by 2014, scientists at BioNTech created the disrupted poly(A) tail
`that would later be used in Comirnaty®. (See, e.g., D.I. 104, Ex. 18.) BioNTech’s development
`work also involved collaborations with various partners. For example, by 2017, Acuitas
`Therapeutics, Inc. (“Acuitas”) and BioNTech were collaborating on the development of mRNA
`therapeutic products using Acuitas’ technology as a delivery system. During this time, Acuitas
`painstakingly engineered a microscopic sphere of fats called a lipid nanoparticle (“LNP”) that can
`envelop and protect the mRNA. These LNPs allow the mRNA to cross the membrane of a human
`cell and then release the mRNA payload so it can be used to create the proteins that can potentially
`generate a protective immune response. BioNTech licensed LNPs from Acuitas for use with
`mRNA therapeutic products.
`
`ANSWER: CureVac admits that Acuitas has developed LNP technology; that Acuitas
`
`and BioNTech entered into a collaboration; and that BioNTech licensed LNP technology from
`
`Acuitas. CureVac denies the remaining allegations in Paragraph 13.
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`BioNTech’s scientists, including Dr. Karikó, demonstrated that modified mRNA
`14.
`vaccines successfully conferred immunity against HIV, Zika, and influenza viruses in animal
`models; and published these results in the Journal of Experimental Medicine (the “2018 JEM
`Paper”). (See D.I. 105, Ex. 19.) The 2018 JEM Paper recognized that BioNTech’s mRNA vaccine
`platform has the “advantages of a favorable safety profile, potentially inexpensive manufacturing,
`and the capacity for rapid development in emerging epidemics.” (Id. at 1580 (emphasis added).)
`
`ANSWER: CureVac admits that D.I. 104-19 contains the quoted language, and that it
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`states that it was included in a volume of the “Journal of Experimental Medicine” published in
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`2018, and that Dr. Karikó was one of thirty-nine authors thereof. CureVac denies that any other
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`person stated to be an author of D.I. 104-19 was affiliated with BioNTech, and denies that D.I.
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`104-19 refers to “BioNTech’s mRNA vaccine platform.” CureVac lacks knowledge and
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`information sufficient to form a belief as to the truth of the remaining allegations in Paragraph 14,
`
`and therefore denies them.
`
`That same year, Pfizer and BioNTech partnered to develop an mRNA-based
`15.
`vaccine for influenza. As part of the agreement, BioNTech and Pfizer would jointly conduct
`research and development to advance mRNA-based flu vaccines. In announcing the collaboration,
`the head of Pfizer’s vaccine research and development unit, Dr. Kathrin Jansen, noted that
`“[i]nnovative vaccine approaches are urgently needed to provide improved protection against
`seasonal flu, and to respond rapidly and in quantity to pandemic influenza threats.” (D.I. 105, Ex.
`20 at 1 (emphasis added).) Dr. Jansen further emphasized that “mRNA vaccines offer a novel
`approach to code for any protein or multiple proteins, and the potential to manufacture higher
`potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines.” (Id.)
`
`ANSWER: CureVac admits that D.I. 104-20 contains the quoted language. CureVac
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`lacks knowledge and information sufficient to form a belief as to the truth of the remaining
`
`allegations in Paragraph 15, and therefore denies them.
`
`In December 2019, SARS-CoV-2 was reported in Wuhan, China. When this novel
`16.
`coronavirus emerged, BioNTech was well-positioned to respond rapidly by constructing a vaccine
`around its existing modified mRNA platform, which had already been tested against viruses such
`as HIV, Zika, and influenza. Leveraging decades of foundational research, BioNTech rapidly
`identified several candidates for clinical testing as mRNA-based vaccines to protect against
`COVID-19.
`
`ANSWER: CureVac admits that SARS-CoV-2 was first identified in Wuhan, China, in
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`December 2019. CureVac denies that Pfizer and BioNTech were well-positioned to respond
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`rapidly by constructing a vaccine around their existing modified mRNA platform: rather, CureVac
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`avers that Pfizer and BioNTech were able to rapidly develop and deploy Comirnaty® because they
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`incorporated the inventions claimed in CureVac’s patents-in-suit into Comirnaty®. CureVac lacks
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`knowledge and information sufficient to form a belief concerning the truth of the remaining
`
`allegations in Paragraph 16, and therefore denies them.
`
`By early 2020, soon after the genetic sequence for SARS-CoV-2 (the virus that
`17.
`causes COVID-19) was published, BioNTech and its development partner Pfizer initiated “Project
`Lightspeed,” an accelerated vaccine development program to fight COVID-19. BioNTech and
`Pfizer’s COVID-19 vaccine development program leveraged BioNTech’s experience and
`expertise with mRNA technologies, as well as the work of other partners, including Acuitas and
`the National Institutes of Health (“NIH”).
`
`ANSWER: CureVac lacks knowledge and information sufficient to form a belief
`
`concerning the truth of the allegations in Paragraph 17, and therefore denies them.
`
`For example, BioNTech developed innovative, proprietary mRNA-based
`18.
`technologies to achieve effective translational performance and direction of the immune response.
`BioNTech also leveraged its prior work with Acuitas on LNP technology and used Acuitas lipids
`ALC-315 and ALC-159. Further, BioNTech licensed and incorporated the work of NIH scientists
`relating to a particular modification to the sequence of the coronavirus spike protein (i.e., the
`protein structures covering the exterior of the SARS-CoV-2 virus), which causes the modified
`spike protein to be locked in a certain configuration. (See, e.g., D.I. 105, Ex. 21.) This
`configuration allows the modified spike protein to be recognized more easily by human cells and
`elicit a more robust bodily response that results in immunity.
`
`ANSWER: CureVac admits that Comirnaty® contains the lipids ALC-315 and ALC-
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`159. CureVac denies the remaining allegations in Paragraph 18.
`
`With the benefit of its prior development work for its mRNA platform, BioNTech
`19.
`rapidly developed and performed numerous toxicological and pharmacological studies to
`determine the safety and efficacy of the Comirnaty® vaccine. For example, BioNTech’s studies
`showed, inter alia, that the vaccine is highly immunogenic in animal models and provided the
`confirmation needed to move quickly into Phase 1 clinical studies.
`
`ANSWER: CureVac lacks knowledge and information sufficient to form a belief
`
`concerning the truth of the allegations in Paragraph 19, and therefore denies them.
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 12 of 32 PageID# 9890
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`testing,
`the development, clinical
`BioNTech partnered with Pfizer on
`20.
`manufacturing, distribution, and regulatory approval of the Comirnaty® vaccine. (See D.I. 1,
`Exhibit 6.) By March 2020, when the World Health Organization (“WHO”) declared the COVID-
`19 outbreak a global pandemic, Pfizer and BioNTech had already begun their collaborative effort.
`
`ANSWER: CureVac admits that D.I. 1-6 states that it is a “Collaboration Agreement”
`
`between BioNTech and Pfizer. CureVac lacks knowledge and information sufficient to form a
`
`belief as to the truth of the remaining allegations in Paragraph 20, and therefore denies them.
`
`Clinical trials of the Comirnaty® vaccine began in late April 2020, with preliminary
`21.
`results demonstrating its safety and efficacy published within six months. This rapid development
`and start of clinical trials of product candidates was not a chance event, the result of sudden
`inspiration, or copying someone else’s work. It was the result of the relentless work by dedicated
`scientists and the vision of BioNTech and Pfizer working together.
`
`ANSWER: CureVac denies that the rapid development and launch of Pfizer and
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`BioNTech’s product candidates was not the result of “copying someone else’s work,” and denies
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`that it was result of the “vision” of Pfizer and BioNTech: rather, CureVac avers that Pfizer and
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`BioNTech were able to rapidly develop and launch Comirnaty® because they copied critical
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`features from CureVac’s intellectual property, including the features recited in the claims of the
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`patents-in-suit. CureVac lacks knowledge and information sufficient to form a belief as to the truth
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`of the remaining allegations in Paragraph 21, and therefore denies them.
`
`On May 5, 2020, BioNTech and Pfizer announced that the first participants had
`22.
`been dosed in the United States in the Phase 1/2 clinical trial for their vaccine, codenamed
`BNT162, designed to determine safety and efficacy against COVID-19. (See D.I. 1, Exhibit 9.)
`After attaining promising Phase 1/2 clinical study results, on July 27, 2020, BioNTech and Pfizer
`began a Phase 2/3 study on their Comirnaty® vaccine. (See D.I. 1, Exhibit 12.) The pivotal Phase
`3 study was conducted on a global scale—encompassing more than 44,000 patients—to continue
`determining its safety and efficacy in humans. (See D.I. 1, Exhibit 8.)
`
`ANSWER: CureVac admits that D.I. 1-9 states “the first participants have been dosed
`
`in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19.”
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`CureVac admits that D.I. 1-12 states that on July 27, 2020, Pfizer Inc. and BioNTech SE
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`“announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 13 of 32 PageID# 9891
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`evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162
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`mRNA-based vaccine program, against SARS-CoV-2.” CureVac admits that D.I. 1-8, states
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`“Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of
`
`BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine,” and “Data
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`from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo,
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`showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing
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`COVID-19 in those without prior infection 7 days or more after the second dose.” CureVac lacks
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`knowledge and information sufficient to form a belief as to the truth of the remaining allegations
`
`in Paragraph 22, and therefore denies them.
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`Meanwhile, Pfizer was also working on the logistics and infrastructure needed to
`23.
`successfully manufacture and distribute the Comirnaty® vaccine. Pfizer leveraged its extensive
`manufacturing network to produce an approved COVID-19 vaccine as quickly as possible for those
`most in need in the United States.
`
`ANSWER: CureVac lacks knowledge and information sufficient to form a belief as to
`
`the truth of the allegations in Paragraph 23, and therefore denies them.
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`In November 2020, the Comirnaty® vaccine was shown to have met all the primary
`24.
`efficacy endpoints in a Phase 3 clinical trial, demonstrating an “efficacy rate of 95% (p < 0.0001)
`in participants without prior SARS-CoV-2 infection (first primary objective) and in participants
`with and without prior SARS-CoV-2 infection (second primary objective),” as measured from
`seven days after the second dose of the vaccine. (See D.I. 1, Exhibit 13.)
`
`ANSWER: CureVac admits that D.I. 1-13 includes the quoted language. CureVac lacks
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`knowledge and information sufficient to form a belief as to the truth of the remaining allegations
`
`in Paragraph 24, and therefore denies them.
`
`On November 20, 2020, Pfizer, on behalf of itself and BioNTech, submitted the
`25.
`clinical trial data as part of an Emergency Use Authorization (“EUA”) request to the Food and
`Drug Administration (“FDA”) for administering the Comirnaty® vaccine to people 16 years of age
`and older.
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`ANSWER: CureVac lacks knowledge and information sufficient to form a belief as to
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`the truth of the allegations in Paragraph 25, and therefore denies them.
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`Case 2:23-cv-00222-JKW-DEM Document 257 Filed 04/12/24 Page 14 of 32 PageID# 9892
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`On December 11, 2020, the FDA granted the first EUA for a COVID-19 vaccine
`26.
`to Pfizer and BioNTech’s Comirnaty® vaccine with vaccinations rolling out immediately
`thereafter, completing the fastest development of a vaccine in history.
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`ANSWER: CureVac admits that on December 11, 2020, the FDA granted