`
`Filed: June 6, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY'S LABORATORIES, INC.
`Petitioners
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners
`
`_______________________
`
`Case No. IPR2018-002721
`U.S. Patent No. 9,393,208
`_______________________
`
`PATENT OWNERS’ REPLY TO PETITIONERS’ OPPOSITION
`TO MOTION TO EXCLUDE EVIDENCE
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-01341, has been joined
`as a Petitioner to this proceeding.
`
`
`
`
`
`
`
`Patent Owners submit this reply to Petitioners’ opposition (“Opp.” (Paper
`
`58)) to Patent Owners’ motion to exclude certain evidence. (“PO Mot.” (Paper
`
`55).)
`
`I.
`
`ARGUMENT
`A.
`Purported Drug Labels (Exs. 1009, 1010, 1020, and 1030) and
`Printouts of Web Pages (Ex. 1008 and 1083) Should Be Excluded
`for Containing Hearsay, Lacking Authentication, and Not
`Supporting Petitioners’ Characterization of the Truth of the
`Matter Asserted
`At the outset, Petitioners attempt to rely on a procedural argument to avoid
`
`the exclusion of any of its purported drug labels or printouts of FDA web pages.
`
`Petitioners argue that Patent Owners have waived all objections to evidence cited
`
`in Mylan’s Petition. (Opp. at 2-3.) Patent Owners did not waive objections, as
`
`timely evidentiary objections were raised in response to the institution of Dr.
`
`Reddy’s Petition in IPR2018-01341. Petitioner Mylan does not dispute this. (Opp.
`
`at 4.) Moreover, Petitioners cannot dispute that the evidence cited in Dr. Reddy’s
`
`Petition is the same evidence cited in Mylan’s Petition. (See IPR2018-01341,
`
`Paper 3 at 4-6; Paper 21 at 2-3.) IPR2018-01341 was instituted and joined with
`
`IPR2018-00272 on April 1, 2019. (See IPR2018-01341, Paper 21.) Petitioners
`
`Mylan and Dr. Reddy’s cite no authority for ignoring Patent Owners’ timely
`
`objections in the joined proceedings.2
`
`
`2 Moreover, Petitioner Mylan cannot argue prejudice or surprise here, as Patent
`
`
`
`1
`
`
`
`
`
`Significantly, Patent Owners identified the evidentiary problems with the
`
`EC-Naprosyn label (Exhibit 1009) in Patent Owners’ Response. (See Paper 32 at
`
`25-29.) These included issues related to the authenticity of the document. For
`
`example, the copyright notice on the document is represented as “1999-2007” with
`
`a strike through the “7” and portions of the document appeared to have been
`
`modified in September 2007 although Petitioners asserted that Ex. 1009 was
`
`available on the FDA website in January 2007. The only evidence that Petitioners
`
`pointed to in related IPR2017-01995 to prove that Exhibit 1009 is the same EC-
`
`Naprosyn label that was publicly available in 2007 is a declaration from
`
`Petitioners’ counsel providing the web address from which the document was
`
`downloaded (presumably in 2018, although the declaration does not state when
`
`Exhibit 1009 was actually downloaded). (PO Mot. at 26-27.)
`
`Although these issues with Exhibit 1009 were raised in Patent Owner’s
`
`Response, Petitioners failed to adduce sufficient evidence to establish that Ex.
`
`1009 is an authentic copy of the EC-Naprosyn label as it existed in 2007.
`
`Owners raised the same evidentiary objections against the identical evidence cited
`
`in related IPR2017-01995. In response to Patent Owners’ Motion to Exclude in
`
`this proceeding, Petitioners served an attorney declaration identical to the
`
`declaration they filed in IPR2017-01995. (Compare Ex. 1090 with Ex. 2068 in
`
`IPR2017-01995; see also PO Mot. at 1-5.)
`
`
`
`2
`
`
`
`
`
`Petitioners’ argument that Patent Owners have somehow waived any objection to
`
`the admissibility of Exhibit 1009 is meritless.
`
`Petitioners now argue that Exhibit 1009, and, by extension, the other
`
`challenged drug labels (Exs. 1010, 1020, and 1030) are authentic under Fed. R.
`
`Evid. 901(b)(4) because they bear company trademarks and mandated label
`
`formatting. They further argue that such labels are self-authenticating under Fed.
`
`R. Evid. 902 because they include “trade inscriptions, trademarks, and other
`
`affixations indicating origin, ownership, or control of the labeling information.”
`
`(Opp. at 7.) Petitioners argue that the FDA web pages (Exs. 1008 and 1083) are
`
`authentic because they bear an FDA web address. But Petitioners arguments miss
`
`the mark—company trademarks, label formatting, and web addresses are not
`
`evidence that the document is an authentic copy of the label as it existed at the time
`
`Petitioners purport it was publicly available.
`
`Petitioners point to a declaration of Dr. Metz (Ex. 1091, also submitted in
`
`IPR2017-01995), attesting to his personal knowledge that Exhibit 1010 is a true
`
`and correct of the Zegerid drug label as it existed before 2007. However, when
`
`questioned at his deposition about Exhibit 1010, Dr. Metz admitted that he was
`
`uncertain whether Exhibit 1010 was an identical copy of the Zegerid label as it
`
`existed in 2004. (Ex. 2027 at 72:10-74:18 (“If you are asking me if every single
`
`word in this label was exactly the same in 2004 as it is now, I can’t be 100 percent
`
`
`
`3
`
`
`
`
`
`sure of that. . . .This is not a copy of the label that I would have seen in 2004. I - -
`
`you mean, the exact copy? No.”).) Petitioners cannot therefore rely on Dr. Metz’s
`
`testimony to bolster the authenticity of Exhibit 1010.
`
`With respect to hearsay, Petitioners only state that each of these exhibits is
`
`offered for a non-hearsay purpose. (Opp. at 10-11, n.7.) This assertion belies
`
`Petitioners reliance on the copyright date of Ex. 1009 for the truth of the matter
`
`asserted, i.e., that the document was published as of that date. The same argument
`
`applies to the other drug labels and FDA web pages—Petitioners rely on the
`
`copyright dates to establish that these documents were publicly available. The
`
`Board has found that copyright dates are “entitled to any greater weight than that
`
`afforded to hearsay in determining public accessibility.” ServiceNow, Inc. v.
`
`Hewlett-Packard Co., IPR2015-00707, Paper 14 at 9-10 (P.T.A.B. Nov. 2, 2015);
`
`see also QSC Audio Prods., LLC v. Crest Audio, Inc., IPR2014-00129, Paper 41 at
`
`9–11 (P.T.A.B. Apr. 29, 2015) (noting that a copyright date was hearsay).
`
`Petitioners have identified no exception to the hearsay rule that would apply here.
`
`B.
`
`Portions of Dr. Mayersohn’s Reply Declaration (Ex. 1074) and
`Exhibits Cited Therein (Exs. 1064, 1065, 1066, 1076 and 1088)
`Should be Excluded as Improper New Opinion Testimony
`Petitioners again attempt to rely on a procedural argument to excuse their
`
`reliance on new opinion testimony of Dr. Mayersohn and related exhibits, they do
`
`not dispute that these exhibits were not included with their Petition and were only
`
`
`
`4
`
`
`
`
`
`relied upon for the first time in their Reply brief—presumably to make up for the
`
`fatal deficiencies of failing to prove that Exhibit 1009, the EC-Naprosyn label, is
`
`prior art. While Petitioners argue that these challenged materials were included in
`
`response to Patent Owners’ argument regarding the prior art status of Exhibit 1009
`
`(Opp. at 13), none of these materials addresses the printed publication status of
`
`Exhibit 1009. Petitioners’ argument thus falls flat.
`
`It is well established that a “reply may only respond to arguments raised in
`
`the corresponding opposition … or patent owner response.” 37 C.F.R. § 42.23(b).
`
`The Board has noted that Section 42.23(b) “does not authorize or otherwise
`
`provide a means for supplementing the evidence of record.” Toshiba Corp. v.
`
`Optical Devices, LLC, IPR2014-01447, Paper 34 at 45 (P.T.A.B. Mar. 9, 2016)
`
`(“[A] reply that . . . belatedly presents evidence will not be considered and may be
`
`returned”) (citing Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,767). In
`
`Toshiba, the Board granted the patent owner’s motion to exclude two exhibits that
`
`were improperly included for the first time in the petitioner’s reply. Id. at 44-47.
`
`See also Intri-Plex Techs., Inc. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`
`IPR2014-00309, Paper 83, at 13-14 (P.T.A.B. Mar. 23, 2015) (excluding belated
`
`evidence presented for the first time in reply).
`
`Because portions of Exhibit 1074 and Exhibits 1064, 1065, 1066, 1076 and
`
`1088 in their entirety fall outside the scope of a proper reply, the challenged
`
`
`
`5
`
`
`
`
`
`exhibits should be excluded from this proceeding.
`
`C.
`
`Portions of Dr. Metz’s Reply Declaration (Ex. 1059) and
`Deposition Testimony (Ex. 2083) Should be Excluded as Improper
`New Opinion Testimony
`Similarly, Petitioners do not dispute that Dr. Metz testified at deposition that
`
`he could replace the ’285 patent with the ’907 patent in his opinions regarding the
`
`invalidity of the ’208 patent. (PO Mot. at 7-8.) This deposition testimony is
`
`consistent with the opinions in his Reply Declaration equating the disclosures in
`
`the ’907 patent with the ’285 patent. (Id.) For example, Dr. Metz’s declaration
`
`claims, without any analysis or support, that the ’907 patent is prior art to the ’208
`
`patent and his declaration refers to the “invention claimed in both the ’907 and
`
`’285 patents,” reciting an excerpt from the ’907 specification. (Ex. 1059 at ¶17.)
`
`The ’907 patent is not included in any instituted grounds in the instant
`
`Petition and Dr. Metz cannot, at this late stage, be allowed to substitute the ’907
`
`patent for the ’285 patent in his opinions. Dr. Metz’s new opinions about the
`
`purported invalidity of the ’208 patent that rely on the ’907 patent are outside the
`
`proper scope of a reply and should not be considered by the Board. See, e.g.,
`
`Scotts Co. v. Encap, LLC., IPR2013-00110, Paper 79 at 5-8 (P.T.A.B. June 24,
`
`2014). Because Petitioners cannot rely on any new invalidity opinions of Dr. Metz
`
`that rely upon the ’907 patent, the challenged exhibits should be excluded from this
`
`proceeding.
`
`
`
`6
`
`
`
`
`
`Date: June 6, 2019
`
`
`
`Respectfully submitted,
`
`
`
`
`
`/Thomas A. Blinka/
`Thomas A. Blinka
`Reg. No. 44,541
`Counsel for Patent Owners
`COOLEY LLP
`Attn: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington DC 20004
`Counsel for Patent Owner
`
`
`
`7
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`I, Thomas A. Blinka, hereby certify that on June 6, 2019, the foregoing
`
`PATENT OWNERS’ REPLY TO PETITIONERS’ OPPOSITION TO
`
`MOTION TO EXCLUDE EVIDENCE was served electronically via email on
`
`
`
`
`
`
`
`Counsel for MYLAN
`
`the following:
`
`Brandon M. White
`Emily J. Greb
`Autumn N. Nero
`Bryan D. Beel
`Maria A. Stubbings
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`anero@perkinscoie.com
`bbeel@perkinscoie.com
`mstubbings@perkinscoie.com
`EsoNaproxen@perkinscoie.com
`
`Alan H. Pollack
`Stuart D. Sender
`Louis H. Weinstein
`WINDELS MARX LANE & MITTENDORF, LLP
`apollack@windelsmarx.com
`ssender@windelsmarx.com
`lweinstein@windelsmarx.com.com
`
`Date: June 6, 2019
`
`
`
`
`
`
`
`
`
`
`
`
`Counsel for DR. REDDY'S
`
`/Thomas A. Blinka/
`Thomas A. Blinka
`Reg. No. 44,541
`Counsel for Patent Owners
`
`
`
`
`
`8
`
`
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
