Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 1 of 6 PageID #: 15403
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`RAVGEN, INC.,
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` Plaintiff,
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`v.
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`BIORA THERAPEUTICS, INC.,
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`Defendant.
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 20-cv-1734-JLH
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`FILED UNDER SEAL
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`PLAINTIFF’S OPENING DISCOVERY DISPUTE LETTER
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`Dated: April 4, 2024
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`John M. Desmarais (pro hac vice)
`Kerri-Ann Limbeek (pro hac vice)
`Brian D. Matty (pro hac vice)
`Jamie L. Kringstein (pro hac vice)
`Kyle G. Petrie (pro hac vice)
`Joze Welsh (pro hac vice)
`Jun Tong (pro hac vice)
`Deborah J. Mariottini (pro hac vice)
`Peter Zhu (pro hac vice)
`Benjamin N. Luehrs (pro hac vice)
`Frederick J. Ding (pro hac vice)
`Julianne M. Thomsen (pro hac vice)
`William Benjamin Nichols (pro hac vice)
`DESMARAIS LLP
`230 Park Avenue New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
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`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`FARNAN LLP
`919 N. Market St., 12th Floor
`Wilmington, DE 19801
`Telephone: (302) 777-0300
`Facsimile: (302) 777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
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`Attorneys for Plaintiff Ravgen, Inc.
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`Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 2 of 6 PageID #: 15404
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`Dear Judge Fallon:
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`Biora is withholding financial valuation spreadsheets, business communications, executive
`board presentations, and a lab notebook created by and shared among non-attorney Biora
`employees as allegedly attorney-client privileged or work product. But attorney-client privilege
`applies only to communications between privileged persons for the purpose of transmitting,
`seeking, or receiving legal advice. See Idenix Pharms., Inc. v. Gilead Scis., Inc., 195 F. Supp. 3d
`639, 642 (D. Del. 2016). Biora’s work-product claims similarly fail, but even if there is any such
`protection, Ravgen has a substantial need for the withheld documents. Fed. R. Civ. P. 26(b)(3).
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`Years before this litigation, Ravgen founder Dr. Ravinder Dhallan and Biora’s CEO Harry
`Stylli discussed Ravgen’s patents and the value of Ravgen’s intellectual property in view of
`widespread infringement by competitors in the non-invasive prenatal testing (“NIPT”) market.
`Biora then launched its own infringing NIPT product. Ravgen contends that Biora willfully
`infringed Ravgen’s U.S. Patent No. 7,332,277, based in part on Biora’s knowledge of the patent
`and knowledge of infringement and validity demonstrated by the earlier discussions. Now that
`Biora has been sued, Mr. Stylli claims that Ravgen’s recollection is a “
`,” and Biora appears
`to be using dubious privilege claims to hide documents that
`Mr. Stylli’s story. See Ex.
`21 at 263:6-11. Biora recently asserted that,
`, Biora was
`anticipating “potential future offensive litigation” in June 2015 (ostensibly indicating that Biora
`was valuing Ravgen’s ’277 Patent and portfolio for an acquisition so that Biora could use the patent
`against competitors), further highlighting the need for these documents to set the record straight.
`Ex. 22 at 2-3. The Court should compel Biora to produce the disputed documents.
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`1. Financial valuation spreadsheets created and communicated by non-attorneys.
`Biora improperly redacts valuation spreadsheets and communications (Exs. 1-14, the “Valuation
`Documents”) created by non-attorney Biora employees Aaron Scalia and Sumit Aggarwal in
`November 2015. Recently unredacted portions of the Valuation Documents show that, after
`meeting in October 2015, Biora assessed Ravgen’s value in the market for NIPT tests—the same
`market Dr. Dhallan and Mr. Stylli discussed as widely infringing the ʼ277 Patent. E.g., Ex. 10 at
`“Valuation” sheet at cells L14-16; C10-12, C27-34 (Biora valuing Ravgen’s technology for NIPT
`aneuploidy detection). Biora has redacted almost all of the spreadsheets Mr. Scalia and Mr.
`Aggarwal created, as well as portions of emails between the two, claiming that they “reflect[] legal
`advice from outside counsel Ropes & Gray,” or are “prepared in anticipation of litigation and
`reflecting mental impressions of counsel.” See, e.g., Ex. 10 at the “Valuation”, “Aaron + Sumit”,
`and “Deal Structure” sheets; Ex. 23 at Entry Nos. 69-82. When Ravgen challenged the redactions,
`Biora vaguely asserted that “any heavy redactions simply reflect the fact that the primary purpose
`of these documents is legal in nature.” Ex. 22 at 9-11.
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`The Valuation Documents cannot be privileged because they were created entirely by and
`for non-attorneys who cannot offer legal advice, and for primarily business purposes. Elm 3DS
`Innovations, LLC v. Samsung Elecs. Co., 2021 WL 4819904, at *3 (D. Del. Oct. 15, 2021)
`(ordering production of valuation spreadsheets including “analysis of potential targets for
`infringement claims,” where it was not clear they were prepared by an attorney). Emails confirm
`that Mr. Scalia and Mr. Aggarwal created these documents to provide business advice for Biora’s
`courtship of Ravgen for acquisition. Ex. 24; Ex. 25 (attaching Ex. 10 as “Copy of Ravgen
`Valuation_updated.xlsx”). Biora’s spreadsheets themselves are financial analyses, not legal
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`Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 3 of 6 PageID #: 15405
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`advice. E.g., Ex. 10 (unredacted cells containing “pricing,” “Annual Revenue or Savings,”
`“Estimated Value,” and “Commercial Milestones”). Biora has offered no evidence that any
`attorney or legal advice was involved in Mr. Scalia’s or Mr. Aggarwal’s valuation process. See
`Ex. 23 at Entry Nos. 69-82. And even if an attorney were consulted at some point, the purpose of
`the Valuation Documents is financial regarding a business deal with Ravgen, and the ultimate
`valuations (e.g., dollar amounts and projections) are not legal advice. Elm 3DS, 2021 WL 4819904,
`at *3 (analyzing damages from infringement for licensing deals is primarily a business purpose).
`Thus, Biora has not met its burden to demonstrate that any privilege protection applies.
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`2. Communications between non-attorneys regarding Ravgen. Biora redacts “ideas”
`created by Mr. Scalia for how to approach Ravgen for business negotiations in September 2015.
`See Ex. 15. Mr. Scalia (who is not an attorney and
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`) performed business development work for Biora, including with respect to Ravgen. See
`Ex. 21 at 202:23-206:7, 266:7-15; Ex. 19. The redacted email includes three “Ideas on how to
`approach Dr. Dhallan,” which Mr. Scalia wrote after “scour[ing] Ravgen’s websites for the past 8
`years.” Ex. 15. His third idea is redacted under claims of privilege and work product. Id.
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`The redacted “idea” in Mr. Scalia’s email is business information created by and shared
`between non-attorneys and cannot be privileged. Idenix, 195 F. Supp. 3d at 642 (“The attorney-
`client privilege protects communications between a client and an attorney related to the purpose
`of securing legal advice.”). Biora redacts an idea that Mr. Scalia wrote based on his own research—
`not legal consultation. Ex. 15. And Mr. Scalia was preparing to approach Ravgen to discuss
`business ventures. Ex. 26. The generic description in Biora’s privilege log does not suggest that
`any attorney or legal advice was involved. See Ex. 23 at Entry No. 10. Thus, Biora has not met its
`burden for maintaining the redactions in Ex. 15 as attorney-client privileged.
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`Biora also improperly withholds 12 documents dated from June 2015 to March 2016. Ex.
`20 at Entry Nos. 1, 2, 21, 59, 64, 65, 79, 80, 103-106. None of these documents were sent to or
`from an attorney, and they are not privileged. Idenix, 195 F. Supp. 3d at 642. Instead, the
`timeframe and individuals involved suggest that these documents relate to Biora’s discussions with
`Ravgen. For example, Entry Nos. 1 and 2 are independent discussions between nonlawyers weeks
`before any indication of attorney involvement in Biora’s privilege log. Ex. 20. Entry No. 21 is a
`“Ravgen Presentation” (which may be related to the presentation having that title discussed in the
`next section below) and was sent by Mr. Scalia to Mr. Stylli the same day the two had a “download”
`on Ravgen. AbbVie Inc. v. Boehringer Ingelheim Int'l GmbH, 2018 WL 2995677, at *2-4 (D. Del.
`June 14, 2018) (reviewing a presentation containing a mix of legal and business concerns and
`ordering production of individual slides unless their contents would not have been communicated
`“but for the client’s need for legal advice or services”). See Ex. 20; Ex. 27. Entry Nos. 79 and 80
`relate to Biora’s business development budget, including Mr. Scalia’s IP spend. See Ex. 20; Ex.
`19. And Entry Nos. 59, 64, 65, 79, 80, and 103-106 are similarly communications between Biora
`employees involved in negotiations with Ravgen leading up to or shortly after discussions between
`the parties, with no indication of any attorney involvement. See Ex. 20.
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`Despite repeated requests from Ravgen over months, Biora refused to provide any
`information other than threadbare assertions and recitations of legal standards in its privilege log,
`but then produced Exs. 19 and 28 at 10:00pm the night before this letter is being filed. See Ex. 20
`at Entry Nos. 1, 2, 21, 59, 64, 65, 79, 80, and 103-106. Given the connection to business
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`Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 4 of 6 PageID #: 15406
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`negotiations, business development purposes referenced in Exs. 19 and 28, and the lack of any
`attorney involvement, Biora has failed to carry its “burden of demonstrating the applicability of
`the attorney client privilege” to these withheld communications. Idenix, 195 F. Supp. 3d at 642.
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`3. “Ravgen Presentation” (Ex. 16). Biora withholds a PowerPoint titled “Ravgen
`Presentation” that nonlawyer Mr. Scalia identified as his contribution to a “Board Meeting
`Brainstorming Session.” Ex. 17. The email attaching the presentation is also redacted. Id. Biora
`recently asserted for the first time that this presentation, which was created five years before this
`litigation began, was “prepared in anticipation of potential future offensive litigation” (i.e., not in
`anticipation of litigation brought by Ravgen against Biora). Ex. 22 at 3. While this admission
`Mr. Stylli’s testimony, it does not make Exs. 16 or 17 privileged or work product.
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`Slides and information presented at executive meetings or employee brainstorming
`sessions are not privileged unless the individual slides actually convey legal advice. AbbVie, 2018
`WL 2995677, at *2-4. At least two slides in the “Ravgen Presentation” contain—by his own email
`characterization—contributions from Mr. Scalia, who is not an attorney. Ex. 17. Nor are the slides
`privileged simply because an attorney may have attended the meeting. Abbvie, 2018 WL 2995677,
`at *4 (“The presence of an attorney in a room full of employees brainstorming about new
`inventions does not convert everything said into privileged communications. Neither is a slide
`summarizing the results of the brainstorming meeting privileged because an attorney is sitting in
`on the slide presentation. The question is whether what was said at the conference—or on the
`slide—would not have been communicated ‘but for the client’s need for legal advice or
`services.’”). Biora has not met that required standard here. See Ex. 23 at Entry Nos. 8-9.
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`4. Lab Notebook 17 (Ex. 18). Biora claims privilege over thirteen pages of a lab notebook
`from the development of its NIPT test. Lab Notebook 17 was prepared by a software engineer and
`contains non-legal technical information. See Ex. 18 at 700 (listing non-attorney employees). Such
`technical documentation is not privileged. Idenix, 195 F. Supp. 3d at 642.
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`Biora has provided no evidence that Lab Notebook 17 was
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`.” Ex. 23 at Entry No. 1. The creator of Lab
`Notebook 17, Mr. Tobias Mann, is a scientist and not an attorney. Ex. 18 at 697. There is no
`evidence that Lab Notebook 17 was requested by or shared with counsel. And even if Lab
`Notebook 17 was intended for patent prosecution, Biora has put forth no evidence that the
`document contains confidential legal advice related to that prosecution. See Allegheny Ludlum
`Corp. v. Nippon Steel Corp., 1991 WL 61144, at *3 (E.D. Pa. Apr. 15, 1991) (“The party claiming
`the privilege must clearly show that a document renders legal advice and does not, for example,
`merely contain facts later disclosed in a patent or trademark application.”). Given the scientific
`nature of the document, the ambiguous description in Biora’s privilege log does not establish
`privilege protection for the redacted pages. Idenix, 195 F. Supp. 3d at 644-646 (ordering
`production of a scientific document attached to an email to counsel because “[g]iven the nature of
`the document, and given Idenix’s ambiguous description of it in the log… Idenix has failed to
`show that the ‘primary purpose’ of the document was not the seeking of advice on a non-legal
`matter”).
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`Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 5 of 6 PageID #: 15407
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`5. Biora’s claims of work product before Biora ever met with Ravgen are untenable.
`Biora’s blanket work-product protection assertions are inappropriate because the documents
`Ravgen seeks were created prior to and in the ordinary course of Biora’s negotiations with Ravgen.
`Immersion Corp. v. HTC Corp., 2014 WL 3948021, at *2 (D. Del. Aug. 7, 2014) (noting that the
`work product doctrine does not apply to documents prepared in the ordinary course of business).
`This is sound policy; if the relationship between the value of a patent portfolio and litigation was
`sufficient for a work product claim, every valuation involving a patent portfolio would be work
`product. Further, Biora has not alleged that it was anticipating any specific lawsuit. See Pfizer Inc.
`v. Ranbaxy Lab’ys Ltd., 2004 WL 2323135, at *3 (D. Del. Oct. 7, 2004) (denying work product
`where there was no evidence documents were prepared “in anticipation of any specific litigation.”).
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`Biora’s claims of work product are also
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` with Mr. Stylli’s testimony
`. Ex. 21 at 243:13-20. If
`, these materials could not have been prepared in anticipation of
`Biora’s CEO
`litigation. Fed. R. Civ. P. 26(b)(3). But if Ravgen is correct that—
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`—Biora was interested in obtaining Ravgen’s ’277 Patent to assert it against competitors
`in the NIPT market, then Ravgen’s substantial need for these documents to expose Mr. Stylli’s
` trumps any work product protection. Recently unredacted portions of the disputed
`documents already confirm that Biora was valuing Ravgen’s IP for an aneuploidy test and suggest
`that Biora was considering suing other competitors with Ravgen’s patents. Ex. 10 at “Valuation”
`sheet at cells L14-16; C10-12, C27-34. However, the redactions obscure Biora’s full valuation of
`Ravgen and prevent Ravgen from properly cross-examining Mr. Stylli at trial. Ravgen cannot
`obtain the equivalent of these Biora internal documents by any other means. And Biora’s recent
`assertion that it was considering “potential future offensive litigation” in June 2015 only further
`highlights Ravgen’s need for these documents to properly cross-examine Mr. Stylli on his
`assertions that no such consideration was made.
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`6. Ravgen has diligently pursued this dispute since fact discovery. Biora has suggested
`it might object to the timing of this dispute. But Biora is responsible for that timing. Biora did not
`confer on these issues during fact discovery and has continuously delayed resolution since. See
`Ex. 22. At the close of fact discovery on Oct. 27, 2023, Biora confirmed that it would not raise
`timeliness with respect to this privilege dispute because Biora had not resolved these issues in a
`timely manner. Id at 19 (Oct. 27 Pisani email to Ding). After the parties’ Nov. 3, 2023 conferral,
`Biora waited nearly a month before producing a subset of disputed documents and updating its
`privilege log on Dec. 1, 2023—days before opening expert reports were due. Id. at 12-13 (Dec. 14
`Nichols email to Biora). On Dec. 14, 2023, Ravgen informed Biora that their production did not
`resolve the issues. Id. at 12-13 (Dec. 14 Nichols email to Biora). Ravgen followed up with Biora
`twice before receiving a response on Jan. 17, 2024, while the parties were in the midst of expert
`discovery. Id. at 9-12. Ravgen responded within a week to confirm that Ravgen still disputed
`Biora’s privilege claims, then followed up again shortly after rebuttal reports were served. Id. at
`6-7. And Biora has continued to iteratively pare back its privilege claims, producing additional
`disputed documents and again updating its privilege logs on March 27, 2024, and again at 10:00
`PM on April 3, 2024, the night before this letter is being filed. Claiming privilege and work product
`is not gradual, either it applies or it does not. Biora’s contrary approach of slow playing this dispute
`and gradually peeling back layers of its privilege claims when challenged by Ravgen is the cause
`of the delayed resolution and continually changing landscape of the dispute here.
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`Case 1:20-cv-01734-JLH Document 271 Filed 04/11/24 Page 6 of 6 PageID #: 15408
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`Respectfully submitted,
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`/s/ Michael J. Farnan
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`Michael J. Farnan
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`cc: Counsel of Record (Via E-Mail)
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