Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 1 of 22
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`THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`BIONTECH SE, BIONTECH
`MANUFACTURING GMBH, AND
`PFIZER INC.,
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`Plaintiffs,
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`CUREVAC AG,
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`Defendant.
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`C.A. No. 1:22-cv-11202
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`JURY TRIAL DEMANDED
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`COMPLAINT FOR DECLARATORY JUDGMENT OF NONINFRINGEMENT
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`Plaintiffs BioNTech SE and BioNTech Manufacturing GmbH (“BioNTech Manufacturing,”
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`and with BioNTech SE collectively, “BioNTech”) and Pfizer Inc. (“Pfizer”) (collectively,
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`“Plaintiffs”), by their undersigned attorneys, respectfully submit this Complaint for Declaratory
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`Judgment of Noninfringement against CureVac AG (“CureVac” or “Defendant”), and hereby allege
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`as follows:
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`INTRODUCTION
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`1.
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`This is an action brought by BioNTech and Pfizer who partnered together, and
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`continue to work together, to address the greatest public health threat the United States and the world
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`has faced in at least a century: the COVID-19 pandemic. Now, BioNTech and Pfizer must also face
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`threats of a groundless patent infringement suit by a company, CureVac, who has been unable to
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`bring to market any product to help in the fight against COVID-19.
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`THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`BIONTECH SE, BIONTECH
`MANUFACTURING GMBH, AND
`PFIZER INC.,
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`Plaintiffs,
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`v.
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`CUREVAC AG,
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`Defendant.
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`C.A. No. 1:22-cv-11202
`
`JURY TRIAL DEMANDED
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`
`
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`COMPLAINT FOR DECLARATORY JUDGMENT OF NONINFRINGEMENT
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`
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`Plaintiffs BioNTech SE and BioNTech Manufacturing GmbH (“BioNTech Manufacturing,”
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`and with BioNTech SE collectively, “BioNTech”) and Pfizer Inc. (“Pfizer”) (collectively,
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`“Plaintiffs”), by their undersigned attorneys, respectfully submit this Complaint for Declaratory
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`Judgment of Noninfringement against CureVac AG (“CureVac” or “Defendant”), and hereby allege
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`as follows:
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`INTRODUCTION
`
`1.
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`This is an action brought by BioNTech and Pfizer who partnered together, and
`
`continue to work together, to address the greatest public health threat the United States and the world
`
`has faced in at least a century: the COVID-19 pandemic. Now, BioNTech and Pfizer must also face
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`threats of a groundless patent infringement suit by a company, CureVac, who has been unable to
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`bring to market any product to help in the fight against COVID-19.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 2 of 22
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`2.
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`BioNTech and Pfizer partnered together to develop, manufacture, and secure
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`regulatory approval for a vaccine that proved to be effective in preventing severe disease,
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`hospitalization, and death from COVID-19 infection. BioNTech and Pfizer did so at great risk to
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`their companies, by investing considerable sums of money and countless hours in an effort to
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`address this global pandemic. BioNTech and Pfizer successfully developed a product, proved its
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`efficacy, established global manufacturing and supply chains, and gained regulatory approval in
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`record time. Through their efforts they were able to help the United States and the world begin to
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`move past the COVID-19 public health crisis.
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`3.
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`Unlike BioNTech’s and Pfizer’s efforts, CureVac’s failed, as it was unable to develop
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`a COVID-19 vaccine product. After this failure, CureVac turned its attention to an attempt to profit
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`from the success of BioNTech and Pfizer through threats of patent infringement.
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`4.
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`5.
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`BioNTech and Pfizer bring this action to resolve CureVac’s meritless allegations.
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`NATURE OF THE ACTION
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`This is a civil action for a declaratory judgment that U.S. Patent Nos. 11,135,312,
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`11,149,278, and 11,241,493 (collectively, “the patents-in-suit” and attached as Exhibits 1 to 3 of this
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`Complaint) are not infringed by the manufacture, use, offer to sell, and sale in the United States, and
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`the importation into the United States, of the mRNA vaccine against COVID-19 that BioNTech
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`created and made available to doctors and patients with Pfizer.
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`6.
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`This action arises under the Declaratory Judgment Act, 28 U.S.C. § 2201 and the
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`patent laws of the United States, including Title 35, United States Code.
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`THE PARTIES
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`7.
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`Plaintiff BioNTech SE 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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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 3 of 22
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`8.
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`Plaintiff BioNTech Manufacturing is a company organized and existing under the
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`laws of Germany, having a principal place of business at An der Goldgrube 12, D-55131 Mainz,
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`Germany.
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`9.
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`10.
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`BioNTech Manufacturing is a wholly owned subsidiary of BioNTech SE.
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`Plaintiff 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 235 East 42nd Street, New York, New York 10017.
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`11.
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`Upon information and belief, Defendant CureVac is a company organized and
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`existing under the laws of Germany, having a place of business at Friedrich-Miescher-Straße 15,
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`72076 Tübingen, Germany.
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`JURISDICTION AND VENUE
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`12.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a), and
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`2201.
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`13.
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`As described in detail below, an actual, immediate, substantial, and justiciable
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`controversy exists between Plaintiffs and CureVac as to whether the Pfizer-BioNTech COVID-19
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`vaccine (sold commercially as “COMIRNATY® vaccine”) has infringed or will infringe the patents-
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`in-suit.
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`14.
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`15.
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`This Court has personal jurisdiction over CureVac under Fed. R. Civ. P. 4(k)(2).
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`This Court also has personal jurisdiction over CureVac, because, inter alia, upon
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`information and belief, CureVac: (1) maintains pervasive, continuous, and systematic contacts with
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`Massachusetts; (2) conducts business in Massachusetts through its office and agents located in
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`Massachusetts; (3) sends agents into Massachusetts on a regular basis to conduct business; and
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`(4) holds itself out as doing business in Massachusetts.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 4 of 22
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`16.
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`Upon information and belief, since at least November 2017, CureVac has entered into
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`agreements and conducted business with multiple entities located in Massachusetts.
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`17.
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`Upon information and belief, in 2020, in connection with its initial public offering,
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`(a) CureVac N.V. was incorporated and became the holding company of CureVac and (b) the
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`historical consolidated financial statements of CureVac became part of the historical consolidated
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`financial statements of CureVac N.V. (Exhibit 4.)
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`18.
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`19.
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`Upon information and belief, CureVac is a wholly owned subsidiary of CureVac N.V.
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`Upon information and belief, CureVac also conducts business in Massachusetts, inter
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`alia, through its wholly owned subsidiary CureVac, Inc.
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`20.
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`Upon information and belief, CureVac, Inc. acts as an agent for CureVac for
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`conducting business in the United States, including Massachusetts.
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`21.
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`Upon information and belief, CureVac N.V. has designated CureVac, Inc. as its agent
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`for service of process in the United States.
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`22.
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`Upon information and belief, CureVac, Inc. maintains a lease on a property of more
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`than 12,000 square feet at 250 Summer Street, 3rd Floor, Boston, Massachusetts 02210.
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`23.
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`Upon information and belief, CureVac, Inc. is registered with the Commonwealth of
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`Massachusetts as a business in Massachusetts.
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`24.
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`Upon information and belief, the Foreign Corporation Certificate of Registration filed
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`by CureVac, Inc. with the Commonwealth of Massachusetts lists the CEO of CureVac as a corporate
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`officer and director of CureVac, Inc.
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`25.
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`Upon information and belief, CureVac sends employees and agents into
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`Massachusetts, including to CureVac, Inc.’s office located at 250 Summer Street, 3rd Floor, Boston,
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`Massachusetts 02210, on a regular basis.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 5 of 22
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`26.
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`Upon information and belief, CureVac lists Boston, USA as one of its offices. For
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`example, CureVac holds itself out as a “Tübingen, Germany/Boston, MA, USA” entity, inter alia,
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`on its corporate website and in press releases. CureVac has also stated that it “employs more than
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`900 people at its sites in Tübingen, Frankfurt, and Boston, USA.” (Exhibit 20.)
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`27.
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`This Court also has personal jurisdiction over CureVac because, inter alia, it sent
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`communications regarding CureVac’s assertion of intellectual property (“IP”) rights in connection
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`with COMIRNATY® vaccine to individuals at BioNTech US Inc., which is located in Cambridge,
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`Massachusetts.
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`28.
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`This Court also has personal jurisdiction over CureVac because, inter alia, the group
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`of representatives who were involved in CureVac’s assertion of IP rights in connection with
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`COMIRNATY® vaccine included the Director IP Management US of CureVac, Inc., which is
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`located in Boston, Massachusetts.
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`29.
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`This Court has personal jurisdiction over CureVac for at least the reasons set forth
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`above and for other reasons that will be presented to the Court if such personal jurisdiction were to
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`be challenged.
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`30.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391(c)(3) and 1400(b) because
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`CureVac is a foreign corporation and is subject to this Court’s personal jurisdiction for at least the
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`reasons set forth above.
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`31.
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`Venue is proper for at least the reasons set forth above and for other reasons that will
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`be presented to the Court if such venue were to be challenged.
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`32.
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`This Court is authorized to issue declaratory judgments pursuant to 28 U.S.C. § 2201.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 6 of 22
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`BACKGROUND
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`BioNTech
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`33.
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`BioNTech SE is a global biotechnology company specializing in the development of
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`novel medicines. BioNTech SE scientists have been researching and developing proprietary mRNA-
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`based technologies for more than 20 years, achieving expertise in, inter alia, translational drug
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`discovery and development, GMP manufacturing, and commercial capabilities.
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`34.
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`BioNTech SE has been using its proprietary technologies across multiple technology
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`platforms—including not only mRNA vaccines, but also small molecules, protein therapeutics, and
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`other cell and gene therapies—to address human diseases with unmet medical need and major health
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`burdens, such as cancer and infectious disease.
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`35.
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`Since its foundation, BioNTech SE has worked on mRNA-based vaccine candidates,
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`earning itself a reputation as an industry leader in mRNA technology. BioNTech partnered with
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`several companies and research institutes to develop mRNA-based vaccines.
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`36.
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`BioNTech Manufacturing is the holder of Biologics License Application No. 125742
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`for COMIRNATY® vaccine.
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`Pfizer
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`37.
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`Pfizer Inc. is a research-based biopharmaceutical company. Pfizer applies science
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`and its global resources to bring therapies to people that extend and significantly improve their lives
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`through the discovery, development, manufacture, marketing, sale, and distribution of
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`biopharmaceutical products.
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`38.
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`Pfizer works across developed and emerging markets to advance wellness,
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`prevention, treatments, and cures that challenge the most feared diseases of our time. Pfizer
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`collaborates with healthcare providers, governments, and local communities to support and expand
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 7 of 22
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`access to reliable, affordable healthcare around the world. Pfizer was incorporated under the laws of
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`the State of Delaware on June 2, 1942.
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`39.
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`Research and development (“R&D”) is at the heart of fulfilling Pfizer’s purpose to
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`deliver breakthroughs that change patients’ lives as Pfizer works to translate advanced science and
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`technologies into the therapies that may be the most impactful for patients. The discovery and
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`development of drugs, vaccines, and biological products are time consuming, costly, and
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`unpredictable.
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`The Development of COMIRNATY® Vaccine
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`40.
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`In December 2019, reports began circulating about an outbreak of pneumonia
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`resulting in severe illness and death among people who were linked to the Huanan Seafood
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`Wholesale Market in Wuhan, China.
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`41.
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`By January 2020, it was discovered that the cause of this pneumonia outbreak was a
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`novel coronavirus, eventually designated by the World Health Organization (“WHO”) as SARS-
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`CoV-2 with the disease it causes reclassified as Coronavirus disease 2019 (“COVID-19”).
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`42.
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`On March 11, 2020, the WHO designated COVID-19 an international pandemic as
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`the disease quickly spread worldwide and tore through immunologically naïve populations,
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`threatening the collapse of the healthcare system and loss of life at scales not seen since the advent
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`of modern medicine.
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`43.
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`In response, countries around the world instituted society-shaking restrictions on
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`movement, requiring people to temporarily stay confined and isolated to their homes in an attempt to
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`slow transmission of disease, save lives, and gain time to develop a fulsome response.
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`44.
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`To date, COVID-19 has infected at least 508 million people around the world,
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`resulting in more than 6 million deaths. (Exhibit 4.)
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 8 of 22
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`45.
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`In the midst of the COVID-19 pandemic, many saw the development of highly
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`effective and safe vaccines that successfully targeted and neutralized COVID-19 as the path out of
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`the pandemic without a continuing, massive loss of life.
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`46.
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`By early January of 2020, BioNTech initiated “Project Lightspeed,” an accelerated
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`vaccine development program to fight COVID-19. BioNTech’s COVID-19 vaccine development
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`program leveraged BioNTech’s experience and expertise with mRNA technologies. For example,
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`BioNTech has developed innovative, proprietary mRNA-based technologies to achieve effective
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`translational performance and direction of the immune response.
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`47.
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`BioNTech rapidly developed and performed numerous toxicological and
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`pharmacological studies to determine the safety and efficacy of the COVID-19 vaccine. For
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`example, BioNTech’s studies showed, inter alia, that its COVID-19 vaccine is highly immunogenic
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`in animal models and provided the needed confirmation to quickly move into Phase 1 clinical
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`studies.
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`48.
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`BioNTech and Pfizer decided to partner together on the development, clinical testing,
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`manufacturing, distribution, and regulatory approval of the Pfizer-BioNTech COVID-19 vaccine.
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`(Exhibit 6.)
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`49.
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`BioNTech and Pfizer agreed to share the costs of developing the COVID-19 vaccine.
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`By the end of the first quarter of 2020, Pfizer had increased its yearly R&D budget by $500 million
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`to reflect investments in combatting COVID-19. (Exhibit 7.)
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`50.
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`On May 5, 2020, BioNTech and Pfizer announced that the first participants had been
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`dosed in the United States in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent
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`COVID-19. (Exhibit 9.) After attaining promising Phase 1 clinical study results, BioNTech and
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`Pfizer rapidly moved the Pfizer-BioNTech COVID-19 vaccine into the pivotal Phase 2 and 3
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 9 of 22
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`studies—on a global scale encompassing more than 44,000 patients—to determine its safety and
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`efficacy in humans. (Exhibit 8.)
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`51. Meanwhile, Pfizer was also working on the logistics and infrastructure needed to
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`successfully manufacture and distribute the Pfizer-BioNTech COVID-19 vaccine. Pfizer activated
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`its extensive manufacturing network and invested at risk in an effort to produce an approved
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`COVID-19 vaccine as quickly as possible for those most in need around the world. Pfizer-owned
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`sites in three U.S. states (Massachusetts, Michigan, and Missouri) and Puurs, Belgium were
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`identified as manufacturing centers for COVID-19 vaccine production, with more sites to be
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`selected. (Exhibit 10.)
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`52.
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`On July 13, 2020, BioNTech SE and Pfizer announced that investigational vaccine
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`candidates from their BNT162 mRNA-based vaccine program being developed to help protect
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`against SARS-CoV-2 (the virus that causes COVID-19) received Fast Track designation from the
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`U.S. Food and Drug Administration (“FDA”). (Exhibit 11.)
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`53.
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`On July 27, 2020, BioNTech and Pfizer began a Phase 2/3 clinical study of their
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`advanced nucleoside-modified messenger RNA candidate BNT162b2. (Exhibit 12.)
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`54.
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`In about November of 2020, the Pfizer-BioNTech COVID-19 vaccine was shown to
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`have met all the primary efficacy endpoints in a Phase 3 clinical trial, demonstrating an efficacy rate
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`of 95% (p < 0.0001) in participants without prior SARS-CoV-2 infection (first primary objective)
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`and in participants with and without prior SARS-CoV-2 infection (second primary objective), as
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`measured from seven days after the second dose of the vaccine. (Exhibit 13.)
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`55.
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`On November 20, 2020, Pfizer, on behalf of itself and BioNTech, submitted clinical
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`trial data as part of an Emergency Use Authorization (“EUA”) request to the FDA for administering
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`the Pfizer-BioNTech COVID-19 vaccine to people 16 years of age and older.
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`56.
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`On December 11, 2020, the FDA granted an EUA for the Pfizer-BioNTech COVID-
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`19 vaccine for use in individuals 16 years of age and older.
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`57.
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`The Pfizer-BioNTech COVID-19 vaccine was the first mRNA drug product, and the
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`first vaccine to target COVID-19, authorized for emergency use in the United States.
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`58.
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`As part of the fastest development of a vaccine in history, doses of the Pfizer-
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`BioNTech COVID-19 vaccine were distributed immediately after the FDA granted an EUA.
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`59.
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`On May 11, 2021, the FDA expanded the EUA for the Pfizer-BioNTech COVID-19
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`vaccine to include children as young as 12 years of age.
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`60.
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`On October 29, 2021, the FDA also expanded the EUA for the Pfizer-BioNTech
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`COVID-19 vaccine to include children as young as 5 years of age.
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`61.
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`On June 17, 2022, the FDA further expanded the EUA for the Pfizer-BioNTech
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`COVID-19 vaccine to include children as young as 6 months of age.
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`62.
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`Based on a comprehensive data package and real-world results demonstrating the
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`overwhelming safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, on August 23, 2021,
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`the FDA granted full approval of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years
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`of age and older.
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`63.
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`In 2021, Pfizer manufactured more than three billion doses of the Pfizer-BioNTech
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`COVID-19 vaccine. (Exhibit 14.) BioNTech and Pfizer expect to manufacture up to four billion
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`doses in total by the end of 2022. Id.
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`64.
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`The Pfizer-BioNTech COVID-19 vaccine fully approved by the FDA is marketed
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`under the trade name COMIRNATY®.
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`65.
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`COMIRNATY® vaccine was the first mRNA drug product, and the first COVID-19
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`vaccine to receive full FDA approval.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 11 of 22
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`66.
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`COMIRNATY® vaccine is indicated for “active immunization to prevent coronavirus
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`disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
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`2).” (Exhibit 15.)
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`67.
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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. (Exhibit
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`16.) Furthermore, widespread vaccination of populations with COMIRNATY® vaccine allowed
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`Massachusetts and other jurisdictions to remove restrictions on movement, easing the burdens
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`countless individuals suffered during forced isolation.
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`CureVac
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`68.
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`Upon information and belief, CureVac was founded in 2000 and holds itself out to be
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`a clinical stage biotechnology company.
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`69.
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`Upon information and belief, CureVac had undertaken efforts aimed at developing at
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`least one COVID-19 vaccine.
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`70.
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`Upon information and belief, on or about June 16, 2021, a pivotal Phase 2b/3 clinical
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`trial showed that CureVac’s COVID-19 vaccine candidate, “CVnCoV,” had an interim vaccine
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`efficacy of only about 47% against COVID-19 of any severity and did not meet the pre-specified
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`statistical success criteria. (Exhibit 4.)
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`71.
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`Upon information and belief, in the day following the publication of the unsuccessful
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`Phase 2b/3 clinical trial data of CVnCoV, the price of CureVac N.V.’s stock, which is publicly
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`traded in the United States, fell by about 50%. (Exhibit 17.)
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`72.
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`Upon information and belief, in about October of 2021, based on the disappointing
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`results of its clinical studies, CureVac withdrew its CVnCoV vaccine candidate from the approval
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`process with the European Medicines Agency. (Exhibit 18.)
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`73.
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`Upon information and belief, CureVac N.V.’s consolidated net losses for the years
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`ending December 31, 2021 and December 31, 2020 were approximately €411.7 million and
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`€129.1 million, respectively. As of December 31, 2021, CureVac N.V.’s accumulated deficit was
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`approximately €1.06 billion. (Exhibit 4.)
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`74.
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`Upon information and belief, in January 2022, CureVac N.V.’s Chief Technology
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`Officer resigned from the company. (Exhibit 5.)
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`75.
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`Upon information and belief, CureVac N.V. has reported an expectation of continued
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`losses in the future. (Exhibit 4.)
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`76.
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`Upon information and belief, CureVac has reported that it has no history of
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`commercializing pharmaceutical products, including any COVID-19 vaccine. (Exhibit 4.)
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`77.
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`Upon information and belief, CureVac has reported that it cannot give any assurance
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`that any of its product candidates will receive regulatory approval in the future. (Exhibit 4.)
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`78.
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`Upon information and belief, CureVac licensed from Acuitas Therapeutics, Inc.
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`(“Acuitas”) lipid nanoparticle (“LNP”) technology developed by Acuitas.
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`79.
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`Upon information and belief, as of January 2020, CureVac was aware that BioNTech
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`had licensed LNPs from Acuitas for use with mRNA therapeutic products.
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`80.
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`Upon information and belief, CureVac used the LNP technology it licensed from
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`Acuitas in its failed COVID-19 vaccine candidate.
`
`CureVac’s Assertion of the Patents-in-Suit against BioNTech and Pfizer
`
`81.
`
`In about February 2022, after CureVac had withdrawn its CVnCoV vaccine candidate
`
`from the regulatory approval process, CureVac N.V. contacted BioNTech SE, Pfizer’s collaboration
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`partner, seeking to initiate discussions between the IP counsel of CureVac and BioNTech SE
`
`regarding the potential licensing of certain IP rights from CureVac.
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 13 of 22
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`
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`82.
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`Upon information and belief, CureVac N.V. had at that time a deadline to report
`
`financial results and provide business updates for the fourth quarter and full-year of 2021 on April
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`28, 2022.
`
`83.
`
`CureVac contacted the Senior Patent Counsel of BioNTech US Inc., which is located
`
`in Cambridge, Massachusetts, regarding the licensing of certain IP rights from CureVac in
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`connection with COMIRNATY® vaccine. At that time, it was publicly known that BioNTech and
`
`Pfizer were collaborating on the manufacture of COMIRNATY® vaccine and that Pfizer
`
`manufactured COMIRNATY® vaccine in the United States.
`
`84.
`
`Upon information and belief, at all relevant times since the initial contact described
`
`above, CureVac was aware that Pfizer manufactures and is responsible for the distribution and sale
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`of COMIRNATY® vaccine in the United States, including in Massachusetts.
`
`85.
`
`At all relevant times, BioNTech and Pfizer have worked together with respect to
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`CureVac’s accusations.
`
`86.
`
`CureVac and BioNTech SE held a videoconference on April 4, 2022, and an in-
`
`person meeting on April 7, 2022.
`
`87.
`
`On March 29, 2022, CureVac sent BioNTech SE a document identifying CureVac’s
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`purported IP portfolio. This document included the patents-in-suit and related patents, of which the
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`patents-in-suit are representative family members.
`
`88.
`
`On June 9, 2022, CureVac and BioNTech SE conducted a meeting relating to
`
`CureVac’s threat to assert its patents in connection with COMIRNATY® vaccine. Such threat
`
`included both United States patents and their European counterparts.
`
`89.
`
`Upon information and belief, CureVac was aware that BioNTech SE was acting in the
`
`discussions with the knowledge of both BioNTech and Pfizer.
`
`
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`- 13 -
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 14 of 22
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`
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`90.
`
`The parties did not reach an amicable resolution of CureVac’s threats. CureVac has
`
`stated that the parties’ “out-of-court dispute resolution efforts have not been successful.” (Exhibit
`
`19.)
`
`91.
`
`Upon information and belief, individuals from CureVac who were involved in the
`
`communications regarding CureVac’s IP rights in connection with COMIRNATY® vaccine included
`
`the Chief Business Officer and Chief Commercial Officer of CureVac, the Vice President, Patents of
`
`CureVac, the Head of IP Management of CureVac, and the Director IP Management US of CureVac,
`
`Inc.
`
`92.
`
`On June 29, 2022, following the failed dispute resolution efforts, CureVac submitted
`
`an infringement complaint to the German Regional Court in Düsseldorf against BioNTech SE,
`
`BioNTech Manufacturing GmbH, and BioNTech Manufacturing Marburg GmbH, alleging, inter
`
`alia, that the manufacture and sale of COMIRNATY® vaccine infringes European counterparts to the
`
`patents-in-suit. (Exhibit 19.)
`
`93.
`
`On July 5, 2022, CureVac N.V. issued a press release announcing that “it has moved
`
`to assert its intellectual property rights” against BioNTech. (Exhibit 20.)
`
`94.
`
`That same day, following CureVac’s announcement of its lawsuit against BioNTech
`
`and that it intended to assert its intellectual property rights against COMIRNATY® vaccine, news
`
`reports indicated that Pfizer’s stock fell over 3.5%. (Exhibit 21.)
`
`95.
`
`The German infringement complaint does not name Pfizer. Pfizer does not
`
`manufacture or sell COMIRNATY® vaccine in Germany. According to news reports, however,
`
`when asked in a media call, CureVac’s chief executive said that he was not ruling out further legal
`
`action against BioNTech partner Pfizer. (Exhibit 22.)
`
`
`
`- 14 -
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`
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 15 of 22
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`
`
`96.
`
`Based on, at a minimum, CureVac’s assertion of the patents-in-suit and
`
`commencement of litigation with respect to European counterparts of such patents in connection
`
`with COMIRNATY® vaccine, an actual, immediate, substantial, and justiciable controversy exists
`
`between BioNTech, Pfizer, and CureVac as to whether COMIRNATY® vaccine has infringed or will
`
`infringe the patents-in-suit.
`
`97.
`
`Plaintiffs fund pharmaceutical research and development in part with revenues from
`
`COMIRNATY® vaccine. CureVac’s assertion of the patents-in-suit in connection with
`
`COMIRNATY® vaccine has created a cloud of uncertainty, inter alia, with respect to what portion
`
`of the revenues from COMIRNATY® vaccine Plaintiffs may invest into that research and
`
`development.
`
`THE PATENTS-IN-SUIT
`
`U.S. Patent No. 11,135,312 (“the ’312 patent”)
`
`98.
`
`Upon information and belief, the ’312 patent, titled “Pharmaceutical Composition
`
`Containing a Stabilised mRNA Optimised for Translation in its Coding Regions,” issued on
`
`October 5, 2021. The ’312 patent names Florian Von Der Mülbe, Ingmar Hoerr, and Steve Pascolo
`
`as inventors. Upon information and belief, CureVac appears to be the assignee of the ’312 patent. A
`
`true and correct copy of the ’312 patent is attached to this Complaint as Exhibit 1.
`
`99.
`
`The ’312 patent contains an independent claim 1 that recites a “method for producing
`
`a stabilized mRNA molecule encoding a polypeptide, wherein the stabilized mRNA molecule
`
`encoding the polypeptide comprises a coding sequence that has an increased Guanine/Cytosine
`
`(G/C) content relative to the original coding sequence encoding the polypeptide, said relative G/C
`
`content being increased by at least 7 percentage points compared to the original coding sequence
`
`encoding the polypeptide, to thereby produce a stabilized mRNA molecule, wherein said increase in
`
`
`
`- 15 -
`
`
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 16 of 22
`
`
`
`relative G/C content results in the elimination of at least one destabilizing sequence element (DSE),
`
`wherein the stabilized mRNA molecule exhibits enhanced expression of the polypeptide compared
`
`to mRNA having the original coding sequence encoding the polypeptide.”
`
`U.S. Patent No. 11,149,278 (“the ’278 patent”)
`
`100. Upon information and belief, the ’278 patent, titled “Artificial Nucleic Acid
`
`Molecules for Improved Protein Expression,” issued on October 19, 2021. The ’278 patent names
`
`Andreas Thess, Thomas Schlake, and Stefanie Grund as inventors. Upon information and belief,
`
`CureVac appears to be the assignee of the ’278 patent. A true and correct copy of the ’278 patent is
`
`attached to this Complaint as Exhibit 2.
`
`101. The ’278 patent contains an independent claim 1 that recites a “method for treating or
`
`preventing an infectious disease, the method comprising administering an RNA molecule
`
`comprising: a) at least one open reading frame (ORF) encoding an antigen from a pathogen
`
`associated with the infectious disease; and b) a 3’-untranslated region (3’-UTR) comprising at least
`
`two poly(A) sequences, wherein at least one of the poly(A) sequences comprises at least 70 adenine
`
`nucleotides, wherein the at least two poly(A) sequence elements are separated by a nucleic acid
`
`sequence comprising from 10 to 90 nucleotides, wherein the RNA molecule is administered
`
`intramuscularly.”
`
`U.S. Patent No. 11,241,493 (“the ’493 patent”)
`
`102. Upon information and belief, the ’493 patent, titled “Coronavirus Vaccine,” issued on
`
`February 8, 2022. The ’493 patent names Susanne Rauch, Hans Wolfgang Große, and Benjamin
`
`Petsch as inventors. Upon information and belief, CureVac appears to be the assignee of the
`
`’493 patent. A true and correct copy of the ’493 patent is attached to this Complaint as Exhibit 3.
`
`
`
`- 16 -
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`
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`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 17 of 22
`
`
`
`103. The ’493 patent contains an independent claim 1 that recites a “composition
`
`comprising a mRNA comprising,” inter alia, “at least one coding sequence encoding a SARS-CoV-2
`
`spike protein (S)” and “at least one pharmaceutically acceptable carrier, wherein the mRNA is
`
`complexed or associated with lipid nanoparticles.” Claim 1 also recites that “the LNP comprises”
`
`“at least one cationic lipid according to formula III-3,” “at least one neutral lipid, comprising
`
`1,2-distearoylsn-glycero-3-phosphocholine (DSPC),” “at least one steroid, comprising cholesterol,”
`
`and “at least one PEG-lipid according to formula IVa.” Claim 1 further recites that the lipids
`
`comprising the LNP “are in a molar ratio of about 20-60% cationic lipid, 5-25% neutral lipid, 25-
`
`55% sterol, and 0.5-15% PEG-lipid.”
`
`COUNT I: NONINFRINGEMENT OF THE ’312 PATENT
`
`104. Plaintiffs incorporate by reference herein all of the allegations of paragraphs 5 to 103.
`
`105. There is an actual case or controversy between Plaintiffs and CureVac as to whether
`
`COMIRNATY® vaccine is manufactured by a method that meets all of the limitations of any claim
`
`of the ’312 patent and whether the manufacture, use, offer to sell, and sale of COMIRNATY®
`
`vaccine, and the importation of COMIRNATY® vaccine into the United States, infringes any claim
`
`of the ’312 patent.
`
`106. The manufacture, use, offer to sell, and sale of COMIRNATY® vaccine, and the
`
`importation of COMIRNATY® vaccine into the United States, does not infringe any claim of the
`
`’312 patent.
`
`107. For example, COMIRNATY® vaccine is not manufactured by a method that
`
`comprises “synthesizing a stabilized mRNA molecule encoding a polypeptide, wherein the stabilized
`
`mRNA molecule encoding the polypeptide comprises a coding sequence that has an increased
`
`
`
`- 17 -
`
`
`
`Case 1:22-cv-11202-JCB Document 1 Filed 07/25/22 Page 18 of 22
`
`
`
`Guanine/Cytosine (G/C) content relative to the original coding sequence encoding the polypeptide,”
`
`as required by all of the claims of the ’312 patent to the extent understood.
`
`108. Plaintiffs are entitled to a judgment that COMIRNATY® vaccine is not manufactured
`
`by a method that meets all of the limitations of any claim of the ’312 patent and that the
`
`manufacture, use, offer to sell, and sale of COMIRNATY® vaccine, and the importation of
`
`COMIRNATY® vaccine into the United States, does not infringe any claim of the ’312 patent.
`
`COUNT II: NONINFRINGEMENT OF THE ’278 PATENT
`
`109. Plaintiffs incorporate by reference herein all of the allegations of paragraphs 5 to 108.
`
`110. There is an actual case or controversy between Plaintiffs and CureVac as to whether
`
`COMIRNATY® vaccine meets all the limitations of any claim of the ’278 patent and whether the
`
`manufacture, use, offer to sell, and sale of COMIRNATY® vaccine, and the importation of
`
`COMIRNATY® vaccine into the United States, infringes any cl
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