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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`ARGENTUM PHARMACEUTICALS LLC
`Petitioner,
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`v.
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`CIPLA LTD.
`Patent Owner
`______________________
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`Case. IPR2017-00807
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`Patent 8,168,620
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`______________________
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`PATENT OWNER’S MOTION FOR ENTRY OF STIPULATED
`PROTECTIVE ORDER AND MOTION TO SEAL
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`I.
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`Introduction
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` IPR2017-00807
`Patent No. 8,168,620
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`As authorized by the Board on November 17, 2017, Patent Owner Cipla Ltd.
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`respectfully submits this joint Motion for Entry of Stipulated Protective Order
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`under 37 C.F.R. § 42.54 and Motion to Seal under 37 C.F.R. § 42.14, filed
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`concurrently with Cipla’s Patent Owner Response.
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`II. Motion For Entry Of Stipulated Protective Order
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`Cipla anticipates disclosing highly confidential
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`information
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`in
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`this
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`proceeding and also anticipates that deposition testimony will be taken relating to
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`this highly confidential information. For example, Patent Owner intends to rely in
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`its Response on non-public, highly confidential information disclosed to the United
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`States Food and Drug Administration concerning the commercial embodiments of
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`U.S. Patent No. 8,168,620.
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`The Stipulated Protective Order differs from the Default Protective Order in
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`that it deviates from the Default Protective Order for disclosure of confidential
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`information to (1) all persons who are owners of the patent involved, (2) all in-
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`house counsel of a party, and (3) other employees of the parties. The parties have
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`agreed that designated confidential information may only be disclosed to counsel
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`of record in this proceeding, two in-house representatives who agree to the
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`IPR2017-00807
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`U.S. Patent No. 8,168,620
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`provisions of the protective order, the designated experts who agree to the
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`provisions of the protective order, the Office, and their support staff. These
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`amendments are necessary because Cipla would suffer serious injury, including a
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`potential loss of competitive advantage, if this confidential information was
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`disclosed to its competitors. Limitations on disclosure to Petitioner's employees are
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`the least restrictive means to ensure that both Cipla's and Petitioner's interests are
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`served.
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`Cipla met and conferred with Petitioner and the parties stipulate to entry of
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`the Stipulated Protective Order. Attached as CIP2160 is the agreed-to Stipulated
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`Protective Order, showing in redline the modifications from the Default Protective
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`Order. Patent Owner therefore respectfully requests entry of this Stipulated
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`Protective Order.
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`III. Motion To Seal Exhibits CIP2151-CIP2155, Portions of the Second
`Declaration of Dr. Hugh Smyth (CIP2150), and Potential Deposition
`Testimony of Dr. Smyth
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`Cipla moves to seal CIP2150-CIP2155, portions of the Second Declaration
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`of Dr. Hugh Smyth, and Dr. Smyth’s upcoming deposition transcript (“Proposed
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`Sealed Exhibits”) to prevent public disclosure of Cipla’s confidential research
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`IPR2017-00807
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`U.S. Patent No. 8,168,620
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`information. The public’s interests are served because Cipla has filed non-
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`confidential redacted versions of the sealed documents, bearing exhibit numbers
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`CIP2171-2175, that contain unredacted headers and other information to provide
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`an overview of the type of information contained in the redacted material discussed
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`within the documents. And because portions of Dr. Smyth’s Second Declaration
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`(CIP2150) cite to and disclose this sealed information, and Cipla anticipates that
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`portions of Dr. Smyth’s deposition transcript may reveal this confidential
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`information, Cipla moves to seal portions of Dr. Smyth’s Second Declaration and
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`deposition transcript. A redacted version of Dr. Smyth’s Second Declaration,
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`bearing exhibit number CIP2176, ensures that the public’s interests are served.
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`IV. Good Cause exists for Sealing Certain Confidential Information.
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`In determining whether to grant a Motion to Seal, the Board must find “good
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`cause” and “strike a balance between the public's interest in maintaining a
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`complete and understandable file history and the parties' interest in protecting truly
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`sensitive information.” 37 C.F.R. § 42.54(a); 77 Fed. Reg. 48756, 48760 (Aug. 14,
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`2012). As laid out in the Office Trial Practice Guide, confidential information is
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`“consistent with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for
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`IPR2017-00807
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`protective orders for trade secret or other confidential research, development, or
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`commercial information.” Id. The Federal Circuit has further held that while “it is
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`impossible to define the exact contours of what may and may not be marked as
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`confidential pursuant to [Federal Circuit] Rule 28(d), it is clear that the parties
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`must confine their confidentiality markings to information covered by a protective
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`order” and such confidentiality markings must not “fall[] outside the scope of the
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`protective order.” In re Violation of Rule 28(d), 635 F.3d 1352, 1360 (Fed. Cir.
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`2011).
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`Specifically, the Proposed Sealed Exhibits contain confidential formulation
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`details of Cipla’s Duonase product and/or Meda/Mylan’s Dymista® product. These
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`exhibits are important to establish a nexus between commercial embodiments of
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`the challenged claims and the several persuasive objective indicia of non-
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`obviousness presented by Cipla in its Patent Owner Response. The information
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`contained in the Proposed Sealed Exhibits reveals proprietary formulation and
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`manufacturing information that, were it disclosed to Petitioner’s employees or the
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`public, could be used to Cipla’s, Meda’s, or Mylan's competitive disadvantage,
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`e.g., to draft blocking patent claims, provide important formulation details to
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`U.S. Patent No. 8,168,620
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`Cipla’s competitors, or otherwise influence Petitioner’s or the public’s research
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`strategies. These Proposed Sealed Exhibits are also covered by the Stipulated
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`Protective Order (CIP2160) and in no way “falls outside the scope” of the Order.
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`The relevant portions of the Proposed Sealed Exhibits are discussed in detail
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`in portions of Dr. Hugh Smyth’s Second Declaration (and likely will be discussed
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`in his upcoming deposition). Thus, the relevant portions of the Second Declaration
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`of Hugh Smyth and any deposition transcript arising from that declaration should
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`be sealed for the same reasons. A redacted version of Dr. Smyth’s Second
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`Declaration (CIP2176) provides the public a general understanding of the redacted
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`material, and therefore serves the public’s interest in disclosure.
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`V. Certification Of Nonpublication
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`Undersigned counsel, on behalf of Cipla Ltd., certifies that the information
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`sought to be sealed has not, to their knowledge, been published or otherwise made
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`public by Cipla Ltd.
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`VI. Certification of Conference with Opposing Party Pursuant to 37 C.F.R.
`§ 42.54.
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`Patent Owner Cipla Ltd. has in good faith conferred with Petitioner as to the
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`scope of a proposed Protective Order. The joint proposed Stipulated Protective
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`IPR2017-00807
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`U.S. Patent No. 8,168,620
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`Order resulting from the parties' discussions has been filed as CIP2160.
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`VII. Conclusion
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`For the foregoing reasons, Cipla respectfully requests that the Board enter
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`Stipulated Protective Order CIP2060 and seal Exhibits CIP2150– CIP2155,
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`portions of the Second Declaration of Hugh Smyth, and portions of Dr. Smyth’s
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`upcoming deposition transcript as confidential information.
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`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Dennies Varughese
`Registration No. 61,868
`Attorney for Patent Owner
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`Date: November 20, 2017
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
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`8627178.1
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` IPR2017-00807
`Patent No. 8,168,620
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Patent Owner's
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`Motion for Entry of Stipulated Protective Order and Motion to Seal” was served in
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`its entirety on November 20, 2017, upon the following parties via electronic mail:
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`Michael R. Houston: mhouston@foley.com
`Joseph P. Meara: jmeara@foley.com
`James P. McParland: jmcparland@foley.com
`ARG-dymista@foley.com
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`FOLEY & LARDNER LLP
`321 North Clark Street
`Suite 2800
`Chicago, IL 60654
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Date: November 20, 2017
`1100 New York Avenue, N.W.
`Washington, D.C. 20005
`(202) 371-2600
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`
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`Dennies Varughese
`Registration No. 61,868
`Attorney for Patent Owner
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