Paper No.__
`Filed: November 25, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC,
`Petitioner,
`v.
`CELGENE CORPORATION
`Patent Owner
`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
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`PATENT OWNER REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`Filed: November 25, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC,
`Petitioner,
`v.
`CELGENE CORPORATION
`Patent Owner
`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
`
`PATENT OWNER REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`Patent Owner Request for Rehearing
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`TABLE OF CONTENTS
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`Case IPR2015-01096
` Patent 6,315,720
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`Page
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`I.
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`II.
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`III.
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`STATEMENT OF RELIEF REQUESTED ........................................................................ 1
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`LEGAL STANDARD ......................................................................................................... 1
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`PTAB OVERLOOKED AND/OR MISAPPREHENDED EVIDENCE AND
`ARGUMENT SHOWING THAT PETITIONER FAILED TO CARRY ITS
`BURDEN ON CLAIM 10 ................................................................................................... 2
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`IV.
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`CONCLUSION ................................................................................................................... 4
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`Case IPR2015-01096
`Patent Owner Request for Rehearing
` Patent 6,315,720
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`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner Celgene Corporation
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`(“Celgene”) submits this Request for Rehearing in response to the Final Written
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`Decision entered October 26, 2016 (Paper 73) (“Final Decision”) by the Patent
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`Trial and Appeal Board (“PTAB”) regarding U.S. Patent No. 6,315,720 (“the ’720
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`patent”).
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`I.
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`Statement of Relief Requested
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`In the Final Decision, the PTAB held that the claims of the ’720 patent are
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`unpatentable as obvious over Thalomid PI (Ex. 1006) in view of Cunningham
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`(Ex. 1009), and further in view of Keravich (Ex. 1018), Zeldis (Ex. 1012), and
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`Mundt (Ex. 1024). See Final Decision at 34.
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`In doing so, the PTAB overlooked and/or misapprehended Celgene’s
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`evidence and argument showing that claim 10 of the ’720 patent would not have
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`been obvious. Accordingly, Celgene respectfully requests that the PTAB vacate its
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`decision with respect to claim 10, and confirm the patentability of that claim.
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`II. Legal Standard
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`“A party dissatisfied with a decision may file a single request for rehearing”
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`that “specifically identif[ies] all matters the party believes the Board
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`misapprehended or overlooked, and the place where each matter was previously
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`addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).
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`IPR2015-01096
`Patent Owner Request for Rehearing
`Patent 6,315,720
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`III. PTAB Overlooked and/or Misapprehended Evidence and Argument
`Showing that Petitioner Failed to Carry its Burden on Claim 10
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`Celgene respectfully submits that the PTAB overlooked and/or
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`misapprehended Celgene’s evidence and argument showing that Petitioner failed to
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`carry its burden of proving claim 10 of the ’720 patent obvious. As explained in
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`the Patent Owner Response (Paper 40, “Response”), claim 10 requires obtaining
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`the results of genetic testing from patients. See Response at 45-46.
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`The PTAB held that this claim would have been obvious allegedly because
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`“genetic testing was a known diagnostic procedure as of the effective filing date,”
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`and because a geneticist spoke at an FDA Meeting where thalidomide was
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`discussed. See Final Decision at 27-28.
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`While the PTAB noted Celgene’s argument that the “references of record do
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`not disclose or suggest genetic testing” (id. at 27), the PTAB did not address, and
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`therefore overlooked, Celgene’s evidence and argument in the Response
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`demonstrating that the references of record did “disclos[e] various other types of
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`tests,”—but not genetic testing—which “undermines Dr. Fudin’s opinion that
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`[genetic] testing was ‘common.’” See Response at 46; see also Ex. 1006 at 2,10,
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`11-12; Ex. 1018 at 1722; Ex. 1012 at 319, 322; Ex. 2059 ¶99; Ex. 2060 ¶101-02
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`(cited in Response at 46). The PTAB also did not address, and therefore
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`overlooked, the controlling case law in Celgene’s Response, which holds that
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`- 2 -
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`IPR2015-01096
`Patent Owner Request for Rehearing
`Patent 6,315,720
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`Dr. Fudin’s unsupported opinion that genetic testing was common, is entitled to
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`little weight, if any. See Response at 46.
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`Instead, the PTAB improperly placed the burden on Celgene, finding that
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`Celgene allegedly “did not dispute that genetic testing was known in the art for
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`obtaining diagnostic information.” Final Decision at 27. In doing so, Celgene
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`respectfully submits that the PTAB misapprehended Celgene’s argument and
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`misapplied the relevant law. First, Celgene did, in fact, dispute that genetic testing
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`was either known in the art or “common.” See Response at 45-46. Second, the
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`burden was on Petitioner to prove that genetic testing was known, not on Celgene
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`to prove that genetic testing was not known. As explained in the Response,
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`Petitioner did not provide any evidence showing that genetic testing would be
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`used, let alone that it would have been common. See id.
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`Further, the PTAB misapprehended Petitioner’s evidence regarding the
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`geneticist’s statement at the FDA meeting. See Final Decision at 28 (citing Ex.
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`1013 at 137). Petitioner relied solely on a single passage of that statement (see
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`Paper 52 at 25-26) that focuses on the geneticist acting as a clinical teratologist that
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`might counsel patients on the risks of exposure. See Ex. 1013 at 137. Notably, the
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`cited passage says nothing about genetic testing, nor does it suggest such testing.
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`See id. Thus, Petitioner’s evidence does not support its argument that claim 10
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`would have been obvious.
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`- 3 -
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`Patent Owner Request for Rehearing
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`IV. Conclusion
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`IPR2015-01096
`Patent 6,315,720
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`For the reasons described above, Celgene respectfully requests that the
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`PTAB vacate its Final Decision with respect to claim 10 of the ’720 patent, and
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`confirm the patentability of that claim.
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`- 4 -
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`IPR2015-01096
`Patent 6,315,720
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`Patent Owner Request for Rehearing
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`Date: November 25, 2016
` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Eric C. Stops (Reg. No. 51,163)
` Andrew S. Chalson (pro hac vice)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`Anthony M. Insogna (Reg. No. 35,203)
`J. Patrick Elsevier (Reg. No. 44,668)
`JONES DAY
`12265 El Camino Real
`Suite 200
`San Diego, CA 92130
`General Tel: (858) 314-1200
`Fax: (858) 314-1150
`aminsogna@jonesday.com
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`250 Vesey Street
`New York, NY 10281
`General Tel: (212) 326-3939
`Fax: (212) 755-7306
`gjlarosa@jonesday.com
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`Attorneys for Celgene Corporation
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`- 5 -
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
`v.
`CELGENE CORPORATION
`Patent Owner
`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
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`CERTIFICATE OF SERVICE
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
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`PATENT OWNER REQUEST FOR REHEARING PURSUANT TO 37 C.F.R. §
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`42.71(d) was served on November 25, 2016 by filing this document through the
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`Patent Review Processing System, as well as e-mailing a copy to
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`sarah.spires@skiermontderby.com, parvathi.kota@skiermontderby.com, and
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`paul.skiermont@skiermontderby.com.
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`Date: November 25, 2016
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` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for Celgene Corporation
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