Case 1:22-cv-02229-MKV Document 78-1 Filed 08/01/23 Page 1 of 77
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`Exhibit A
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`Liza M. Walsh
`Mariel L. Belanger
`Jessica K. Formichella
`Lauren R. Malakoff
`WALSH PIZZI O’REILLY FALANGA LLP
`Three Gateway Center
`100 Mulberry Street, 15th Floor
`Newark, New Jersey 07102
` (973) 757-1100
`lwalsh@walsh.law
`mbelanger@walsh.law
`jformichella@walsh.law
`lmalakoff@walsh.law
`
`Attorneys for Defendant/Counterclaimant
`Pfizer Inc.
`
`
`William P. Deni, Jr.
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`(973) 596-4500
`wdeni@gibbonslaw.com
`jlower@gibbonslaw.com
`
`Attorneys for Defendant/Counterclaimant
`BioNTech SE
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ARBUTUS BIOPHARMA CORP. and
`GENEVANT SCIENCES GMBH,
`
`Plaintiffs,
`
`v.
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`PFIZER INC. and BIONTECH SE,
`
`Defendants.
`
`PFIZER INC. and BIONTECH SE,
`
`Counterclaimants,
`
`v.
`
`
`
`
`
`Civil Action No. 3:23-cv-1876-ZNQ-TJB
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`Document Filed Electronically
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`JURY TRIAL DEMANDED
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`PFIZER INC. AND BIONTECH SE’S
`ANSWER, AFFIRMATIVE
`DEFENSES, AND
`COUNTERCLAIMS IN RESPONSE
`TO COMPLAINT FOR PATENT
`INFRINGEMENT
`
`ARBUTUS BIOPHARMA CORP. and
`GENEVANT SCIENCES GMBH,
`
`Counterclaim-Defendants.
`
`
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`
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`Defendants Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) (collectively,
`
`
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`“Defendants”) hereby answer the Complaint for Patent Infringement (“Complaint”) filed by
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`

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`Plaintiffs Arbutus Biopharma Corp. (“Arbutus”) and Genevant Sciences GmbH (“Genevant”)
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`(collectively, “Plaintiffs”). Any allegations not expressly admitted are denied. This answer
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`follows the numbering provided in Plaintiffs’ Complaint. To the extent that the section headings
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`of Plaintiffs’ Complaint contain allegations, those allegations are denied. To the extent Plaintiffs’
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`footnotes contain allegations, those allegations are denied.
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`INTRODUCTION
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`Arbutus invented and was awarded numerous patents on the breakthrough lipid
`1.
`nanoparticle (“LNP”) technologies needed to deliver messenger ribonucleic acid (“mRNA”)
`therapeutics to human cells. Genevant, a world leader in nucleic acid drug delivery and
`development, licenses these patents from Arbutus.
`
`RESPONSE: Defendants admit that the Patent and Trademark Office issued United States
`
`Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098 (collectively, the
`
`“Asserted Patents”), but deny that the Asserted Patents are valid or infringed by Defendants.
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`Defendants otherwise lack the knowledge or information sufficient to form a belief as to the truth
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`of the remaining allegations of Paragraph 1 and therefore deny the allegations.
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`When the world was thrust into a devastating pandemic and urgently needed LNP
`2.
`technologies to deliver an mRNA-based COVID-19 vaccine to cells in the body, the necessary
`LNP technologies had, fortunately, already been invented by Arbutus’s scientists years before and
`stood ready for use. Defendants could not have accomplished the feat of creating and
`manufacturing a vaccine at a speed unprecedented in the history of medicine but for their use of
`Plaintiffs’ existing and proven LNP technologies. Yet Defendants never paid Plaintiffs to use those
`technologies. And Defendants continue to knowingly use the technologies to make and sell the
`vaccine, amassing tens of billions of dollars in revenues. Plaintiffs have thus filed this case to
`obtain fair compensation for their inventions, without which the vaccine would not exist.
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`RESPONSE: Defendants deny infringement of any valid claim of the Asserted Patents
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`and that Plaintiffs are entitled to damages. At least because of the scope, breadth, and vagueness
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`of this allegation, Defendants otherwise lack the knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations of Paragraph 2 and therefore deny the allegations.
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`Defendants’ vaccine works by delivering a synthetic mRNA to the body’s cells.
`3.
`The biggest technological barrier to mRNA-based medicines is not the mRNA itself—BioNTech’s
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`2
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`CEO designed the mRNA over a weekend. The biggest barrier is instead how to deliver the mRNA
`to cells safely and effectively. As Pfizer’s CEO Albert Bourla has explained, “[t]he whole mRNA
`[vaccine] platform is not how to build an mRNA molecule; that’s the easy thing.” The hard thing
`is “how to make sure the mRNA molecule will go into your cells and give the instructions.”1 A
`Nobel Prize-winner has similarly explained that the key to RNA therapeutics was “delivery,
`delivery, delivery.”2
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`RESPONSE: To the extent the allegations of Paragraph 3 purport to rely on public
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`statements, those statements speak for themselves. Defendants admit that Defendants’ vaccine
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`(referred to herein by its trade name Comirnaty®) contains synthetic mRNA. At least because of
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`the scope, breadth, and vagueness of this allegation, Defendants otherwise lack the knowledge or
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`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 3
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`and therefore deny the allegations.
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`The delivery problem had persisted for decades until a team of Arbutus scientists,
`4.
`many now at Genevant companies, developed and refined technologies that solved the problem,
`for which they were awarded many patents. Their solution involved microscopic particles, built
`from four carefully-selected types of fat-like molecules, that are stable enough to shelter and
`protect fragile ribonucleic acid (“RNA”) molecules on a voyage through the human body to a
`target cell, and then through the target cell’s membrane, before finally releasing the RNA. These
`particles are called lipid nanoparticles and their invention was widely recognized as a major
`achievement that is essential for mRNA vaccines.
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`RESPONSE: Defendants admit that the Asserted Patents were issued, but deny that the
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`Asserted Patents are valid or infringed by Defendants. At least because of the scope, breadth, and
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`vagueness of this allegation, Defendants lack the knowledge or information sufficient to form a
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`belief as to the truth of the remaining allegations of Paragraph 4 and therefore deny the allegations.
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`Arbutus also developed the technologies needed to manufacture these LNPs.
`5.
`Before Arbutus’s scientists tackled the manufacturing challenges, methods of manufacturing LNPs
`for RNA employed harsh conditions that would damage the RNA that the LNPs were supposed to
`protect. Arbutus’s scientists developed new, elegant manufacturing methods that preserved the
`
`1 Nathan Vardi, Covid’s Forgotten Hero: The Untold Story Of The Scientist Whose
`Breakthrough Made The Vaccines Possible, Forbes, Aug. 17, 2021
`(https://tinyurl.com/86ud83kj).
`2 Erika Check, RNA to the Rescue?, Nature, 425:10-12 (2003)
`(www.nature.com/articles/425010a).
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`3
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`RNA and allowed for it to reach target cells in an undamaged state. Their solution used what is
`called a T-connector to mix together flows of lipids and dissolved RNAs in a process that ensures
`the RNA is both encapsulated and protected during the formulation process.
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`RESPONSE: At least because of the scope, breadth, and vagueness of this allegation,
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`Defendants lack the knowledge or information sufficient to form a belief as to the truth of the
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`allegations of Paragraph 5 and therefore deny the allegations.
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`Defendants have long recognized the value of Plaintiffs’ LNP technologies and
`6.
`patent rights. For example, in 2018, BioNTech paid for a license to use the technologies in a
`contract that described Genevant’s platform as “the best lipid nanoparticle technology.” The
`license only permitted BioNTech to use the technology in specific cancer and rare liver disease
`treatments and did not extend to uses for infectious diseases like COVID-19. Pfizer, on information
`and belief, has long known about that license and Plaintiffs’ patents. Yet neither BioNTech nor
`Pfizer asked for a license to use Plaintiffs’ LNP technologies in a COVID-19 vaccine. They just
`used the technologies without paying for them—keeping for themselves tens of billions in revenue
`that would never have existed were it not for Plaintiffs’ innovation.
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`RESPONSE: Defendants admit that there is a license agreement between BioNTech and
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`Genevant, which speaks for itself. Defendants deny infringement of any valid claim of the
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`Asserted Patents and that Plaintiffs are entitled to damages. Defendants deny the remaining
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`allegations of Paragraph 6.
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`Plaintiffs have licensed their technologies to many companies and would have
`7.
`granted a license to Defendants on reasonable terms for use in a COVID-19 vaccine. Indeed, the
`parties engaged in licensing discussions that unfortunately failed to result in a settlement. Plaintiffs
`have therefore been left no choice but to file this lawsuit to seek fair compensation in the form of
`a reasonable royalty for Defendants’ unlicensed use of Plaintiffs’ patents.
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`RESPONSE: Defendants admit that Plaintiffs sent a letter to Pfizer copying BioNTech
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`on November 23, 2020, and that Defendants have not entered into a license with Plaintiffs.
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`Defendants deny infringement of any valid claim of the Asserted Patents and that Plaintiffs are
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`entitled to damages. At least because of the scope, breadth, and vagueness of this allegation,
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`Defendants otherwise lack the knowledge or information sufficient to form a belief as to the truth
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`of the remaining allegations of Paragraph 7 and therefore deny the allegations.
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`4
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`NATURE OF THE ACTION
`
`This is a civil action by Plaintiffs against Defendants under the patent laws of the
`8.
`United States, 35 U.S.C. § 101 et seq., seeking damages for Defendants’ infringing manufacture,
`use, sale, offer for sale, and/or importation of their COVID-19 vaccine and any COVID-19
`mRNA-LNP vaccine products, including: pediatric doses; booster doses; supplemental doses;
`reformulations; boosters or re-vaccinations; variant-specific formulations; bivalent formulations;
`and the products known or marketed as Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine,
`Comirnaty, Tozinameran, BNT162b2, or PF-07302048 (collectively, the “Accused Product” or
`“Defendants’ vaccine”).
`
`RESPONSE: Paragraph 8 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants admit that the Complaint purports to state a claim for
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`infringement arising under 35 U.S.C. § 1, et seq. for the sale of Comirnaty® but deny that they
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`have infringed or will infringe, directly or indirectly, the Asserted Patents. Defendants deny the
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`remaining allegations of Paragraph 8.
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`Defendants’ manufacture, use, sale, offer to sell, and/or importation of the Accused
`9.
`Product directly and/or indirectly infringes or will infringe, or actively induces or will actively
`induce infringement of, one or more valid enforceable claims of, and Plaintiffs’ rights arising
`under, the following patents relating to nucleic acid-lipid particles, compositions thereof, their
`manufacture, and/or their use to deliver mRNA and/or other nucleic acid-based medicines: U.S.
`Patent Nos. 9,504,651 (Exhibit A); 8,492,359 (Exhibit B); 11,141,378 (Exhibit C); 11,298,320
`(Exhibit D); and 11,318,098 (Exhibit E) (collectively, the “Asserted Patents”). At all relevant
`times, Arbutus owned the Asserted Patents and licensed exclusive rights to sublicense, practice,
`and sue for infringement of them to Genevant in certain fields of use that include the vaccine
`application at issue in this Complaint, with certain exceptions not relevant here (hereinafter,
`Genevant’s “Exclusive Rights”).
`
`RESPONSE: Defendants admit that Exhibits A through E are documents that purport to
`
`be copies of the Asserted Patents, but deny that the Asserted Patents are valid and enforceable. At
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`least because of the scope, breadth, and vagueness of this allegation, Defendants otherwise lack
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`the knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of Paragraph 9 and therefore deny the allegations.
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`PARTIES
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`Plaintiff Arbutus Biopharma Corporation is a Canadian corporation with its
`10.
`principal place of business at 701 Veterans Circle, Warminster, Pennsylvania, 18974. The
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`include discovering, developing, and
`research and development efforts
`company’s
`commercializing a cure for chronic hepatitis B virus, as well as drug discovery and development
`for treating coronaviruses, including SARS-CoV-2, which causes COVID-19.
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`RESPONSE: On information and belief, Defendants admit that Arbutus is a Canadian
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`corporation with its principal place of business at 701 Veterans Circle, Warminster, Pennsylvania
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`18974. Defendants otherwise lack the knowledge or information sufficient to form a belief as to
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`the truth of the remaining allegations of Paragraph 10 and therefore deny the allegations.
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`Plaintiff Genevant Sciences GmbH is a Swiss company with its principal place of
`11.
`business at Viaduktstrasse 8, 4051 Basel, Switzerland. Together with its affiliated companies, it
`maintains an office in Cambridge, Massachusetts, and Vancouver, British Columbia. Genevant is
`a technology-focused nucleic acid delivery solutions company with cutting-edge LNP platforms.
`Genevant owns or licenses the industry’s most important LNP intellectual property—that of
`Arbutus—and has decades of experience and expertise in nucleic acid drug delivery and
`development. Genevant’s mission is to utilize its LNP and other technologies to deliver innovative
`new medicines that use mRNA or other nucleic acids.
`
`RESPONSE: On information and belief, Defendants admit that Genevant Sciences GmbH
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`is a Swiss company with its principal place of business at Viaduktstrasse 8, 4051 Basel,
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`Switzerland and maintains, through its affiliated companies, offices in Cambridge, Massachusetts
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`and Vancouver, British Columbia. Defendants otherwise lack the knowledge or information
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`sufficient to form a belief as to the truth of the remaining allegations of Paragraph 11 and therefore
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`deny the allegations.
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`Defendant Pfizer is a Delaware corporation with its principal place of business in
`12.
`New York City and significant operations in New Jersey. According to Pfizer’s 2022 annual report,
`Pfizer’s global supply “leadership teams” are located primarily in New York City and New Jersey.
`
`RESPONSE: Defendants admit that Pfizer is incorporated in Delaware with a principal
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`place of business in New York City and business operations in New Jersey. Pfizer’s 2022 annual
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`report speaks for itself. Defendants deny the remaining allegations of Paragraph 12.
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`Defendant BioNTech SE is a German corporation with its principal place of
`13.
`business in Germany and its North American headquarters in Cambridge, Massachusetts.
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`6
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`RESPONSE: Defendants admit that BioNTech SE is a German corporation with its
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`principal place of business in Germany. Defendants deny the remaining allegations of Paragraph
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`13.
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`Pfizer and BioNTech are and have been operating jointly and as agents of one
`14.
`another as to Defendants’ vaccine and share equally in profits from sales of the vaccine. For
`example:
`
` ●
`
` A March 17, 2020, Collaboration Agreement reflects Pfizer and BioNTech’s agreement
`to engage in “collaborative research and development” to develop and launch a
`Covid-19 vaccine “in all countries of the Territory,” and their “wish that Pfizer
`Commercialize[]
`the Product
`in all countries of
`the Territory,” where
`(i) “Commercialize” is defined as “market, promote, distribute, offer for sale, sell, have
`sold, import, have imported, export, have exported or otherwise commercialize a
`compound or product,” and (ii) “Territory” is defined to include the United States.
`
`● Pfizer’s 2022 annual report, published on or about February 23, 2023, states that Pfizer
`and BioNTech have been “collaborat[ing]” to “jointly develop[] and commercialize[]”
`the vaccine; discusses “Comirnaty-related manufacturing activities performed [by
`Pfizer] on behalf of BioNTech”; and explains that Pfizer and BioNTech “equally share
`the costs of development” and “share gross profits equally from commercialization.”
`Similarly, Pfizer and BioNTech’s press releases have stated that “BioNTech is the
`Marketing Authorization Holder [for the vaccine]… and the holder of emergency use
`authorizations … in the United States (jointly with Pfizer).”
`
`● In a Complaint filed July 25, 2022, Pfizer and BioNTech alleged that they “partnered
`together, and continue to work together” on the vaccine; “partnered together to develop,
`manufacture, and secure regulatory approval” of the vaccine, including as to “clinical
`testing [and] distribution”; and “agreed to share the costs of developing” the vaccine.
`The Complaint also alleges that “Pfizer, on behalf of itself and BioNTech, submitted
`clinical trial data as part of an Emergency Use Authorization (‘EUA’) request to the
`FDA for administering the Pfizer-BioNTech COVID-19 vaccine….”3
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`RESPONSE: Paragraph 14 states a legal conclusion to which no response is required. To
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`the extent a response is required, the allegations of Paragraph 14 purport to rely on a March 17,
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`2020 Collaboration Agreement, Pfizer’s 2022 annual report, and the Complaint filed on July 25,
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`2022 in BioNTech SE v. CureVac AG, No. 22-11202 (D. Mass.), since transferred as BioNTech SE
`
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`3 Complaint, BioNTech SE, BioNTech Manufacturing GMBH, and Pfizer Inc. v. Curevac AG,
`Case No. 1:22-cv-11202 (D. Mass. July 25, 2022) at ⁋⁋ 1, 2, 48, 49, 55.
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`v. CureVac AG, No. 23-222 (E.D. Va.), which speak for themselves. Defendants deny the
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`remaining allegations of Paragraph 14.
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`JURISDICTION AND VENUE
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`A.
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`Subject Matter Jurisdiction
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
`15.
`1338(a) because this is an action for infringement under the patent laws of the United States, Title
`35 of the United States Code.
`
`RESPONSE: Paragraph 15 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants respond that, solely for purposes of this action only,
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`they do not contest that this Court has subject matter jurisdiction over this action.
`
`B.
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`Personal Jurisdiction
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`This Court has personal jurisdiction over Pfizer because it maintains a regular and
`16.
`established place of business in this District.
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`RESPONSE: Paragraph 16 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants respond that, solely for purposes of this action and
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`solely for the claims asserted in the Complaint, they do not contest personal jurisdiction.
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`This Court has personal jurisdiction over both Pfizer and BioNTech because they
`17.
`transact business relating to Plaintiffs’ claims in this District, engage in systematic and continuous
`business contacts here, and have purposefully availed themselves of the benefits and protections
`of New Jersey’s laws such that they should reasonably anticipate being haled into court here.
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`RESPONSE: Paragraph 17 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants respond that, solely for purposes of this action and
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`solely for the claims asserted in the Complaint, they do not contest personal jurisdiction.
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`Defendants otherwise deny the remaining allegations of Paragraph 17.
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`Among other things, Pfizer and BioNTech operate jointly and/or as agents of one
`18.
`another to develop, manufacture, import, market, distribute, offer to sell, and/or sell the Accused
`Product in the State of New Jersey and throughout the United States, for use in the State of New
`Jersey and throughout the United States. Directly or through others, Pfizer and BioNTech make,
`use, induce others to use, offer for sale, and/or sell the Accused Product within the United States,
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`and/or import the same into the United States, including into the District of New Jersey. They have
`also contracted with one another with the purpose and intent of inducing and participating in sales
`of the Accused Product in the United States, including in this State and District.
`
`RESPONSE: Paragraph 18 states legal conclusions to which no response is required. To
`
`the extent a response is required, Defendants respond that, solely for purposes of this action and
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`solely for the claims asserted in the Complaint, they do not contest personal jurisdiction.
`
`Defendants otherwise deny the remaining allegations of Paragraph 18.
`
`For example, on December 11, 2020, Defendants received Emergency Use
`19.
`Authorization (“EUA”) from the United States Food and Drug Administration (“FDA”) for
`Defendants’ vaccine to be distributed and administered to people 16 years of age and older
`throughout the United States, including in the District of New Jersey, and, on August 23, 2021,
`the FDA approved Defendants’ Biologics License Application (“BLA”) for the vaccine. Upon
`information and belief, as of April 2, 2023, more than 11.9 million doses of Defendants’ vaccine
`have been administered in the State of New Jersey.4 Therefore, Pfizer and BioNTech transact
`business within New Jersey relating to Plaintiffs’ claims and have engaged in systematic and
`continuous business contacts here.
`
`RESPONSE: Paragraph 19 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants admit that on December 11, 2020, the FDA granted
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`an EUA for Defendants’ vaccine. Defendants also admit that on August 23, 2021, the FDA
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`approved the BLA for Comirnaty®. Defendants also respond that, solely for purposes of this action
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`and solely for the claims asserted in the Complaint, they do not contest personal jurisdiction.
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`Defendants otherwise deny the remaining allegations of Paragraph 19.
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`For the above reasons, there is nothing unreasonable or fundamentally unfair about
`20.
`requiring Pfizer and BioNTech to litigate this action in this District, and the Court has personal
`jurisdiction over them here.
`
`RESPONSE: Paragraph 20 states legal conclusions to which no response is required. To
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`the extent a response is required, Defendants respond that, solely for purposes of this action and
`
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`4 https://www.nj.gov/health/cd/topics/covid2019_dashboard.shtml.
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`solely for the claims asserted in the Complaint, they do not contest personal jurisdiction.
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`Defendants otherwise deny the remaining allegations of Paragraph 20.
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`C.
`
`Venue
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`Venue is proper in this District as to Pfizer pursuant to 28 U.S.C. § 1400(b) because
`21.
`Pfizer has committed acts of infringement in this District and has a regular and established place
`of business in this District. Among other things, Pfizer has committed acts of infringement in this
`District by making, using, selling, and/or offering for sale in this District the Accused Product and
`inducing others to use the Accused Product in this District. Moreover, Pfizer has a campus in this
`District, where leadership teams are located.
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`RESPONSE: Paragraph 21 states legal conclusions to which no response is required. To
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`the extent a response is required, Pfizer responds that, solely for purposes of this action and solely
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`for the claims asserted in the Complaint, Pfizer does not contest venue. Defendants otherwise
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`deny the remaining allegations of Paragraph 21.
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`Venue is proper in this District as to BioNTech pursuant to 28 U.S.C. §§ 1400 and
`22.
`1391 because it is subject to personal jurisdiction here.
`
`RESPONSE: Paragraph 22 states legal conclusions to which no response is required. To
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`the extent a response is required, BioNTech responds that, solely for purposes of this action and
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`solely for the claims asserted in the Complaint, BioNTech does not contest venue. Defendants
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`otherwise deny the remaining allegations of Paragraph 22.
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`BACKGROUND
`
`A.
`
`Nucleic Acids
`
`Defendants’ vaccine belongs to a new class of medicines that delivers nucleic acids,
`23.
`such as mRNA, into the cells of the body to treat diseases or, in the case of Defendants’ vaccine,
`to trigger an immune response to protect a person from future infection.
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`RESPONSE: Defendants admit that Comirnaty®, when properly administered, has been
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`shown to have the ability to deliver mRNA into certain cells of a patient to trigger an immune
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`response. At least because of the scope, breadth, and vagueness of this allegation, Defendants
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`otherwise lack the knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of Paragraph 23 and therefore deny the allegations.
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`Nucleic acids are molecules that encode the genetic information essential to sustain
`24.
`all forms of life. One type of nucleic acid is deoxyribonucleic acid, or “DNA.” Every human
`(except identical twins) has a unique set of genetic information in the “genes” (composed of DNA)
`within his or her chromosomes. Among other things, these genes spell out the instructions for
`producing proteins that make human cells and bodies function.
`
`RESPONSE: Defendants admit that nucleic acids, such as DNA, can encode genetic
`
`information. At least because of the scope, breadth, and vagueness of this allegation, Defendants
`
`otherwise lack the knowledge or information sufficient to form a belief as to the truth of the
`
`remaining allegations of Paragraph 24 and therefore deny the allegations.
`
`In order to make the protein encoded by a particular gene, cells first convert the
`25.
`genetic code in the gene’s DNA into another type of nucleic acid known as messenger ribonucleic
`acid, or “mRNA.” mRNA is effectively a copy of the portion of DNA that the cell’s protein-making
`machinery uses as a blueprint to assemble the protein encoded by the gene.
`
`RESPONSE: Defendants admit that DNA can be transcribed to produce RNA, which can
`
`encode proteins. At least because of the scope, breadth, and vagueness of this allegation,
`
`Defendants otherwise lack the knowledge or information sufficient to form a belief as to the truth
`
`of the remaining allegations of Paragraph 25 and therefore deny the allegations.
`
`B.
`
`How Vaccines Work
`
`A virus is typically a small packet of DNA or RNA. If a virus enters a living host
`26.
`cell—for example, after being ingested, transmitted through bodily fluids, or inhaled through a
`person’s mouth or nose—the virus’s DNA or RNA hijacks the cell’s machinery and instructs the
`cell to make copies of the virus. These copies, often numbering into the millions, leave the infected
`cell and enter other cells where the process repeats. Infected cells can be damaged or die while
`hosting the virus. Left unchecked, the host organism itself can die.
`
`RESPONSE: Defendants admit that a virus typically contains DNA or RNA. Defendants
`
`also admit that a virus may enter a living host cell and use it to make copies of itself, which
`
`eventually can damage or kill the host cell, and, potentially, the host organism. At least because
`
`of the scope, breadth, and vagueness of this allegation, Defendants otherwise lack the knowledge
`
`11
`
`

`

`
`
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`or information sufficient to form a belief as to the truth of the remaining allegations of Paragraph
`
`26 and therefore deny the allegations.
`
`Although vaccines targeting viruses may have varying mechanisms of action, they
`27.
`traditionally work by injecting into the body a weakened or inactive form of the virus that is unable
`to cause infection but retains features of the infectious virus and can teach the immune system to
`recognize and attack the infectious virus if it invades in the future. These vaccines take tremendous
`amounts of time to develop and bring to patients due to the extensive amount of work needed to
`target specific infectious agents, associated regulatory hurdles, and other factors.
`
`RESPONSE: Defendants admit that some vaccines work by injecting into the body a
`
`weakened or inactive form of the virus. At least because of the scope, breadth, and vagueness of
`
`this allegation, Defendants otherwise lack the knowledge or information sufficient to form a belief
`
`as to the truth of the remaining allegations of Paragraph 27 and therefore deny the allegations.
`
`In a 2021 essay, Pfizer’s CEO observed that “the typical vaccine development
`28.
`program can take up to 10 years and cost anywhere from $1 billion to more than $2 billion,”
`including because “[t]raditionally, making a vaccine starts with growing weakened forms of the
`virus, which can take months.”5
`
`RESPONSE: To the extent the allegations of Paragraph 28 purport to rely on a public
`
`statement, that statement speaks for itself. Defendants deny the remaining allegations of Paragraph
`
`28.
`
`Thus, scientists began experimenting with a new, mRNA-based approach.
`29.
`Fundamentally, the proposed mRNA vaccines would work the same way as any other vaccine—
`exposing people to a piece of a virus or pathogen so as to trigger the immune system and induce
`adaptive immunity. However, with an mRNA vaccine, the immune system would not be triggered
`by a piece of virus or pathogen manufactured in a laboratory, as with older vaccines. Instead, the
`trigger would be manufactured in and by a person’s own cells.
`
`
`
`5 Albert Bourla, The CEO of Pfizer on Developing a Vaccine in Record Time, Harvard Bus.
`Rev. Magazine, May-June 2021 (https://hbr.org/2021/05/the-ceo-of-pfizer-on-developing-a-
`vaccine-in-record-time).
`
`12
`
`

`

`
`
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`RESPONSE: At least because of the scope, breadth, and vagueness of this allegation,
`
`Defendants lack the knowledge or information sufficient to form a belief as to the truth of the
`
`allegations of Paragraph 29 and therefore deny the allegations.
`
`A major advantage of mRNA-based vaccines, if they could be made to work, was
`30.
`that they could be used with any mRNA. Rather than requiring years of development as with
`traditional vaccines, it was envisioned that the relevant mRNA could be identified and generated
`using existing technology, inserted into a general-use delivery mechanism, and made ready to
`inject into people, all in the space of days or weeks.
`
`RESPONSE: At least because of the scope, breadth, and vagueness of this allegation,
`
`Defendants lack the knowledge or information sufficient to form a belief as to the truth of the
`
`allegations of Paragraph 30 and therefore deny the allegations.
`
`C.
`
`Challenges for RNA-Based Medicines and Arbutus’s Pioneering Solutions
`
`Vaccines and other medicines using RNA technologies are an emerging frontier