Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 1 of 26 PageID #: 20617
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`Plaintiffs,
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`v.
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`) C.A. No. 22-252-MSG
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`PLAINTIFFS ARBUTUS BIOPHARMA CORPORATION AND GENEVANT
`SCIENCES GMBH’S ANSWER TO DEFENDANTS MODERNA, INC. AND
`MODERNATX, INC.’S COUNTERCLAIMS
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`MODERNA, INC. and MODERNATX, INC.,
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`MODERNA, INC. and MODERNATX, INC.,
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`Defendants.
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`Counterclaim-Plaintiffs,
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`v.
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`Counterclaim-Defendants.
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`Plaintiffs/Counterclaim-Defendants Arbutus Biopharma Corporation (“Arbutus”) and
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`Genevant Sciences GmbH (“Genevant”) (collectively, “Plaintiffs”), by their attorneys, answer
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`the counterclaims of Defendants/Counterclaim-Plaintiffs Moderna, Inc. and ModernaTX, Inc.
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`(collectively, “Moderna”) as follows. This Answer reproduces Defendants’ counterclaims
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`followed by Plaintiffs’ responses.
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`INTRODUCTION
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`Moderna brings these counterclaims in response to Arbutus and Genevant’s
`1.
`lawsuit, which baselessly seeks to profit from Moderna’s innovations that led to its ground-
`breaking mRNA-1273 “COVID-19 Vaccine.” Specifically, Moderna asks this Court to declare
`that Moderna’s COVID-19 Vaccine does not infringe the Asserted Patents, and that those patents
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 2 of 26 PageID #: 20618
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`are invalid. In short, this lawsuit will confirm that Moderna and its scientists, employees, and
`collaborators are the true innovators in the mRNA delivery technology that led to its lifesaving
`COVID-19 Vaccine. Plaintiffs played no role in Moderna’s significant accomplishments.
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`ANSWER: The allegations of Paragraph 1 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs ADMIT that they filed a
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`Complaint against Moderna on February 28, 2022, and an Amended Complaint against
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`Moderna on May 1, 2024. Otherwise, DENIED.
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`For a decade before COVID-19 emerged, Moderna had been pioneering a new
`2.
`class of medicines made of messenger RNA, or mRNA, and developed its own platform
`technologies that could deliver mRNA in a variety of therapeutic and prophylactic applications,
`including vaccines. These mRNA medicines have the potential to treat and prevent a wide range
`of diseases—from infectious diseases like influenza and HIV, to autoimmune and cardiovascular
`diseases and rare forms of cancer. Over the past twelve years, Moderna has worked diligently in
`its laboratories to pioneer a number of fundamental breakthroughs in the field of mRNA
`technology. These discoveries span all aspects of mRNA medicines—from the characteristics
`and design of the mRNA itself and the protein it encodes, to the technologies to deliver mRNA
`to patients safely and effectively.
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`ANSWER: Plaintiffs lack knowledge or information sufficient to form a belief about
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`the allegations in Paragraph 2, and therefore DENY them.
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`Included among the mRNA advancements that Moderna developed over years of
`3.
`extensive work, is its proprietary lipid nanoparticle (“LNP”) delivery technologies to encapsulate
`the mRNA for delivery. The LNPs function to protect the mRNA and deliver it into cells.
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`ANSWER: Plaintiffs ADMIT that lipid nanoparticles (“LNPs”) can function to
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`protect mRNA and deliver it into cells. Plaintiffs lack knowledge or information sufficient to
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`form a belief about the remaining allegations in Paragraph 3, and therefore DENY them.
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`Moderna invested years of work and resources to develop LNPs that are tailored
`4.
`to work with mRNA. Those efforts included developing novel proprietary lipids and optimal
`lipid compositions, and improving LNP manufacturing processes. Moderna’s inventions in this
`area have been recognized with multiple U.S. patents.
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`ANSWER:
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` Plaintiffs lack knowledge or information sufficient to form a belief as to
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`the truth of the allegations in Paragraph 4 and therefore DENY them.
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`Moderna’s innovative proprietary LNP formulation technology, developed to
`5.
`address the complex problem of reliably delivering mRNA to a patient, goes well beyond the
`rudimentary, early technology for delivery of siRNA described in Arbutus’s Asserted Patents,
`nor is it covered by those patents.
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`ANSWER: Plaintiffs DENY the allegations of Paragraph 5.
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`In contrast to Moderna’s proprietary LNP technology to deliver mRNA, Arbutus
`6.
`(and its predecessor Protiva Biotherapeutics, Inc., “Protiva”) conducted research relating to
`delivery of small interfering RNA (“siRNA”), small pieces of RNA “about 15–60 . . .
`nucleotides in length” as defined by Arbutus. See, e.g., U.S. Patent No. 8,058,069 (“’069
`Patent”) at 6:55–66. siRNA is a far cry from the long, complex mRNA that Moderna’s
`technology is designed to deliver. By way of example, Moderna’s COVID-19 Vaccine delivers
`mRNA that is approximately 4,000 nucleotides—over 60 times the length contemplated by the
`Arbutus patents.
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`ANSWER: Plaintiffs ADMIT that some research conducted by Arbutus and Protiva
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`included work on siRNA. Plaintiffs ADMIT that U.S. Patent No. 8,058,069 (“’069 Patent”)
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`includes the following statement: “Interfering RNA includes ‘small-interfering RNA’ or
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`‘siRNA,’ e.g., interfering RNA of about 15-60, 15-50, or 15-40 (duplex) nucleotides in length,
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`more typically about 15-30, 15-25, or 19-25 (duplex) nucleotides in length, and is preferably
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`about 20-24, 21-22, or 21-23 (duplex) nucleotides in length . . . .” ’069 Patent at 6:55–60.
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`Plaintiffs DENY the remaining allegations in Paragraph 6.
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`None of the Asserted Patents focus on mRNA. For example, the specification of
`7.
`the ’069 Patent (and related Asserted Patents) focuses on siRNA, not mRNA, discussing “Selection
`of siRNA Sequences,” “Generating siRNA Molecules,” “Modifying siRNA Sequences,” and
`“Target Genes” of siRNA. See, e.g., ’069 Patent at cols. 29, 32, 33, and 35. Indeed, all 11
`examples of the ’069 Patent (and its asserted family members) are directed to “nucleic acid-lipid
`particles” comprising siRNA—none involve mRNA. Id. at 67:64–86:18; see also U.S. Patent
`9,504,651 at cols. 14–19 (Examples 1–8, none of which are directed to mRNA formulations).
`This is consistent with Arbutus predecessor Protiva’s public statements at the time that the
`company was “focused on” “formulations for RNAi therapeutics.” As another example, the ’651
`Patent focuses on plasmid DNA, rather than mRNA. See ’651 Patent at 2:17–19 (“The present
`invention can be used to form lipid vesicles that contain encapsulated plasmid DNA or small
`molecule drugs.”), and cols. 14–15.
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`ANSWER: Plaintiffs ADMIT that the ’069 Patent contains headings titled “Selection
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`of siRNA Sequences,” “Generating siRNA Molecules,” “Modifying siRNA Sequences,” and
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 4 of 26 PageID #: 20620
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`“Target Genes.” ’069 Patent at cols. 29, 32, 33, and 35. Plaintiffs ADMIT that the website
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`cited by Defendants states that “Tekmira and Protiva each have liposome formulations suitable
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`for a range of nucleic acid-based drugs, although both are focused on and have several
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`formulations for RNAi therapeutics. Protiva’s liposomal platform is called SNALP (for stable
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`nucleic acid-lipid particles).” Plaintiffs ADMIT that the ’651 Patent states that “[t]he present
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`invention can be used to form lipid vesicles that contain encapsulated plasmid DNA or small
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`molecule drugs.” Otherwise, DENIED.
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`Tellingly, Plaintiffs/Counterclaim Defendants never developed an LNP capable of
`8.
`delivering mRNA, let alone manufactured or sold any approved products of their own, whether
`siRNA or mRNA-based.
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`ANSWER: Plaintiffs DENY the allegations of Paragraph 8.
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`Failing to develop any products of its own, Arbutus instead improperly expanded
`9.
`the scope of its patent estate in an attempt to cover the inventions of others, including pioneers
`like Moderna. Consequently, the purported inventions that Arbutus lays claim to in the Asserted
`Patents bear no resemblance to the rudimentary technology described in the specifications.
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`ANSWER: Plaintiffs DENY the allegations of Paragraph 9.
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`The SARS-CoV2 virus, which causes COVID-19, was first detected in December
`10.
`2019. On January 10, 2020, the genetic sequence of the SARS-CoV-2 virus became public.
`Leveraging its decade of research and proprietary technologies, Moderna quickly responded when
`the pandemic struck, swiftly developing, manufacturing, and providing doses of its COVID-19
`vaccine to people around the world. The COVID-19 Vaccine, also referred to as the mRNA-
`1273 vaccine, uses Moderna’s proprietary LNP delivery technology that Moderna developed and
`described years earlier. For that groundbreaking work, Moderna’s scientists were recently
`honored by the American Chemistry Society’s 2022 Heroes of Chemistry Award, the highest
`honor for industrial chemical scientists, recognizing their “work developing formulations that
`protect against . . . COVID-19.”
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`ANSWER: Plaintiffs ADMIT that the SARS-CoV2 virus, which causes COVID-19,
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`was first detected in December 2019. Plaintiffs ADMIT that on January 10, 2020, the genetic
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`sequence of the SARS-CoV-2 virus became public. Plaintiffs lack knowledge or information
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 5 of 26 PageID #: 20621
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`sufficient to form a belief as to the truth of the remaining allegations in Paragraph 10 and
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`therefore DENY them.
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`Following the declaration of a public health emergency, Moderna entered into
`11.
`numerous agreements with the U.S. Government regarding its COVID-19 Vaccine. In April
`2020, Moderna entered into a grant agreement with the Biomedical Advanced Research and
`Development Authority (“BARDA”)—an office of HHS—to support clinical development of the
`mRNA-1273 vaccine. BARDA chose to partner with Moderna to develop the COVID-19
`vaccine because “Moderna’s mRNA-based vaccine platform has been used to rapidly prepare
`vaccine candidates against Cytomegalovirus, Zika, Respiratory Syncytial Virus, Influenza, Human
`Metapneumovirus and Parainfluenza virus.”
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`ANSWER: Plaintiffs ADMIT that the COVID-19 pandemic was declared a public
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`health emergency. Plaintiffs ADMIT that the document cited by Defendants states that
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`“Moderna’s mRNA-based vaccine platform has been used to rapidly prepare vaccine candidates
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`against Cytomegalovirus, Zika, Respiratory Syncytial Virus, Influenza, Human
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`Metapneumovirus and Parainfluenza virus.” Plaintiffs lack knowledge or information sufficient
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`to form a belief as to the truth of the remaining allegations in Paragraph 11 and therefore
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`DENY them.
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`Once Moderna had obtained promising clinical results, on August 9, 2020,
`12.
`ModernaTX, Inc. entered into a supply contract with the Army Contracting Command of the
`U.S. Department of Defense, Contract No. W911QY20C0100 (“C0100 Contract”). Under the
`C0100 Contract, Moderna was obligated to produce and deliver doses of its COVID-19 Vaccine
`to the U.S. Government, with the option to supply additional doses. The C0100 Contract
`specifically states that Moderna manufactured the COVID-19 Vaccine doses “for the United
`States Government.” The C0100 contract also incorporates by reference FAR 52.227-1, entitled
`“Authorization and Consent,” and FAR 52.227-1 Alt 1, entitled “Authorization And Consent
`(JUN 2020) - Alternate I.”
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`ANSWER: On information and belief, Plaintiffs ADMIT that the document cited by
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`Defendants, D.I. 17-1, Ex. A, is listed as “Contract No. W911QY20C0100” with an Effective
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`Date listed as August 9, 2020. D.I. 17-1, Ex. A at 1. Plaintiffs ADMIT that ModernaTX, Inc.
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`is listed as the contractor on the document cited by Defendants, and the contract states that it is
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`administered by the Defense Contract Management Agency of Boston, MA. Id. Plaintiffs
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 6 of 26 PageID #: 20622
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`ADMIT that the document cited by Defendants states that “The Department of Defense and
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`Health and Human Services (HHS) require large scale manufacturing of vaccine doses in
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`support of the national emergency response to the Coronavirus Disease 2019 (COVID-19) for
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`the United States Government (USG) and the US population.” Id. at 19. Plaintiffs ADMIT
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`that the document cited by Defendants contains a list of “CLAUSES INCORPORATED BY
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`REFERENCE,” and contained in this list is 52.227-1, titled “Authorization and Consent” and
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`dated June 2020, and 52.227-1 Alt I, titled “Authorization And Consent (JUN 2020) – Alternate
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`I” dated April 1984. Id. at 46. Plaintiffs lack knowledge or information sufficient to form a
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`belief about the remaining allegations in Paragraph 12, and therefore DENY them.
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`13. Moderna received unprecedented emergency use authorization for its COVID-19
`Vaccine in the U.S. from the Food & Drug Administration (“FDA”) on December 16, 2020—
`within less than a year of beginning development. Promptly thereafter, Moderna shipped U.S.-
`manufactured COVID-19 Vaccine doses to the U.S. Government pursuant to the C0100 Contract.
`Moderna also supplied foreign governments with doses of the COVID-19 Vaccine. On January
`31, 2022, Moderna received full approval from the FDA for its Biologics License Application for
`the COVID-19 Vaccine.
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`ANSWER: Plaintiffs ADMIT that on January 31, 2022, the FDA approved Moderna’s
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`Biologics License Application (“BLA”) for its COVID-19 vaccine. Upon information and
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`belief, Plaintiffs ADMIT that Moderna supplied foreign governments with doses of its COVID-
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`19 vaccine. Plaintiffs DENY that Moderna received emergency use authorization for its
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`COVID-19 vaccine in the U.S. from the FDA on December 16, 2020. Plaintiffs lack
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`knowledge or information sufficient to form a belief about the remaining allegations in
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`Paragraph 13, and therefore DENY them.
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`PARTIES
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`14. Moderna, Inc. is a corporation organized and existing under the laws of Delaware
`with its principal place of business at 200 Technology Square, Cambridge, Massachusetts,
`02139.
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 7 of 26 PageID #: 20623
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`ANSWER: On information and belief, Plaintiffs ADMIT the allegations of Paragraph
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`14.
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`15. ModernaTX, Inc. is a corporation organized and existing under the laws of
`Delaware with its principal place of business at 200 Technology Square, Cambridge,
`Massachusetts, 02139.
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`ANSWER: On information and belief, Plaintiffs ADMIT the allegations of Paragraph
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`15.
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`Upon information and belief, Plaintiff/Counterclaim-Defendant Arbutus
`16.
`Biopharma Corporation is a corporation organized and existing under the laws of Canada, with its
`principal place of business at 701 Veterans Circle, Warminster, Pennsylvania, 18974.
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`ANSWER: Plaintiffs ADMIT the allegations of Paragraph 16.
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`Upon information and belief, Plaintiff/Counterclaim-Defendant Genevant Sciences
`17.
`GmbH is a company organized and existing under the laws of Switzerland, with its principal place
`of business at Viaduktstrasse 8, 4051 Basel, Switzerland.
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`ANSWER: Plaintiffs ADMIT the allegations of Paragraph 17.
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`NATURE OF ACTION
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`18. Moderna seeks declaratory judgment under the patent laws of the United States,
`35 U.S.C. § 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. § 2201 et seq., that U.S.
`Patent Nos. 8,058,069 (the “’069 Patent”), 8,492,359 (the “’359 Patent”), 8,822,668 (the “’668
`Patent”), 9,364,435 (the “’435 Patent”), 9,504,651 (the “’651 Patent”), and 11,141,378 (the “’378
`Patent”) (collectively, “Asserted Patents”) are invalid and/or not infringed.
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`ANSWER: Paragraph 18 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Plaintiffs ADMIT that Moderna’s counterclaims against
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`Plaintiffs seek declaratory judgment that U.S. Patent Nos. 8,058,069 (the “’069 Patent”),
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`8,492,359 (the “’359 Patent”), 8,822,668 (the “’668 Patent”), 9,364,435 (the “’435 Patent”),
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`9,504,651 (the “’651 Patent”), and 11,141,378 (the “’378 Patent”) (collectively, “Asserted
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`Patents”) are invalid and/or not infringed. To the extent there are allegations not expressly
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`admitted above, such allegations are DENIED.
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 8 of 26 PageID #: 20624
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`JURISDICTION AND VENUE
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`This Court has exclusive subject matter jurisdiction over this action pursuant to
`19.
`federal question jurisdiction, 28 U.S.C. §§ 1331, 1338; and the patent laws of the United States,
`35 U.S.C. § 1 et seq.
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`ANSWER: The allegations of Paragraph 19 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs do not contest that this
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`Court has subject matter jurisdiction over this action.
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`This Court has personal jurisdiction over Arbutus and Genevant because each has
`20.
`subjected itself to the jurisdiction of this Court by filing the Amended Complaint.
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`ANSWER: The allegations of Paragraph 20 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs ADMIT that they filed the
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`Amended Complaint and do not contest that they are subject to personal jurisdiction for
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`purposes of this action.
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`Venue in this Court is proper based on the choice of forum by Plaintiffs and
`21.
`pursuant to 28 U.S.C. §§ 1391(b)-(c), and 1400(b).
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`ANSWER: The allegations of Paragraph 21 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs do not contest that this
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`District is a proper venue for this action.
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`FACTUAL BACKGROUND
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`On or about November 15, 2011, the ’069 Patent was issued to Protiva
`22.
`Biotherapeutics, Inc.
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`ANSWER: Plaintiffs ADMIT that the ’069 Patent was issued to Protiva
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`Biotherapeutics, Inc. on November 15, 2011.
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`Inc.
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`23.
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`On or about July 23, 2013, the ’359 Patent was issued to Protiva Biotherapeutics,
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 9 of 26 PageID #: 20625
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`ANSWER: Plaintiffs ADMIT that the ’359 Patent was issued to Protiva
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`Biotherapeutics, Inc. on July 23, 2013.
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`On or about September 2, 2014, the ’668 Patent was issued to Protiva
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`Biotherapeutics, Inc.
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`ANSWER: Plaintiffs ADMIT that the ’668 Patent was issued to Protiva
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`Biotherapeutics, Inc. on September 2, 2014.
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`Inc.
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`25.
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`On or about June 14, 2016, the ’435 Patent was issued to Protiva Biotherapeutics,
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`ANSWER: Plaintiffs ADMIT that the ’435 Patent was issued to Protiva
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`Biotherapeutics, Inc. on June 14, 2016.
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`On or about November 29, 2016, the ’651 Patent was issued to Protiva
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`Biotherapeutics, Inc.
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`ANSWER: Plaintiffs ADMIT that the ’651 Patent was issued to Protiva
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`Biotherapeutics, Inc. on November 29, 2016.
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`On or about October 12, 2021, the ’378 Patent was issued to Arbutus Biopharma
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`27.
`Corporation.
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`ANSWER: Plaintiffs ADMIT that the ’378 Patent was issued to Arbutus Biopharma
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`Corporation on October 12, 2021.
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`28.
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`Arbutus purports to be the owner and assignee of all Asserted Patents.
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`ANSWER: Plaintiffs ADMIT that all Asserted Patents are assigned to and owned by
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`Arbutus.
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`29.
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`Genevant purports to be the exclusive licensee to all Asserted Patents.
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`ANSWER: Plaintiffs ADMIT that at all times since Arbutus and Genevant entered
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`into a license agreement, Genevant has held Exclusive Rights (as defined in the Complaint, D.I.
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 10 of 26 PageID #: 20626
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`1 at Paragraph 9) to all of the Asserted Patents in certain fields of use, including the vaccine
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`application at issue here.
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`On February 28, 2022, Plaintiffs Arbutus and Genevant filed a lawsuit against
`30.
`Moderna asserting that Moderna’s COVID-19 Vaccine infringes the Asserted Patents.
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`ANSWER: Plaintiffs ADMIT that they filed the Complaint on February 28, 2022 and
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`respectfully refer the Court to the Complaint for its actual language and complete content.
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`Pursuant to 28 U.S.C. § 2201(a), an actual and justiciable controversy has arisen
`31.
`and exists between Moderna and Plaintiffs. Moderna is entitled to a judicial determination and
`declaration that it has not infringed and is not infringing the Asserted Patents, and that the Asserted
`Patents are invalid.
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`ANSWER: The allegations of Paragraph 31 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
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`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
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`Moderna’s infringement, active inducement of infringement, and contribution to the
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`infringement by others of the Asserted Patents.
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`COUNT I: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’069
`PATENT
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`32. Moderna repeats and incorporates paragraphs 1-31 as if fully set forth herein.
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`ANSWER: Plaintiffs incorporate by reference their responses to Paragraphs 1-31 as if
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`fully set forth herein.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`33.
`Vaccine infringes the ’069 Patent.
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`ANSWER:
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` Plaintiffs ADMIT that they filed the Complaint on February 28, 2022,
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`and the Amended Complaint on May 1, 2024, and respectfully refer the Court to the Complaint
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`and Amended Complaint for their actual language and complete content.
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
`34.
`Moderna regarding Moderna’s alleged infringement of the ’069 Patent.
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`ANSWER: The allegations of Paragraph 34 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
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`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
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`Moderna’s infringement, active inducement of infringement, and contribution to the
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`infringement by others of the ’069 Patent.
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`35. Moderna has not infringed and is not infringing any valid claim of the ’069 Patent,
`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
`equivalents. For example, Moderna’s COVID-19 Vaccine does not meet each and every element
`of claim 1 of the ’069 Patent at least because it does not comprise a nucleic acid-lipid particle
`comprising the claimed lipids (including, for example, the “cationic lipid”) in the claimed ratios,
`and all dependent claims of the ’069 Patent depend from claim 1.
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`ANSWER: Plaintiffs DENY the allegations of Paragraph 35.
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`36. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`’069 Patent, either literally or under the doctrine of equivalents.
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`ANSWER:
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` Plaintiffs DENY the allegations of Paragraph 36.
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`COUNT II: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’359
`PATENT
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`37. Moderna repeats and incorporates paragraphs 1-36 as if fully set forth herein.
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`ANSWER: Plaintiffs incorporate by reference their responses to Paragraphs 1-36 as if
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`fully set forth herein.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`38.
`Vaccine infringes the ’359 Patent.
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`ANSWER: Plaintiffs ADMIT that they filed the Complaint on February 28, 2022, and
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`the Amended Complaint on May 1, 2024, and respectfully refer the Court to the Complaint and
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`Amended Complaint for their actual language and complete content.
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`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 12 of 26 PageID #: 20628
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
`39.
`Moderna regarding Moderna’s alleged infringement of the ’359 Patent.
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`ANSWER: The allegations of Paragraph 39 set forth legal conclusions to which no
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`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
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`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
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`Moderna’s infringement, active inducement of infringement, and contribution to the
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`infringement by others of the ’359 Patent.
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`40. Moderna has not infringed and is not infringing any valid claim of the ’359 Patent,
`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
`equivalents. For example, Moderna’s COVID-19 Vaccine does not meet each and every element
`of claim 1 of the ’359 Patent at least because it does not comprise a nucleic acid-lipid particle
`comprising the claimed lipids (including, for example, the “cationic lipid”) in the claimed ratios,
`and all dependent claims of the ’359 Patent depend from claim 1.
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`ANSWER: Plaintiffs DENY the allegations of Paragraph 40.
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`41. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`’359 Patent, either literally or under the doctrine of equivalents.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 41.
`
`COUNT III: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’668
`PATENT
`
`
`
`42. Moderna repeats and incorporates paragraphs 1-41 as if fully set forth herein.
`
`ANSWER:
`
` Plaintiffs incorporate by reference their responses to Paragraphs 1-41 as if
`
`fully set forth herein.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`43.
`Vaccine infringes the ’668 Patent.
`
`
`ANSWER: Plaintiffs ADMIT that they filed the Complaint on February 28, 2022, and
`
`the Amended Complaint on May 1, 2024, and respectfully refer the Court to the Complaint and
`
`the Amended Complaint for their actual language and complete content.
`
`12
`
`

`

`
`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 13 of 26 PageID #: 20629
`
`
`
`
`
`
`A real, immediate, and justiciable controversy exists between Plaintiffs and
`44.
`Moderna regarding Moderna’s alleged infringement of the ’668 Patent.
`
`
`ANSWER: The allegations of Paragraph 44 set forth legal conclusions to which no
`
`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
`
`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
`
`Moderna’s infringement, active inducement of infringement, and contribution to the
`
`infringement by others of the ’668 Patent.
`
`45. Moderna has not infringed and is not infringing any valid claim of the ’668 Patent,
`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
`equivalents. For example, Moderna’s COVID-19 Vaccine does not meet each and every element
`of claim 1 of the ’668 Patent at least because it does not comprise a nucleic acid-lipid particle
`comprising the claimed lipids (including, for example, the “cationic lipid”) in the claimed ratios,
`and all dependent claims of the ’668 Patent depend from claim 1.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 45.
`
`46. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`’668 Patent, either literally or under the doctrine of equivalents.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 46.
`
`COUNT IV: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’435
`PATENT
`
`
`
`47. Moderna repeats and incorporates paragraphs 1-46 as if fully set forth herein.
`
`ANSWER: Plaintiffs incorporate by reference their responses to Paragraphs 1-46 as if
`
`fully set forth herein.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`48.
`Vaccine infringes the ’435 Patent.
`
`
`ANSWER: Plaintiffs ADMIT that they filed the Complaint on February 28, 2022, and
`
`the Amended Complaint on May 1, 2024, and respectfully refer the Court to the Complaint and
`
`the Amended Complaint for their actual language and complete content.
`
`13
`
`

`

`
`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 14 of 26 PageID #: 20630
`
`
`
`
`
`
`A real, immediate, and justiciable controversy exists between Plaintiffs and
`49.
`Moderna regarding Moderna’s alleged infringement of the ’435 Patent.
`
`
`ANSWER: The allegations of Paragraph 49 set forth legal conclusions to which no
`
`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
`
`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
`
`Moderna’s infringement, active inducement of infringement, and contribution to the
`
`infringement by others of the ’435 Patent.
`
`50. Moderna has not infringed and is not infringing any valid claim of the ’435 Patent,
`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
`equivalents. For example, Moderna’s COVID-19 Vaccine does not meet each and every element
`of at least claim 7 of the ’435 Patent at least because it does not comprise a nucleic acid-lipid
`particle comprising the claimed lipids (including, for example, the “cationic lipid”) in the claimed
`ratios, and all dependent claims of the ’435 Patent depend from claim 1.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 50.
`
`51. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`’435 Patent, either literally or under the doctrine of equivalents.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 51.
`
`COUNT V: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’651
`PATENT
`
`
`
`52. Moderna repeats and incorporates paragraphs 1-51 as if fully set forth herein.
`
`ANSWER: Plaintiffs incorporate by reference their responses to Paragraphs 1-51 as if
`
`fully set forth herein.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`53.
`Vaccine infringes the ’651 Patent.
`
`
`ANSWER: Plaintiffs ADMIT that they filed the Complaint on February 28, 2022, and
`
`the Amended Complaint on May 1, 2024, and respectfully refer the Court to the Complaint and
`
`the Amended Complaint for their actual language and complete content.
`
`14
`
`

`

`
`Case 1:22-cv-00252-MSG Document 334 Filed 06/05/24 Page 15 of 26 PageID #: 20631
`
`
`
`
`
`
`A real, immediate, and justiciable controversy exists between Plaintiffs and
`54.
`Moderna regarding Moderna’s alleged infringement of the ’651 Patent.
`
` The allegations of Paragraph 54 set forth legal conclusions to which no
`
`ANSWER:
`
`response is required. To the extent a response is required, Plaintiffs ADMIT that there is a case
`
`of actual controversy between Plaintiffs on the one hand and Moderna on the other regarding
`
`Moderna’s infringement, active inducement of infringement, and contribution to the
`
`infringement by others of the ’651 Patent.
`
`55. Moderna has not infringed and is not infringing any valid claim of the ’651 Patent,
`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
`equivalents. For example, Moderna’s COVID-19 Vaccine does not meet each and every element
`of claim 1 of the ’651 Patent at least because it does not comprise the claimed “lipid vesicles . . .
`wherein at least 70% of the mRNA in the formulation is fully encapsulated in the lipid vesicles,”
`and all dependent claims of the ’651 Patent depend from claim 1.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 55.
`
`56. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`’651 Patent, either literally or under the doctrine of equivalents.
`
`
`ANSWER: Plaintiffs DENY the allegations of Paragraph 56.
`
`COUNT VI: DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’378
`PATENT
`
`
`
`57. Moderna repeats and incorporates paragraphs 1-56 as if fully set forth herein.