`
`Andrea L. Martin
`amartin@burnslev.com
`617.345.3869
`
`Via ECF
`
`Honorable Allison D. Burroughs
`United States District Court Judge
`John Joseph Moakley U.S. Courthouse
`1 Courthouse Way
`Boston, Massachusetts 02210
`
`March 2, 2021
`
`Re:
`
`Teva Pharmaceuticals International GmbH et al v. Eli Lilly and Company,
`Civil Action No. 1:18-cv-12029-ADB
`
`Dear Judge Burroughs:
`
`This firm, with Finnegan LLP, represents Eli Lilly and Company in the above-captioned
`matter. Lilly raises one question with the Court: whether Teva should be compelled to produce
`relevant documents “created” after September 27, 2018—the date Lilly received FDA approval to
`sell its accused product and the same day Teva filed its Complaint.1
`
`As the parties near the current date for the close of fact discovery (March 31), Lilly has
`learned that, with limited exceptions, Teva intends to stand on an arbitrary date cutoff for its
`document production, refusing to produce or even review documents created after September 27,
`2018 (the “Post-Complaint Documents”). Teva’s date cutoff is arbitrary, allows for cherry-picking,
`conflicts with the ESI Protocol, and deprives Lilly of ~2.5 years of relevant discovery from “over
`one hundred thousand” Post-Complaint Documents.
`
`Background
`
`To every one of Lilly’s 56 requests for production (“RFPs”), Teva asserted the following
`improper objection:
`
`Teva objects to each and every Request to the extent it seeks production of documents
`generated after Teva’s filing of this Action on September 27, 2018 or is otherwise
`not limited by any appropriate or reasonable time limitation.
`
`1 Lilly submits this straightforward request by letter pursuant to the Court’s guidance.
`See ADB Q15 & Q17 at http://www.mad.uscourts.gov/boston/burroughs.htm.
`
`
`
`Case 1:18-cv-12029-ADB Document 102 Filed 03/02/21 Page 2 of 5
`
`ECF Letter to Judge Burroughs
`March 2, 2021
`Page 2
`
`Ex. 1 at 3 ¶ 9. Lilly promptly complained, see Ex. 2 at 2 (Lilly Ltr. dated Oct. 9, 2020), and the
`parties later met and conferred. On that call, Teva acknowledged it would produce some Post-
`Complaint Documents but maintained its refusal to withdraw its date cutoff, citing only “undue
`burden.” See Ex. 3 at 2 (Lilly Ltr. dated Dec. 11, 2020).
`
`To alleviate Teva’s purported concerns on burden, Lilly narrowed its request for Post-
`Complaint Documents to 33 of its 56 RFPs. Ex. 4 at 1–3 (Lilly Ltr. dated Dec. 23, 2020). Despite
`repeated prodding by Lilly—on January 6, 20, 28, and February 9—Teva ignored Lilly’s proposed
`compromise for nearly two months. See Ex. 5 at 2; Ex. 6; Ex. 7 at 1; Ex. 8 at 2. When Teva finally
`responded, it reiterated its untenable position and only agreed to produce certain Post-Complaint
`Documents responsive to seven Lilly RFPs2 on “damages and financial issues”—documents Teva
`needs for its damages case. See Ex. 9 at 2 (Teva Ltr. dated Feb. 11, 2021).
`
`In a meet and confer on February 18, Teva repeated that it will not produce—or even
`review—Post-Complaint Documents captured by the ESI search terms Teva has agreed to. See
`Ex. 10 at 2–3 (Lilly Ltr. dated Feb. 23, 2021). Teva also acknowledged that it is even applying its
`date cutoff to the damages and financial information it has agreed to produce. For those seven RFPs,
`Teva revealed it will only produce select documents located using so-called “targeted searches.” See
`id. While Teva would not disclose the details of these “targeted searches,” it confirmed such
`searching disregards the search terms Teva agreed to run under the ESI protocol. See id.; ECF No.
`99, Ex. A at Table 2; Ex. 11 at 2 (“Teva agrees to run . . . Lilly’s additional proposed ESI terms.”).
`A few days later, Teva “estimate[d]” that removing its improper date cutoff would require reviewing
`“over 100,000 additional documents at an estimated cost of ~$325,000.” Ex. 12.
`
`Teva followed up on February 25, stating it would “consider a compromise” where Teva
`would produce certain Post-Complaint Documents for six more RFPs3 “if it would resolve the
`dispute.” Ex. 13 at 2–3. Unsurprisingly, these RFPs also cover damages-related documents Teva
`presumably wants to produce, including information on alleged lost sales to Lilly (RFP 30),
`valuations (RFP 33), and licenses (RFPs 50–51). Teva, however, maintained that it would not review
`“over one hundred thousand” Post-Complaint Documents that hit on the parties’ ESI search terms.
`See id. (emphasis added). Instead, for these RFPs, Teva will again employ “select, targeted
`searching” that disregards the ESI Protocol.
`
`The parties met and conferred again on February 26 but could not reach agreement.
`
`2 RFP Nos. 27, 28, 29, 31, 32, 33, and 35.
`3 RFP Nos. 30, 34, 50, 51, 53, and 56.
`
`
`
`Case 1:18-cv-12029-ADB Document 102 Filed 03/02/21 Page 3 of 5
`
`ECF Letter to Judge Burroughs
`March 2, 2021
`Page 3
`
`Teva’s Arbitrary Date-Cutoff Objection Should Be Overruled
`
`Teva’s objection is improper for at least four reasons.
`
`First, the objection is arbitrary. There is no valid reason a document “created” before
`September 27, 2018, is discoverable whereas that same document—if “created” after September 27,
`2018—would somehow be protected from discovery. The date Teva sued does not dictate what is
`discoverable. Just a few examples quickly illustrate the arbitrary and improper nature of Teva’s
`cutoff:
`
`• Documents concerning—and communications with—the named inventors of the
`Patents-in-Suit or third parties who have had (or may still have) an interest in the
`Patents-in-Suit (RFP Nos. 3 and 4).
`
`• Documents and communications relating to the “Tan Thesis”—the main prior art
`reference on which Lilly has based its §§ 102 and 103 invalidity defenses (RFP Nos.
`11 and 12).
`
`• Documents relating to any alleged secondary considerations or objective evidence of
`non-obviousness, including documents relating to commercial success, industry
`praise (or the lack thereof), and nexus to the Patents-in-Suit (RFP No. 18).
`
`• Documents relating to Teva’s research and development efforts aimed at using Ajovy
`for treating cluster headache (RFP No. 23).4
`
`Teva cannot credibly argue these (or any other) categories of documents should not be
`produced based on when they were created. The relevance of such requests is beyond dispute—
`confirmed by Teva’s agreement to produce the same documents if they were “created” before the
`arbitrary date cutoff. Lest there be any doubt on this point, Teva just acknowledged to the Court
`that relevance does turn on an “arbitrary date.”5 See ECF No. 99 at 4.
`
`4 These documents are directly relevant to Teva’s asserted claims, see, e.g., U.S. Patent No.
`9,884.908 at claim 5 (“wherein the headache is a . . . cluster headache”), and Lilly’s invalidity
`defenses, see Lilly’s Preliminary Disclosures Pursuant to Rule 16.6(d)(4) at 11–16 (discussing
`Teva’s abandoned cluster-headache program in the context of invalidity under 35 U.S.C. §112, ¶ 1).
`Notably, Teva announced it abandoned the clinical studies on cluster headache after September 27,
`2018.
`
`5 In its letter to the Court, Teva states, “Lilly has provided no explanation for why
`development activities occurring before August 2015 are relevant, while those occurring after that
`
`
`
`Case 1:18-cv-12029-ADB Document 102 Filed 03/02/21 Page 4 of 5
`
`ECF Letter to Judge Burroughs
`March 2, 2021
`Page 4
`
`Second, Teva’s arbitrary date cutoff allows it to cherry-pick the Post-Complaint Documents
`it wants to produce. And that is exactly what Teva admits it will do using undisclosed “targeted
`searches.” Under this approach, Teva is free to produce only those documents it views as supporting
`its damages case, while excluding all others, including unfavorable ones—a practice Teva
`acknowledges is improper. See Ex. 14 at 3 (arguing that “cherry-picking certain documents while
`excluding others” is a “violation” of a party’s discovery obligations). But even if Teva does not take
`such a nefarious approach, Lilly has no way of knowing what Teva will consider and withhold, much
`less what it will even review.
`
`Third, Teva is attempting to skirt the requirements of the Court-ordered ESI Protocol. ECF
`No. 57. As Teva recognizes, the parties established an ESI Protocol to “[s]treamline [d]ocument
`[d]iscovery.” ECF No. 99 at 2. If Teva thought a date cutoff was needed to streamline discovery,
`it should have raised the issue while negotiating the ESI Protocol—it never did. Having agreed to
`the ESI Protocol, Teva is supposed to “locate potentially responsive ESI” using a set of tailored
`search terms it accepted, not unidentified “targeted searches.” See ECF No. 57 at § 3(b). Yet Teva
`now refuses to even review “over one hundred thousand” Post-Complaint Documents captured by
`those very search terms, merely because such documents were created during the timeframe in which
`Lilly’s accused product has been on the market. That position is untenable, and it underscores why
`Teva’s cherry-picking enables it to withhold large swathes of relevant information.
`
`And fourth, “[a]s the party resisting discovery, [Teva] bear[s] the burden of showing some
`sufficient reason why discovery should not be allowed.” Katz v. Liberty Power Corp., LLC, No. 18-
`CV-10506-ADB, 2020 WL 3492469, at *2 (D. Mass. June 26, 2020) (internal quotation marks and
`citation omitted) (Burroughs, J.). Teva’s only basis for refusing to produce the requested Post-
`Complaint Documents—increased costs—lacks support.
`
`Beyond mere attorney argument that removing its improper date cutoff would require
`reviewing “over 100,000 additional documents at an estimated cost of ~$325,000,” Ex. 12, Teva has
`provided no underlying details and no concrete evidence supporting those purported figures. By any
`measure, Teva has not met its burden. See Katz, 2020 WL 3492469, at *5 (explaining that
`“[b]oilerplate language that discovery is ‘overbroad and unduly burdensome’ is insufficient to meet
`the ‘burden of showing by affidavit or otherwise that [discovery] would be unduly burdensome.’”);
`ECF No. 99 at 6 (Teva acknowledging the Federal Rules require the resisting party to provide
`“concrete evidence to meet its burden”).
`
`arbitrary date are not.” ECF No. 99 at 4. Teva misconstrues Lilly’s position, as Lilly has never
`instituted any such date cutoff. Despite being misguided, Teva’s argument underscores why its
`September 27, 2018, date cutoff is improper.
`
`
`
`Case 1:18-cv-12029-ADB Document 102 Filed 03/02/21 Page 5 of 5
`
`ECF Letter to Judge Burroughs
`March 2, 2021
`Page 5
`
`* * * *
`
`Lilly respectfully requests that the Court overrule Teva’s blanket date-cutoff objection and
`compel it to produce all relevant, responsive documents “created” after September 27, 2018. Thank
`you for Your Honor’s kind attention to this matter. Lilly is available for a status call at the Court’s
`convenience.
`
`Respectfully submitted,
`
`/s/Andrea L. Martin
`Andrea L. Martin
`amartin@burnslev.com
`D 617-345-3869
`
`cc: All Counsel of Record (by ECF)
`
`