Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 1 of 83 PageID #: 729
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 22-252 (MSG)
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`JURY TRIAL DEMANDED
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`MODERNA, INC. and MODERNATX, INC.
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`Defendants.
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`MODERNA, INC. and MODERNATX, INC.,
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`Plaintiffs,
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`
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`v.
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`Counterclaim-Plaintiffs,
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`
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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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`DEFENDANTS’ COUNTERCLAIMS AND ANSWER TO COMPLAINT
`
`DECLARATORY JUDGMENT COUNTERCLAIMS
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`Defendants/Counterclaim-Plaintiffs Moderna, Inc. and ModernaTX, Inc. (collectively,
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`“Moderna”) demand a trial by jury on all issues so triable and assert the following counterclaims
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`against Plaintiffs/Counterclaim-Defendants Arbutus Biopharma Corporation (“Arbutus”) and
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`Genevant Sciences GmbH (“Genevant”):
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`INTRODUCTION
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`Moderna brings these counterclaims in response to Arbutus and Genevant’s
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`1.
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`lawsuit, which baselessly seeks to profit from Moderna’s innovations that led to its ground-
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`breaking mRNA-1273 “COVID-19 Vaccine.” Specifically, Moderna asks this Court to declare
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`that Moderna’s COVID-19 Vaccine does not infringe the Asserted Patents, and that those patents
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No. 22-252 (MSG)
`
`JURY TRIAL DEMANDED
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
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`)
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`)
`)
`)
`
`
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`
`
`
`MODERNA, INC. and MODERNATX, INC.
`
`Defendants.
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`
`Plaintiffs,
`
`
`
`v.
`
`Counterclaim-Plaintiffs,
`
`
`
`v.
`
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`
`Counterclaim-Defendants.
`
`DEFENDANTS’ COUNTERCLAIMS AND ANSWER TO COMPLAINT
`
`DECLARATORY JUDGMENT COUNTERCLAIMS
`
`Defendants/Counterclaim-Plaintiffs Moderna, Inc. and ModernaTX, Inc. (collectively,
`
`“Moderna”) demand a trial by jury on all issues so triable and assert the following counterclaims
`
`against Plaintiffs/Counterclaim-Defendants Arbutus Biopharma Corporation (“Arbutus”) and
`
`Genevant Sciences GmbH (“Genevant”):
`
`INTRODUCTION
`
`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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`
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 2 of 83 PageID #: 730
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`are invalid. In short, this lawsuit will confirm that Moderna and its scientists, employees, and
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`collaborators are the true innovators in the mRNA delivery technology that led to its lifesaving
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`COVID-19 Vaccine. Plaintiffs played no role in Moderna’s significant accomplishments.
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`A. Moderna’s Development of mRNA Medicines Using Lipid Nanoparticle
`Delivery
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`2.
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`For a decade before COVID-19 emerged, Moderna had been pioneering a new class
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`of medicines made of messenger RNA, or mRNA, and developed its own platform technologies
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`that could deliver mRNA in a variety of therapeutic and prophylactic applications, including
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`vaccines.1 These mRNA medicines have the potential to treat and prevent a wide range of
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`diseases—from infectious diseases like influenza and HIV, to autoimmune and cardiovascular
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`diseases and rare forms of cancer. Over the past twelve years, Moderna has worked diligently in
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`its laboratories to pioneer a number of fundamental breakthroughs in the field of mRNA
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`technology. These discoveries span all aspects of mRNA medicines—from the characteristics and
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`design of the mRNA itself and the protein it encodes, to the technologies to deliver mRNA to
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`patients safely and effectively.
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`3.
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`Included among the mRNA advancements that Moderna developed over years of
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`extensive work, is its proprietary lipid nanoparticle (“LNP”) delivery technologies to encapsulate
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`the mRNA for delivery.2 The LNPs function to protect the mRNA and deliver it into cells.3
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`4.
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`Moderna invested years of work and resources to develop LNPs that are tailored to
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`work with mRNA. Those efforts included developing novel proprietary lipids and optimal lipid
`
`
`D.I. 17-1, Ex. B (Decl. of Shaun Ryan, Mot. to Supplement the Record to Provide Evidence
`1
`of Standing) ¶ 2.
`2
`Id. ¶¶ 2-3.
`3
`Id.
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`2
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 3 of 83 PageID #: 731
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`compositions, and improving LNP manufacturing processes. Moderna’s inventions in this area
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`have been recognized with multiple U.S. patents.4, 5
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`5.
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`Moderna’s innovative proprietary LNP formulation technology, developed to
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`address the complex problem of reliably delivering mRNA to a patient, goes well beyond the
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`rudimentary, early technology for delivery of siRNA described in Arbutus’s Asserted Patents, nor
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`is it covered by those patents.
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`B.
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`6.
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`Arbutus’s Failed Attempts to Develop Products of its Own
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`In contrast to Moderna’s proprietary LNP technology to deliver mRNA, Arbutus
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`(and its predecessor Protiva Biotherapeutics, Inc., “Protiva”) conducted research relating to
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`delivery of small interfering RNA (“siRNA”), small pieces of RNA “about 15–60 . . . nucleotides
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`in length” as defined by Arbutus. See, e.g., U.S. Patent No. 8,058,069 (“’069 Patent”) at 6:55–66.
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`siRNA is a far cry from the long, complex mRNA that Moderna’s technology is designed to
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`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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`7.
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`None of the Asserted Patents focus on mRNA. For example, the specification of
`
`the ’069 Patent (and related Asserted Patents) focuses on siRNA, not mRNA, discussing “Selection
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`of siRNA Sequences,” “Generating siRNA Molecules,” “Modifying siRNA Sequences,” and
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`“Target Genes” of siRNA. See, e.g., ’069 Patent at cols. 29, 32, 33, and 35. Indeed, all 11 examples
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`of the ’069 Patent (and its asserted family members) are directed to “nucleic acid-lipid particles”
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`comprising siRNA—none involve mRNA. Id. at 67:64–86:18; see also U.S. Patent 9,504,651 at
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`cols. 14–19 (Examples 1–8, none of which are directed to mRNA formulations). This is consistent
`
`
`https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-
`4
`vaccines/99/i8.
`5
`E.g., https://www.modernatx.com/patents.
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`3
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 4 of 83 PageID #: 732
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`with Arbutus predecessor Protiva’s public statements at the time that the company was “focused
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`on” “formulations for RNAi therapeutics.”6 As another example, the ’651 Patent focuses on
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`plasmid DNA, rather than mRNA. See ’651 Patent at 2:17–19 (“The present invention can be used
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`to form lipid vesicles that contain encapsulated plasmid DNA or small molecule drugs.”), and cols.
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`14–15.
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`8.
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`Tellingly, Plaintiffs/Counterclaim Defendants never developed an LNP capable of
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`delivering mRNA, let alone manufactured or sold any approved products of their own, whether
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`siRNA or mRNA-based.
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`9.
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`Failing to develop any products of its own, Arbutus instead improperly expanded
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`the scope of its patent estate in an attempt to cover the inventions of others, including pioneers like
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`Moderna. Consequently, the purported inventions that Arbutus lays claim to in the Asserted
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`Patents bear no resemblance to the rudimentary technology described in the specifications.
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`C. Moderna’s Development and Sale of its COVID-19 Vaccine
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`10.
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`The SARS-CoV2 virus, which causes COVID-19, was first detected in December
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`2019. On January 10, 2020, the genetic sequence of the SARS-CoV-2 virus became public.7
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`Leveraging its decade of research and proprietary technologies, Moderna quickly responded when
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`the pandemic struck, swiftly developing, manufacturing, and providing doses of its COVID-19
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`vaccine to people around the world. The COVID-19 Vaccine, also referred to as the mRNA-1273
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`vaccine, uses Moderna’s proprietary LNP delivery technology that Moderna developed and
`
`
`https://investor.arbutusbio.com/news-releases/news-release-details/tekmira-
`6
`pharmaceuticals-and-protiva-biotherapeutics-announce-0.
`7
`“SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen
`Preparedness,” bioRvix.org, at 5–6 (June 11, 2020) (“Moderna/NIH Preprint”).
`
`4
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 5 of 83 PageID #: 733
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`described years earlier. 8 For that groundbreaking work, Moderna’s scientists were recently
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`honored by the American Chemistry Society’s 2022 Heroes of Chemistry Award, the highest
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`honor for industrial chemical scientists, recognizing their “work developing formulations that
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`protect against . . . COVID-19.”9
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`11.
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`Following the declaration of a public health emergency, Moderna entered into
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`numerous agreements with the U.S. Government regarding its COVID-19 Vaccine. In April 2020,
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`Moderna entered into a grant agreement with the Biomedical Advanced Research and
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`Development Authority (“BARDA”)—an office of HHS—to support clinical development of the
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`mRNA-1273 vaccine.10 BARDA chose to partner with Moderna to develop the COVID-19
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`vaccine because “Moderna’s mRNA-based vaccine platform has been used to rapidly prepare
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`vaccine candidates against Cytomegalovirus, Zika, Respiratory Syncytial Virus, Influenza, Human
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`Metapneumovirus and Parainfluenza virus.”11
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`12.
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`Once Moderna had obtained promising clinical results, on August 9, 2020,
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`ModernaTX, Inc. entered into a supply contract with the Army Contracting Command of the U.S.
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`Department of Defense, Contract No. W911QY20C0100 (“C0100 Contract”).12 Under the C0100
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`Contract, Moderna was obligated to produce and deliver doses of its COVID-19 Vaccine to the
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`U.S. Government, with the option to supply additional doses. The C0100 Contract specifically
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`states that Moderna manufactured the COVID-19 Vaccine doses “for the United States
`
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`https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-
`8
`vaccines/99/i8.
`9
`https://pubs.acs.org/doi/10.1021/cen-10028-acsnews2.
`10
`https://www.hhs.gov/sites/default/files/moderna-75a50120c00034.pdf
`Contract) at 9.
`11
`Id. at 9.
`12
`D.I. 17-1, Ex. A.
`
`(BARDA
`
`5
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 6 of 83 PageID #: 734
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`Government.” 13 The C0100 contract also incorporates by reference FAR 52.227-1, entitled
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`“Authorization and Consent.”14
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`13. Moderna received unprecedented emergency use authorization for its COVID-19
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`Vaccine in the U.S. from the Food & Drug Administration (“FDA”) on December 16, 2020—
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`within less than a year of beginning development. Promptly thereafter, Moderna shipped U.S.-
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`manufactured COVID-19 Vaccine doses to the U.S. Government pursuant to the C0100 Contract.
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`Moderna also supplied foreign governments with doses of the COVID-19 Vaccine. On January
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`31, 2022, Moderna received full approval from the FDA for its Biologics License Application for
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`the COVID-19 Vaccine.15
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`PARTIES
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`14. Moderna, Inc. is a corporation organized and existing under the laws of Delaware
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`with its principal place of business at 200 Technology Square, Cambridge, Massachusetts, 02139.
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`15. ModernaTX, Inc. is a corporation organized and existing under the laws of
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`Delaware with its principal place of business at 200 Technology Square, Cambridge,
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`Massachusetts, 02139.
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`16.
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`Upon
`
`information and belief, Plaintiff/Counterclaim-Defendant Arbutus
`
`Biopharma Corporation is a corporation organized and existing under the laws of Canada, with its
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`principal place of business at 701 Veterans Circle, Warminster, Pennsylvania, 18974.
`
`
`
`Id. at 19.
`13
`Id. at 46.
`14
`https://investors.modernatx.com/news/news-
`2022),
`31,
`(Jan.
`Press Release
`15
`details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-
`Spikevax/default.aspx.
`
`6
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`17.
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`Upon information and belief, Plaintiff/Counterclaim-Defendant Genevant Sciences
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`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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`NATURE OF ACTION
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`18. Moderna seeks declaratory judgment under the patent laws of the United States,
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`35 U.S.C. § 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. § 2201 et seq., that U.S.
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`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
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`Patent”) (collectively, “Asserted Patents”) are invalid and/or not infringed.
`
`JURISDICTION AND VENUE
`
`This Court has exclusive subject matter jurisdiction over this action pursuant to
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`19.
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`federal question jurisdiction, 28 U.S.C. §§ 1331, 1338; and the patent laws of the United States,
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`35 U.S.C. § 1 et seq.
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`20.
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`This Court has personal jurisdiction over Arbutus and Genevant because each has
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`subjected itself to the jurisdiction of this Court by filing the Complaint.
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`21.
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`Venue in this Court is proper based on the choice of forum by Plaintiffs and
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`pursuant to 28 U.S.C. §§ 1391(b)-(c).
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`FACTUAL BACKGROUND
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`On or about November 15, 2011, the ’069 Patent was issued to Protiva
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`22.
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`Biotherapeutics, 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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`Inc.
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`7
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`24.
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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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`25.
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`On or about June 14, 2016, the ’435 Patent was issued to Protiva Biotherapeutics,
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`Inc.
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`26.
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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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`27.
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`On or about October 12, 2021, the ’378 Patent was issued to Arbutus Biopharma
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`Corporation.
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`28.
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`29.
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`30.
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`Arbutus purports to be the owner and assignee of all Asserted Patents.
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`Genevant purports to be the exclusive licensee to all Asserted Patents.
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`On February 28, 2022, Plaintiffs Arbutus and Genevant filed a lawsuit against
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`Moderna asserting that Moderna’s COVID-19 Vaccine infringes the Asserted Patents.
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`31.
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`Pursuant to 28 U.S.C. § 2201(a), an actual and justiciable controversy has arisen
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`and exists between Moderna and Plaintiffs. Moderna is entitled to a judicial determination and
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`declaration that it has not infringed and is not infringing the Asserted Patents, and that the Asserted
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`Patents are invalid.
`
`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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`33.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
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`Vaccine infringes the ’069 Patent.
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`34.
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
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`Moderna regarding Moderna’s alleged infringement of the ’069 Patent.
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`8
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`35. Moderna has not infringed and is not infringing any valid claim of the ’069 Patent,
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`willfully or otherwise, directly or indirectly, either literally or by application of the doctrine of
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`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
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`comprising the claimed lipids (including, for example, the “cationic lipid”) in the claimed ratios,
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`and all dependent claims of the ’069 Patent depend from claim 1.
`
`36. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
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`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.
`
`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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`38.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
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`Vaccine infringes the ’359 Patent.
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`39.
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement 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.
`
`9
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`41. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
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`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.
`
`COUNT III
`DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’668 PATENT
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`42. Moderna repeats and incorporates paragraphs 1-41 as if fully set forth herein.
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`43.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’668 Patent.
`
`44.
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement 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.
`
`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.
`
`COUNT IV
`DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’435 PATENT
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`47. Moderna repeats and incorporates paragraphs 1-46 as if fully set forth herein.
`
`48.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’435 Patent.
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`10
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`49.
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`A real, immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’435 Patent.
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`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.
`
`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.
`
`COUNT V
`DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’651 PATENT
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`52. Moderna repeats and incorporates paragraphs 1-51 as if fully set forth herein.
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`53.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’651 Patent.
`
`54.
`
`A real, immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement 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 . . .
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`wherein at least 70% of the mRNA in the formulation is fully encapsulated in the lipid vesicles,”
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`and all dependent claims of the ’651 Patent depend from claim 1.
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`11
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`56. Moderna is entitled to a declaratory judgment that Moderna does not infringe, either
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`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
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`’651 Patent, either literally or under the doctrine of equivalents.
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`COUNT VI
`DECLARATORY JUDGMENT OF NONINFRINGEMENT OF THE ’378 PATENT
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`57. Moderna repeats and incorporates paragraphs 1-56 as if fully set forth herein.
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`58.
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`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’378 Patent.
`
`59.
`
`A real, immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’378 Patent.
`
`60. Moderna has not infringed and is not infringing any valid claim of the ’378 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 ’378 Patent at least because it does not comprise a nucleic acid-lipid particle
`
`comprising the claimed lipids (including, for example, the “polyethyleneglycol (PEG)-lipid
`
`conjugate”) in the claimed ratios, and all dependent claims of the ’378 Patent depend from claim
`
`1.
`
`61. 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
`
`’378 Patent, either literally or under the doctrine of equivalents.
`
`COUNT VII
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’069 PATENT
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`62. Moderna repeats and incorporates paragraphs 1-61 as if fully set forth herein.
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`12
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`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 13 of 83 PageID #: 741
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`63.
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`Plaintiffs have brought claims against Moderna alleging infringement of at least
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`claim 1 of the ’069 Patent.
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`64. Moderna alleges that the claims of the ’069 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, 112, and/or obviousness-type double patenting. For example,
`
`there are no patentable distinctions between the earlier-expiring claims of U.S. Patent No.
`
`9,006,191, 7,807,815 and/or 9,814,777, and the claims of the ’069 Patent, which are commonly
`
`owned and/or have common inventors, rendering them invalid under the doctrine of obviousness-
`
`type double patenting. Such obviousness-type double patenting references, alone or in combination
`
`with one or more prior art references such as U.S. Patent App. Pub. Nos. 2010/0015218,
`
`2010/0297023, 2008/0249046, or U.S. Patent No. 7,005,140 also render the claims obvious.
`
`65.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“nucleic acid-lipid particle[s]” in claim 1 with the recited ranges of “cationic lipid,” “non-cationic
`
`lipid” and “conjugated lipid.” As another example, claim 1 recites compositions comprising the
`
`broad genus of “nucleic acid[s],” but, other than siRNA, the specification fails to describe or enable
`
`any examples of nucleic acids including mRNA.
`
`66.
`
`A present, genuine, and justiciable controversy exists between Moderna and
`
`Plaintiffs regarding, inter alia, the validity of the claims of the ’069 Patent.
`
`67. Moderna is entitled to a declaration that one or more claims of the ’069 Patent are
`
`invalid.
`
`
`
`
`
`13
`
`
`
`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 14 of 83 PageID #: 742
`
`
`
`COUNT VIII
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’359 PATENT
`
`68. Moderna repeats and incorporates paragraphs 1-67 as if fully set forth herein.
`
`69.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’359 Patent.
`
`70. Moderna alleges that the claims of the ’359 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, 112, and/or obviousness-type double patenting. For example,
`
`there are no patentable distinctions between the earlier-expiring claims of U.S. Patent No.
`
`9,006,191, 7,807,815 and/or 9,814,777, and the claims of the ’359 Patent, which are commonly
`
`owned and/or have common inventors, rendering them invalid under the doctrine of obviousness-
`
`type double patenting. Such obviousness-type double patenting references, alone or in combination
`
`with one or more prior art references such as U.S. Patent App. Pub. Nos. 2010/0015218,
`
`2010/0297023, 2008/0249046, or U.S. Patent No. 7,005,140 also render the claims obvious.
`
`71.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“nucleic acid-lipid particle[s]” in claim 1 with the recited ranges of “cationic lipid,” “non-cationic
`
`lipid” and “conjugated lipid.” As another example, claim 1 recites compositions comprising the
`
`broad genus of “nucleic acid[s],” but, other than siRNA, the specification fails to describe or enable
`
`any examples of nucleic acids including mRNA.
`
`72.
`
`A present, genuine, and justiciable controversy exists between Moderna and
`
`Plaintiffs regarding, inter alia, the validity of the claims of the ’359 Patent.
`
`73. Moderna is entitled to a declaration that one or more claims of the ’359 Patent are
`
`invalid.
`
`14
`
`
`
`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 15 of 83 PageID #: 743
`
`
`
`COUNT IX
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’668 PATENT
`
`74. Moderna repeats and incorporates paragraphs 1-73 as if fully set forth herein.
`
`75.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’668 Patent.
`
`76. Moderna alleges that the claims of the ’668 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, 112, and/or obviousness-type double patenting. For example,
`
`there are no patentable distinctions between the earlier-expiring claims of U.S. Patent No.
`
`9,006,191, 7,807,815 and/or 9,814,777, and the claims of the ’668 Patent, which are commonly
`
`owned and/or have common inventors, rendering them invalid under the doctrine of obviousness-
`
`type double patenting. Such obviousness-type double patenting references, alone or in combination
`
`with one or more prior art references such as U.S. Patent App. Pub. Nos. 2010/0015218,
`
`2010/0297023, 2008/0249046, or U.S. Patent No. 7,005,140 also render the claims obvious.
`
`77.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“nucleic acid-lipid particle[s]” in claim 1 with the recited ranges of “cationic lipid,” “non-cationic
`
`lipid” and “conjugated lipid.” As another example, claim 1 recites compositions comprising the
`
`broad genus of “nucleic acid[s],” but, other than siRNA, the specification fails to describe or enable
`
`any examples of nucleic acids including mRNA.
`
`78.
`
`A present, genuine, and justiciable controversy exists between Moderna and
`
`Plaintiffs regarding, inter alia, the validity of the claims of the ’668 Patent.
`
`79. Moderna is entitled to a declaration that one or more claims of the ’668 Patent are
`
`invalid.
`
`15
`
`
`
`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 16 of 83 PageID #: 744
`
`
`
`COUNT X
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’435 PATENT
`
`80. Moderna repeats and incorporates paragraphs 1-79 as if fully set forth herein.
`
`81.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’435 Patent.
`
`82. Moderna alleges that the claims of the ’435 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, 112, and/or obviousness-type double patenting. For example,
`
`there are no patentable distinctions between the earlier-expiring claims of U.S. Patent No.
`
`9,006,191, 7,807,815 and/or 9,814,777, and the claims of the ’435 Patent, which are commonly
`
`owned and/or have common inventors, rendering them invalid under the doctrine of obviousness-
`
`type double patenting. Such obviousness-type double patenting references, alone or in combination
`
`with one or more prior art references such as U.S. Patent App. Pub. Nos. 2010/0015218,
`
`2010/0297023, 2008/0249046, or U.S. Patent No. 7,005,140 also render the claims obvious.
`
`83.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“nucleic acid-lipid particle[s]” in claim 1 with the recited ranges of “cationic lipid,” “non-cationic
`
`lipid” and “conjugated lipid.” As another example, claim 1 recites compositions comprising the
`
`broad genus of “nucleic acid[s],” but, other than siRNA, the specification fails to describe or enable
`
`any examples of nucleic acids including mRNA.
`
`84.
`
`A present, genuine, and justiciable controversy exists between Moderna and
`
`Plaintiffs regarding, inter alia, the validity of the claims of the ’435 Patent.
`
`85. Moderna is entitled to a declaration that one or more claims of the ’435 Patent are
`
`invalid.
`
`16
`
`
`
`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 17 of 83 PageID #: 745
`
`
`
`COUNT XI
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’651 PATENT
`
`86. Moderna repeats and incorporates paragraphs 1-85 as if fully set forth herein.
`
`87.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’651 Patent.
`
`88. Moderna alleges that the claims of the ’651 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, and/or 112. For example, there are no patentable distinctions
`
`between the earlier-expiring claims of U.S. Patent No. 6,841,537 or U.S. 6,734,171, and the claims
`
`of the ’651 Patent, which are commonly owned and/or have common inventors, rendering them
`
`invalid under the doctrine of obviousness-type double patenting. Further, claim 1 is anticipated or
`
`obvious in light of prior art references including, but not limited to, U.S. Patent No. 6,271,208,
`
`U.S. Patent No. 6,110,745, WO 01/11068 A2, WO 01/15726 A2, WO 98/51278, and Saravolac
`
`2000.16
`
`89.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“lipid vesicles” in claim 1 with the recited broad genus of “cationic lipid,” “amphipathic lipid” and
`
`“polyethyleneglycol (PEG)-lipid,” wherein “at least 70% of the mRNA in the formulation is fully
`
`encapsulated” as claimed. As another example, claim 1 recites compositions comprising
`
`“messenger RNA (mRNA),” but the specification fails to describe or enable any examples of “lipid
`
`vesicles” comprising mRNA, let alone those wherein “at least 70% of the mRNA in the
`
`formulation is fully encapsulated” as claimed.
`
`
`16 Saravolac, E. G., et al. "Encapsulation of plasmid DNA in stabilized plasmid–lipid particles
`composed of different cationic lipid concentration for optimal transfection activity." Journal of
`drug targeting 7.6 (2000): 423-437.
`
`17
`
`
`
`Case 1:22-cv-00252-MSG Document 35 Filed 11/30/22 Page 18 of 83 PageID #: 746
`
`
`
`90.
`
`A present, genuine, and justiciable controversy exists between Moderna and
`
`Plaintiffs regarding, inter alia, the validity of the claims of the ’651 Patent.
`
`91. Moderna is entitled to a declaration that one or more claims of the ’651 Patent are
`
`invalid.
`
`COUNT XII
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’378 PATENT
`
`92. Moderna repeats and incorporates paragraphs 1-91 as if fully set forth herein.
`
`93.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’378 Patent.
`
`94. Moderna alleges that the claims of the ’378 Patent are invalid for failure to comply
`
`with the statutory prerequisites of Title 35 of the United States Code, including without limitation,
`
`one or more of §§ 101, 102, 103, 112, and/or obviousness-type double patenting. For example,
`
`claim 1 is anticipated or obvious in light of prior art references including, but not limited to,
`
`Zimmerman 2006,17 Thomas 2007,18 and U.S. Patent Pub. No. 2008/0020058 A1. Further, there
`
`are no patentable distinctions between the earlier-expiring claims of U.S. Patent No. 9,006,191,
`
`and the claims of the ’378 Patent, which are commonly owned and/or have common inventors,
`
`rendering them invalid under the doctrine of o
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