Trials@uspto.gov Paper No. 10
`571-272-7822
`
`Entered: April 3, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_______________
`
`
`
`Case IPR2018-00507
`Patent US 8,410,131 B2
`_______________
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`571-272-7822
`
`Entered: April 3, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_______________
`
`
`
`Case IPR2018-00507
`Patent US 8,410,131 B2
`_______________
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`INTRODUCTION
`I.
`West-Ward Pharmaceuticals International Limited (“West-Ward”)
`filed a Petition requesting an inter partes review of claims 1–3 and 5–9 of
`U.S. Patent No. 8,410,131 B2 (“the ’131 patent”). Paper 1 (“Pet.”).1 Patent
`Owner Novartis Pharmaceutical Corporation (“Novartis”) waived its right to
`file a Preliminary Response to the Petition. Paper 9.
`Along with its Petition, West-Ward filed a Motion for Joinder to join
`this proceeding with IPR2017-01592. Paper 3 (“Mot.”). West-Ward filed
`the Petition and Motion for Joinder in the present proceeding on January 17,
`2018, within one month after we instituted trial in IPR2017-00737. Novartis
`timely filed a response to West-Wards’s Motion for Joinder. Paper 7.
`As explained further below, we institute trial on the same grounds as
`instituted in IPR2017-01592 and grant West-Ward’s Motion for Joinder.
`
`DISCUSSION
`II.
`In IPR2017-01592, Breckenridge Pharmaceuticals, Inc.
`(“Breckenridge”) challenged claims 1–3 and 9 of the ’131 patent on the
`following grounds:
`
`
`1 According to the Petition, “as a result of ongoing integration and
`reorganization activities, Petitioner identifies Hikma Pharmaceuticals PLC
`(“Hikma”) and West-Ward Pharmaceuticals Corp. as real-parties-in-interest
`who, going forward, may have control over this proceeding.” We also note
`that, in contrast to the identification of West-Ward in, for example, the
`Petition caption and Power of Attorney (Paper 1), the entity entering the
`Petition in the E2E electronic filing system identified Hikma as Petitioner.
`In the event West-Ward is not, or ceases to be the Petitioner, the new entity
`must promptly file an updated mandatory notice to that effect along with a
`new power of attorney.
`
`2
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`Ground Claim(s)
`
`Basis
`
`
`
`Reference(s)
`
` 1
`
`1–3 and 5–9
`
` § 102(a)/102(e)(1) Wasik2
`
` 2
`
`1–3 and 5–9
`
` § 103(a)
`
` 3
`
`1–3 and 5–9
`
` § 103(a)
`
` 4
`
`1–3 and 5–9
`
` § 103(a)
`
` 5
`
`1–3 and 5–9
`
` § 103(a)
`
`Wasik alone or in
`combination with Navarro3
`
`Wasik, Navarro, Crowe,4
`and Luan5
`Alexandre,6 Crowe,
`Hidalgo,7 Schuler,8
`Neumayer, and Navarro 9
`Alexandre, Crowe, Hidalgo,
`Schuler, Neumayer,
`Navarro, and Luan
`
`
`2 WO 01/51049 A1, published July 19, 2001. Ex. 1002.
`3 WO 00/33878 A2, published June 15, 2000. Ex. 1003.
`4 Crowe et al., Absorption and Intestinal Metabolism of SDZ-RAD and
`Rapamycin in Rats, 27(5) Drug Metab. Disp. 627-632 (1999). Ex. 1004.
`5 Luan et al., Sirolimus Prevents Tumor Progression: mTOR Targeting for
`the Inhibition of Neoplastic Progression, 1 Suppl. 1 Am. J. Transplant. 243,
`Abstr. No. 428 (2001). Ex. 1005.
`6 Alexandre et al., CCI-779, A new Rapamycin Analog, Has Antitumor
`Activity at Doses Including Only Mild Cutaneous Effects and Mucositis:
`Early Results of an Ongoing Phase I Study, 5(suppl.), Clin. Cancer Res.
`3730s, Abstr. No. 7 (1999). Ex. 1007.
`7 Hidalgo et al., The Rapamycin-sensitive Signal Transduction Pathway as a
`Target for Cancer Therapy, 19(56) Oncogene 6680-6686 (2000). Ex. 1006.
`8 Schuler et al., SDZ RAD, A New Rapamycin Derivative, 64(1)
`Transplantation 36–42 (1997). Ex. 1008.
`9 Neumayer et al., Entry-into-human Study with the Novel
`Immunosuppressant SDZ RAD in Stable Renal Transplant Patients, 48(5)
`Br. J. Clin. Pharmacol. 694–703 (1999). Ex. 1009.
`
`
`3
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`After considering the Petition and Patent Owner’s Preliminary
`Response, we instituted trial in IPR2017-01592 on each of the above-
`asserted grounds. IPR2017-01592, Paper 12, 35.
`As asserted in Petitioner’s Motion for Joinder, “West-Ward’s Petition
`is substantively identical to the petition in the Breckenridge IPR,”
`challenging the same claims based on the same art and the same grounds.
`See Mot. 6; compare IPR2018-00507, Paper 2, with IPR2017-01592, Paper
`1. West-Ward also relies on the same expert testimony as Breckenridge.
`See Pet. 7 n.1 (asserting that Petitioner would withdraw the declaration of
`Dr. Cho and rely on the testimony of Dr. Pantuck submitted in IPR2017-
`01592 if it could retain Dr. Pantuck); Ex. 3001 (email correspondence to the
`Board stating, “West-Ward has retained Dr. Pantuck and will rely solely on
`Dr. Pantick if IPR2018-00507 is instituted”).
`For the same reasons stated in our Decision on Institution in IPR2017-
`01592, we institute trial in this proceeding on the same five grounds.
`Having determined that institution is appropriate, we now turn to
`West-Ward’s Motion for Joinder. 35 U.S.C. § 315(c). Section 315(c)
`provides, in relevant part, that “[i]f the Director institutes an inter partes
`review, the Director, in his or her discretion, may join as a party to that inter
`partes review any person who properly files a petition under section 311.”
`Id. When determining whether to grant a motion for joinder we consider
`factors such as timing and impact of joinder on the trial schedule, cost,
`discovery, and potential simplification of briefing. Kyocera Corp. v.
`SoftView, LLC, Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013)
`(Paper 15). Under the circumstances of this case, we determine that joinder
`is appropriate.
`
`4
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`West-Ward avers that joinder will “not create any additional burden
`on Patent Owner,” as it “raises no issues that are not already before the
`Board in the Breckenridge IPR.” Mot. 6, 10. In particular, West-Ward
`argues that “the present Petition challenges the same instituted claims on the
`same grounds, and is supported by the same prior art, prior art combinations,
`and arguments as relied upon in Breckenridge’s IPR petition and considered
`by the Board in instituting review in the Breckenridge IPR.” Id. at 6.10
`West-Ward further asserts that it will:
`Effectively . . . act as a “silent understudy” unless, and until such
`time as, Breckenridge drops out of the proceedings for any
`reason. If the Breckenridge IPR is terminated with respect to the
`Breckenridge, Petitioner intends to “step into the shoes” of
`Breckenridge and materially participate in the remainder of the
`proceedings. Only if Breckenridge drops out of the proceedings
`for any reason, will Petitioner cease its understudy role.
`Id. at 8–9.
`Novartis responds that does not oppose joinder on conditions that,
`absent termination by Breckenridge, West-Ward “acts as a silent understudy
`in the joint proceedings,” consents to consolidated filings not exceeding
`Breckenridge’s allotted word and page counts, and consents to consolidated
`discovery that does not increase the allotted time for cross-examination or
`redirect examination. Paper 7, 8–9. While we generally agree with
`Novartis’s position, an overly-strict adherence to its proposed conditions
`would be at odds with our discretion to managing this case. See generally,
`37 C.F.R. § 42.71(a). Accordingly, we retain our discretion to entertain
`
`
`10 As discussed above, West-Ward also relies on the same expert as
`Breckenridge.
`
`5
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`requests for additional briefing, additional discovery, and other relief as
`conditions may warrant.
`In view of the foregoing, we find that joinder based upon the
`conditions stated in West-Ward’s Motion for Joinder will have little or no
`impact on the timing, cost, or presentation of the trial on the instituted
`grounds and promote the just, speedy, and inexpensive resolution of the
`involved proceedings. Moreover, discovery and briefing will be simplified
`if the proceedings are joined. Having considered West-Ward’s Motion in
`light of Novartis’ response, the Motion is granted.
`
`III.
`
`ORDER
`
`Accordingly, it is
`ORDERED that the Petition is granted and an inter partes review of
`U.S. Patent No. 8,410,131 B2 is instituted on the following grounds:
`1) Claims 1–3 and 5–9 under 35 U.S.C. § 102 as anticipated by
`Wasik;
`2) Claims 1–3 and 5–9 under 35 U.S.C. § 103 as obvious in view of
`Wasik alone, or in combination with Navarro;
`3) Claims 1–3 and 5–9 under 35 U.S.C. § 103 as obvious over the
`combination of Wasik, Navarro, Crowe, and Luan;
`4) Claims 1–3 and 5–9 under 35 U.S.C. § 103 as obvious over the
`combination of Alexandre, Crowe, Hidalgo, Schuler, Neumayer,
`and Navarro;
`5) Claims 1–3 and 5–9 under 35 U.S.C. § 103 as obvious over the
`combination of Alexandre, Crowe, Hidalgo, Schuler, Neumayer,
`Navarro, and Luan.
`FURTHER ORDERED that West-Ward’s Motion for Joinder with
`IPR2017-01592 is granted;
`
`6
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`FURTHER ORDERED that IPR2018-00507 is terminated and joined
`to IPR2017-01592, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
`conditions discussed above;
`
`FURTHER ORDERED that absent the withdrawal of Breckenridge
`from this proceeding or express leave of the Board, West-Ward shall
`maintain an understudy role with respect Breckenridge, coordinate filings
`with Breckenridge, not submit separate substantive filings, not request
`additional cross-examination or redirect time beyond that allotted to
`Breckenridge, and not participate substantively in oral argument;
`
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2017-01592 (Paper 13) shall govern the joined proceedings;
`
`FURTHER ORDERED that all future filings in the joined proceeding
`shall be made only in IPR2017-01592;
`
`FURTHER ORDERED that the case caption in IPR2017-01592 for all
`further submissions shall be changed to add West-Ward as a named
`Petitioner after Breckenridge, and to indicate by footnote the joinder of
`IPR2018-00507 to that proceeding, as indicated in the attached sample case
`caption; and
`
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2017-01592.
`
`
`
`
`
`7
`
`
`
`IPR2018-00507
`Patent US 8,410,131 B2
`
`
`
`
`FOR PETITIONER WEST-WARD:
`
`Keith A. Zullow
`Marta E. Delsignore
`GOODWIN PROCTER LLP
`kzullow@goodwinprocter.com
`mdelsignore@goodwinprocter.com
`
`
`FOR PATENT OWNER NOVARTIS:
`Nicholas N. Kallas
`Laura K. Fishwick
`Charlotte Jacobsen
`FITZPATRICK, CELLA, HARPER & SCINTO
`nkallas@fchs.com
`lfishwick@fchs.com
`cjacobsen@fchs.com
`
`
`FOR PETITIONER BRECKENRIDGE PHARMACEUTICAL, INC.,
`(IPR2017-01592):
`Daniel R. Evans
`Melissa M. Hayworth
`Jeffrey D. Blake
`MERCHANT & GOULD P.C.
`devans@merchantgould.com
`mhayworth@merchantgould.com
`jblake@merchantgould.com
`
`
`
`
`
`
`
`
`
`
`8
`
`
`
`Trials@uspto.gov Paper No.
`571-272-7822
`
`Entered:
`
`
`
`
`
`Sample Case Caption
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`BRECKENRIDGE PHARMACEUTICAL, INC., AND
`WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioners,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_______________
`
`Case IPR2017-015921
`Patent US 8,410,131 B2
`_______________
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 IPR2018-00507 has been joined to this proceeding.
`
`
`
`
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