`Sent: Friday, October 27, 2017 4:29 PM
`To: Trials <Trials@USPTO.GOV>
`Cc: Kallas,Nicholas <NKallas@fchs.com>; Fishwick, Laura <LFishwick@FCHS.COM>;
`#ZortressAfinitorIPR <ZortressAfinitorIPR@fchs.com>; Jeffrey Blake <JBlake@MerchantGould.com>;
`Melissa M. Hayworth <MHayworth@merchantgould.com>
`Subject: RE: IPR2017-01592 -- Request for permission to file reply to POPR pursuant to 37 C.F.R. §
`42.108(c).
`
`Dear PTAB,
`
`Thank you for your email dated October 24, 2017, inviting Petitioner to renew its request for leave
`to file a reply to Patent Owner’s Preliminary Response (“POPR”). In response to that email,
`Breckenridge conferred with Patent Owner Novartis, who confirmed its opposition to Breckenridge’s
`request to file a reply. Should the Board wish to have a call to discuss Breckenridge’s request, the
`parties are available on November 8, 2017 (1:00 PM to 5:00 PM ET) and November 9, 2017 (2:00 PM
`to 5:00 PM ET).
`
`As stated previously, I am counsel for Petitioner Breckenridge Pharmaceutical, Inc. ("Breckenridge")
`in IPR2017-01592. Breckenridge submits this email to seek leave to file a reply to the POPR pursuant
`to 37 C.F.R. § 42.108(c). Breckenridge submits that good cause exists for a focused reply because
`the POPR raises a number of issues that could not have been reasonably anticipated when the
`Petition was submitted. Further, the POPR states factual and legal inaccuracies, and in certain places
`omits evidence that directly contradicts Patent Owner's arguments. Principles of due process and
`fairness require that Breckenridge be allowed to respond to the new issues raised in the POPR,
`correct the factual and legal inaccuracies, and present the Board with the evidence relevant to
`Patent Owner's positions that Patent Owner chose to omit.
`
`The proposed subject matter for Breckenridge's reply includes the following:
`
`1. Priority Date for the '131 Patent - Breckenridge established in its Petition that U.S.
`Patent No. 8,410,131 ("the '131 Patent") is not entitled to a priority date before
`February 18, 2002, because the priority documents were lacking in their written
`description. (Pet. at 11-14.) Patent Owner, which has the burden to establish the
`priority date, challenges the priority date issues by arguing what the ‘131 Patent and
`prosecution history teach. (POPR at 10-21.) Patent Owner, however, omits evidence
`that an Examiner of an application for a European counterpart to the '131 Patent
`directly contradicted these new positions from Patent Owner. Due process and
`
`
`
`fairness dictate that Breckenridge be allowed to submit the contradictory evidence
`that Patent Owner omitted from its argument. Moreover, Breckenridge should be
`allowed to demonstrate Patent Owner's misleading citations to the disclosure of the
`priority documents.
`
`2. The Wasik Prior Art Reference – Patent Owner argues in the POPR that the Wasik prior
`art reference in Grounds 1-2 should not be relied upon because it discloses
`information only about treatment of lymphatic tumors, not solid excretory system
`tumors. (POPR at 21-33.) Patent Owner again omits relevant evidence that directly
`undermines its position. For example, Patent Owner chose not to disclose that
`multiple Examiners of the application for a European counterpart to the '131 Patent
`concluded that the disclosure of Wasik applied to solid excretory system tumors, not
`just lymphatic tumors. Further, Patent Owner fails to mention that statements Patent
`Owner relies upon from the prosecution of Wasik were made in 2007 – five years after
`the February 18, 2002 filing date for the '131 patent. (See POPR at 25.) In addition,
`Patent Owner incorrectly characterizes its own admission from the prosecution of the
`'131 Patent that the Cottens WO '010 patent is not "limited to solid tumors." (POPR at
`28-29.) As Breckenridge could not anticipate that Patent Owner would fail to disclose
`evidence directly contrary to its arguments in the POPR (or would misrepresent the
`evidence), Breckenridge now seeks an opportunity to present such evidence in a reply
`to the POPR.
`
`3. The Anti-Tumor Activity of Everolimus – The POPR raises a number of arguments that
`there was no motivation to select or combine the prior art references relied upon in
`the Petition because there were other prior art therapies available for excretory
`cancers and some of the prior art references discuss immunosuppression. (POPR at
`33-35.) First, Patent Owner is legally incorrect in claiming that a patent challenger
`must establish that the claimed compound was “preferred” over other potential
`therapeutic agents in order to establish the obviousness of claims to a method of using
`a known compound. Second, Patent Owner’s immunosuppressant argument directly
`ignores the fact that the prior art disclosed that the immunosuppressant drugs
`(rapamycin and everolimus) exhibited anti-tumor activity and disclosed inhibiting the
`growth of advanced solid excretory system tumors. Patent Owner ignores these
`points, and Breckenridge should be allowed to clarify any inaccuracies about the
`purpose of the prior art references.
`
`4. The Luan Prior Art Reference – The POPR raises two arguments relative to the prior art
`Luan reference cited in Grounds 3 and 5 that Petitioner could not have reasonably
`anticipated. First, Patent Owner takes issue with documents submitted in Ex. 1028 to
`authenticate the Luan reference as prior art. (POPR at 46-49.) Patent Owner
`characterizes these authentication documents as hearsay, but that is incorrect. The
`
`
`
`
`
`
`
`documents are submitted merely for authentication support of information on the
`face of the Luan reference showing it to be prior art. Second, Patent Owner alleges
`without proof that Breckenridge "made alterations" to an email submitted as
`authentication support that Luan is prior art. (POPR at 48.) While Breckenridge had no
`way to know Patent Owner would make this "alteration" allegation, Breckenridge
`should be allowed to show that the Patent Owner's allegation is plainly wrong.
`
`
`In view of the foregoing, therefore, Breckenridge respectfully requests leave to file a reply to the
`POPR pursuant to 37 C.F.R. § 42.108(c).
`
`Respectfully submitted,
`
`Daniel Evans
`(Reg. No. 55,868)
`Counsel for Breckenridge
`
`
`Daniel R. Evans
`Merchant & Gould P.C.
`191 Peachtree Street, NE
`Suite 3800
`Atlanta, GA 30303
`USA
`
`Telephone (404) 954-5061
`Mobile (404) 539-6995
`Fax (612) 332-9081
`www.merchantgould.com
`
`GUARDIANS OF GREAT IDEAS ®
`
`Atlanta | Denver | Knoxville | Madison | Minneapolis | New York | Silicon Valley* | Washington, D.C. area
`
`Note: This e-mail message is confidential and may be privileged or otherwise protected by law. If you are not the intended recipient, please: (1) reply
`via e-mail to sender; (2) destroy this communication entirely, including deletion of all associated text files from all individual and network storage
`devices; and (3) refrain from copying or disseminating this communication by any means whatsoever. Thank you.
` *Practicing in California as Merchant & Gould LLP
`
`
`