Genentech, Inc. v. Trustees of the University of Pennsylvania

Filing 324

ORDER by Judge Paul S. Grewal granting in part 288 Motion to Compel (psglc2, COURT STAFF) (Filed on 9/19/2011)

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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United States District Court
For the Northern District of California

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SAN JOSE DIVISION

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GENENTECH, INC.,

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Plaintiff,
v.

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THE TRUSTEES OF THE UNIVERSITY OF
PENNSYLVANIA,

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Defendant.

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Case No.: C 10-2037 PSG
ORDER GRANTING-IN-PART
DEFENDANT’S MOTION TO
COMPEL
(Re: Docket No. 288)

In this patent infringement suit, Defendant and Counterclaim-Plaintiff The Trustees of the
University of Pennsylvania (“Penn”) moves to compel Plaintiff Genentech, Inc. (“Genentech”) to

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produce documents responsive to Penn’s request for production (“RFP”) nos. 29, 34, 69, and 97, as
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well as responses to Penn’s interrogatory nos. 17 and 18. Having considered the letter briefs, oral

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argument, evidence and authority presented by both parties, Penn’s motion to compel is

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GRANTED-IN-PART.

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I. BACKGROUND

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On July 26, 2010, Penn served its first set of requests for production of documents to

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Genentech. This set includes RFP no. 29, which is the subject of the court’s order of June 16, 2011
(“June 16 Order”) granting in part Penn’s previous motion to compel. 1 RFP no. 29 requests:

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See Docket No. 272.
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Case No.: CV 10-2037 PSG
ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

Documents sufficient to describe the results of all studies or experiments, or
analysis of data, related to the mechanism of action of Trastuzumab, Pertuzumab,
the antibodies designated as 4C8, 3E8, 3H8, 7.16.4, 7.5.5, 7.9.5, 7.21.2, or any
other antibodies that bind to HER2, neu, or p185. 2

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In its June 16 Order, the court concluded that RFP no. 29 is appropriately limited to
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“documents sufficient to describe the results of all studies or experiments, or analysis of data

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related to the mechanism of action” of Herceptin and the recited antibodies in breast cells that

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overexpress p185 and that are not breast cancer cells. 3 The court ordered that Genentech conduct a

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“reasonable search” for these documents, including checking email records of lead researchers,

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interviewing researchers and scientists, searching for experiments regarding the 4D5 antibody after

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For the Northern District of California

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production in previous litigation, and searching internal presentations, summaries, and reports that

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relate to the defined criteria. 4

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Even prior to the June 16 Order, Genentech had produced a substantial number of

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documents relating to the mechanisms of action of Herceptin and the antibodies 4D5 and 7.16.4,

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including “over one million pages of responsive documents.” 5 After the court’s order, counsel

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interviewed Genentech’s lead scientists on the issues directed by the court and produced additional,

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non-privileged materials, including minutes and presentations by several Herceptin teams at
Genentech and materials from its research and development review committees. 6 Counsel also

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followed up with several individuals listed by a Genentech senior staff scientist in his deposition as
“knowledgeable” or “qualified” to testify about the issue of “disseminated tumor cells and their

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Docket No. 289, Ex. A.

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Docket No. 272 at 5:9-10 (emphasis in original).

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Id. at 10:17-11:1.

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Id. at 2:13-22.

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Docket No. 305-3 ¶¶ 4, 7, 8.

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ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

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presence in patients, in the context of breast cancer.” 7 Except for one set of documents already

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produced to Penn, Genentech found that none of the individuals had responsive documents. 8 In

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August 9, 2011, after several attempts to resolve disagreements over the sufficiency of this

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response to RFP no. 29 and the June 16 Order, Penn filed the motion now before the court.

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Additionally, Penn challenges a number of Genentech’s responses to Penn’s other requests,
specifically RFP nos. 34, 69, and 97, as well as Interrogatory nos. 17 and 18.

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In RFP no. 34, Penn requests:

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Documents sufficient to describe the results of all studies or experiments, or
analysis or data, related to the phenotype, genotype and other characteristics of
cells involved in the spread of metastatic disease, and all internal presentations or
discussions relating to the foregoing. 9

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For the Northern District of California

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Initially, Genentech stated a wide range of general objections to RFP no. 34, focusing especially on

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the phrase “all studies or experiments, or analysis of data.” 10 It then offered to meet and confer

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with Penn regarding the scope of the request. Despite those attempts, Genentech continues to argue

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that RFP no. 34 is too broad and seeks discovery on issues far beyond the scope of this lawsuit.

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A similar stalemate exists with respect to the other disputed matters. In RFP no. 69, Penn
requests “[a]ll documents relating to whether Trastuzumab acts on breast cells that overexpress
HER2 but that are outside of the breast.” 11 Genentech responded that it was not aware of any

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responsive documents based on its stated interpretation of the request. 12 RFP no. 97 asks for “[a]ll
documents relating to studies on ductal carcinoma in situ, circulating tumor cells, disseminated
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Id. ¶ 5.

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Id.

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Docket No. 289, Ex. A.

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See id. Ex. B.

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Id. Ex. C.

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Genentech interpreted RFP 69 as (1) being “directed to breast cells in human patients that
receive Herceptin and not to cell lines,” and (2) presuming “breast cells that overexpress HER2” to
exclude cancer cells. Id. Ex. D.
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ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

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tumor cells, and step cells that overexpress HER2.” 13 For RFP no. 97, Genentech agreed, subject to

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numerous objections, to produce responsive documents relating to circulating tumor cells (“CTCs”)

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and disseminated tumor cells (“DTCs”) “to the extent they exist and can be located after a

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reasonable search.” 14

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Penn remains dissatisfied with the scope of Genentech’s responses, particularly as they
relate to which cells are subject to discovery and whether Genentech believes those cells to be

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relevant in light of the court’s claim construction. On largely these same bases, Penn claims that
Genentech also has failed to respond fully or fairly to its Interrogatory nos. 17 and 18. Genentech

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For the Northern District of California

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argues that it is unable to respond to Penn’s requests relating to at least one disputed cell category –

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the “isolated tumor cell” – because it constitutes a recently adopted, “newly-coined and thoroughly

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confused term” introduced by Penn as a means to obtain otherwise off-limits discovery. Otherwise,

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Genentech argues, it already has responded properly and in full to the RFPs and interrogatories

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raised in this motion.
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II. LEGAL STANDARD

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Parties may obtain discovery regarding any nonprivileged matter that is relevant to any

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party's claim or defense. Relevant information need not be admissible at trial if the discovery

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appears reasonably calculated to lead to the discovery of admissible evidence. The court must limit

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the frequency or extent of discovery if it is unreasonably cumulative or duplicative, or can be

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obtained from some other source that is more convenient, or the burden or expense of the proposed
discovery outweighs its likely benefit. 15

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Id. Ex. C.

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Id. Ex. D.

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See Fed. R. Civ. P. 26.
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Case No.: CV 10-2037 PSG
ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

III. DISCUSSION

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A. June 16 Order and Requests for Production Nos. 29, 34, 69, 97
In a series of communications following the June 16 Order, Penn and Genentech dispute the

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sufficiency of Genentech’s response to RFP nos. 29, 34, 69, and 97 and the June 16 order,

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specifically with respect to (1) the categories of cells subject to the requests and the June 16 Order,

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(2) the follow up with Genentech scientists and researchers identified as knowledgeable on key

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For the Northern District of California

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issues, (3) the level of p185/HER2 expression that qualifies as “overexpressing” for the purpose of
producing discovery, and (4) whether Genentech is limiting its discovery efforts to include only in
vivo patient research.

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Penn notes that under the June 16 Order, Genentech must produce relevant documents
pertaining to “HER2 overexpressing mammary epithelial cells that are not cancer cells” and are
present at locations distant from the breast. According to Penn, this requires production of
documents concerning isolated tumor cells (“ITCs”) 16 and cancer stem cells (“CSCs”), in addition

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to DTCs and CTCs.
Genentech disputes this characterization of ITCs and CSCs and the manner in which Penn

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has introduced “new” terms into the litigation without clear definition. First, Genentech disputes

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Penn’s assertion that ITCs and CSCs are not cancer, because Penn’s own authorities suggest that

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ITCs and CSCs have the ability for uncontrolled growth. Genentech also states that Penn’s

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“evasive, circular and inconsistent” references to what ITCs are or where they are found make it

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unclear whether ITC is simply a generic term for both DTCs and CTCs, in which case Genentech
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already has agreed to produce documents. 17 Finally, noting that Penn does not refer to ITCs either
in the pending document request or in its briefings to the court during the previous motion to
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See Docket No. 289, Ex. V at 13-14 (describing ITCs as “individual or small groups of cells, that,
among other things, ‘do not typically show evidence of metastatic activity (e.g., proliferation)’”).

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See Docket No. 305 at 2.
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ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

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compel on RFP 29, Genentech argues that Penn actually is seeking reconsideration of the June 16
Order by demanding that Genentech update its document production to include ITCs. 18
Penn is right that, even if certain ITCs and CSCs satisfy the court’s “cancer” construction,

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and therefore fall outside the scope of appropriate discovery, this does not justify withholding

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discovery of all ITC and CSC-related studies that are otherwise relevant. As Genentech’s expert

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Dr. Cote has explained, “[t]umor can refer to cancer and often does refer to cancer but tumor can
also refer to non cancerous conditions.” 19 Dr. Cote further explained that CSCs “have been
demonstrated to exist as a subpopulation in DTCs.” 20 To the extent that Genentech has performed

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For the Northern District of California

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otherwise relevant studies on ITCs and CSCs that lack malignant form and structure, the ability for

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uncontrolled growth, or the potential or ability to invade or metastasize, Penn is entitled to

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discovery on them.

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As to Penn’s assertions that Genentech has failed to follow up with key scientists and

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researchers, has used an arbitrary cut-off for the level of p185/HER2 expression that qualifies as
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“overexpressing,” and has limited discovery efforts to include only in vivo patient research – the

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declarations of Genentech’s counsel indicate otherwise. Nonetheless, there are a few gaps in

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Genentech’s follow up to the June 16 Order that require a limited, supplemental discovery

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response.

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First, Genentech must follow up with those researchers listed by Dr. Sliwkowski as
knowledgeable or qualified to speak about the presence in patients of DTCs, pursuant to the June

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16 Order to “conduct a reasonable search, including checking the email records of its lead
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researchers for internal studies or presentations, interviewing researchers to determine what studies

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Genentech cites June 16, 2011 as the first instance that Penn referred to ITCs. See Docket No.
305-4 ¶ 8.

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Docket No. 320, Ex. C at 5.
See Docket No. 289, Ex. Z-2 at 7.
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were performed, [and] speaking with its scientists who conduct research on the antibodies

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specified.” 21 Dr. Sliwkowski’s use of a qualifier prior to listing the individuals’ names does not

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negate the fact that they may have relevant information that could lead to the discovery of

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admissible evidence. The fact that Genentech followed up and found only one person to have such

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information indicates that no further action is required with respect to that person. However, it is

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not clear from counsel’s declaration whether Genentech interviewed all of the individuals listed. 22

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The court agrees with Penn that Genentech must conduct a reasonable search with respect to all the
researchers named by Dr. Sliwkowski, to ensure that no relevant and producible documents have

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For the Northern District of California

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been overlooked. To the extent that Genentech’s counsel has not at least conducted an initial

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inquiry by interviewing each of the researchers on the list, the court finds it reasonable to require

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Genentech to do so.

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Second, Genentech may not refuse to search for cells identified according to the same

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standard that is used in Penn’s infringement contentions, specifically, “based on the fact that they
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stain for HER2 using immunohistochemistry (or show any amplification of the HER2 gene

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locus).” 23 Genentech notes simply that it refused only to search for all cells that stain for HER2

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because the request was not limited to non-cancer cells or breast cells, and it would be

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unreasonable for Genentech to produce documents about the various normal cells and non-breast

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cancer cells that meet this standard. The court agrees that, to the extent Penn’s request seeks

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documents on cells that stain for HER2 and are either cancerous or non-breast cells, Genentech

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need not respond. However, Genentech must respond regarding breast cells that overexpress p185
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See Docket No. 305-3 (stating that counsel “followed up with individuals [Dr. Sliwkowski] had
identified as possibly qualified to testify….” and determined not to collect e-mails from the
individuals identified “because there was no reason to expect that there would be responsive
information”).
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Docket No. 272 at 10:17-20 (emphasis added).

See Docket No. 289, Ex. S at 3.
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Case No.: CV 10-2037 PSG
ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL

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and are not cancer cells, and that stain for HER2 using immunohistochemistry or show any
amplification of the HER2 gene locus.
Finally, Genentech disputes Penn’s contention that it is limiting discovery efforts to

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Herceptin’s effect on CTCs or DTCs in patients only. Genentech states that it has researched and

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produced discovery on both in vivo and in vitro research on CTCs and DTCs. 24 Given Genentech’s

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sworn assertions to this effect, and the absence of any evidence to the contrary, the court finds this

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part of Penn’s motion to compel to be without merit.
B. Interrogatory Nos. 17 and 18
On April 6, 2011, Penn served Interrogatory nos. 17 and 18 on Genentech as part of its

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For the Northern District of California

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sixth set of interrogatories. The same general arguments outlined above underlie Penn’s motion to

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compel additional substantive response to these interrogatories.

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1. Interrogatory no. 17

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Interrogatory no. 17 states:
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Fully describe all data or analysis addressing whether TRASTUZUMAB acts on
cells (including, but not limited to, mammary epithelial cells and including cells at
locations outside of the breast) that overexpress HER2 but do not exhibit one or
both of the properties of uncontrolled growth and invasiveness, identify all
individuals at Genentech knowledgeable about the subject, and identify all
documents relating to the above data or analysis. 25

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Through subsequent meet and confers and correspondence, Penn agreed to limit the scope of

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Interrogatory 17 such that Genentech need not respond as to cells that are not invasive but possess

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the property of uncontrolled growth; Penn also provided guidance for what constitutes

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“uncontrolled growth.” 26 Yet according to Penn, Genentech nevertheless refuses to respond

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substantively by addressing the existence of any of the disputed cell types (i.e. ITCs, DTCs, CTCs,

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See Docket No. 305-3 ¶ 6; Docket No. 305-4 ¶¶ 9, 10.

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Docket No. 289, Ex. E.

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Id. Ex. P at 2.

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or CSCs), even though whether, and to what extent, the cells at issue grow uncontrollably or are
invasive is relevant to the question of whether they have the ability to do so.
Genentech objects to Interrogatory no. 17 on multiple grounds, including that it is

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overbroad and burdensome because it is “not limited to whether Trastuzumab acts on breast cells,”

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and vague and ambiguous because “‘at any given moment in time, it would be impossible to

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determine … whether a particular cell exhibits one or both properties’ of uncontrolled growth or
invasiveness.” 27 Genentech also argues that the data Interrogatory 17 requests is rendered irrelevant
under the claim construction, because it relates to cells that do not exhibit uncontrolled growth or

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For the Northern District of California

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invasiveness, rather than cells with the ability for uncontrolled growth and invasiveness. 28 And

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finally, Genentech contends that Penn now improperly seeks to transform the interrogatory into a

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new question about DTCs, CTCs, CSCs, and ITCs.

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The court agrees with Penn that the characteristics of uncontrolled growth and invasiveness
– or lack thereof – are relevant to whether the cells may exhibit the ability to do so. In this case, the

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difference between the court’s construction and Penn’s phrasing of the interrogatory does not

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render the question irrelevant: while the ability for uncontrolled growth is a necessary precursor to

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exhibition of that characteristic (and if known would definitively remove that cell or data from the

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scope of discovery), an absence of uncontrolled growth does not preclude the possibility that the

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cell nevertheless has the ability to develop the characteristic, and thus may remain within the scope

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of discovery.

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In other words, Genentech need not describe data or analysis on breast cells for which the
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ability for uncontrolled growth or invasiveness is established, even if those cells do not yet exhibit
such characteristics. But it must respond as to cells that do not exhibit uncontrolled growth and

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See id. Ex. F (quoting Docket No. 305, Ex. F at 169:17-21).

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See id. Ex. O at 4.

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invasiveness but for which the ability to do so remains. To the extent there is any doubt about the

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ability of a particular cell type for uncontrolled growth, Genentech should err on the side of

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responding.

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As to Genentech’s contention that Penn seeks to transform Interrogatory no. 17 into a new
question about DTCs, CTCs, CSCs, and ITCs, those cell types are necessarily included in the
interrogatory to the extent that their definitions meet the description put forth by the interrogatory,

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For the Northern District of California

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e.g., breast cells acted on by Herceptin, including but not limited to mammary epithelial cells and
including cells at locations outside of the breast, that overexpress HER2 but do not exhibit one or
both of the properties of uncontrolled growth and invasiveness.

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2. Interrogatory no. 18

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Interrogatory no. 18 states:

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Fully describe all data or analysis addressing whether TRASTUZUMAB acts on
breast cells that overexpress HER2 but that are outside of the breast, identify all
individuals at Genentech knowledgeable about the subject, and identify all
documents relating to the above data or analysis. 29

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Genentech states that it understands the phrase “breast cells that overexpress p185” to refer to noncancer breast cells, consistent with the claim term of the ‘752 patent. Based on this understanding,

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it initially responded that it is “unaware of any non-cancer breast cells that overexpress p185 but
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are outside of the breast” and that there is “no evidence that Trastuzumab acts on breast cells that

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overexpress HER2 but are outside of the breast.” 30 Subsequently, Genentech agreed to provide

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supplemental discovery specifically as regards CTCs and DTCs, but not ITCs or CSCs.31

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Id. Ex. E.

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See id. Ex. F at 12.

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See Docket No. 305-1 ¶ 14.

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Genentech’s stated purpose behind this concession was to “specifically state why [Genentech]
believes HER2 overexpressing breast CTCs and DTCs are cancer cells.” 32
According to Penn, Genentech’s response amounts to a refusal to acknowledge that other

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cell types, including ITCs and CSCs, must be included as “breast cells that overexpress HER2 but

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that are outside of the breast.” Genentech responds by reiterating its frustration with the term ITC

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as one that Penn recently introduced into the litigation, has failed to define clearly, and that appears

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either to be a generic term for DTCs or CTCs or to be something else that actually falls within the
court’s construction of cancer.
For the same reasons set forth in the court’s earlier directive to the parties regarding ITCs

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and CSCs, Genentech may not avoid otherwise legitimate discovery simply because the discovery

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relates to an ITC or CSC. Accordingly, Genentech shall respond to this interrogatory with respect

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to any ITC or CSC that does not meet any one of the three requirements for “cancer” set forth by

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Judge Koh.
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IV. CONCLUSION

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No later than October 14, 2011, Genentech shall provide the discovery required by this

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order. All other relief requested by Penn is denied.
Dated: September 19, 2011

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_________________________________
PAUL S. GREWAL
United States Magistrate Judge

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Case No.: CV 10-2037 PSG
ORDER GRANTING-IN-PART DEFENDANT’S MOTION TO COMPEL