Case 1:18-cv-00924-CFC-SRF Document 438 Filed 10/21/19 Page 1 of 5 PageID #:
`32474
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC.,
`
`v.
`AMGEN INC.,
`
`Plaintiff,
`
`Defendant.
`
`C.A. No. 18-924-CFC
`
`PUBLIC VERSION
`
`AMGEN INC.’S LETTER IN SUPPORT OF ITS MOTION FOR A PROTECTIVE
`ORDER AGAINST UNTIMELY THIRD-PARTY SUBPOENAS
`
`Of Counsel:
`
`Michelle Rhyu
`Daniel Knauss
`Susan Krumplitsch
`Cooley LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`P (650) 843-5000
`rhyums@cooley.com
`dknauss@cooley.com
`skrumplitsch@cooley.com
`
`Orion Armon
`Eamonn Gardner
`Cooley LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`P (720) 566-4000
`oarmon@cooley.com
`egardner@cooley.com
`
`SMITH, KATZENSTEIN & JENKINS LLP
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attorneys for Defendant Amgen Inc.
`
`Lois Kwasigroch
`Nancy Gettel
`Brian Kao
`Amgen Inc.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P (805) 447-1000
`ngettel@amgen.com
`loisk@amgen.com
`bkao@amgen.com
`
`Christopher B. Mead
`London & Mead
`1225 19th Street, N.W., Ste 230
`Washington, D.C. 20036
`P (202) 331-3334
`cmead@londonandmead.com
`
`Dated: October 13, 2019
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 438 Filed 10/21/19 Page 2 of 5 PageID #:
`32475
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`Dear Judge Connolly:
`
`On October 3, 2019, long after the close of fact discovery and without leave of Court,
`
`Genentech served deposition and document subpoenas on 15 third-party oncology clinics and
`healthcare providers that are located throughout this country and in Puerto Rico. The subpoenas,
`attached as Exhibit 1, request patient records relating to the administration of Kanjinti and
`depositions. Because Genentech cannot establish good cause to pursue this prejudicial discovery
`on the eve of trial, Amgen respectfully requests that the Court enter a protective order that (i) voids
`the subpoenas and mandates their withdrawal, and (ii) excludes as evidence at the December 2019
`trial any information that Genentech may already have received in response to its subpoenas.
`
`I.
`
`Factual Background
`The information requested by the subpoenas appears to relate to Genentech’s claims that
`doctors will directly infringe U.S. Patent Nos. 6,627,196, 7,371,379, and/or 10,160,811
`(collectively, “the Dosing Patents”) by prescribing Kanjinti. Genentech has alleged since June 21,
`2018—when it filed its original Complaint—that Amgen will “aid and abet another’s direct
`infringement” of claims of the Dosing Patents and that “medical practitioners will prescribe and/or
`administer [Kanjinti] according to Amgen’s proposed package insert…and, therefore, will directly
`infringe” claims of the Dosing Patents. See Complaint at 33 (D.I. 2.) In other words, from the
`first day of this action, Genentech acknowledged that it had the burden of proving direct
`infringement by medical practitioners as a predicate for establishing induced infringement. See
`Limelight Networks. v. Akamai Tech., 572 U.S. 915, 922 (2014) (“where there has been no direct
`infringement, there can be no inducement of infringement under § 271(b).”).1 “[O]nly two of the
`four indications on the Kanjinti label allegedly infringe the Dosing Patents, meaning there are two
`recited methods of using Kanjinti that are free of any allegations of infringement.” D.I. 299 at 8
`n.7. Accordingly, it has always been Genentech’s burden to establish that doctors prescribe
`Kanjinti according to the accused methods.
`
`Fact discovery on liability issues in this case closed on June 10, 2019. D.I. 196. On July
`18, 2019, the Court denied Genentech’s preliminary injunction motion and lifted the standstill on
`the launch of Kanjinti, D.I. 274, and Amgen launched Kanjinti that day. See D.I. 347 at 4. On
`July 29, 2019, Amgen served Genentech with a declaration stating that it had received
`confirmation that patients were being administered Kanjinti. Ex. 2 (Second Declaration of Robert
`Jacobson), ¶¶ 6–8, Case No. 2019-2156.
`
`After Kanjinti’s launch, Genentech served an opening expert report on infringement of the
`Dosing Patents on July 26, and Amgen served a rebuttal expert report on September 6.
`Genentech’s infringement expert, Dr. Susan Tannenbaum, appeared for deposition on October 2.
`During deposition, Dr. Tannenbaum admitted that her report contained no evidence of direct
`infringement of any asserted claim by healthcare providers. Ex. 3 (Tannenbaum Tr.) at 91:20–
`93:18 (“So maybe I’m a little confused, but I thought my task was to see if the claim was infringed
`upon by the label, not about prescribing practices.”). The next day, Genentech issued the 15 late
`
`1 Amgen denied direct infringement in disclosures served pursuant to 42 U.S.C. § 262(l)(3)(B) on
`February 13, 2018, see, e.g., Ex. 4, Ex. 9 to 3(B) disclosures at 4; and in its First Supplemental
`Response to Genentech’s First Interrogatories on April 5, 2019, Ex. 5 at 12, and Second
`Supplemental Response to Genentech’s First Interrogatories on June 10, 2019, Ex. 6 at 9.
`
`
`
`
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 438 Filed 10/21/19 Page 3 of 5 PageID #:
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`subpoenas to patch this hole. The subpoenas demand that, by October 14, recipients produce
`patient treatment records showing how Kanjinti has been administered, and appear for depositions.
`See Ex. 1 (subpoena). The parties conferred in good faith regarding the subpoenas on October 4,
`8, and 10 but were unable to resolve this dispute. Genentech acknowledged that the subpoenas
`seek evidence of direct infringement, and refused to stipulate that evidence it obtained should be
`excluded from the upcoming December trial on liability and used solely for the bifurcated damages
`trial, should that need arise. Genentech also refused to withdraw the subpoenas.2
`
`II.
`
`Legal Standard
`“[A] subpoena is subject to the same scheduling order deadlines as other forms of
`discovery.” Behne v. Halstead, No. 1:13-CV-0056, 2014 WL 4672486, at *2 (M.D. Pa. Sept. 18,
`2014). “Rule 45 subpoenas may not be used to circumvent the discovery deadlines.” Wantanable
`Realty Corp. v. City of New York, 159 F. Appx. 235, 240 n.2 (2d Cir. 2005). When a party seeks
`to conduct discovery after the deadline has passed, the party must first seek a modification of the
`scheduling order by demonstrating “good cause” under Fed. R. Civ. P. 16(b)(4). The court may
`limit discovery through a protective order. Fed. R. Civ. P. 26(c). In contrast to a motion to quash,
`a motion for a protective order is available to “a party or any person from whom discovery is
`sought.” Id. (emphasis added). Accordingly, Amgen has standing to seek a protective order here.
`Underwood v. Riverview of Ann Arbor, No. 08-CV-11024, 2008 WL 5235992, at *2 (E.D. Mich.
`Dec. 15, 2008) (“The explicit mention of ‘a party’ in the rule has been interpreted to provide
`standing for a party to contest discovery sought from third-parties.”); Thomas v. Marina Assocs.,
`202 F.R.D. 433, 435 n.2 (E.D. Pa. 2001) (same).
`
`III.
`
`Argument
`Genentech Was Not Diligent in Issuing the Subpoenas
`Genentech never moved to modify the scheduling order and cannot show good cause to do
`so to accommodate its untimely subpoenas. The subpoenas appear to have been precipitated by
`Dr. Tannenbaum’s admissions during her October 2 deposition that she had no evidence of direct
`infringement of the dosing patents. Genentech’s failure to initiate the discovery needed by its
`expert defeats any possibility of showing good cause. Graham v. Progressive Direct Ins. Co., 271
`F.R.D. 112, 121 (W.D. Pa. 2010) (“Carelessness, or attorney error…is insufficient to constitute
`‘good cause’ under Rule 16(b).”) (citations omitted). Nearly three months ago, Amgen launched
`Kanjinti, and Amgen also provided notice that patients were being administered Kanjinti. See Ex.
`2. Yet, Genentech delayed until after discovery closed on its expert’s opinions on infringement
`and just two months before trial to issue the subpoenas.3 Genentech cannot establish that it was
`
`2 In the parties’ last meet and confer, Genentech agreed to notify the subpoena recipients that they
`need not produce documents or provide witnesses for deposition until the Court rules on Amgen’s
`motion, per L.R. 30.2.
`3 When the parties conferred, Genentech claimed that delaying issuance of the subpoenas until
`October was necessary to allow patients to receive all steps in an infringing treatment regimen.
`This excuse fails to explain why Genentech did not seek leave of court. Nor does it explain
`Genentech’s lengthy delay. The asserted Dosing Patents require an initial dose plus a plurality of
`subsequent doses, which the patents define as “two or more,” so the claimed steps can be
`performed in approximately six weeks. See, e.g., Ex. 7, ’196 patent at 6:36-46. Considering the
`statutory notice requirements for subpoenas, Genentech could have issued subpoenas in late
`August and six weeks would have elapsed by the time recipients responded.
`
`2
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 438 Filed 10/21/19 Page 4 of 5 PageID #:
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`diligent in pursuing the discovery it now seeks. Dow Chem. Canada Inc. v. HRD Corp., 287
`F.R.D. 268, 270 (D. Del. 2012), aff'd, 587 F. App’x 741 (3d Cir. 2014) (“To establish good cause,
`[Genentech] must show that a more diligent pursuit of discovery was impossible.”)
`
`Genentech’s Subpoenas are Unreasonably Numerous and Burdensome and, As-
`Issued, Appear to Violate Federal Privacy Regulations
`A protective order is warranted to protect Amgen and its customers—the subpoenaed
`clinics and healthcare providers—from annoyance, undue burden and expense. It appears that
`Genentech may have served these 15 subpoenas to clinics across the U.S. and Puerto Rico to create
`a chilling effect on Amgen’s customers’ use of Kanjinti. This concern is significant in light of
`Genentech’s demand for production of documents and witnesses within a week. Genentech
`created this urgency by waiting too long to serve the subpoenas. The added burden this timing
`creates would require health care providers to divert time and resources away from patient care.
`Genentech’s subpoenas for patient treatment information also raises privacy concerns.
`HIPAA imposes limitations on the disclosure of protected health information, and it appears that
`Genentech’s subpoenas violate those requirements. Title 45 of the Code of Federal Regulations,
`Section 164.512(e)(1)(ii)(A)-(B), allows the disclosure of protected health information in response
`to a subpoena only if (i) the party seeking the information has made reasonable efforts to ensure
`that the individual who is the subject of the protected health information has been given notice of
`the request and a chance to object, or (ii) if the subpoena recipient has been provided a written
`statement and accompanying documentation demonstrating that a qualified protective order has
`been entered by the court to protect the information. The subpoenas contain no indication that
`Genentech complied with either of these regulatory requirements. Genentech’s late service of
`these complex subpoenas greatly prejudices Amgen, as discussed below. To the extent the
`subpoenas may apply to the damages phase, they should be quashed or deferred until after the trial
`on liability, when there is time to ensure minimal disruption of patient care and appropriate privacy
`protections.4
`
`Prejudice to Amgen
`Amgen would be unfairly prejudiced if discovery is reopened for Genentech to pursue its
`subpoenas. As Genentech acknowledges, “[f]act discovery has been closed for months, expert
`discovery is in its very final stages, and the parties are hard at work on their pretrial submission.”
`D.I. 397 at 1. Genentech’s belated subpoenas would require 15 depositions, new expert reports on
`infringement, and additional expert depositions, which would take months to complete. Each of
`these activities would severely disrupt Amgen’s trial preparation efforts, as well as the Court’s
`preparations to adjudicate the trial scheduled to commence on December 9. “In deciding whether
`to modify a scheduling order, the Court may consider any prejudice to the party opposing the
`modification.” Dow Chem. Canada Inc., 287 F.R.D. at 270. Id. Reopening fact and expert
`discovery to accommodate Genentech’s 15 subpoenas would prejudice Amgen by delaying
`resolution of this matter at trial. See id. (“Prejudice may include the delay of a trial date.”)
`
`4 Genentech’s instructions to redact patients’ records are inadequate to avoid these privacy
`requirements because the subpoenas contain geographical information that HIPAA defines as
`individual identifying information. See, e.g., 45 C.F.R. § 160.103 (defining individually
`identifiable health information as information including demographic information about an
`individual and that relates to a past, present, or future medical condition).
`
`3
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`

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`Case 1:18-cv-00924-CFC-SRF Document 438 Filed 10/21/19 Page 5 of 5 PageID #:
`32478
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`Respectfully submitted,
`
`/s/ Neal C. Belgam
`
`Neal C. Belgam (No. 2721)
`
`Enclosures
`
`cc:
`
`Clerk of Court (via hand delivery)
`All Counsel of Record (via email)
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`212958128 v10
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`4
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