Paper 79
`
`Trials@uspto.gov
`571-272-7822 Entered: January 4, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORP.,
`Patent Owner.
`____________
`
`Case IPR2017-015921
`Patent 8,410,131 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`ORDER
`Authorizing Additional Briefing
` 37 C.F.R. § 42.5; 37 C.F.R. 42.20(d)
`
`
`
`
`
`1 IPR2018-00507 has been joined to this proceeding. Paper 29, 6–7.
`
`
`
`Trials@uspto.gov
`571-272-7822 Entered: January 4, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORP.,
`Patent Owner.
`____________
`
`Case IPR2017-015921
`Patent 8,410,131 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`ORDER
`Authorizing Additional Briefing
` 37 C.F.R. § 42.5; 37 C.F.R. 42.20(d)
`
`
`
`
`
`1 IPR2018-00507 has been joined to this proceeding. Paper 29, 6–7.
`
`
`
`IPR2017-01592
`Patent 8,410,131 B2
`
`
`Breckenridge Pharmaceutical, Inc. (“Breckenridge”) filed a Petition for an
`
`inter partes review of claims 1–3 and 5–9 of U.S. Patent No. 8,410,131 B2. Paper
`
`1. On January 3, 2018, we instituted trial with respect to all challenged claims.
`
`Paper 12, 35. We subsequently joined Petitioner West-Ward Pharmaceuticals
`
`International, Inc. (“West-Ward”) from proceeding IPR2018-00507 to the present
`
`proceeding. Paper 29, 6–7. Breckenridge and Patent Owner later filed a Joint
`
`Motion to Terminate IPR as to Breckenridge (Paper 52), which we granted (Paper
`
`57, 4). Counsel for West-Ward and for Patent Owner presented oral argument on
`
`September 19, 2018 (see Paper 77), and on December 31, 2018, we adjusted the
`
`pendency of this proceeding by six months, such that a Final Written Decision in
`
`this matter is due no later than July 3, 2019 (Paper 78). In the particular
`
`circumstances of this case, we exercise our discretion under 37 C.F.R. § 42.20(d)
`
`to authorize post-hearing briefing as described below.
`
`With respect to claim construction, Petitioner argues that the solid excretory
`
`system tumors of the challenged claims need not arise from the tissues of the
`
`recited subject and, thus, include xenografts and metastases thereof, in
`
`experimental animal models. See, e.g., Pet. 16; Pet. Reply 7 (“[A]ll that is required
`
`by the claims is that the tumor be present in the subject when the method starts (i.e.
`
`when everolimus begins to be administered).”); see also PO Resp. 7 (agreeing that
`
`the claim term “‘subject’ should be construed as ‘an animal’”).
`
`With respect to Ground 4, Petitioner presents a three-part argument wherein
`
`(1) Hildalgo and Alexandre teach that a rapamycin derivative, temsirolimus,
`
`inhibits growth of solid excretory tumors, specifically renal cell carcinomas, and
`
`that its antitumor activity, like that of rapamycin, is due to mTOR inhibition; (2)
`
`Schuler and Crowe teach that, as mTOR inhibitors, rapamycin and everolimus
`
`2
`
`
`
`IPR2017-01592
`Patent 8,410,131 B2
`
`
`share the same mechanism of action but that everolimus has an improved oral
`
`absorption profile as compared to rapamycin; and (3) Neumayer and Navarro
`
`further teach that that everolimus is more convenient to administer than rapamycin
`
`and therapeutically effective oral doses of everolimus are well tolerated. See
`
`generally, Pet. 45–54.
`
`In addressing step 1 of Petitioner’s argument, Patent Owner contends that
`
`the combination of Hidalgo and Alexandre “would not have provided a reasonable
`
`expectation that temsirolimus . . . would be therapeutically effective against solid
`
`kidney system tumors, like advanced RCC.” PO Resp. 56–63. Although the
`
`parties’ arguments in this regard are largely focused on the Phase I clinical trial
`
`data reported in Hidalgo and Alexandre, the record indicates that temsirolimus was
`
`known to have antitumor activity in preclinical studies, including against advanced
`
`renal cell carcinomas. See e.g., Ex. 1016 (Dancey); Ex. 1039 (Dukart).
`
`In view of the above, we invite the parties to submit additional briefing
`
`directed to (1) whether the claims encompass inhibiting growth of solid excretory
`
`system tumors in experimental animal models (i.e., xenografts); (2) the weight we
`
`should accord the experimental animal data of record in determining whether one
`
`of ordinary skill in the art reading Hidalgo and Alexandre would understand that
`
`temsirolimus inhibits growth of solid excretory tumors including RCC; and (3) the
`
`extent, if any, that a claim construction that encompasses inhibiting growth of solid
`
`excretory system tumors in experimental animal models affects the parties’
`
`arguments regarding reasonable expectation of success. Timing and length
`
`requirements of the authorized briefing are set forth in the Order below. The
`
`parties are not authorized to file additional evidence in support of their respective
`
`briefs beyond that already of record in this proceeding.
`
`3
`
`
`
`IPR2017-01592
`Patent 8,410,131 B2
`
`
`
`
`It is
`
`ORDERED that both Petitioner and Patent Owner are authorized to submit
`
`initial and responsive briefing on the topics set forth above;
`
`FURTHER ORDERED that initial briefs shall not exceed seven pages and
`
`shall be due no later than two weeks from the date of this Order;
`
`FURTHER ORDERED that responsive briefs shall not exceed five pages
`
`and shall be due no later than four weeks from the date of this Order.
`
`
`
`
`
`
`
`
`
`
`
`4
`
`
`
`IPR2017-01592
`Patent 8,410,131 B2
`
`
`
`
`For PETITIONER:
`
`Keith Zullow
`Marta Delsignore
`Michael Cottler
`GOODWIN PROCTER LLP
`kzullow@goodwinprocter.com
`mdelsignore@goodwinprocter.com
`mcottler@goodwinlaw.com
`
`For PATENT OWNER:
`
`Nicholas Kallas
`VENABLE LLP
`nkallas@venable.com
`
`Laura Fishwick
`Susanne Flanders
`FITZPATRICK, CELLA, HARPER & SCINTO
`lfishwick@fchs.com
`sflanders@fchs.com
`
`
`
`
`5
`
`
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