Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`Paper 37
`Date: December 14, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`ORDER
`Granting Petitioner’s Motion to Submit Supplemental Information
`37 C.F.R. § 42.123(a)
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 37
`Date: December 14, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and KRISTI L. R. SAWERT,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`ORDER
`Granting Petitioner’s Motion to Submit Supplemental Information
`37 C.F.R. § 42.123(a)
`
`
`
`I.
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`INTRODUCTION
`Petitioner requested authorization to file a motion to submit
`supplemental information under 37 C.F.R. § 42.123(a) within one-month of
`our institution of trial. Paper 30. We authorized Petitioner to file the
`motion. Id. Petitioner filed a Motion to Submit Supplemental Information
`(Paper 32; “Mot.”) and Patent Owner filed an Opposition (Paper 36;
`“Opp.”).
`In its motion, Petitioner proposes to submit, as supplemental
`information, a corrected version of Rudnic containing the correct header
`pages. Mot. 1. Rudnic is cited by Petitioner in support of Grounds 2 and 4
`in the Petition as Exhibit 1010. Id. at 1–2. Petitioner explains that the
`substantive portion of Ex. 1010 is Chapter 10 of the third edition of the
`textbook Modern Pharmaceutics published in 1996, while the header pages
`were mistakenly taken out of the fourth edition of the textbook Modern
`Pharmaceutics published in 2002. Id. at 4. The corrected version of Rudnic
`that Petitioner requests be entered into the record, Exhibit 1042, contains the
`header pages and Chapter 10 from the third edition of the textbook Modern
`Pharmaceutics. Id. at 5. Petitioner contends that “the supplemental
`information does not change the substantive evidence provided in the
`original version of Rudnic; rather, it merely clarifies the edition of Modern
`Pharmaceutics from which the substance was obtained.” Id.
`In its Opposition, Patent Owners first contend that Petitioner’s request
`should be denied because the proposed supplemental information does not
`sufficiently address the issue of establishing Rudnic (Ex. 1010) as a prior art
`reference and that it is “important for the Board to ensure that supplemental
`information is not used to edit them after the fact.” Opp. 3–4. Patent Owner
`
`
`
`2
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`also contends that it has been prejudiced by Petitioner’s mistake because
`“Patent Owners prepared their Preliminary Response without knowing what
`reference Petitioner meant to refer to.” Id. at 4. “Patent Owners cannot
`effectively contest the public availability or substance of a reference that
`Petitioner has not adequately identified.” Id. at 4–5. Finally, Patent Owner
`argues that Petitioner could have discovered its mistake sooner, but “waited
`until after institution to explain it away.” Id. at 5.
`Upon consideration of the documents and the parties’ arguments, and
`for the reasons stated below, Petitioner’s motion is granted.
`
`II. ANALYSIS
`As the moving party, Petitioner bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). Here, because
`Petitioner seeks to submit supplemental information within one-month of
`institution, it must show that the information is “relevant to a claim for
`which the trial has been instituted.” 37 C.F.R. § 42.123(a). That said,
`however, section 123(a) “does not connote the PTAB must accept
`supplemental information so long as it is timely and relevant.” Redline
`Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015)
`(citation omitted). In other words, satisfying the criteria of section 123(a)
`does not guarantee we will grant the motion and allow submission of the
`supplemental information.
`Instead, our guiding principle in evaluating a motion to submit
`supplemental information is “to ensure the efficient administration of the
`Office and the ability of the Office to complete IPR proceedings in a timely
`manner.” Redline Detection, 811 F.3d at 445 (citations and internal
`quotations omitted). “Requiring admission of supplemental information so
`
`
`
`3
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`long as it was timely submitted and relevant to the IPR proceeding would cut
`against this mandate and alter the intended purpose of IPR proceedings.” Id.
`That purpose is to “secure the just, speedy, and inexpensive resolution of
`every proceeding.” 37 C.F.R. § 42.1(b). Consistent with that purpose, we
`consider whether submission of the supplemental information would change
`the grounds initially presented in the petition or otherwise unfairly change
`the evidence underlying those grounds. We also consider whether the patent
`owner would be prejudiced in having to respond to the supplemental
`information if permitted.
`Turning to the question of whether Petitioner’s supplemental
`information is “relevant to a claim for which the trial has been instituted,” 37
`C.F.R. § 42.123(a), we determine that the supplemental information
`Petitioner seeks to admit generally relates to the public availability of
`Rudnic, which is a basis for grounds of unpatentability in this proceeding,
`and is therefore relevant to the claims of the ’945 patent for which this trial
`was instituted. We recognize that permitting a petitioner to supplement the
`record could potentially change the evidence supporting the grounds
`originally presented in a petition in a manner that is not in accord with the
`statutory requirement that the petition identify “with particularity . . . the
`evidence that supports the grounds for the challenge to each claim,”
`including “affidavits or declarations of supporting evidence and opinions, if
`the petitioner relies on expert opinions.” 35 U.S.C. § 312(a)(3)(B). Here,
`however, the supplemental information does not change the grounds of
`unpatentability authorized in this proceeding, nor does it change the
`evidence initially presented in the Petition to support the grounds of
`unpatentability. In our Decision to Institute, we addressed Patent Owners’
`
`
`
`4
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`arguments concerning the status of Rudnic as a printed publication. Paper
`24, 31–34. We noted that the factual dispute as to when Rudnic was
`published “may be resolved during trial.” Id. at 33. In that regard,
`Petitioner seeks to admit Ex. 1042 as evidence that Rudnic was published in
`the third edition of the textbook Modern Pharmaceutics published in 1996,
`thus allegedly confirming Rudnic as a printed publication. We see nothing
`wrong with Petitioner seeking to submit evidence on a dispositive issue at an
`early stage of trial so that Patent Owners may address the issue of whether
`Rundic is a prior art publication in its Patent Owner Response, should it
`wish to do so.
`We turn now to the question of whether granting the Motion is
`consistent with the efficient administration of this proceeding and the ability
`of the Board to ensure “the just, speedy, and inexpensive resolution of every
`proceeding.” 37 C.F.R. § 42.1(b). Here, we are not persuaded that the
`submission of the proposed supplemental information in this proceeding
`would limit our ability to satisfy that mandate. If we allow the supplemental
`information into the record at this juncture, Patent Owner will have
`sufficient time to address the supplemental information before filing the
`deadline of its Patent Owner Response, due January 15, 2019. Paper 25.
`Accordingly, we determine that admitting Exhibit 1042 as supplemental
`information will not inhibit the just, speedy, or efficient resolution of this
`proceeding, or our ability to complete it in a timely manner.
`Moreover, because Patent Owners will have sufficient time to address
`the supplemental information, we are not persuaded that Patent Owners will
`be unduly prejudiced. Furthermore, in this regard, we note that Patent
`
`
`
`5
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`Owners already addressed the identical substance of Rudnic in its
`Preliminary Response. Paper 18, 16 and 23.
`
`III. ORDER
`For the reasons given:
`ORDERED that Petitioner’s motion to submit supplemental
`information under 37 C.F.R. § 42.123(a) is granted.
`FURTHER ORDERED that Exhibit 1042 shall be entered as evidence
`into the record.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`For PETITIONER:
`
`Robert Florence
`Karen Carroll
`Micheal Binns
`Sharad Bijanki
`PARKER POE ADAMS & BERNSTEIN LLP
`robertflorence@parkerpoe.com
`karencarroll@parkerpoe.com
`michealbinns@parkerpoe.com
`sharadbijanki@parkerpoe.com
`
`For PATENT OWNER:
`
`Heather Petruzzi
`Timothy Cook
`Kevin Yurkerwich
`Michael Nelson
`WILMER CUTLER PICKERING HALE AND DORR LLP
`Heather.Petruzzi@wilmerhale.com
`Tim.Cook@wilmerhale.com
`Kevin.Yurkerwich@wilmerhale.com
`Michael.Nelson@wilmerhale.com
`
`
`
`7
`
`
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
