CONTROL NOS. 90/007,542 A"\,fD 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Control Nos.:
`
`Confirmation Nos.:
`
`90/007,542
`90/007,859
`
`7585 ('542)
`6447 ('859)
`
`Filed:
`
`13 May 2005
`23 December 2005
`
`('542)
`('859)
`
`Patent Owner:
`
`Genentech, Inc. and
`City of Hope
`
`Group Art Unit:
`
`3991
`
`Examiner:
`
`P. Ponnaluri
`
`For:
`
`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly eta!.)
`
`Mail Stop Ex Parte Reexam
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA22313-1450
`
`REOUEST FOR RECONSIDERATION and/or PETITION UNDER 37 C.F.R. § 1.183
`
`Sir:
`
`This petition is directed to the "DECISION DENYING PETITION TO EXPUNGE
`
`INFORMATION (37 CFR 1.59(b) AND 182) AND PETITION TO WAIVE SERVICE
`
`RULE" mailed in the merged reexamination proceeding identified above on 5 May 2009.
`
`On a final review of the reexamination file, Owners have discovered that one of the
`
`documents filed with the submission under M.P.E.P. § 724.02 on 6 June 2008 was not the
`
`version that Owners intended to present to the Office. In particular, as discussed below,
`
`Owners inadvertently and erroneously provided an expert report from a then-pending
`
`litigation that included an appendix containing highly confidential information, whereas it
`
`had been intended to submit the expert report without that appendix.
`
`Owners renew their petition to expunge infonnation specifically with respect to the
`
`inadvertently submitted appendix. As an alternative basis for providing the requested relief,
`
`Owners petition the Director under § 1.183 to suspend the rules to substitute the attached
`
`copy of the expert report, without the appendix in question, for inclusion in the record.
`
`This petition requires the fee specified in § 1.17(f) (S 400). The Director is requested
`
`to debit that amount, as well as any other fees which may be required in connection with this
`
`petition, from our Deposit Account No. 18-1260.
`
`PETITION UNDER 37 C.F.R. § 1.183
`
`15 MAY 2009 PAGE 1
`
`Sanofi/Regeneron Ex. 1 042, pg 1062
`
`Merck Ex. 1042, pg 1088
`
`

`
`CONTROL NOS. 90/007,542 A"\,fD 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
`
`Background
`
`1.
`
`Genentech, Inc. and City of Hope are co-owners of the patent that is the subject of the
`
`captioned merged reexamination proceeding.
`
`2.
`
`On ().Tune 200g, Owners filed certain materials from a then-pending litigation
`
`involving the patent under reexamination under the provisions ofM.P.E.P. § 724.02.
`
`Owners' submission included a petition under 37 C.F.R. §§ 1.59(b) and 1.1 g2 to
`
`expunge the cited information from the file, and a petition under § 1.183 to waive the
`
`service requirement of§ 1.550(t).
`
`3.
`
`In an advisory action mailed on 19 July 2008, the examiner acknowledged the
`
`submission of information under M.P.E.P. § 724.02 and stated:
`
`Pursuant to MPEP § 724.04 the submitted information is found to be material
`to the patentability and/or confirmation of the instant reexamination claims.
`
`4.
`
`There has been no further discussion of the information submitted under M.P.E.P.
`
`§ 724.02 on 6 .Tune 2008 by the examiner in this reexamination proceeding.
`
`5.
`
`A Notice oflntent to Issue a Reexamination Certificate (NIRC) was mailed in this
`
`proceeding on 23 February 2009. A Certificate has not yet been granted.
`
`6.
`
`An interview summary dated 30 April2009 states that Owners' representative
`
`indicated to the Office that petitions to expunge filed on 13 September and 24
`
`October 2007 would not be renewed. The interview summaty does not record any
`
`representation concerning the petition to expunge associated with the 6 .Tune 2008
`
`submission.
`
`7.
`
`In a decision mailed on 5 May 2009, the Office denied both of the petitions related to
`
`the submission under M.P.E.P. § 724.02 filed on 6 .Tune 2008.
`
`Discussion
`
`One of the two items of information cited in the submission under M.P.E.P. § 724.02
`
`filed on 6 .Tune 2008 was the expert report of a licensing expert, Dr. E. Fintan Walton, that
`
`was submitted in MedJmmune, Jnc. v. Genentech, Jnc., No. CV-03-2567 (C.D. Cal.). One
`
`component of Dr. Walton's report, specifically Appendix 3, contains highly sensitive
`
`proprietary information. The public disclosure of the proprietary information in Appendix 3
`
`PETITION UNDER 37 C.F.R. § 1.183
`
`15 MAY 2009 PAGE 2
`
`Sanofi/Regeneron Ex. 1 042, pg 1063
`
`Merck Ex. 1042, pg 1089
`
`

`
`CONTROL NOS. 90/007,542 A"\,fD 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
`
`would severely prejudice the interests of not only the patent owners, but of third parties as
`
`well. Because of the inclusion of that information, Dr. Walton's report is marked "Restricted
`
`Confidential- Attorney's Eyes Only."
`
`The body of Dr. Walton's expert report sets forth his analysis ofhow the
`
`biotechnology industry's licensing of the Cab illy patents is probative of the commercial
`
`success of the invention claimed in the '415 patent. This was the information that Owners
`
`intended to present for review by the Office.
`
`Appendix 3 of Dr. Walton's original report provides a table that identifies licenses
`
`taken under the Cabilly patent, the licensees, and the nature and essential economic terms of
`
`the licenses. Genentech is under contractual obligations to its licensees to protect the
`
`confidentiality of the proprietary information in Appendix 3 of Dr. Walton's report.
`
`Owners did not intend to present Appendix 3 for consideration by the Office. Indeed,
`
`Owners' attention to the sensitivity of the infonnation is shown in a corresponding
`
`declaration under§ 1.132 by Dr. Walton, filed by Owners in the public record on 6 June
`
`2008. In that declaration, Dr. Walton stated that "[b ]ecause of confidentiality considerations
`
`regarding these licenses, T have not provided a detailed table of the companies, products, and
`
`tenns of the licenses." See Walton§ 1.132 dec., page 4, footnote 3.
`
`Relief requested
`
`Expungement of proprietary information
`
`Specifically with reference only to the portion of Dr. Walton's expert report identified
`
`as Appendix 3, Owners respectfully renew their request that the Office expunge infonnation
`
`filed in the submission under M.P.E.P. § 724.02 on 6 June 2008 from the record of this
`
`proceeding. Owners reiterate the representations stated in their petition under §§ 1.59(b) and
`
`182 filed on 6 June 2008 as to Appendix 3. Owners do not maintain their petition to expunge
`
`information either as to the balance of Dr. Walton's report (i.e., the body of the report and
`
`Appendices 1 and 2), or as to the other document cited in that submission (i.e., a transcript of
`
`the deposition of Dr. Walton taken in connection with the Medlmmune litigation).
`
`A copy of the expert report, from which only Appendix 3 has been deleted, is
`
`provided as an exhibit to this petition. Owners request that this document be entered in the
`
`public file in place of the copy of Dr. Walton's expert report filed on 6 June 2008.
`
`PETITION UNDER 37 C.F.R. § 1.183
`
`15 MAY 2009 PAGE 3
`
`Sanofi/Regeneron Ex. 1 042, pg 1064
`
`Merck Ex. 1042, pg 1090
`
`

`
`CONTROL NOS. 90/007,542 A"\,fD 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
`
`Owners and their licensees would suffer significant harm if the terms of specific
`
`licenses were made public. The Office should provide relief that adequately protects the
`
`business interests of Owners and their licensees while also ensuring the integrity of the public
`
`record. Expungement of only Appendix 3 will not impair the ability of the public to
`
`appreciate the basis for the Office's determination of patentability in this proceeding. The
`
`extent and economic value of the licenses under the Cabilly patents, as well as Dr. Walton's
`
`discussion of why the licenses demonstrate the commercial success of the invention claimed
`
`in the '415 patent, are fully discussed in aggregate in the body of Dr. Walton's report.
`
`Service of documents on third-party requesters
`
`In the decision mailed on 5 May 2009, the Office required Owners to serve copies of
`
`the information submitted under M.P.E.P. § 724.02 on 6 June 2008 on the third-party
`
`requesters in the reexamination proceeding.
`
`Specifically with reference only to Appendix 3 to of Dr. Walton's expert report,
`
`Owners renew their petition under § 1.183 that the Office waive the service requirement of
`
`§ 1.550(f). Owners further request that the Office stay the requirement set forth in the
`
`decision mailed on 5 May 2009 to serve the papers filed on 6 May 2009, insofar as that
`
`requirement applies to Appendix 3, pending a decision on this renewed petition.
`
`Owners arc concuncntly serving on the third-party requesters a copy of Dr. Walton's
`
`expert report from which Appendix 3 has been removed, inasmuch as that document is
`
`provided as an exhibit to this petition. Owners arc also concurrently serving on the third
`
`parties a copy of Dr. Walton's deposition transcript, which was the only other item of
`
`information cited in the submission under M.P.E.P. § 724.02 on 6 June 2008, as indicated on
`
`the attached certificate of service.
`
`Alternative basis under§ 1.183 for providing the requested relief
`
`Should the Office consider that the result stated in its 5 May 2009 decision is required
`
`by the Rules, Owners submit that the Office should grant the requested relief under the
`
`authority of§ 1.1 !B. The Office's policies concerning petitions to expunge material from the
`
`records of public files are not mandated by statute. Moreover, the interest of justice requires
`
`that the Office act to protect the business interests of Owners and their licensees, as well as
`
`the public interest, in its treatment of the proprietary infom1ation at issue. Finally, Owners
`
`PETITION UNDER 37 C.F.R. § 1.183
`
`15 MAY 2009 PAGE 4
`
`Sanofi/Regeneron Ex. 1 042, pg 1065
`
`Merck Ex. 1042, pg 1091
`
`

`
`CONTROL NOS. 90/007,542 A"\,fD 90/007,859
`
`ATTORNEY DOCKET NOS. 22338-10230 AND -10231
`
`respectfully submit that this is an extraordinary situation within the meaning of§ 1.183 that
`
`justifies granting the requested relief.
`
`Owners appreciate the procedural difficulties for the Office in responding to this
`
`request at this point in this reexamination proceeding. Key personnel only recently came to
`
`appreciate the nature of the information that is the subject of the Office's denial of the
`
`petitions filed on 6 June 2008, thus necessitating the present petition. Owners regret the
`
`inconvenience to the Office caused by this request.
`
`Conclusion
`
`Owners respectfully request that the Office reconsider its decision mailed on 5 May
`
`2009, and grant the petitions to expunge proprietary information from the record and to waive
`
`the service requirement of§ 1.550(t), to the limited extent discussed above. Owners request
`
`that the attached copy of the expert report of Dr. E. Fintan Walton, from which Appendix 3
`
`has been removed, replace the copy filed on 6 June 2008.
`
`Additionally or in the altemative, Owners request that the Office waive or suspend its
`
`rules under the authority of§ 1.183 to grant the relief requested above.
`
`Respectfully submitted,
`
`/David L. Fitzgerald/
`
`David L. Fitzgerald, Reg, no. 47,347
`Attorney of Record
`
`15 May 2009
`
`SIDLEY AUSTIN LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
`
`Telephone: (202) 736-8818
`Facsimile: (202) 736-8711
`
`PETITION UNDER 37 C.F.R. § 1.183
`
`15 MAY 2009 PAGE 5
`
`Sanofi/Regeneron Ex. 1 042, pg 1066
`
`Merck Ex. 1042, pg 1092