Paper 71
`Date Filed: September 6, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ OPPOSITION TO PETITIONERS’ SECOND
`MOTION TO EXCLUDE
`
`
`Date Filed: September 6, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.,
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ OPPOSITION TO PETITIONERS’ SECOND
`MOTION TO EXCLUDE
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`ARGUMENT...................................................................................................1
`
`A.
`
`B.
`
`C.
`
`D.
`
`Exhibits 2073, 2075, 2077-2079, and 2081 Should Not Be
`Excluded Under 37 C.F.R. § 42.64(a)...................................................1
`
`Exhibits 2075 and 2077 Should Not Be Excluded Under 37
`C.F.R. § 42.63(b)...................................................................................3
`
`Exhibits 2074 and 2076 Should Not Be Excluded as Irrelevant...........3
`
`Exhibits 2074–2079 Should Not Be Excluded as Irrelevant. ...............4
`
`III. CONCLUSION................................................................................................4
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Mazzari v. Rogan, 323 F.3d 1000 (Fed. Cir. 2003)...................................................2
`
`Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373 (Fed. Cir. 2003)..................1
`
`Rules and Statutes
`
`35 U.S.C. § 120..........................................................................................................3
`
`37 C.F.R. § 42.61 .......................................................................................................3
`
`37 C.F.R. § 42.63 .......................................................................................................3
`
`37 C.F.R. § 42.64 ...................................................................................................1, 3
`
`Other Authorities
`
`F.R.E. 402 ..................................................................................................................1
`
`F.R.E. 403 ..................................................................................................................1
`
`M.P.E.P. § 2112 .........................................................................................................1
`
`M.P.E.P. § 2124 .........................................................................................................1
`
`The LCCN Namespace, U.S. LIBR. OF CONG. (Nov. 2003),
`https://web.archive.org/web/20170819205149/http://www.loc.gov/marc /lccn-
`namespace.html ......................................................................................................2
`
`iii
`
`
`
`I.
`
`INTRODUCTION
`Patent Owners respectfully oppose Petitioners’ Second Motion to Exclude,
`
`which should be denied for the following reasons.
`
`II.
`
`ARGUMENT
`A.
`Exhibits 2073, 2075, 2077-2079, and 2081 Should Not Be Excluded
`Under 37 C.F.R. § 42.64(a), F.R.E. 402, or F.R.E. 403.
`Petitioners argue that these exhibits should be excluded under grounds
`
`referred to by Petitioners’ counsel in Dr. Patrick DeLuca’s Deposition (Exh. 2081).
`
`The passages Petitioners cite are ambiguous, but they hint that the actual basis for
`
`the objection is that the exhibits might not be prior art, and in their view, irrelevant.
`
`(Id. at 132:24–133:11.) These exhibits were properly presented in response to
`
`arguments first made in Dr. DeLuca’s Supplemental Declaration (Exh. 1024) and
`
`the Petitioners’ Reply (Paper 40). Petitioners make a similar argument in II.E
`
`(Paper 70 at 4) regarding Exhs. 2073, 2078, and 2079, which we address here.
`
`As Patent Owners have pointed out before (Paper 56 at 8–10), inherency
`
`does not require recognition in the prior art. Schering Corp. v. Geneva Pharm.
`
`Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003); M.P.E.P. § 2112. An exhibit need not
`
`be prior art to be relevant evidence. M.P.E.P. § 2124 (“[R]eferences cited to show
`
`a universal fact need not be available as prior art.”).
`
`Exh. 2073, an excerpt from the Rheology Modifiers Handbook, compares
`
`Aqualon CMCs offered at different purities (food, pharmaceutical, and industrial)
`
`1
`
`
`
`and finds their viscosities identical (Table 2.7). Exh. 2073 was filed in the Library
`
`of Congress Catalog with a Card Number (LCCN) of 99-32076, indicating that it
`
`was filed in 1999. See The LCCN Namespace, U.S. LIBR. OF CONG. (Nov. 2003),
`
`https://web.archive.org/web/20170819205149/http://www.loc.gov/marc/lccn-
`
`namespace.html (explaining that the first two digits of the LCCN signify the year
`
`the reference was catalogued). Exh. 2073 rebuts Petitioners’ argument that Patent
`
`Owners’ tests were flawed for using CMCs that were not identified as
`
`pharmaceutical grade (Paper 40 at 10–11), and is relevant.
`
`Exh. 2075, WO99/48841, is a German PCT application published on
`
`September 30, 1999, showing the use of Blanose 7UL, 7EL, and 7ULC. (Id. at 3,
`
`10, 11.) Exh. 2077, WO98/02486, is a French PCT application published on
`
`January 22, 1998, showing the use of Blanose 7ULC. (Id. at 15, 22.) Both are
`
`prior art. See Mazzari v. Rogan, 323 F.3d 1000, 1005-06 (Fed. Cir. 2003) (holding
`
`that a printed publication need not be in English to be prior art). Both rebut
`
`Petitioners’ argument that Patent Owners’ tests were flawed by the use of CMCs
`
`that were not commercially available at the time of the invention and are relevant.
`
`Exhs. 2078 and 2079 are not prior art, but disclose the use of another ultra-
`
`low CMC, Sigma 360384 (Exh. 2039; Exh. 2014 at ¶ 58), used in microneedles
`
`and medical adhesives. Both rebut Petitioners’ argument that Patent Owners’ tests
`
`were flawed for using CMCs that Petitioners allege would not be used in a
`
`2
`
`
`
`pharmaceutical application (Paper 40 at 10–11), and are thus relevant.
`
`Petitioners have also moved for exclusion of unspecified portions of Exh.
`
`2081, which “relate” to these exhibits. (Paper 70 at 2.) This request is vague and
`
`fails to explain the objections as required under 37 C.F.R. § 42.64(c). It should
`
`therefore be denied. As discussed herein and in Paper 50, Dr. DeLuca’s deposition
`
`testimony also confirms the relevance of Exhs. 2073–2079, which Petitioners have
`
`only now moved to exclude.
`
`B.
`
`Exhibits 2075 and 2077 Should Not Be Excluded Under 37 C.F.R.
`§ 42.63(b).
`Petitioners further argue that Exhs. 2075 and 2077 should be excluded for
`
`lacking translation. (Paper 70 at 2–3.) As PCT publications, Exhs. 2075 and 2077
`
`have English translations on the record already in Exhs. 2074 and 2076
`
`respectively, the U.S. patents which claim priority to the PCT applications. Patent
`
`Owners were thus not obligated to present a separate translation. 37 C.F.R. §
`
`42.61(b) (“Certification is not necessary . . . when the evidence to be submitted is a
`
`record of the Office.”). Neither exhibit should be excluded.
`
`Exhibits 2074 and 2076 Should Not Be Excluded as Irrelevant.
`C.
`Petitioners claim that Exhs. 2074 and 2076 are irrelevant because they
`
`issued after the critical date. However, each patent claims priority to the earlier
`
`filed PCT application (Exhs. 2075 and 2077). Such priority claims are not
`
`contingent upon whether the reference applications were properly authenticated in
`
`3
`
`
`
`a given proceeding. See 35 U.S.C. § 120. Furthermore, both exhibits actually
`
`designate the 102(e) dates on the face of the patent. Both exhibits, therefore, show
`
`the prior art use of Blanose 7UL and 7EL and directly rebut Petitioners’ argument
`
`that Patent Owners’ tests were flawed by the use of CMCs that were not
`
`commercially available at the time of the invention. Neither Exh. 2074 nor Exh.
`
`2076 should be excluded as irrelevant.
`
`Exhibits 2074–2079 Should Not Be Excluded as Irrelevant.
`D.
`Petitioners argue that Exhs. 2074–2079 are irrelevant because they are
`
`directed to “nonanalogous art.” (Paper 70 at 3-4.) CMC is a versatile polymer
`
`with many applications, and patents and publications—including the ’061 patent,
`
`Johnson, Gustafsson, and Kino—often do not disclose the grade, or even the
`
`manufacturer, of CMC used. Petitioners’ own case illustrates the difficulty of
`
`finding references that state which CMC grade was used. After defining a narrow
`
`category of relevant CMCs (Paper 40 at 10), Petitioners have failed to provide the
`
`Board with a single example of a low (but not extra low or ultra low) viscosity
`
`CMC used in an injection vehicle before May 25, 2000. Exhs. 2074–2079 are
`
`relevant and should not be excluded.
`
`III. CONCLUSION
`
`Petitioners have provided no reason to exclude Exhs. 2073–2079, or any
`
`portion of Exh. 2081, and their Second Motion to Exclude should be denied.
`
`4
`
`
`
`September 6, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNERS’ OPPOSITION TO PETITIONERS’ SECOND MOTION TO
`
`EXCLUDE EVIDENCE was served on September 6, 2017 by causing it to be sent
`
`by email to counsel for Petitioner at the following email addresses:
`
`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`September 6, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`6
`
`
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
