UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
`
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
`
`
`
`
`
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
`
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
`
`
`
`
`
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(c), the Board’s Scheduling Order (Paper 8),
`
`and the Federal Rules of Evidence, Petitioner Taro Pharmaceuticals U.S.A., Inc.
`
`hereby moves to exclude Exhibits 2006, 2008, 2010, 2014, 2015, and 2016
`
`submitted by Patent Owner Apotex Technologies, Inc.
`
`II.
`
`IDENTIFICATION OF ORIGINAL OBJECTIONS
`
`Petitioner timely objected to Exhibits 2006, 2008, 2010, 2014, 2015, and
`
`2016 on December 12, 2017. (Paper 10.)
`
`III. EXHIBIT 2006 IS INADMISSIBLE HEARSAY AND SHOULD BE
`EXCLUDED FROM THE RECORD
`
`Exhibit 2006 is a purported copy of an article titled “Longitudinal analysis
`
`of heart and liver iron in thalassemia major,” dated 2008. Exhibit 2006 is not
`
`prior art to the ’328 patent, which has an earliest effective priority date of June 30,
`
`2000. Patent Owner relied on Exhibit 2006 in its Preliminary Response as alleged
`
`evidence that “the liver and heart have different mechanisms of iron uptake and
`
`release.” (Paper 6 at 2.) Exhibit 2006 is thus relied on for the truth of the matter
`
`stated therein. Exhibit 2006 does not contain any independent indicia of
`
`trustworthiness and is therefore inadmissible hearsay not within any hearsay
`
`exception. The Board should therefore exclude and not consider Exhibit 2006.
`
`FRE 802, 803.
`
`
`
`
`
`
`
`IV. EXHIBIT 2008 IS IRRELEVANT, NOT AUTHENTICATED, AND
`INADMISSIBLE HEARSAY AND SHOULD BE EXCLUDED FROM
`THE RECORD
`
`The Board should exclude and not consider Exhibit 2008 for at least three
`
`independent reasons.
`
`First, Exhibit 2008 is not authenticated. Exhibit 2008 is a document titled
`
`“FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body.” Patent
`
`Owner’s Exhibit list states that Exhibit 2008 is an “internet publication” (Paper 6 at
`
`Exhibit List), but Patent Owner provides no authenticating evidence for this
`
`proposition. Thus, Exhibit 2008 is unauthenticated and the Board should therefore
`
`exclude and not consider this exhibit for that reason. FRE 901.
`
`Second, Exhibit 2008 is not relevant to this proceeding. Patent Owner relied
`
`on Exhibit 2008 as evidence that Ferrirpox® was allegedly approved by FDA in
`
`2011 after an accelerated review. (Paper 6 at 9.)1 The FDA approval of Ferriprox®
`
`is not relevant to any issues in this proceeding, which concerns only the
`
`unpatentability of the ’328 patent, and does not concern any particular product.
`
`Moreover, no record evidence establishes that the methods claimed in the ’328
`
`1 Apotex did not disclose that it first filed its application for approval for Ferriprox
`
`on December 21, 2006, and that it took five years to gain FDA approval for that
`
`drug. See https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825
`
`Orig1s000SumR.pdf.
`
`2
`
`
`
`
`
`patent are embodied by the FDA’s approval of Ferriprox®. Thus, the Board should
`
`exclude and not consider Exhibit 2008 under FRE 402 because it is not relevant
`
`under FRE 401. In the alternative, the Board should exclude and not consider
`
`Exhibit 2008 under FRE 403 because any probative value is substantially
`
`outweighed by the danger of unfair prejudice or confusing the issues.
`
`Third, Exhibit 2008 is inadmissible hearsay. Patent Owner relied on Exhibit
`
`2008 for the truth of the matter asserted therein. Exhibit 2008 does not contain any
`
`independent indicia of trustworthiness and is therefore inadmissible hearsay not
`
`within any hearsay exception. The Board should therefore exclude and not
`
`consider Exhibit 2008 for this reason. FRE 802, 803.
`
`V. EXHIBIT 2010 IS IRRELEVANT AND SHOULD BE EXCLUDED
`FROM THE RECORD
`
`Exhibit 2010 is a copy of the Claim Construction Opinion and Order issued
`
`in district court litigation Case No. 2:16-cv-00528 (E.D. Tex), in which the validity
`
`of the ’328 patent is one of many contested issues. The district court construed the
`
`contested claim terms under the Phillips standard, as appropriate in district court.
`
`The Board, however, must construe the claims according to the broadest
`
`reasonable interpretation in light of the specification of the ’328 patent. 37 C.F.R.
`
`§ 42.100(b). Because these two claim construction standards are different, the
`
`court’s claim construction order is irrelevant to the instant proceedings under FRE
`
`401, and should not be considered by the Board as controlling, or even as
`
`3
`
`
`
`
`
`persuasive. The Board should therefore exclude and not consider Exhibit 2010
`
`under FRE 402, or under FRE 403 because any probative value is substantially
`
`outweighed by the danger of unfair prejudice or confusing the issues.
`
`VI. EXHIBIT 2014 IS NOT AUTHENTICATED AND INADMISSIBLE
`HEARSAY AND SHOULD BE EXCLUDED FROM THE RECORD
`
`The Board should exclude and not consider Exhibit 2014 for at least two
`
`independent reasons.
`
`First, Exhibit 2014 is not authenticated. Exhibit 2014 is a document titled
`
`“Canadian Scientists Honored for Role in Breakthrough drug.” Patent Owner’s
`
`Exhibit list states that Exhibit 2014 is an “internet publication” (Paper 6 at Exhibit
`
`List), but Patent Owner provides no authenticating evidence for this proposition.
`
`Thus, Exhibit 2014 is unauthenticated and the Board should therefore exclude and
`
`not consider this exhibit for that reason. FRE 901.
`
`Second, Exhibit 2014 is inadmissible hearsay. Patent Owner relied on
`
`Exhibit 2014 as evidence that named inventor Dr. Michael Spino was allegedly
`
`praised by others for his work related to the ’328 patent. (Paper 6 at 59.) Exhibit
`
`2014 is thus relied on for the truth of the matter stated therein. Exhibit 2014 does
`
`not contain any independent indicia of trustworthiness and is therefore
`
`inadmissible hearsay not within any hearsay exception. The Board should
`
`therefore exclude and not consider Exhibit 2014. FRE 802, 803.
`
`4
`
`
`
`
`
`VII. EXHIBIT 2015 IS INADMISSIBLE HEARSAY AND SHOULD BE
`EXCLUDED FROM THE RECORD
`
`Exhibit 2015 is a purported copy of an article titled “Cardiovascular T2-star
`
`(T2*) magnetic resonance for the early diagnosis of myocardial iron overload.”
`
`dated 2001. Exhibit 2015 is not prior art to the ’328 patent, which has an earliest
`
`effective filing date of June 30, 2000. Patent Owner’s expert, Dr. Pennell, relied
`
`on Exhibit 2015 as alleged evidence that “there was no significant correlation
`
`between myocardial T2* and the conventional parameters of iron status, serum
`
`ferritin and liver iron.” (Ex. 2003 at ¶ 26.) Exhibit 2015 is thus relied on for the
`
`truth of the matter stated therein. Exhibit 2015 does not contain any independent
`
`indicia of trustworthiness and is therefore inadmissible hearsay not within any
`
`hearsay exception. The Board should therefore exclude and not consider Exhibit
`
`2015. FRE 802, 803.
`
`VIII. EXHIBIT 2016 IS INADMISSIBLE HEARSAY AND SHOULD BE
`EXCLUDED FROM THE RECORD
`Exhibit 2016 s a purported copy of an article titled “Comparison of effects of
`
`oral deferiprone and subcutaneous desferrioxamine on myocardial iron
`
`concentrations and ventricular function in beta-thalassaemia,” dated 2002.
`
`Exhibit 2016 is not prior art to the ’328 patent, which has an earliest effective
`
`filing date of June 30, 2000. Patent Owner’s expert, Dr. Pennell, relied on Exhibit
`
`2016 as alleged evidence that “myocardial iron cannot be predicted from liver iron
`
`5
`
`
`
`
`
`concentration.” (Ex. 2003 at ¶ 26.) Exhibit 2016 is thus relied on for the truth of
`
`the matter stated therein. Exhibit 2016 does not contain any independent indicia of
`
`trustworthiness and is therefore inadmissible hearsay not within any hearsay
`
`exception. The Board should therefore exclude and not consider Exhibit 2016.
`
`FRE 802, 803.
`
`
`
`Dated: June 28, 2018
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Robert V. Cerwinski (to seek pro hac vice
`admission)
`Sarah Fink (Reg. No. 64,886)
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`
`Counsel for Petitioner
`
`6
`
`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 28th day of June, 2018,
`
`I caused to be served a true and correct copy of the foregoing “PETITIONER’S
`
`MOTION TO EXCLUDE EVIDENCE” via electronic mail on the following
`
`By: /Ryan Curiel/
` Ryan Curiel
`
`attorneys of record:
`
`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
`
`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
`
`
`
`
`
`
`
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
