Case 1:22-cv-00252-MSG Document 195-4 Filed 01/16/24 Page 1 of 5 PageID #: 13364
`Case 1:22-cv-00252-MSG Document 195-4 Filed 01/16/24 Page 1 of 5 PagelD #: 13364
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 22-252 (MSG)
`
`
`
`) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`Vv.
`
`MODERNA,INC. and MODERNATX,INC.
`
`Defendants.
`MODERNA,INC. and MODERNATX,INC.,
`
`Counterclaim-Plaintiffs,
`
`Vv.
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Counterclaim-Defendants.
`
`LETTER TO THE HONORABLE MITCHELL S. GOLDBERGIN OPPOSITION TO
`PLAINTIFFS’ MOTION TO COMPEL SAMPLES
`
`OF COUNSEL:
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`Yan-Xin Li
`Caitlin Dean
`Nancy Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 ClarendonStreet
`Boston, MA 02116
`(617) 385-7500
`
`Morris, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Attorneys for Defendants
`
`January 5, 2024
`
`

`

`Case 1:22-cv-00252-MSG Document 195-4 Filed 01/16/24 Page 2 of 5 PageID #: 13365
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`Dear Judge Goldberg:
`
`Plaintiffs filed their Motion (D.I. 161) because the extensive lipid content data Moderna
`produced showsits COVID-19 vaccine does not infringe. To try to keep their case alive, Plaintiffs
`now seek unprecedented numbers of samples to run unidentified, unconventional tests to try to
`obtain contradictory results, including by testing many expired samples that Plaintiffs know are
`not representative of the unexpired product. Although Plaintiffs have all information necessary to
`assess infringement—including certificates of analysis (“CoAs”) reporting lipid content and
`underlying data for every accused batch, Moderna has further agreed to provide a substantial
`number of samples as discussed below.Plaintiffs’ request for even more drug product samples
`from 1000+ batches and samples of
`SE—cc! tac bounds of proportionality.
`
`The unreasonable scope of these requests, compounded by Plaintiffs’ other burdensome
`discovery demands have, as forecasted, put Moderna in a position where an extension to the
`schedule is necessary. Moderna wishesto discuss such an extension at any hearing on this dispute.
`
`1.
`
`Drug Product Samples (RFP No. 97)
`
`Modernais producinglipid content data for each accused batch: Plaintiffs filed this
`suit asserting infringementof claims requiring specific lipid molar ratios and then pressed Moderna
`for its regulatory filings, arguing that “testing Modernahas done. . . related to the lipid molar ratio
`... 18 highly relevant.” Ex. 1 at 2; Ex. 2. Modena promptly producedits filings, which included
`lipid content testing that confirm Moderna’s vaccinelacks the claimedlipid ratios. Ex. 4 at 14-28.
`Modernais also complying with Plaintiffs’ further requests to produce CoAs with lipid content
`results for every accused batch! and underlying raw data. Ex. 5 at 3-4; Ex. 6 at 1-2.
`
`Unhappywith the data they received, Plaintiffs pivoted to argue the FDA regulatory filings
`and CoAs—madeunderpenalty of criminal prosecution per 18 U.S.C.A. § 1001 and § 10.20(4)—
`“largely comprise information irrelevant to infringement.” Mot. at 2. Plaintiffs now contend that
`infringement turns on lipid content of individual LNPsrather than “aggregate” formulations. Mot.
`at 2-3. Plaintiffs’ new contention is baseless. HPLC—Moderna’s FDA-approved method to
`measure aggregate lipid content—is standard andis also used by Plaintiffs and the inventors of the
`asserted patents.” Ex. 9, 9 56; Ex. 10; Ex. 11 at -942 and -950; Exs. 12 & 13 at 6-7; Ex. 14, 99 21,
`31-32. In fact, Plaintiffs’ complaint and infringement contentions rely solely on aggregate lipid
`content. Ex. 15 at 2-10; D.I. 1, J 45. Confirming the speculative nature of this new contention,
`Moderna’s expert, Professor Byrn, explains he is unaware of amy method for isolating an
`individual LNP,let alone determiningits lipid content. Ex. 14, J] 49-51. Despite having a set of
`Moderna’s samples for over 8 months (Ex. 16), Plaintiffs presented no evidence refuting the HPLC
`results Moderna submitted to the FDA. See Ex. 17, Par Pharm., Inc. v. Hospira, Inc., C.A. No.
`
`' Moderna agrees to produce samples for accused batches, and does not agree to Plaintiffs’ recent
`attempt to seek discovery into batches not made, imported, or sold in the U.S. See, e.g. Invensas,
`D.I. 53 (Ex. 3) (limiting production of samples of product defendant “‘makes, uses, offersto sell,
`or sells .
`.
`. within the United States or imports into the United States.’ 35 U.S.C. § 271”).
`* Although the asserted patents do not describe a method for measuringlipid content, the inventors’
`lab notebooks show they also used HPLC.Ex. 7 at 559; Ex. 8 at 5; Ex. 14, 49 36-37.
`
`

`

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`17-944-JFB-SRF, D.I. 63, at *5,6 (D. Del. May 14, 2018) (denying motion to compel expired
`samples without prejudice where Hospira produced ANDA).
`
`Moderna’s compromise properly balances need and burden: Despite Plaintiffs having
`all the information they need,in the spirit of compromise, Modernaoffered to produce a reasonable
`numberof samples, i.e., 3 drug productvials*“ from one batch per unique part number(i.e., every
`version of its COVID-19 vaccine).> The accused batches fall into three categories: (1) unexpired
`and (2) up to 1 year past expiry, for both of which Moderna mustkeep regulatory retains (Ex. 18,
`4] 3-4), and (3) more than 1 year past expiry. Moderna would pull such samples from available
`inventory and/or regulatory retains for (1) and available regulatory retains for (2)/(3). To further
`narrow the dispute, Moderna is producing samples from 400+ batches from (3) that, as Plaintiffs
`knew,were being transferred from a third-party and thus, more accessible to produce. Ex. 19 at 1.
`
`Plaintiffs’ request is the epitome of undue burden:Plaintiffs baselessly claim “[i]t is not
`burdensome for Moderna to produce samples.” D.I. 161 at 3. This could not be further from the
`truth. Production of FDA-regulated drug product stored at JJ is an arduous, manualexercise
`of developing and documenting a complex process, including checking various electronic systems,
`confirming inventory inj freezers (which Moderna’s personnel mustenterin pairs and remain
`in for mere minutesat a time for safety), and procuring and preparing specific packaging to control
`temperature during shipment. Ex. 20 at 4; Ex. 21, 9§ 12-13; Ex. 18, § 2. Even for the 400+ batches
`Modernais pulling samples from, a team of 15+ Moderna employees has been working for weeks
`to make the production possible. Ex. 21, 9§[ 8—10. That Modernais undertakingthis effort for those
`uniquely situated batches does not lessen the burden for the remaining 1000+ batches, particularly
`where Plaintiffs have not even committed to testing any,let alone all samples. Ex. 22 at 2. Without
`any credible explanation as to why samples from every batch are needed, particularly where many
`are expired, Plaintiffs have failed to show the extreme “burden or expense of the proposed
`discovery outweighsits likely benefit,” warranting denial of its motion. Fed. R. Civ. P. 26(b)(1);
`Rembrandt Diagnostics, LP v. Innovacon, Inc., 2017 WL 4391707, at *3 (S.D. Cal. Oct. 3, 2017).
`
`While Moderna’s proposal is grounded in precedent—-see, e.g., Everlight, 2013 WL
`6713789, at *2 (ordering production of one sample per part number); 3Com, 2007 WL 949596,at
`*2 (ordering production of each ‘version’ }—Plaintiffs cite no cases ordering production of samples
`of every batch, let alone where FDA-approvedtesting for the claimed characteristics was produced
`for all batches. See Vitamins Online, 2016 WL1305144,at *1 (ordering production from 5 lots);
`P&G, 2013 WL 152801, at *6 (ordering production of “representative samples”); Integra, 2016
`WL 675553, at *1 (ordering production of “[flive samples of each [] Product,” not each batch).
`Moderna’s proposal is also particularly reasonable in light of the material Moderna hasalready
`produced and Plaintiffs’ failure to articulate relevance “sufficient to justify production for each
`[batch] and overcome the burdensomenature of the request.” Rembrandt, at *3, 5-6. Unlike Prism
`(Mot. at 2), where Defendant “fail[ed] to produce amy documents,” Moderna has produced
`hundreds of thousands of pages relevant to non-infringement. Prism, 2015 WL 5883764, at *3
`
`3 For batches manufactured as single-dose syringes, Modernawill produce equivalent volume.
`4 Plaintiffs’ motion did not specify a volume, but previously demanded 100 mgoflipid content
`per batch. Ex. 5 to Mot. at 2. This far exceeds proportionality. Ex. 14, 9] 23, 38-48. An
`HPLC/UHPLC method used by Plaintiffs requires 3 pg; 3 vials allows up to 6,000+ tests. Id. ¥ 47.
`> “Part numbers”identify product based on formulation and manufacturing process.
`
`

`

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`(deciding motionto strike expert theories, with no mention of samples); see also Invensas (Ex. 3
`at 23, 26) (ordering production of “samples of each of its [] products” where documents lacked
`“relevant information .
`.
`. to evaluate infringement.”). Moderna’s proposal is more than sufficient.
`
`Plaintiffs’ representativeness proposal is unreasonable: Plaintiffs argue Moderna’s
`proposal is “untenable” because Modernarefuses to concede infringement of batches from which
`no samples are produced. But Plaintiffs’ proposal was a non-starter: Plaintiffs wanted to select 100
`batches from which samples would be produced, and have Moderna“stipulate[] that a finding of
`infringement as to one or more of the Accused Batches will constitute a finding that all of the
`Accused Batchesinfringe.” Ex. 23. This would allow Plaintiffs to selectively produce results from
`a single batch, while preventing Moderna from contesting infringement of any other batch (even
`batchesit produced samples from). Again,this is not a scenario wherethelipid content is unknown;
`Modernais producing data for all batches, Plaintiffs simply do notlike the results. Wonderland,
`2021 WL 2315191, at *2 (defendant had “no design documents showingthe structure of some of
`
`the accused products”). Moderna also cannotagree that each sample is representative as many are
`expired.
`
`
`
`for such limits on Moderna’s ability to contest
`Plaintiffs identify mo precedent
`infringement, which remains Plaintiffs’ burden. For example, in Apple (Mot. at 2), the court
`suggested the defendant “negotiate a stipulation that its production [of documents] adequately
`represents .
`.
`. the entire set of accused products,” rather than samples. 2012 WL 1511901, at *6.
`Matters of testing methodology and representativeness should be left to the experts.
`
`Il. QR Samples & Raw Data (RFP Nos. 108, 174)
`Unsatisfied that Moderna’s vaccine doesnot infringe,J
`
`
`
`Medtronic, cited by Plaintiffs,
`
`confirms they have all they need: there, the court ordered production of “manufacturing process
`documents” whichPlaintiffs already have. 2004 WL 115594, at *3 (Mot.at 3).
`
`Modernarespectfully requests that the Court deny Plaintiffs’ Motion to Compel.
`
`6 Although Plaintiffs do not specify the “raw data” that they seek, it underlies the same HPLClipid
`content testing that Plaintiffs claim is irrelevant and tainted to support their demands for drug
`product samples. Mot. at2-3,
`a
`
`

`

`Case 1:22-cv-00252-MSG Document 195-4 Filed 01/16/24 Page 5 of 5 PageID #: 13368
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`Respectfully,
`
`/s/Travis Murray
`
`Travis Murray (#6882)
`
`ce:
`
`All Counsel of Record (via CM/ECF andelectronic mail)
`
`