Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 1 of 44 PageID #: 5196
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`C.A. No. 22-cv-925-CFC
`(CONSOLIDATED WITH LEAD
`CASE 22-cv-335-CFC)
`
`
`Plaintiff,
`
`v.
`
`Defendants.
`
`ALNYLAM PHARMACEUTICALS,
`INC.,
`
`
`
`
`
`MODERNA, INC., MODERNA TX,
`INC., and MODERNA US, INC.,
`
`
`
`
`MODERNA’S COUNTERCLAIMS AND ANSWER TO THE COMPLAINT
`Pursuant
`to Rule 13 of
`the Federal Rules of Civil Procedure,
`
`Defendants/Counterclaim-Plaintiffs Moderna, Inc., Moderna TX, Inc., and Moderna
`
`US, Inc. (collectively, “Moderna”) by and through their attorneys, bring the
`
`following Counterclaims against Plaintiff/Counterclaim-Defendant Alnylam
`
`Pharmaceuticals, Inc. (“Alnylam”):
`
`FACTUAL BACKGROUND
`
` Moderna brings these Counterclaims in response to Alnylam’s
`
`1.
`
`Complaint, which baselessly seeks to profit from Moderna’s innovations that led to
`
`its groundbreaking mRNA-1273 COVID-19 Vaccine
`
`(“SPIKEVAX®”).
`
`Specifically, Moderna asks this Court to declare the following: (a) SPIKEVAX®
`
`does not infringe the ’979 Patent; (b) the ’979 Patent is invalid; and (c) Alnylam has
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 2 of 44 PageID #: 5197
`
`no claim against Moderna to the extent Moderna used or manufactured
`
`SPIKEVAX® “for the Government” and “with the authorization or consent of the
`
`Government” under 28 U.S.C. § 1498. 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 the lifesaving SPIKEVAX® vaccine.
`
`Alnylam played no role in Moderna’s significant accomplishments.
`
`A. Moderna’s Development of mRNA Medicines Using Lipid
`Nanoparticle Technology
`For a decade before COVID-19 emerged, Moderna had been pioneering
`
`2.
`
`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 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.
`
`3.
`
`Included among the mRNA advancements that Moderna developed
`
`over years of extensive work is its proprietary lipid nanoparticle (“LNP”) delivery
`
`
`
`2
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 3 of 44 PageID #: 5198
`
`technologies to provide the mRNA for delivery. The LNPs function to protect the
`
`mRNA and deliver it into cells. Critical to the LNP delivery technology used in
`
`SPIKEVAX® is Moderna’s proprietary lipid, SM-102. Moderna scientist Dr. Kerry
`
`Benenato discovered SM-102. Dr. Benenato and her team conducted extensive work
`
`to discover a lipid for use in an LNP that would address the issues of being able to
`
`protect the delivery of fragile mRNA to the right location in the body, effectively
`
`deliver the mRNA to the cells of interest, and then biodegrade so as not to cause
`
`tolerability issues. This was no small feat.
`
`4. Moderna invested years of work and resources to develop LNPs that
`
`are tailored to work with mRNA. Those efforts included developing novel
`
`proprietary lipids, including SM-102, and improving LNP manufacturing processes.
`
`B. Moderna’s development and Sale of SPIKEVAX®
`5.
`The SARS-CoV2 virus, which causes COVID-19, was first detected in
`
`December 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 SPIKEVAX® to people around the world.
`
`SPIKEVAX®, 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
`
`
`
`3
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 4 of 44 PageID #: 5199
`
`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.”1
`
`6.
`
`Following the declaration of a public health emergency, Moderna
`
`entered
`
`into numerous agreements with
`
`the U.S. Government regarding
`
`SPIKEVAX®. 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 SPIKEVAX® 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.”2
`
`7.
`
`Once Moderna had obtained promising clinical results, on August 9,
`
`2020, ModernaTX, Inc. entered into a supply contract with the Army Contracting
`
`Command of the U.S. Department of Defense, Contract No. W911QY20C0100
`
`
`1 Nina Notman, Chemists are Recognized for Their Contributions to Sustainable
`Packaging, Dental Cements, Breast Cancer Treatments, and Formulations that
`Protect Against or Treat COVID-19, C&EN, https://pubs.acs.org/doi/10.1021/cen-
`10028-acsnews2.
`2 Contract No. 75A50120000034 Development of an mRNA Vaccine for SARS-
`CoV-2, § C.1 at 9, https://www.hhs.gov/sites/default/files/moderna-
`75a50120c00034.pdf.
`
`
`
`4
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 5 of 44 PageID #: 5200
`
`(“C0100 Contract”).3 Under the C0100 Contract, Moderna was obligated to produce
`
`and deliver doses of SPIKEVAX® to the U.S. Government, with the option to
`
`supply additional doses.4 The C0100 Contract specifically states that Moderna
`
`manufactured SPIKEVAX® doses “for the United States Government.”5 The C0100
`
`contract also incorporates by reference FAR 52.227-1, entitled “Authorization and
`
`Consent.”6
`
`8. Moderna received emergency use authorization for SPIKEVAX® in
`
`the U.S. from the Food & Drug Administration (“FDA”) on December 16, 2020, less
`
`than a year after beginning development. Promptly thereafter, Moderna shipped
`
`SPIKEVAX® doses to the U.S. Government pursuant to the C0100 Contract. On
`
`January 31, 2022, Moderna received full approval from the FDA for its Biologics
`
`License Application for SPIKEVAX®.7
`
`
`3 Army Contracting Command of the U.S. Department of Defense, Contract No.
`W911QY20C0100, https://www.hhs.gov/sites/default/files/moderna-large-scale-
`production-sars-cov-2-vaccine.pdf.
`4 Id.
`5 Id. at 19.
`6 Id. at 46 (also incorporating FAR clause 52.227-1 Alternate I).
`7 Colleen Hussey, Moderna Receives Full U.S. FDA Approval for COVID-19
`Vaccine SPIKEVAX, https://investors.modernatx.com/news/news-
`details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-
`Vaccine-Spikevax/default.aspx.
`
`
`
`5
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 6 of 44 PageID #: 5201
`
`C. Alnylam does not Develop mRNA Medicines
`9.
` In contrast to Moderna’s mission to deliver the greatest possible impact
`
`to people through mRNA medicines, Alnylam has based its entire business model
`
`on another type of RNA called small interfering RNA (“siRNA”). This distinction
`
`is notable because mRNA and siRNA are markedly different. Structurally, mRNA
`
`is significantly larger than siRNA; this size difference makes it much harder to
`
`package mRNA into drug delivery vehicles (like LNPs). Functionally, mRNA
`
`promotes the expression of proteins in cells; siRNA, by contrast, shuts down cellular
`
`protein expression in a process called RNA interference (“RNAi”).
`
`10. Unlike Moderna, Alnylam has not focused any of its drug development
`
`efforts towards mRNA therapeutics. To be sure, every FDA-approved product
`
`Alnylam has brought to market involves methods of delivering siRNA—not mRNA.
`
`11.
`
` Alnylam’s website is also telling. Its front webpage describes Alnylam
`
`as “THE LEADING RNAi THERAPEUTICS COMPANY.”8 Alnylam’s website
`
`goes on to explain that its two therapeutic delivery platforms—lipid nanoparticles
`
`(“LNPs,” i.e., the subject of this lawsuit) and GalNAc conjugates—“enable delivery
`
`of small interfering RNA (siRNA) to target tissues.”9 Nowhere on its website does
`
`Alnylam describe using either platform to deliver mRNA.
`
`
`8 https://www.alnylam.com/.
`9 https://www.alnylam.com/our-science/sirna-delivery-platforms.
`
`
`
`6
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 7 of 44 PageID #: 5202
`
`12.
`
` The asserted patent in this suit further illustrates that Alnylam has not
`
`historically focused on mRNA. The ’979 Patent is titled “Biodegradable Lipids for
`
`the Delivery of Active Agents.” ’979 Patent at 1. The only “Active Agents” the
`
`’979 Patent’s written description includes, however, are siRNA and miRNA. In fact,
`
`nowhere in the hundreds of pages constituting the ’979 Patent’s written description
`
`or claims does the term “mRNA” appear.
`
`13. At first blush, it may appear as though the same LNPs that effectively
`
`deliver siRNA into target cells would work well in therapeutic mRNA applications.
`
`This could not be further from the truth. As Romesh Subramanian (a former
`
`Moderna-affiliated scientist) stated, “off-the-shelf LNP formulations designed for
`
`siRNA” did not work well for mRNA delivery due to the significant size differences
`
`between the two molecules: “siRNA molecules are . . . about 20 nucleotides each,”
`
`whereas “mRNA . . . can easily span thousands of nucleotides, wind into complex
`
`shapes, and change the properties of the LNP in ways that are hard to predict.” D.I.
`
`1, Ex. 15 at 675.
`
`14. Tellingly, Alnylam never developed a cationic lipid for use in an LNP
`
`that was capable of delivering mRNA, let alone manufactured or sold any mRNA-
`
`based FDA-approved product.
`
`
`
`7
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 8 of 44 PageID #: 5203
`
`D. Alnylam Tries to Claim SM-102, Which It Did Not Invent
`15. Failing to develop any cationic lipid or LNP technology for delivering
`
`mRNA, Alnylam instead improperly expanded the scope of its patent estate in an
`
`attempt to cover the inventions of others, including pioneers like Moderna.
`
`16. The ’979 Patent is directed to specific cationic lipids, which are quite
`
`different than the proprietary lipid Moderna’s scientists discovered, SM-102.
`
`Alnylam filed the original application (PCT/US2012/068491) underlying the ’979
`
`Patent in 2012. From that application, Alnylam sought and was issued claims to
`
`certain cationic lipids, none of which covered SM-102.
`
`17. Although it originally filed its PCT application in 2012, Alnylam did
`
`not seek patent claims that purportedly cover SPIKEVAX® until after Moderna
`
`publicly released SM-102’s structure in 2020. Only then did Alnylam attempt to
`
`cobble together claims it hoped would cover Moderna’s proprietary SM-102 lipid
`
`and its use in Moderna’s groundbreaking LNP-based mRNA delivery technology.
`
`But those claims are fatally flawed, having been stretched far beyond the patents’
`
`disclosure and previously described prior art.
`
`
`
`PARTIES
`
`18. Moderna, Inc. is a company organized and existing under the laws of
`
`the State of Delaware with a principal place of business at 200 Technology Square,
`
`Cambridge, Massachusetts 02139.
`
`
`
`8
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 9 of 44 PageID #: 5204
`
`19. ModernaTX, Inc. is a company organized and existing under the laws
`
`of the State of Delaware with a principal place of business at 200 Technology
`
`Square, Cambridge, Massachusetts 02139.
`
`20. Moderna US, Inc. is a company organized and existing under the laws
`
`of the State of Delaware with a principal place of business at 200 Technology
`
`Square, Cambridge, Massachusetts 02139.
`
`21. On information and belief, Alnylam is a corporation organized and
`
`existing under the laws of the State of Delaware with a principal place of business
`
`at 675 West Kendall Street, Henri A. Termeer Square, Cambridge, Massachusetts
`
`02142.
`
`
`
`NATURE OF THE ACTION
`
`22. 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 No. 11,382,979 (the “’979 Patent”) is invalid and/or
`
`not infringed.
`
`
`
`JURISDICTION AND VENUE
`
`23. This Court has subject matter jurisdiction over these Counterclaims for
`
`declaratory judgment pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202 based
`
`on an actual controversy among the parties arising under the Patent Laws of the
`
`United States, 35 U.S.C. § 1, et seq.
`
`
`
`9
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 10 of 44 PageID #: 5205
`
`24. Personal jurisdiction over Alnylam is proper because Alnylam is a
`
`corporation organized and existing under the laws of the State of Delaware, and
`
`because Alnylam has consented to the personal jurisdiction of the Court by
`
`commencing its action for patent infringement in this Judicial District, as set forth
`
`in its Complaint.
`
`25. Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and
`
`1400 as Alnylam is a corporation organized and existing under the laws of the State
`
`of Delaware, and by virtue of Alnylam’s filing of this lawsuit in this venue.
`
`26.
`
` There is an actual justiciable controversy among the parties concerning
`
`non-infringement and invalidity of the ’979 Patent.
`
`COUNT I
`DECLARATORY JUDGMENT OF
`NONINFRINGEMENT OF THE ’979 PATENT
`
`27.
`
` Moderna repeats and incorporates Paragraphs 1-26 as if fully set forth
`
`
`
`herein.
`
`28. Alnylam has brought claims against Moderna alleging SPIKEVAX®
`
`infringes the ’979 Patent.
`
`29.
`
` A real, immediate, and justiciable controversy exists between Alnylam
`
`and Moderna regarding Moderna’s alleged infringement of the ’979 Patent.
`
`30.
`
` Moderna has not infringed and is not infringing any valid claim of the
`
`’979 Patent, willfully or otherwise, directly or indirectly, either literally or by
`
`
`
`10
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 11 of 44 PageID #: 5206
`
`application of the doctrine of equivalents. For example, SPIKEVAX® does not
`
`meet each and every element of independent claim 1 of the ’979 Patent at least
`
`because it does not contain a lipid particle comprising the claimed cationic lipid, and
`
`dependent asserted claims 2-3, and 5-14 of the ’979 Patent depend from claim 1.
`
`Also, SPIKEVAX® does not meet each and every element of independent claim 18
`
`of the ’979 Patent at least because it does not involve a method for preparing the
`
`claimed lipid particle mixture and dependent asserted claims 19-20 and 22-30 of the
`
`’979 Patent depend from claim 18.
`
`31.
`
` 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 ’979 Patent, either literally or under the doctrine of
`
`equivalents.
`
`COUNT II
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’979 PATENT
`
`32.
`
` Moderna repeats and incorporates Paragraphs 1-31 as if fully set forth
`
`
`
`herein.
`
`33.
`
` Alnylam has brought claims against Moderna alleging infringement of
`
`at least claim 18 of the ’979 Patent.
`
`34.
`
` Moderna alleges that the claims of the ’979 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 any
`
`
`
`11
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 12 of 44 PageID #: 5207
`
`judicially created requirements for patentability and enforceability of patent and/or
`
`in view of the defenses recognized in 35 U.S.C. § 282.
`
`35.
`
` Moderna is entitled to a declaratory judgment from this Court that the
`
`’979 Patent is invalid.
`
`COUNT III
`DECLARATORY JUDGMENT UNDER 28 U.S.C. § 1498
`
`36.
`
` Moderna repeats and incorporates Paragraphs 1-35 as if fully set forth
`
`
`
`herein.10
`
`37.
`
` Under 28 U.S.C. § 1498(a), Alnylam has no claim against Moderna to
`
`the extent that, pursuant to the C0100 Contract, any use or manufacture of doses of
`
`SPIKEVAX® were made “for the Government” and “with the authorization or
`
`consent of the Government”.
`
`38.
`
` Moderna is informed and believes, and based thereon alleges, that
`
`Alnylam disputes that Alnylam has no claim against Moderna to the extent that,
`
`pursuant to the C0100 Contract, any use or manufacture of SPIKEVAX® was done
`
`for the U.S. Government and with the authorization or consent of the U.S.
`
`Government.
`
`
`10 Moderna incorporates by reference its briefing concerning Moderna’s Partial
`Motion to Dismiss Pursuant to Federal Rule of Civil Procedure 12(b)(6) and the
`U.S. Government’s Statement of Interest concerning 28 U.S.C. § 1498 and
`SPIKEVAX® doses made pursuant to the C0100 Contract.
`
`
`
`12
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 13 of 44 PageID #: 5208
`
`39.
`
` By virtue of the above facts, an actual controversy has arisen and now
`
`exists between Moderna and Alnylam as to whether Alnylam has no claim against
`
`Moderna to the extent that, pursuant to the C0100 Contract, any use or manufacture
`
`of SPIKEVAX® was done for the U.S. Government and with the authorization or
`
`consent of the U.S. Government.
`
`40.
`
` Moderna requests a judicial determination that Alnylam has no claim
`
`against Moderna to the extent that, pursuant to the C0100 Contract, any use or
`
`manufacture of SPIKEVAX® was done with the authorization and consent of the
`
`U.S. Government. Such a declaratory judgment is necessary and appropriate at this
`
`time in order to determine the rights and legal relations of the parties, pursuant to 28
`
`U.S.C. § 2201.
`
`RELIEF REQUESTED
`
`WHEREFORE, Moderna respectfully requests that the Court enter a
`
`Judgment and Order in their favor and against Alnylam as follows:
`
`(a) Dismissing Alnylam’s Complaint with prejudice and denying each and
`
`every prayer for relief contained therein;
`
`(b) Declaring that Moderna does not infringe any claim of the ’979 Patent;
`
`(c) Declaring that the manufacture, use, offer to sell, and sale of the
`
`SPIKEVAX® vaccine within the United States, and its importation into the United
`
`States, does not infringe any claim of the ’979 Patent;
`
`
`
`13
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 14 of 44 PageID #: 5209
`
`(d) Declaring that the claims of the ’979 Patent are invalid;
`
`(e) Declaring that Alnylam and its agents, representatives, attorneys, and
`
`those persons in active concert or participation with them who receive actual notice
`
`thereof, be preliminarily and permanently enjoined from threatening or initiating
`
`infringement litigation against Moderna or any of their customers, dealers, or
`
`suppliers, or any prospective or present sellers, dealers, distributors, or customers
`
`of Moderna, or charging any of them either orally or in writing with infringement of
`
`the ’979 Patent;
`
` (j) Declaring that Alnylam has no claim against Moderna to the extent that,
`
`pursuant to the C0100 Contract, any use or manufacture of SPIKEVAX® was done
`
`for the U.S. Government and with the authorization or consent of the U.S.
`
`Government;
`
`(k) Awarding Moderna its attorneys’ fees, together with costs and
`
`disbursements, including because this case is exceptional under 35 U.S.C. § 285;
`
`and
`
`(l) Awarding such other and further relief as the Court deems justified.
`
`*
`
`*
`
`ANSWER
`
`Moderna, Inc., Moderna TX, Inc., and Moderna US, Inc. (collectively
`
`*
`
`“Moderna”) by and through their undersigned attorneys, hereby respond to the
`
`
`
`14
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 15 of 44 PageID #: 5210
`
`allegations contained in the Complaint filed by Alnylam Pharmaceuticals, Inc.
`
`(“Alnylam” or “Plaintiff”) and state their defenses to the claims asserted against it.
`
`To the extent unnumbered headings contained in the Complaint purport to contain
`
`allegations supporting Plaintiff’s claims, they are denied.
`
`NATURE OF THE ACTION
`
`
`
`1. Alnylam is a pioneering RNA therapeutics company based in
`Cambridge, Massachusetts. Over a decade ago, Alnylam invented a breakthrough
`class of cationic biodegradable lipids used to form lipid nanoparticles (“LNP”) that
`carry and safely deliver in the body RNA-based therapeutics or vaccines (the
`“Alnylam LNP Technology”). The Alnylam LNP Technology is foundational to the
`success of the recently-developed messenger RNA (“mRNA”) based COVID
`vaccines. The United States Patent Office recognized Alnylam’s inventive work,
`issuing United States Patent No. 11,246,979 (the “’979 Patent”) that protects the
`Alnylam LNP Technology. (Exhibit 1.)
`
`ANSWER: Moderna admits that the United States Patent Office issued the
`
`’979 Patent, but denies that this patent is valid under Title 35 of the United States
`
`Code. Moderna denies that any technology claimed by the ’979 Patent contributed
`
`in any way to the success of SPIKEVAX® developed by Moderna. Moderna
`
`otherwise lacks the knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of Paragraph 1 and therefore denies the allegations.
`
`2. Moderna’s mRNA COVID-19 Vaccine uses a cationic biodegradable
`lipid covered by ’979 Patent. Specifically, Moderna infringes Alnylam’s ’979 Patent
`through its SM-102 cationic biodegradable lipid formulated into LNPs that protect
`and safely deliver the vaccine’s mRNA. Moderna executives have described the
`infringing SM-102 biodegradable lipid as the “unsung hero” of its COVID-19
`Vaccine.
`
`
`
`
`15
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 16 of 44 PageID #: 5211
`
`ANSWER: Paragraph 2 states legal conclusions to which no response is
`
`required. To the extent a response is required, Moderna denies the allegations in
`
`Paragraph 2.
`
`3. Moderna has been aware of the Alnylam LNP Technology since at least
`early 2014, when Alnylam and Moderna entered into a business discussion regarding
`a license to Alnylam technology including the Alnylam LNP Technology. Alnylam
`brings this action to recover monetary compensation for Moderna’s unlicensed use
`of Alnylam’s ’979 Patent. Alnylam does not seek injunctive relief under 35 U.S.C.
`§ 283 against such use.
`
`ANSWER: Moderna admits that the Complaint (D.I. 1) purports to state that
`
`Alnylam does not seek injunctive relief under 35 U.S.C. § 283. Moderna denies all
`
`of the remaining allegations of Paragraph 3.
`
`
`
`THE PARTIES
`
`Plaintiff Alnylam is a corporation organized under the laws of the State
`4.
`of Delaware with a principal place of business at 675 West Kendall Street, Henri A.
`Termeer Square, Cambridge, Massachusetts 02142. Founded in 2002, Alnylam is a
`groundbreaking life science company that has worked to harness the potential of
`RNA interference (“RNAi”) therapeutics to transform the lives of people living with
`diseases that have limited or inadequate treatment options. Utilizing an earlier
`version of in licensed LNP Technology, in 2018 Alnylam delivered the world’s first
`approved RNAi therapeutic, ONPATTRO® (patisiran). ONPATTRO® is currently
`approved for the treatment of polyneuropathy caused by an illness called hereditary
`ATTR (hATTR) amyloidosis. Alnylam has developed an additional delivery
`modality distinct from the LNP Technology, termed GalNAc Delivery, which is
`utilized in three marketed products, GIVLAARI® (givosiran), approved in 2019,
`and OXLUMO® (lumasiran), approved in 2020, both marketed by Alnylam and
`LEQVIO®(inclisiran), approved in 2021, developed initially by Alnylam and
`licensed to Novartis.
`
`
`ANSWER: On information and belief, Moderna admits that Alnylam is a
`
`Delaware corporation with a principal place of business at 675 West Kendall Street,
`
`
`
`16
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 17 of 44 PageID #: 5212
`
`Henri A. Termeer Square, Cambridge Massachusetts 02142. Moderna otherwise
`
`lacks the knowledge or information sufficient to form a belief as to the truth of the
`
`allegations of Paragraph 4 and therefore denies the allegations.
`
`5. Alnylam has a long history of licensing or offering to license to third
`parties its intellectual property, including the Alnylam LNP Technology and the
`GalNAc Technology.
`
`ANSWER: Moderna lacks the knowledge or information sufficient to form a
`
`belief as to the truth of the allegations of Paragraph 5 and therefore denies the
`
`allegations.
`
`6. Upon information and belief, Defendant Moderna, Inc. is a company
`organized under the laws of the State of Delaware with a principal place of business
`at 200 Technology Square, Cambridge, Massachusetts 02139. Upon information and
`belief, Defendant Moderna, Inc. was previously known as Moderna Therapeutics,
`Inc. Upon information and belief, Defendant Moderna, Inc., is the parent company
`of the other Defendants and recognizes the revenue from sales of Moderna’s
`COVID-19 vaccine. (Exhibit 3 at 98-100.)
`
`ANSWER: Moderna admits that Moderna, Inc. is a Delaware corporation
`
`with a principal place of business at 200 Technology Square, Cambridge,
`
`Massachusetts 02139. Moderna admits that Moderna, Inc. was previously known as
`
`Moderna Therapeutics, Inc. and is the parent company of ModernaTX, Inc. and
`
`Moderna US, Inc. Moderna, Inc. admits that Exhibit 3 at 98-100 purports to be
`
`Moderna, Inc.’s 2021 10-K filing with the U.S. Securities and Exchange
`
`Commission that appears to show revenue from sales of SPIKEVAX®. Moderna
`
`denies the remaining allegations of Paragraph 6.
`
`
`
`17
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 18 of 44 PageID #: 5213
`
`7. Upon information and belief, Defendant ModernaTX, Inc. is a company
`organized under the laws of the State of Delaware with a principal place of business
`at 200 Technology Square, Cambridge, Massachusetts 02139. Upon information and
`belief, Defendant ModernaTX, Inc. is a wholly owned subsidiary of Defendant
`Moderna, Inc. The FDA granted the Biologic License Approval (“BLA”) for
`SPIKEVAX® to Defendant ModernaTX, Inc. (Exhibit 4 at 3). Defendant
`ModernaTX, Inc. is listed as the entity to contact in the prescribing information for
`SPIKEVAX®. (Exhibit 5 at 1.) According to the prescribing information,
`SPIKEVAX® is a trademark of Defendant ModernaTX, Inc. (Id. at 17).
`
`
`ANSWER: Moderna admits that ModernaTX, Inc. is a Delaware corporation
`
`with a principal place of business at 200 Technology Square, Cambridge,
`
`Massachusetts 02139. Moderna admits that ModernaTX, Inc. is a wholly owned
`
`subsidiary of Moderna, Inc. Moderna states that Exhibit 4 is an FDA News Release
`
`titled “Coronavirus (COVID-19) Update: FDA Takes Key Action By Approving
`
`Second COVID-19 Vaccine,” published
`
`in 2022
`
`and
`
`available
`
`at
`
`https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
`
`update-fda-takes-key-action-approving-second-covid-19-vaccine. Exhibit 4 states
`
`that FDA granted the BLA for SPIKEVAX® to ModernaTX, Inc. Exhibit 4 at 3.
`
`Moderna admits that Exhibit 5 purports to be a January 2022 version of the
`
`prescribing information for SPIKEVAX®, as well as purports to list ModernaTX as
`
`the entity to contact for suspected adverse reactions. Exhibit 5 at 1. Moderna further
`
`admits that Exhibit 5 purports to describe SPIKEVAX® as a trademark of
`
`ModernaTX, Inc. Id. at 17. Moderna denies the remaining allegations in Paragraph
`
`7.
`
`
`
`18
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 19 of 44 PageID #: 5214
`
`8. Upon information and belief, Defendant Moderna US, Inc. is a
`company organized under the laws of the State of Delaware with a principal place
`of business at 200 Technology Square, Cambridge, Massachusetts 02139. Upon
`information and belief, Defendant Moderna US, Inc. is a wholly-owned subsidiary
`of Defendant Moderna, Inc. Defendant Moderna US, Inc. is listed in the prescribing
`information as the entity manufacturing SPIKEVAX®. (Exhibit 5 at 17.)
`
`ANSWER: Moderna admits that Moderna US, Inc. is a Delaware corporation
`
`with a principal place of business at 200 Technology Square, Cambridge,
`
`Massachusetts 02139. Moderna admits that Moderna US, Inc. is a wholly-owned
`
`subsidiary of Moderna, Inc. Moderna states that Exhibit 5 purports to be a January
`
`2022 version of the prescribing information for SPIKEVAX® that indicates
`
`SPIKEVAX® is “[m]anufactured for” (not by) Moderna US, Inc. Exhibit 5 at 17
`
`(emphasis added). Moderna denies the remaining allegations in Paragraph 8.
`
` On information and belief, Defendants Moderna Inc., ModernaTX, and
`9.
`Moderna US, Inc. are agents of each other and/or work in concert with each other
`with respect to the development, regulatory approval, marketing, manufacturing,
`sales, offers for sale, and distribution of Moderna’s COVID-19 Vaccine.
`
`ANSWER: Paragraph 9 states legal conclusions to which no response is
`
`required. To the extent a response is required, Moderna denies the allegations of
`
`Paragraph 9.
`
`
`
`JURISDICTION AND VENUE
`
`10. This is an action for patent infringement arising under the patent laws
`of the United States, 35 U.S.C. § 1, et seq.
`
`ANSWER: Paragraph 10 states legal conclusions to which no response is
`
`required. To the extent a response is required, Moderna admits that the Complaint
`
`
`
`19
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 20 of 44 PageID #: 5215
`
`purports to state a claim for infringement arising under the patent laws of the United
`
`States 35 U.S.C. § 1, et seq. Moderna denies the remaining allegations of Paragraph
`
`10.
`
`11. This Court has jurisdiction under 28 U.S.C. §§ 1331 and 1338(a)
`because this is a civil action arising under the Patent Act.
`
`ANSWER: Paragraph 11 states legal conclusions to which no response is
`
`required. To the extent a response is required and for purposes of this action only,
`
`Moderna does not contest that this Court has subject matter jurisdiction over this
`
`action.
`
`12. This Court has personal jurisdiction over Defendant Moderna, Inc.,
`Defendant ModernaTX, Inc., and Defendant Moderna US, Inc. because all three are
`Delaware corporations.
`
`ANSWER: Paragraph 12 states legal conclusions to which no response is
`
`required. To the extent a response is required, Moderna does not contest that the
`
`Court has personal jurisdiction over Moderna, Inc., ModernaTX, Inc. and Moderna
`
`US, Inc., solely for purposes of this action.
`
`13. This Court also has jurisdiction over Defendant Moderna, Inc. because,
`upon information and belief, it directly or indirectly makes, uses, offers for sale,
`and/or sells its COVID-19 Vaccine, made using SM-102, throughout the United
`States, including in this judicial district.
`
`ANSWER: Paragraph 13 states legal conclusions to which no response is
`
`required. To the extent a response is required, Moderna does not contest that the
`
`Court has personal jurisdiction over Moderna, Inc., ModernaTX, Inc., and Moderna
`
`
`
`20
`
`

`

`Case 1:22-cv-00335-CFC Document 88 Filed 05/10/23 Page 21 of 44 PageID #: 5216
`
`US, Inc., solely for purposes of this action. Moderna denies that SPIKEVAX®, made
`
`using SM-102, infringes the ’979 Patent directly or indirectly. Moderna denies the
`
`remaining allegations of Paragraph 13.
`
`14. This Court also has jurisdiction over Defendant ModernaTX, Inc.
`because, upon information and belief, it directly or indirectly makes, uses, offers for
`sale, and/or sells its COVID-19 Vaccine, made using SM-102, throughout the United
`States, including in this judicial district.
`
`ANSWER: Paragraph 14 states legal conclusions to which no response is
`
`required. To the extent a response is req