Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 181

MEMORANDUM in Support re #179 Emergency MOTION for Order Requiring Plaintiff to File Under Seal Documents Containing Defendants' Confidential and Trade Secret Materials filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A)(Rizzo, Nicole)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 181 Att. 1

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HIBIT

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UN STATE INRNATIONAL TRADE COMMISSION
Washington, D.C.

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In the Matter of
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Investigation No. 337- T A-568

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CERTAI PRODUCTS AN

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PHAACEUTICAL COMPOSmONS CONTAIG RECOMBINAN

HU ERYTOPOIETI
Order No.2: Protective Order

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WHREAS, documents and information may be sought, produced or exhibited by and
among the paries to the above captioned proceeding, which materials relate to trade secrets or

other confidential research, development or commercial information, as such terms are used in

the Comission's Rules, 19 C.P.R. Section 210.34(a)(7),

IT is HEREBY ORDERE THT:

1. Confdential business information is information which has not been made public and
which concerns or relates to the

trade secrets, processes, operations, style of work, or appartus,

or to the production, sales, shipments, purchases, transfers, identification of customers,

inventories, amount or source of any income, profits, losses, or expenditures of any person, firm,

parnership, corporation, or other organization, the disclosure of which information is likely to

have the effect of either (1) impairing the Commssion's abilty to obtain such information as is

necessar to pedorm its statutory functions, or (2) causing substantial har to the competitive
position of the person, firm, parnership, corporation, or other organization from which the information was obtained, unless the Commssion is required by law to disclose such

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information;

2: Any information submitted, either voluntarly or pursuant to order, in this
investigation, which is asserted by a supplier to contain or constitute confidential business
information shall be so designated by such supplier in writing, or orally at a deposition,

conference or hearng, and shall be segregated from other information being submitted.

Documents shall be clearly and prominently marked on their face with the legend: "(suppliets

name) CONFENT BUSINSS INORMTION, SUBJECT TO PROTECTI
ORDER," or a comparable notice. Information obtained during discovery and asserted by the

supplier to be confidential under this order wil be deemed to be confidential unless the

administrative law judge or the Commssion rules that it is not. When such information is made

par of a pleading, or is offered into the evidentiar record, the par offering it must state the
basis for its claimed confidentiality. Confidential information whether submitted in writing or in
oral testimony shall be disclosed at a hearng only on the in camera record and shall not be made
par of the public record of

this proceeding. The admnistrative law judge or the Commssion

may determne that information alleged to be confidential is not confidential, or that its
disclosure is necessar for the proper disposition of the proceeding, at any time before, during or

after the close of the hearng herein. If such a determnation is made by the admnistrative law
judge, opportunity shall be provided to the supplier of such information to argue its
confidentiality, prior to the time that such ruling becomes final.

3. In the absence of written permssion from the supplier or an order by the Commssion
or the administrative law judge, any confidential documents or business information submitted in
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accordance with the provisions of paragraph 2 above shall not be disclosed to any person other

than: (I outside counsel for paries to this investigation, including necessar- secretaal and
clerical personnel assisting such counsel, (ii) qualified persons takng testimony involving such
documents or information and necessar stenographic and clerical personnel thereof, (iii)

technical expert and their staff who are employed by outside counsel under (I above for the
purposes of this litigation (unless they are otherwise employed by, consultants to, or otherwise

affiliated with a non-governmental par, or are employees of any domestic or foreign
manufacturer, wholesaler, retailer, or distrbutor of certain products and pharaceutical

compositions containing recombinant human eryhropoietin, which are the subject of this
investigation), and (iv) the Commssion, the admnistrative law judge, the Commssion staf, and

personnel of any governental agency as authorized by the Commssion. However ~
Commssion rule 210.5 (b) which conforms to 19 US.C. § 1337(n)(2), which clarfies the list of
government offcers and employees who may have access to confidential business information,

and (c) which alerts suppliers to the possibilty that confidential business information may be
transmitted to a federal distrct cour, subject to such protective order as the distrct court

determnes necessar. This result might occur in a limited class of cases because of 28 U.S.C. §

1659. Past Commssion practice has ben to permt the transfer of confidential business

information to another court only with permssion of the supplier of the information. Paricularly
where the supplier is a third pary who is involved in neither the Commssion investigation nor
the distrct court case, it is important that the supplier be made aware that treatment of
confidential information would be governed by the district court's protective order and notthat

of the Commssion following transmittal of the record under this provision. See also
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Commssion rule 210.39 which outlnes the circumstances in which the Commssion's reord,

including the in camera record, may be transmitted to a federal district court, subject to such

protective order as the distrct court determnes necessar. In addition, referrng to Commssion
Admnistrative Order No. 97-06, dated Pebruar 4, 1997, information submitted under this

Protective Order may be disclosed to technical contract personnel who are acting in the capacity

of Commssion employees, for developing or maintaining the reords of this investigation or
related proceengs, or in internal audits and investigations relating to the progrs and

operations of the Commssion puruant to 5 U.S.C. Appendix 3. Any contrct personnel wil
sign appropriate non-disclosure agreements. i Where the supplier of information under this order
is a third pary who is not involved in the Commssion investigation, it is important that the

supplier be made aware of the disclosure of such information to contract personnel by being
provided a copy of the protective order.

4. Confidential business information submitted in accordance with the provisions of

paragraph 2 above shall not be made available to any person designated in paragraph 3(1 and (ii)
unless he or she shall have first read this order and shall have agreed, by letter fied with the
Secretar of this Commssion (letter of acknowledgment): (1 to be bound by the terms thereof;

(ii) not to reveal such confidential business information to anyone other than another person

designated in paragraph 3; and (ii) to utilize such confidential business information solely for
purposes of this investigation. Such letter shall also acknowledge that the signatory(ies) has

i A supplier of confidential business information may request that the administrative law
judge identify said contract personnel.
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(have) read the order. Such letter shall further state which paries the person fiing the letter is
involved with and shall state in what capacity he or she is a signatory to the Protective Order
~, as an attorney under Paragraph 3(1 or technical expert under Paragraph 3(iii) and, in the

case of an attorney, in what jurisdictions he or she is admtted to practice. Each attorney seeking

access to confidential business information shall sign such letter individually, but clerical and

support personnel (including law clerks and paralegals) of that attorney need not sign. Allletters
of acknowledgment of this Protetive Order shall be served on all non-pares who have

theretofore siibmitted confidential business information in accordance with the provisions of

paragrph 2, above.

5. Confidential business informaton obtained in the Commssion proceeding may be
used with the consent of the supplier in a parallel distrct court proceeding under a protective
order issued by the district court without losing its confidential status under the protective order

in this proceeding as long as the information is not made public in the distrct court proceeding or
by someone who obtains the information from that source or by anyone else.

. 6. Confidential business information furnished by a supplier may lose its protection
under this order if it is disseminated to anyone not authorized to see it either by this protective

order or by a protective order issued by a distrct court in a parallel proceeding protecting
confidential business information obtained by the pares under the Commssion's protective

order. Information obtained pursuant to the Commssion's protective order, however, may be

produced to the distrct court under the distrct court protective order only with the consent of the
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suppliers of that information.

7. If the Commssion or the administrative law judge orders, or if the supp-lier and all

paries to the investigation agree, that access to, or dissemination of, information submitted as
confidential business information shall be made to persons not included in paragraphs 3, 5 or 6 above, such matter shan only be accessible to, or disseminated to, such persons based on the

conditions pertaining to, and obligations arsing from, this order, and such persons shall be

considered subject to it unless the Commssion or the administrative law judge finds that the

information is not confidential business information as defined in paragrph 1 hereof.

8. Any confidential business information submitted to the Commssion or the
admnistrative law judge in connection with a motion or other proceeding within the purview of this investigation shal be submitted under a designation that confidential information is

contained or attched therein, pursuant to paragraph 2 above. When any confidential business
information submitted in accordance with pargraph 2 above is included in an authorized
trscript of a deposition or exhibits thereto, arangements shall be made with the court reporter

tang t.lie deposition to bind such confidential portions and separtely label them "(supplier's

name), CONFENTIA BUSINSS INORMATION, SUBJECT TO PROTECTI
ORDER." Before a court reporter receives any such information, he or she shall have first read

this order and shall have agreed in writing to be bound by the terms thereof. Alternatively, he or

she shall sign the agrement included as Attachment A hereto. Copies of each such signed
agreement shall be provided to the supplier of such confidential business information and to the
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Secretar of the Commission.

9. The restrictions upon, and obligations accruing to, persons who become subject to this
order shall not apply to any information submitted in accordance with paragraph 2 above to

which the person assertng the confidential status thereof agrees in writing, or the Commssion or
the admnistrative law judge rules, after proper notice and hearng, was publicly known at the

time it was supplied to the receiving par or has since become publicly known through no fault

of the receiving pary.

10. The admnistrative law judge acknowledges that any document or information

submitted as confidential business information pursuant to pargraph 2 above is to be treated as
such within the meaning of 5 U.S.C. § 522(b)(4) and 18 U.S.C. § 1905, subject to a challenge by

any pary pursuant to paragraph 12 below or to a final ruling by the Commssion, the
admnistrative law judge or its Fredom of Information Act Officer to the contr, or by appeal

of such a ruling, interlocutory or otherwise.

11. If no determnation has ben made by the admnistrative law judge or the
Commssion that the information designated as confidential by the submitter is not confidential,
the persons who are recipients of such information shall tae all necessar and proper steps to

preserve the confidentiality of, and to protect each supplier's rights with respect to, any

confidential business information designated by the supplier in accordance with paragraph 2
above.
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12. The supplier of any confidential information is hereby notified that Commssion

regulations 19 C.F.R. § 201.19(c) through (e) generally require that the Commssion wil give
notice to a submitter of confidential information upon the Commssion's receipt of an FOIA

reuest.

13. The supplier of any confidential information is put on notice that Commssion rule

210.20 provides that only a par may move to declassify and that only then are such motions,
whether brought at any time during or after the conclusion of an investigation, addressed to and

ruled upon by an admnistrative law judge. Other requests to declassify made by non-paries,
such as an FOIA request, wil not be referred to the administrative law judge for consideration
under the protetive order.

14. If a pary to this order who is a recipient of any business information designated as

confidential and submitted in accordace with paragraph 2, disagrees with respect to such a

designation, in full or in par, it shall notify the supplier in writing, and they wil thereupon
confer as to the status of the subject information proffered within the context of this order. If
prior to, or at the time of, such a conference, the supplier withdraws its designation of such information as being subject to this order, but nonetheless submits such information for purposes of the investigation, such supplier shall express the withdrawal ln writing and shall serve such

withdrwal upon all pares, the administrtive law judge, and the Commssion investigative
attorney. If the recipient and supplier ar unable to concur upon the status of the subject
information submitted as confidential business information within ten days from the date of
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notification of such disagreement, any pary to this order may raise the issue of the designation of

such a status to the Commssion or to the administrative law judge, and the Commssion or the
admnistrative law judge may raise the issue of designation of the confidential status without any
request from a pary. Upon notice that such confidential status of information is at issue, the

pary to the investigation which submitted the information and designated it as confidential shall
have the burden of proving such confidential status.

15. No less than ten days (or any other period of time designated by the admnistrative
Q

law judge) prior to the initial disclosure to the proposed expert of any confidential information

submitted in accordance with paragraph 2, the par proposing to use such expert shall submit in
writing the name of such proposed expert and his or her educational and employment history to

the supplier. If the supplier objects to the disclosure of such confidential business information to
such proposed expert as inconsistent with the language or intent of this order or on other
grounds, it shall notify the recipient in writing of its objection and the grounds therefor prior to

the initial disclosure. If the dispute is not resolved on an informal basis withn ten days of receipt
of such notice of objection, motion may be made to the administrtive law judge for a ruling on
such objection. The submission of such confidential business information to such proposed
expert shall be withheld pending the ruling of the administrative law judge. The terms of this

paragraph shall be inapplicable to experts within the Commssion or to experts from other
governmental agencies who are consulted with, or used by, the Commssion.

16. If confidential business information submitted in accordance with paragrph 2 is

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disclosed to any person other than in the manner authorized by this protective order, the pary

responsible for the disclosure must immediately bring all pertnent facts relating to such
disclosure to the attention of the supplier and the administrative law judge and, without prejudice
to other rights and remedies of the supplier, make every effort to prevent further disclosure by it
or by the person who was the recipient of such information.

17. Nothing in this order shall abridge the right of any person to seek

judicial review or

to pursue other appropriate judicial action with respect to any ruling made by the Commssion,

its Preedom of Information Act Officer, or the admnistrative law judge concerning the issue of
the status of confidential business information.

18. Upon final termnation of this investigation, each pary that is subject to this order
shall destroy or return to the supplier all items containing confidential business information
submitted in accordance with pargrph 2 above, including all copies of such matter which may

have been made, but not including copies containing notes or other attorney's work product that

may have been placed thereon by counsel for the receiving pary. All copies containing such
notes or other attorney's work product shall be destroyed. Receipt of material retued tp the

supplier shall be acknowledged in writing. This paragraph shall not apply to the Commssion,
including its investigative attorney, and the admnistrative law judge, which shall retain such

material pursuant to statutory reuirements and for other recordkeeping purposes, but may
destroy those additional copies in its possession which are regarded as surplusage.

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19. If any confidential business information which is supplied in accordance with
paragraph 2 above is supplied by a non-pary to this investigation, such a non-par shall be

considered a "supplier" withn the meaning of that term as it is used in the context of this order.

20. At or before the final termnation of the investigation, copies of confidential
information that was in the hands of èxpert witnesses must be retrieved or destroyed.

21. Except as provided in Commission rule 210.20, the jurisdiction of the admnistrative

law judge over this order ternjnates upon filing of the initial determnation issued at the end of
the case. After that date, the Commssion has jurisdiction to enforce this order and to issue

reprimands and other sanctions.

22. The paries may move to amend this order, but any proposed amendment that would
broaden the range of persons having access to confidential business information must be proposed and adopted before such information is supplied in reliance upon the terms of this

order, unless all suppliers of confdential information consent to the amendment.

23. The Secretar shall serve a copy of this order upon all paries.

(?u. ~. ~~
Paul J. LucQrn Administrative Law Judge
Issued: May 12, 2006

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ATTACHM A
NONDISCLOSUR AGREEMENT FOR REPORTERlSTENOGRAHERfANSLA TOR
I,

, do solemnly swear that I wil not divulge any

information communicated to me in any confidential portion of the investigation or hearng in

Certain Products And Pharaceutical Compositions Containing Recombinant Human

Eryhropoietin, Inv. No. 337-T A-568, except as permtted in the protective order issued in this
case. I wil not directly or indirectly use, or allow the use of such information for any purse

other than that directly associated with my offcial duties in this case.
Furer, I wil not by direct action, discussion, recommendation, or suggestion to any

person reveal the nature of content of any information communicated during any confidential

portion of the investigation or hearng in this case.
I also affrm that I do not hold any position or official relationship with any of the

paricipants in said investigation.
I am awar that the unauthorized use or conveyance of information as specified above is a

violation of the Pederal Criminal Code and punishable by a fine of up to $10,00, imprisonment
of up to ten (10) years, or both.

Signed

Dated
Pirm or affiliation

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CERTAIN PRODUCTS AND

Investiga.tion No. 337-TA-568

PHARMCEUTICAL COMPOSITIONS
CONTAINING RECOMBINANT ERYTHROPOIETIN

CERTICATE OF SERVICE
I, Marlyn R. Abbott, hereby certify that the attached Order was served by hand upon Commission Investigative Attorney Anne Goalwin, Esq. and upon the following paries via first
class mail, and air mail where necessar, on May 15, 2006.

R. Abbott, Secretar
S ternational Trade Commssion

500 E Street, SW - Room 112 Washington, DC 20436

Por Complainant Amgen, inc.:

Lloyd R. Day, Jr., Esq.

DAY CASEBEER MADRI & BATCHELDER LLP
20300 Stevens Creek Blvd., Suite 400

Cupertino, CA 95014
Cecila H. Gonzalez, Esq.

HOWREY LLP
1299 Pennslyvania Avenue, NW

Washington, DC 2000
Respondents:
Roche Holding Ltd. Grenzacherstrasse 124, CH-470 Basel, Switzerland

P. Hoffmann-La Roche, Ltd.
Grenzacnerstrsse 124, CH-4070

Basel, Switzerland
Roche Diagnostics Gmbh
Sandhofer Strasse i 16, D-68305

Mannneim, Germany

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CERTAIN PRODUCTS AND

Investigation No. 337-TA-568

PHARMCEUTICAL COMPOSITIONS

CONTAING RECOMBINANT
ERYTHROPOIETIN
Certifcate of Service page 2

Respondents:
Hoffmann La Roche, Inc. 340 Kingsland Street Nutley, New Jersey 07110

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Morgan & Finnegan, L.L.P.
A REGISTERED LIMITED LIABILITY PARTNERSHIP

1775 EYE STREET, NW, SUITE 400

WASHINGTON. DC. 20006-2401
Kent Stevens [phone]
ksteve nst9 morg a n finnegan. com

TEL: [phone] FAX: [phone] www.morganfinnegan.com

June 1, 2006

ILY HAND DELIVERY
Cecilia H. Gonzales, Esq.
Howrey LLP, 1299 Pennsylvania Ave., N.W. WashingtDn, D.C. 20004

Re: CERTAIN PRODUCTS AN PHACEUTICAL COMPOSITIONS CONTAIING RECOMBINANT HU ERYTHROPOIETIN,
Investigation No. 337-TA-568

Dear Cecila:

This is to confirm the agreement reached by outside counsel for Roche and outside counsel for Amgen regarding the confidentiality ofthe Roche Biological License Application ("BLA") and the IN. This agreement is a side agreement to the Protective Order in the above-captioned
investigation to provide additional protection

for the BLA and IN. We have agreed that:

(1) Roche to produce one paper copy of

the subject INs and BLA,
the INs and BLA (which

(2) Roche to produce 10 electronically searchable CD copies of

Amgen's counsel wil not electronically reproduce),
(3) the CD's and single hard copy wil be maintained by outsi4e counsel in a locked room and a log wil be maintained to identify each person who has been given access to the materials,

(4) the CDs wil be reviewed on stand-alone, non-networked computers, and
(5) individuals qualified under the Protective Order now in place may access and use the
information contained in Roche's INs a.iid BLA subject to the provisions and restrictions of

the

Order.

NEW YORK: 3 WORLD FINANCIAL CENTER. NEW YORK, NY 10281-2101 TEL: [phone] FAX: [phone]
CALIFORNIA: 44 MONTGOMERY STREET, SUITE 2550. SAN FRANCISCO. CA 94104-4712 TEL: [phone] FAX: [phone]

CONNECTICUT: 100 FIRST STAMFORD PLACE, STAMFORD, CT 06902 TEL: [phone] FAX: [phone]
SHANGHAI: AETNA TOWERS. 107 ZUNYI ROAD. SUITE 408, GUSEI. SHANGHAI

200051 TEL: [phone] FAX: [phone]

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Letter to Cecilia H. Gonzalez, Esq.
June i, 2006
Page 2

this is to confirm that while the searchable copies are being made, Roche wil produce five of

We are preparing the paper copy and wil have a copy as soon as possible given capacity. Also, the electronic copies previously made in tiff format. These five copies wil not be electronically copied and wil be promptly returned to Roche when the searchable copies are delivered.
Please confirm.

Sincerely

Kent Stevens, Esq.

~.

Agreed on this -- day ofJune, 2006:

,~1 ~ ~
Cecila Go al z
cc: Lloyd R Day, Jr. Esq.

Ane Goalwin, Esq. Leora Ben-Am, Esq.

KRS:rxp

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