Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_16-cv-02581/USCOURTS-cand-3_16-cv-02581-5/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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United States District Court

Northern District of California

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

AMGEN INC., ET AL.,

Plaintiffs,

v.

SANDOZ INC., et al.,

Defendants.

Case No. 16-cv-02581-RS (MEJ)

DISCOVERY ORDER

Re: Dkt. No. 64

INTRODUCTION

Plaintiffs Amgen, Inc. and Amgen Manufacturing Limited (collectively, ―Amgen‖) and 

Defendants Sandoz Inc. and Lek Pharmaceuticals d.d. 1(collectively, ―Sandoz‖) disagree about the 

wording of a provision in their proposed protective order regarding in-house counsel‘s access to 

confidential materials. Jt. Ltr., Dkt. No. 64. Both parties agree that a protective order is 

necessary, and each has submitted a proposed protective order largely based on the one entered in 

Amgen Inc. v. Sandoz Inc., 14-cv-4741 (N.D. Cal.) (the ―filgrastim case‖). The filgrastim case is a 

related case pending before the presiding judge in this matter, the Honorable Richard Seeborg. 

The filgrastim protective order is based on the Northern District of California‘s Patent Model 

Protective Order. But Sandoz seeks to modify the filgrastim protective order by adding an 

additional tier of confidentiality: ―HIGHLY CONFIDENTIAL—OUTSIDE COUNSELS‘ EYES 

ONLY‖ (―OCO‖). Amgen opposes including this additional tier. Having considered the parties‘ 

positions, the relevant legal authority, and the record in this case, the Court issues the following 

order.

 

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Lek Pharmaceuticals is not a party in the filgrastim case. 

Case 3:16-cv-02581-RS Document 66 Filed 01/03/17 Page 1 of 5
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United States District Court

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LEGAL STANDARD

Federal Rule of Civil Procedure 26(c) ―confers broad discretion on the trial court to decide 

when a protective order is appropriate and what degree of protection is required.‖ Seattle Times 

Co. v. Rhinehart, 467 U.S. 20, 36 (1984). ―The court may, for good cause, issue an order to 

protect a party or person from annoyance, embarrassment, oppression, or undue burden or 

expense,‖ including by (1) prohibiting disclosure or discovery; (2) conditioning disclosure or 

discovery on specified terms; (3) preventing inquiry into certain matters; or (4) limiting the scope 

of disclosure or discovery to certain matters. Fed. R. Civ. P. 26(c)(1). 

DISCUSSION

Sandoz proposes that a ―HIGHLY CONFIDENTIAL – OUTSIDE COUNSELS‘ EYES 

ONLY‖ designation should apply to

extremely sensitive ―Confidential Information or Items‖ that consist 

of or relate to communications with the [Food and Drug 

Administration (―FDA‖)] occurring on or after June 24, 2016 

relating to the approval of Biologics License Application [―BLA‖] 

No. 761045 for the Sandoz pegfilgrastim product, that constitute 

hyper-sensitive, competitive information that will cause irreparable 

harm if disclosed to another Party, including to such Party‘s 

Designated House Counsel, or Non-Party, which harm could not be 

avoided by less restrictive means.

Sandoz Prop. Protective Order ¶ 2.11, Ex. B, Jt. Ltr. The Court finds Sandoz has not shown an 

OCO designation is appropriate at this point. 

Courts may not deny access to confidential information solely on the basis of counsel‘s inhouse or retained status. U.S. Steel Corp. v. United States, 730 F.2d 1465, 1467-68 (Fed. Cir.

1984). ―Denial or grant of access . . . cannot rest on a general assumption that one group of 

lawyers are more likely or less likely inadvertently to breach their duty under a protective order.‖ 

Id. at 1468. Rather, ―the factual circumstances surrounding each individual counsel‘s activities, 

association, and relationship with a party, whether counsel be in-house or retained, must govern 

any concern for inadvertent or accidental disclosure.‖ Id. Denial of access may be appropriate in 

some instances; for example, ―where in-house counsel are involved in competitive 

decisionmaking, it may well be that a party seeking access should be forced to retain outside 

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United States District Court

Northern District of California

counsel or be denied the access recognized as needed.‖ Id. 

As Sandoz notes, ―Amgen has yet to identify its Designated House Counsel for [this]

matter[.]‖ Jt. Ltr. at 4. Sandoz presumes, however, that Amgen ―would . . . identify at least 

counsel who have already appeared in this matter – Wendy Whiteford (Vice President, Law) and 

Lois Kwasigroch (Senior Counsel) – whose titles indicate that they have broad responsibilities 

with competitive impact.‖ Id. Given that Amgen has not named its designated in-house counsel, 

the Court cannot conduct the counsel-by-counsel, fact-specific analysis necessary to determine if 

Amgen‘s in-house counsel engages in competitive decisionmaking. The U.S. Steel court defined 

―competitive decisionmaking‖ as ―counsel‘s activities, association, and relationship with a client 

that are such as to involve counsel‘s advice and participation in any or all of the client‘s decisions 

(pricing, product design, etc.) made in light of similar or corresponding information about a 

competitor.‖ 730 F.2d at 1468 n.3; see also Barnes & Noble, Inc. v. LSI Corp., 2012 WL 601806, 

at *2 (N.D. Cal. Feb. 23, 2012) (quoting id.). Although Sandoz identifies Ms. Whiteford and Ms. 

Kwasigroch, their titles alone do not provide sufficient information regarding their responsibilities

toward or their relationship with Amgen such that the Court can determine if these attorneys are 

involved in any competitive decisionmaking. That Ms. Whiteford and Ms. Kwasigroch are 

involved in such activity is, at this point, speculation. 

In Brown Bag Software v. Symantec Corp., the Ninth Circuit reviewed a protective order 

that shielded the plaintiff‘s in-house counsel from viewing documents that contained the 

defendant‘s trade secrets, but allowed an independent consultant access to them to advise the 

plaintiff as to the documents‘ relevancy. 960 F.2d 1465, 1469-72 (9th Cir. 1992). The Brown Bag 

Court noted that ―proper review of protective orders in cases such as this requires the district court 

to examine factually all the risks and safeguards surrounding inadvertent disclosure by any 

counsel, whether in-house or retained.‖ Id. at 1470. The Ninth Circuit found the district court did 

just that: it issued the protective order after conducting ―a comprehensive evidentiary hearing.‖ Id.

at 1470. At the hearing, the district court heard testimony regarding both parties‘ interest in the 

confidential information. Id. at 1470-71. The district court also questioned the plaintiff‘s in-house 

counsel about his responsibilities. Id. at 1741. In-house counsel testified that ―he was responsible 

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for advising his employer on a gamut of legal issues, including contracts, marketing, and 

employment.‖ Id. The district court thus ―reasonably concluded that [in-house] counsel‘s 

employment would necessarily entail advising his employer in areas relating to [the defendant‘s] 

trade secrets.‖ Id. This ―would place in-house counsel in the  ̳untenable position‘ of having to 

refuse his employer legal advice on a host of contract, employment, and competitive marketing 

decisions lest he improperly or indirectly reveal [the defendant‘s] trade secrets.‖ Id. After 

weighing the hardship a protective order may have on the plaintiff‘s prosecutions of its claims, the 

district court issued a protective order that the Ninth Circuit held ―str[uck] a reasonable balance 

between those interests by shielding [the plaintiff‘s] in-house counsel from personal knowledge of 

a competitor‘s trade secrets, but allowing access to information through an independent 

consultant.‖ Id. ―The order did not arbitrarily distinguish [between] outside and in-house counsel. 

Rather, in reaching its decision, the court considered the particular circumstances of [the 

plaintiff‘s] counsel then before it. The same considerations could have applied equally to outside 

counsel.‖ Id. 

In contrast, Amgen‘s in-house counsel‘s identities in this matter are still unknown. The 

Court is therefore unable to consider the specific responsibilities of those attorneys, and is unable 

to evaluate whether they are engaged in competitive decisionmaking for their client. Cf. Pinterest, 

Inc. v. Pintrips, Inc., 2014 WL 5364263, at *2 (N.D. Cal. Oct. 21, 2014) (relying on in-house 

counsel‘s declarations stating they do not engage in competitive decisionmaking and describing 

counsel‘s responsibilities); Barnes & Noble, Inc., 2012 WL 601806, at *2 (same). Adopting

Sandoz‘s OCO provision at this point would be to arbitrarily distinguish between counsel solely 

on the basis of their in-house and retained status. 

CONCLUSION

At this time, the Court will not adopt Sandoz‘s OCO designation. Sandoz may move to 

modify the protective order once Amgen identifies its designated in-house counsel, provided 

Sandoz can point to factual circumstances of each counsel that suggest the risk of inadvertent 

disclosure of confidential information. 

IT IS SO ORDERED.

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United States District Court

Northern District of California

Dated: January 3, 2017

______________________________________

MARIA-ELENA JAMES

United States Magistrate Judge

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