UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2018-00162
`Patent 7,820,788 B2
`Issued: October 26, 2010
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S
`OPPOSITION TO MOTION FOR JOINDER
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.23 and 42.122(b)
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2018-00162
`Patent 7,820,788 B2
`Issued: October 26, 2010
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S
`OPPOSITION TO MOTION FOR JOINDER
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.23 and 42.122(b)
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`DISCOVERY FROM CIPLA HAS NOTHING TO DO WITH THE
`INVALIDITY OF ABRAXIS’S ’788 PATENT ............................................. 1
`
`CONFIDENTIAL INFORMATION CREATES NO
`COMPLICATION TO JOINDER ................................................................... 3
`
`III. ABRAXIS FAILS TO RAISE A CREDIBLE CHALLENGE TO
`CIPLA’S DESIGNATION OF THE NO REAL-PARTY-IN-
`INTEREST IN ITS PETITION ....................................................................... 4
`
`IV. ABRAXIS SUFFERS NO PREJUDICE FROM JOINDER AND NO
`EXTENSION IS REQUIRED ......................................................................... 5
`
`V.
`
`CONCLUSION ................................................................................................ 5
`
`
`
`i
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Actavis LLC v. Abraxis Bioscience, LLC, IPR2017-01101 ....................................... 1
`
`CaptionCall, LLC v. Ultratec, Inc., IPR2015-00636, Paper 42 (PTAB
`Feb. 23, 2016) ....................................................................................................... 5
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001,
`Paper 26 (PTAB Mar. 5, 2013) ............................................................................. 3
`
`In re Keller,
`642 F.2d 413 (C.C.P.A. 1981) .............................................................................. 2
`
`In re Yale,
`434 F.2d 666 (C.C.P.A. 1970) .............................................................................. 2
`
`Other Authorities
`
`37 C.F.R. § 42.1(b) .................................................................................................... 5
`
`77 Fed. Reg. 48756, 48759–60 (Aug. 14, 2012) ....................................................... 5
`
`
`
`ii
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`As stated in Cipla’s motion for joinder, Cipla’s Petition is nearly identical to
`
`the Actavis Petition, including the same grounds for unpatentability and the same
`
`exhibits. Cipla’s Petition relies upon the same expert declarant, and Cipla is not
`
`asking for additional briefing, hearing time, deposition time, or any change to the
`
`existing schedule in Actavis LLC v. Abraxis Bioscience, LLC, IPR2017-01101
`
`(“Actavis IPR”). Cipla would take an understudy role in the joined proceeding,
`
`and Actavis does not oppose this motion for joinder.
`
`Patent Owner Abraxis Bioscience, LLC’s (“Abraxis”), nonetheless, opposes
`
`joinder. Contrary to Abraxis’s assertions, there are no complications with the
`
`requested joinder, no genuine discovery issues with Cipla, no confidentiality
`
`concerns, and no actual issue about whether Cipla designated the real-party-in-
`
`interest. Abraxis’s attempt to manufacture issues looks more like an excuse to
`
`request a six-month extension in the Actavis IPR proceeding––which itself is
`
`unjustified.
`
`I.
`
`DISCOVERY FROM CIPLA HAS NOTHING TO DO WITH THE
`INVALIDITY OF ABRAXIS’S ’788 PATENT
`
`Abraxis states that it needs time to take meaningful discovery from Cipla.
`
`(Paper 6 at 6.) In particular, Abraxis suggests that it may seek to compel Cipla to
`
`produce “all documents and things relating to loss of paclitaxel during processing
`
`or development of any albumin-bound paclitaxel nanoparticle formulation.” (Paper
`
`6 at 7.) Any paclitaxel loss during the commercial-scale manufacture of Cipla’s
`
`1
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`product would be irrelevant to the invalidity of the ’788 patent. The claims of the
`
`’788 patent are not limited to a particular manufacturing process, and a
`
`commercial-scale process has little in common with the prior art teaching of a 9:1
`
`ratio of albumin to paclitaxel disclosed by Example 1 of Desai. (Exhibit 1006.)
`
`When instituting the Actavis IPR, the Board found that “Desai teaches a
`
`cancer treatment using a final pharmaceutical composition with a ratio of albumin
`
`to paclitaxel that is ‘about 9:1’ as required by claim 1 of the ’788 patent.”
`
`(IPR2017-01101, Paper 7 at 17.) Although Abraxis’s expert speculated that the
`
`starting and final ratios could differ due to loss of paclitaxel during manufacturing,
`
`this is irrelevant: The inquiry for anticipation is whether Example 1 places the
`
`claimed 9:1 ratio of albumin and paclitaxel within the possession of the public.
`
`See In re Yale, 434 F.2d 666, 668 (C.C.P.A. 1970). The inquiry for obviousness is
`
`whether Example 1 suggests a 9:1 ratio to a person of ordinary skill in the art at the
`
`time of the invention. See In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981).
`
`Although the Board invited Abraxis to provide evidence from actual
`
`CapxolTM or Abraxane® production that demonstrates significant loss of paclitaxel
`
`during commercial synthesis, Cipla respectfully disagrees that such evidence is
`
`relevant. Neither Abraxis’s manufacturing process of Abraxane nor Cipla’s
`
`manufacturing process of generic Abraxane can explain what a person of ordinary
`
`skill in the art would have gleaned from Example 1 of Desai at the time of the
`
`invention. For this reason, Cipla opposes Abraxis’s request for discovery as not
`
`2
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`furthering the interest of justice.1
`
`Even if the Board allows Abraxis to take limited discovery from Cipla, and
`
`even if Cipla produced responsive documents to Abraxis’s request, such discovery
`
`would not impact the schedule of the Actavis IPR. Oral argument in the Actavis
`
`IPR is scheduled for July 11, 2018, and there is more than sufficient time to deal
`
`with Abraxis’s one discrete discovery request.2 Abraxis also asserts that if Cipla
`
`produces discovery material, Abraxis may need to re-depose Dr. Berkland (the
`
`expert for both Actavis and Cipla). This is moot because Abraxis will be deposing
`
`Dr. Berkland again anyway after he submits a second declaration in support of
`
`Petitioner’s May 1 reply to Patent Owner’s response to petition.
`
`II. CONFIDENTIAL INFORMATION CREATES NO
`COMPLICATION TO JOINDER
`
`Abraxis speculates that Actavis and Cipla will not be able to coordinate
`
`filings if the Board grants joinder. This is wrong: Actavis and Cipla have an
`
`agreement whereby Actavis would bear the primary responsibility for the Actavis
`
`1
`Cipla further objects to the scope of Abraxis’s discovery request as overly
`
`broad and not in the interest of justice. See Garmin Int’l, Inc. v. Cuozzo Speed
`
`Techs. LLC, IPR2012-00001, Paper 26 at 6–7 (PTAB Mar. 5, 2013).
`
`2
`
`Although Abraxis complained that the discovery cut-off in the Actavis IPR
`
`is January 3, 2018, Actavis and Abraxis have since stipulated to extend that date to
`
`January 31. (IPR2017-01101, Paper 20.)
`
`3
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`IPR, and Cipla would take an understudy role. Abraxis also feigns concern that the
`
`respective petitioners––Actavis, Cipla, and Apotex––would not be able to
`
`reconcile confidentiality issues with respect to their own confidential information
`
`produced to Abraxis. This issue should be moot because Cipla, Actavis, and
`
`Apotex are discussing sharing their own confidential material produced in a joined
`
`proceeding with at least outside counsel of the other joined petitioners. This would
`
`likely be memorialized in a two-tiered protective order at the appropriate time.3
`
`III. ABRAXIS FAILS TO RAISE A CREDIBLE CHALLENGE TO
`CIPLA’S DESIGNATION OF THE NO REAL-PARTY-IN-INTEREST
`IN ITS PETITION
`
`Abraxis speculates that there may be a real-party-in-interest issue for Cipla
`
`that could require discovery. There is no issue. Cipla identified Cipla Ltd., the
`
`parent company of all Cipla subsidiaries, including Cipla USA, Inc. (“Cipla USA”)
`
`and InvaGen Pharmaceuticals, Inc. (“InvaGen”). Cipla identified Cipla USA and
`
`InvaGen in an effort to avoid a frivolous challenge to the real-party-in-interest by
`
`Patent Owner. Abraxis, however, theorizes that Cipla should have also named
`
`another subsidiary, Exelan Pharmaceuticals, Inc. (“Exelan”) based on Abraxis’s
`
`observation that both InvaGen and Exelan were acquired at the same time. Exelan
`
`
`3
`Although Abraxis argues that Actavis reneged on its promise to produce
`
`documents after learning about Cipla’s motion for joinder (Paper 6 at 9), that is not
`
`accurate because Actavis has since produced documents to Abraxis.
`
`4
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`is a wholly owned subsidiary of InvaGen and completely unrelated to this matter or
`
`Cipla’s generic Abraxane product. The Petition was not filed at Exelan’s behest,
`
`and Exelan does not fund or control any part of this proceeding. See Office Patent
`
`Trial Practice Guide, 77 Fed. Reg. 48756, 48759–60 (Aug. 14, 2012). Abraxis’s
`
`heedless allegations do not warrant discovery. Garmin, IPR2012-00001, Paper 26
`
`at 6 (request requires more than a possibility of finding something useful). See
`
`CaptionCall, LLC v. Ultratec, Inc., IPR2015-00636, Paper 42 at 13–15 (PTAB
`
`Feb. 23, 2016) (denying real-party-in-interest discovery).
`
`IV. ABRAXIS SUFFERS NO PREJUDICE FROM JOINDER AND NO
`EXTENSION IS REQUIRED
`
`
`
`Abraxis concedes that Cipla sought joinder within the statutory time limit.
`
`Because Cipla would play an understudy role in the Actavis IPR, joinder will save
`
`time and expense and simply briefing and trial, all without impacting the current
`
`schedule. See 37 C.F.R. § 42.1(b) (requiring “just, speedy, and inexpensive
`
`resolution of every proceeding”).
`
`V. CONCLUSION
`
`Cipla respectfully requests that the Board institute IPR2018-00162 on the
`
`same grounds as in IPR2017-01101, and join this proceeding with IPR2017-01101.
`
`
`
`
`
`
`
`5
`
`
`
`
`Dated: January 11, 2018
`
`
`
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`Respectfully submitted,
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Counsel for Petitioner
`
`6
`
`
`
`
`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION
`
`IPR2018-00162 (7,820,788 B2)
`
`Pursuant to 37 C.F.R. § 42.24, I certify that the foregoing PETITIONER’S
`
`REPLY TO PATENT OWNER’S OPPOSITION TO MOTION FOR JOINDER
`
`contains less than 5 pages, pursuant to 37 C.F.R. § 42.24(c)(2).
`
`Respectfully submitted,
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Counsel for Petitioner
`
`
`
`
`
`
`Dated: January 11, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that, on January 11, 2018, true
`
`and correct copies of the foregoing PETITIONER’S REPLY TO PATENT
`
`OWNER’S OPPOSITION TO MOTION FOR JOINDER, were caused to be
`
`served electronically on the following counsel of record for Patent Owner at the
`
`following email addresses:
`
`Christopher J. Harnett
`charnett@jonesday.com
`Lisamarie LoGiudice, Ph.D.
`llogiudice@jonesday.com
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`
`Anthony M. Insogna
`aminsogna@jonesday.com
`Cary Miller, Ph.D.
`cmiller@jonesday.com
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Andrew S. Chalson
`andrewchalson@quinnemanuel.com
`Frank C. Calvosa
`frankcalvosa@quinnemanuel.com
`Daniel C. Wiesner
`danielwiesner@quinnemanuel.com
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`
`
`
`
`
`
`J. Patrick Elsevier, Ph.D.
`pelsevier@celgene.com
`CELGENE CORPORATION
`86 Morris Ave
`Summit, NJ 07901
`
`
`
`IPR2018-00162 (7,820,788 B2)
`
`/Michael J. Freno/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Counsel for Petitioner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
