Case 1:22-cv-00252-MSG Document 344 Filed 06/10/24 Page 1 of 92 PageID #: 20936
`Case 1:22-cv-00252-MSG Document 344 Filed 06/10/24 Page 1 of 92 PagelD #: 20936
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`eeAoddeadeeeeeeiaeeeadedl
`
`Plaintiffs,
`
`C.A. No. 22-252 (MSG)
`
`Vv.
`
`JURY TRIAL DEMANDED
`
`MODERNA,INC. and MODERNATX,INC.
`
`Defendants.———
`MODERNA,INC. and MODERNATX,INC.,
`
`REDACTED - PUBLIC VERSION
`Original filing date: May 15, 2024
`Redactedfiling date: June 10, 2024
`
`Counterclaim-Plaintiffs,
`
`V.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`DEFENDANTS’ COUNTERCLAIMS AND ANSWER TO AMENDED COMPLAINT
`DECLARATORY JUDGMENT COUNTERCLAIMS
`
`Defendants/Counterclaim-Plaintiffs Moderna, Inc. and ModernaTX, Inc. (collectively,
`
`“Moderna”) demanda 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
`
`1.
`
`Moderna brings these counterclaims in response to Arbutus and Genevant’s
`
`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 doesnot infringe the Asserted Patents, and that those patents
`
`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
`
`COVID-19 Vaccine. Plaintiffs played no role in Moderna’s significant accomplishments.
`
`A.
`
`2.
`
`Moderna’s Development of mRNA Medicines Using Lipid Nanoparticle
`Delivery
`
`For a decade before COVID-19 emerged, Moderna had beenpioneering a new 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 workeddiligently 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 mRNAitself and the protein it encodes, to the technologies to deliver mRNA to
`
`patients safely and effectively.
`
`3.
`
`Included among the mRNA advancements that Moderna developed over years of
`
`extensive work,is its proprietary lipid nanoparticle (“LNP”) delivery technologies to encapsulate
`
`the mRNAfor delivery.? The LNPs function to protect the mRNAanddeliverit into cells.’
`
`4,
`
`Modernainvested years of work and resources to develop LNPsthatare tailored to
`
`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.
`
`Id. ¥§ 2-3.
`
`3
`
`Id.
`
`

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`compositions, and improving LNP manufacturing processes. Moderna’s inventions in this area
`
`have been recognized with multiple U.S.patents.* >
`
`5.
`
`Moderna’s innovative proprietary LNP formulation technology, developed to
`
`address the complex problem of reliably delivering mRNAto 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.
`
`B.
`
`6.
`
`Arbutus’s Failed Attempts to Develop Products of its Own
`
`In contrast to Moderna’s proprietary LNP technology to deliver mRNA, Arbutus
`
`(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 mRNAthat is approximately
`
`4,000 nucleotides—over 60 times the length contemplated by the Arbutus patents.
`
`7.
`
`Noneof 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
`
`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./d. at 67:64—86:18; see also U.S. Patent 9,504,651 at
`
`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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`cols. 14-19 (Examples 1-8, none of whichare 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.”), andcols.
`
`14-15.
`
`8.
`
`Tellingly, Plaintiffs/Counterclaim Defendants never developed an LNP capable of
`
`delivering mRNA,let alone manufactured or sold any approved products of their own, whether
`
`siRNA or mRNA-based.
`
`9.
`
`Failing to develop any products of its own, Arbutus instead improperly expanded
`
`the scope ofits patent estate in an attempt to coverthe inventionsof others, including pioneerslike
`
`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.
`
`C.
`
`10.
`
`Moderna’s Development andSale of its COVID-19 Vaccine
`
`The SARS-CoV2virus, which causes COVID-19, wasfirst detected in December
`
`2019. On January 10, 2020, the genetic sequence of the SARS-CoV-2 virus became public.’
`
`Leveragingits 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
`
`https://investor.arbutusbio.com/news-releases/news-release-details/tekmira-
`6
`pharmaceuticals-and-protiva-biotherapeutics-announce-0.
`
`“SARS-CoV-2. mRNA Vaccine Development Enabled by Prototype Pathogen
`7
`Preparedness,” bioRvix.org, at 5—6 (June 11, 2020) (“Moderna/NIH Preprint”).
`
`

`

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`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.”°
`
`11.
`
`Following the declaration of a public health emergency, Moderna entered into
`
`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 Parainfluenzavirus.” !!
`
`12.
`
`Once Moderna had obtained promising clinical results, on August 9, 2020,
`
`ModernaTX,Inc. entered into a supply contract with the Army Contracting Commandof 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
`
`https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-
`8
`vaccines/99/i8.
`
`?
`
`https://pubs.acs.org/doi/10.1021/cen-10028-acsnews?2.
`
`https://www.hbhs.gov/sites/default/files/moderna-75a50120c00034.pdf
`10
`Contract) at 9.
`
`(BARDA
`
`i
`
`2
`
`Id. at 9.
`
`D.I. 17-1, Ex. A.
`
`

`

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`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 I, entitled “Authorization And Consent (JUN
`
`2020)- Alternate I.”!4
`
`13.|Moderna received unprecedented emergency use authorization for its COVID-19
`
`Vaccine in the U.S. from the Food & Drug Administration (“FDA”) on December 18, 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.
`
`Modernaalso supplied foreign governments with doses of the COVID-19 Vaccine. On January
`
`31, 2022, Modernareceived full approval from the FDAfor its Biologics License Application for
`
`the COVID-19 Vaccine.!°
`
`PARTIES
`
`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.
`
`
`
`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.
`
`13
`
`M4
`
`Td. at 19.
`
`Id. at 46.
`
`https://investors.modernatx.com/news/news-
`2022),
`31,
`(Jan.
`Release
`Press
`15
`details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-
`Spikevax/default.aspx.
`
`

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`16.
`
`Upon
`
`information
`
`and
`
`belief,
`
`Plaintiff/Counterclaim-Defendant Arbutus
`
`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.
`
`17.|Upon information andbelief, Plaintiff/Counterclaim-Defendant Genevant Sciences
`
`GmbHis a company organized and existing under the laws of Switzerland, with its principal place
`
`of business at Viaduktstrasse 8, 4051 Basel, Switzerland.
`
`NATURE OF ACTION
`
`18.|Modernaseeks declaratory judgment underthe 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.
`
`JURISDICTION AND VENUE
`
`19.
`
`This Court has exclusive subject matter jurisdiction over this action pursuant to
`
`federal question jurisdiction, 28 U.S.C. §§ 1331, 1338; and the patent laws of the United States,
`
`35 U.S.C. § 1 et seq.
`
`20.
`
`This Court has personal jurisdiction over Arbutus and Genevant because each has
`
`subjected itself to the jurisdiction of this Court by filing the Amended Complaint.
`
`21.|Venuein this Court is proper based on the choice of forum by Plaintiffs and
`
`pursuant to 28 U.S.C. §§ 1391(b)-(c), and 1400(b).
`
`FACTUAL BACKGROUND
`
`22.
`
`On or about November 15, 2011,
`
`the ’069 Patent was issued to Protiva
`
`Biotherapeutics, Inc.
`
`

`

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`23.
`
`On or about July 23, 2013, the °359 Patent was issued to Protiva Biotherapeutics,
`
`Inc.
`
`24.
`
`On or about September 2, 2014,
`
`the °668 Patent was issued to Protiva
`
`Biotherapeutics, Inc.
`
`25.
`
`On or about June 14, 2016, the °435 Patent was issued to Protiva Biotherapeutics,
`
`Inc.
`
`26.
`
`On or about November 29, 2016,
`
`the ’651 Patent was issued to Protiva
`
`Biotherapeutics, Inc.
`
`27.
`
`On or about October 12, 2021, the °378 Patent was issued to Arbutus Biopharma
`
`Corporation.
`
`28.
`
`29.
`
`30.
`
`Arbutus purports to be the ownerandassigneeofall Asserted Patents.
`
`Genevant purports to be the exclusive licensee to all Asserted Patents.
`
`On February 28, 2022, Plaintiffs Arbutus and Genevant filed a lawsuit against
`
`Modernaasserting that Moderna’s COVID-19 Vaccine infringes the Asserted Patents.
`
`31.
`
`Pursuant to 28 U.S.C. § 2201(a), an actual and justiciable controversy has arisen
`
`and exists between Moderna and Plaintiffs. Moderna is entitled to a judicial determination and
`
`declaration that it has not infringed andis not infringing the Asserted Patents, and that the Asserted
`
`Patents are invalid.
`
`COUNTI
`DECLARATORY JUDGMENT OF NONINFRINGEMENTOF THE ’069 PATENT
`
`32.|Moderna repeats and incorporates paragraphs 1-31 asif fully set forth herein.
`
`33.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’069 Patent.
`
`

`

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`34.
`
`A real,
`
`immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’069 Patent.
`
`35.|Moderna hasnotinfringed andis 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 claimedratios,
`
`and all dependent claimsof the ’069 Patent depend from claim 1.
`
`36.|Modernais entitled to a declaratory judgment that Moderna doesnotinfringe, 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.
`
`COUNT II
`DECLARATORY JUDGMENT OF NONINFRINGEMENTOF THE ’359 PATENT
`
`37.|Modernarepeats and incorporates paragraphs 1-36 asif fully set forth herein.
`
`38.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’359 Patent.
`
`39.
`
`A real,
`
`immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’359 Patent.
`
`40.
`
`Modernahasnotinfringed andis 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 claimedratios,
`
`and all dependent claimsof the ’359 Patent depend from claim 1.
`
`

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`41.
`
`Modernais entitled to a declaratory judgment that Moderna doesnotinfringe, 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.
`
`COUNT Ill
`DECLARATORY JUDGMENT OF NONINFRINGEMENTOF THE ’668 PATENT
`
`42.|Modernarepeats and incorporates paragraphs 1-41 as if fully set forth herein.
`
`43.
`
`Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’668 Patent.
`
`44.
`
`A real,
`
`immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’668 Patent.
`
`45.|Modernahasnotinfringed andis 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 claimedratios,
`
`and all dependent claimsof the ’668 Patent depend from claim 1.
`
`46.
`
`Modernaisentitled to a declaratory judgment that Moderna doesnotinfringe, 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 NONINFRINGEMENTOF THE °435 PATENT
`
`47.|Modernarepeats and incorporates paragraphs 1-46 asif fully set forth herein.
`
`48.__Plaintiffs have brought claims against Moderna alleging Moderna’s COVID-19
`
`Vaccine infringes the ’435 Patent.
`
`10
`
`

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`49.
`
`A real,
`
`immediate, and justiciable controversy exists between Plaintiffs and
`
`Moderna regarding Moderna’s alleged infringement of the ’435 Patent.
`
`50.|Moderna hasnotinfringed andis 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.|Modernais entitled to a declaratory judgment that Moderna doesnot infringe, either
`
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`
`435 Patent, eitherliterally or under the doctrine of equivalents.
`
`COUNT V
`DECLARATORY JUDGMENT OF NONINFRINGEMENTOF THE ’651 PATENT
`
`52.|Moderna repeats and incorporates paragraphs 1-51 asif fully set forth herein.
`
`53.
`
`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 hasnotinfringed andis 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 mRNAin the formulation is fully encapsulated in the lipid vesicles,”
`
`and all dependent claimsof the ’651 Patent depend from claim 1.
`
`11
`
`

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`56.|Modernais entitled to a declaratory judgment that Moderna doesnotinfringe, either
`
`directly or indirectly, and has not infringed, either directly or indirectly, any valid claim of the
`
`651 Patent, eitherliterally or under the doctrine of equivalents.
`
`COUNT VI
`DECLARATORY JUDGMENT OF NONINFRINGEMENTOF THE ’378 PATENT
`
`57.|Modernarepeats and incorporates paragraphs 1-56 asif fully set forth herein.
`
`58.
`
`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 hasnotinfringed andis 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.|Modernais entitled to a declaratory judgment that Moderna doesnot 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 7069 PATENT
`
`62.|Moderna repeats and incorporates paragraphs 1-61 asif fully set forth herein.
`
`63.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’069 Patent.
`
`12
`
`

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`64.
`
`Moderna alleges that the claimsof 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 commoninventors, 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 genusof “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.|Modernais entitled to a declaration that one or moreclaimsof the ’069 Patent are
`
`invalid.
`
`COUNT VIII
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’359 PATENT
`
`68.|Moderna repeats and incorporates paragraphs 1-67 asif fully set forth herein.
`
`69.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ?359 Patent.
`
`13
`
`

`

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`
`70.
`
`Moderna alleges that the claimsof 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 commoninventors, 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 genusof “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,interalia, the validity of the claims of the ’359 Patent.
`
`73.|Modernais entitled to a declaration that one or moreclaims of the ’359 Patent are
`
`invalid.
`
`COUNT IX
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’668 PATENT
`
`74.|Moderna repeats and incorporates paragraphs 1-73 asif fully set forth herein.
`
`75.
`
`Plaintiffs have brought claims against Moderna alleging infringement of at least
`
`claim 1 of the ’668 Patent.
`
`14
`
`

`

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`
`76.
`
`Moderna alleges that the claimsof 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 commoninventors, 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 genusof “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,interalia, the validity of the claims of the ’668 Patent.
`
`79.
`
`Modernais entitled to a declaration that one or moreclaims of the ’668 Patent are
`
`invalid.
`
`COUNT X
`DECLARATORY JUDGMENT OF INVALIDITY OF THE 7435 PATENT
`
`80.|Moderna repeats and incorporates paragraphs 1-79 asif fully set forth herein.
`
`81.
`
`‘Plaintiffs have brought claims against Moderna alleging infringement ofat least
`
`claim 1 of the ?435 Patent.
`
`15
`
`

`

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`Case 1:22-cv-00252-MSG Document 344 Filed 06/10/24 Page 16 of 92 PagelD #: 20951
`
`82.
`
`Modernaalleges 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 commoninventors, 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 genusof “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,interalia, the validity of the claims of the ’435 Patent.
`
`85.|Modernais entitled to a declaration that one or more claimsof the ’435 Patent are
`
`invalid.
`
`COUNT XI
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’651 PATENT
`
`86.|Moderna repeats and incorporates paragraphs 1-85 asif fully set forth herein.
`
`87.
`
`Plaintiffs have brought claims against Moderna alleging infringement ofat least
`
`claim 1 of the ’651 Patent.
`
`16
`
`

`

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`Case 1:22-cv-00252-MSG Document 344 Filed 06/10/24 Page 17 of 92 PagelD #: 20952
`
`88.|Modernaalleges 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
`
`betweenthe 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 commoninventors, 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.!¢
`
`89.
`
`In addition, the specification fails to describe or enable, for example, the claimed
`
`“lipid vesicles” in claim 1 with the recited broad genusof “cationic lipid,” “amphipathic lipid” and
`
`“yolyethyleneglycol (PEG)-lipid,” wherein “at least 70% of the mRNAin the formulationis fully
`
`encapsulated” as claimed. As another example, claim 1
`
`recites compositions comprising
`
`“messenger RNA (mRNA),”but the specification fails to describe or enable any examplesof “lipid
`
`vesicles” comprising mRNA,
`
`let alone those wherein “at
`
`least 70% of the mRNA in the
`
`formulation is fully encapsulated” as claimed.
`
`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.|Modernais entitled to a declaration that one or more claims of the ’651 Patent are
`
`invalid.
`
`16 Saravolac, E. G., et al. "Encapsulation of plasmid DNAin stabilized plasmid—lipid particles
`composedof different cationic lipid concentration for optimal transfection activity." Journal of
`drug targeting 7.6 (2000): 423-437.
`
`17
`
`

`

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`
`COUNTXII
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’378 PATENT
`
`92.|Modernarepeats and incorporates paragraphs 1-91 asif fully set forth herein.
`
`93.
`
`Plainti