IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 7,932,268 to Rader
`Filing Date: June 21, 2007
`Issue Date: April 26, 2011
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
`
`Inter Partes Review No.: IPR2015-01836
`
`
`
`PETITIONER’S OPPPOSITION TO PATENT OWNER’S
`
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 7,932,268 to Rader
`Filing Date: June 21, 2007
`Issue Date: April 26, 2011
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
`
`Inter Partes Review No.: IPR2015-01836
`
`
`
`PETITIONER’S OPPPOSITION TO PATENT OWNER’S
`
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`Petitioner, Coalition For Affordable Drugs VIII, LLC opposes Patent Owner
`
`The Trustees of the University of Pennsylvania motion to exclude Exhibits 1024,
`
`1025, and 1050-1056 submitted by Petitioner.
`
`
`
`A. Exhibits 1024 and 1025
`
`Patent Owner argues
`
`that Exhibits 1024 and 1025 has not been
`
`authenticated. In particular, Patent Owner argues that “Petitioner has failed to
`
`provide any witness testimony whatsoever regarding the websites from where it
`
`allegedly obtained Exhibits 1024 and 1025, let alone any testimony from a witness
`
`with personal knowledge that the printouts themselves are authentic.”
`
`Patent Owner fails to address the fact that Petitioner submitted the
`
`Declaration of Jeffrey Marx, an attorney and member in good standing of the Bars
`
`of the State of Illinois (2005) and the State of Wisconsin (2005). Exh. 1034. In
`
`that declaration, Mr. Marx authenticated both Exhibits 1024 and 1025. Contrary to
`
`Patent Owner’s assertions (“it appears that Petitioner would contend that Exhibits
`
`1024 and 1025 are webpage printouts. But the Petition makes no attempt to
`
`establish the province of these exhibits”), Mr. Marx provided in his declaration the
`
`website address at which both of these documents could be found. In its motion,
`
`Patent Owner completely ignores the contents of Mr. Marx’s declaration.
`
`1
`
`
`
`
`
`Patent Owner seemingly argues that the information within the documents
`
`has not been authenticated. In this regard, Patent Owner argued, “Petitioner cites
`
`these exhibits on page 4 of the Petition, to support its allegation regarding the
`
`purported price of JUXTAPID.” Patent Owner, however, never contested the
`
`values cited in Petitioner’s exhibits or provided the actual prices cited in these
`
`documents in any of the numerous papers and exhibits filed by the Patent Owner.
`
`And considering Patent Owner is undoubtedly the best source of such information,
`
`it should hardly be heard to complain about the lack of authenticity of information
`
`it controls.
`
`B.
`
`Exhibits 1046-1051
`
`Exhibits 1046-1051 are the FDA labels for a number of drugs for the
`
`treatment of hypercholesterolemia. Patent Owner objected that the exhibits were
`
`not authenticated. Petitioner responded by submitting the Declaration of
`
`Christopher Casieri (Exhibit 1057) swearing to the authenticity of the labels and
`
`identifying the exact address on the FDA website at which each label could be
`
`located.
`
`Patent Owner seemingly concedes these facts but maintains that the labels
`
`have not been authenticated. In this regard, Patent Owner merely states that
`
`offered proofs “are insufficient to authenticate the labels”. Patent Owner fails to
`
`identify what specifically about the Declaration of Christopher Casieri is
`
`2
`
`
`
`
`
`insufficient to authenticity of the documents.
`
` While not necessary for
`
`authentication, the Declaration provides the specific address where the label is
`
`available.
`
`Patent Owner then argues that the labels are not relevant to prove the state of
`
`the art as of March 7, 2005. The dates of availability of these drugs however are
`
`not contested facts. Statins have been around long before 2005. See for example
`
`testimony of Dr. Richard Gregg:
`
`Q Do you know, at the time that BMS discontinued development on
`lomitapide, were statins commercially available?
`A Yes.
`Q Do you know how long statins had been around at that time?
`A Approximately 10 years. (Ex. 1053, Gregg at 35:18-24)
`
`
`See also, Patent Owner’s Exhibit 2019 reporting the so called “CURVES study” in
`
`1998 comparing five statins. As for ezetimibe, Patent Owner’s expert cites to
`
`several pre-2005 articles describing the ezetimibe alone and in combination with
`
`statins. See Ex. 2179 (Earl, J., et al., Ezetimbe, Nature Reviews, Vol. 2, 2003, 97);
`
`Ex. 2175 (Catapano, A.L., Ezetimibe: a selective inhibitor of cholesterol
`
`absorption, European Heart Journal Supplements (2001) 3 (Supplement E), E6-
`
`E10); Ex. 2182 (Gagne, C., et al., Efficacy and Safety of Ezetimibe
`
`Coadministered With Atorvastatin or Simvastatin in Patients with Homozygous
`
`Familial Hypercholesterolemia, Circulation, 2002; 105:2469-2475).
`
`
`
`Accordingly, the labels are both authenticated and relevant.
`
`3
`
`
`
`
`
`C. Exhibit 1052 (Kimball Deposition Transcript)
`
`Patent Owner filed Exhibit 2304 on August 10, 2016, which is reportedly the
`
`same as Exhibit 1052, for no obvious reason. Exhibits 2304 and 1052 are
`
`transcripts of the deposition of Petitioner's expert. The party taking a deposition
`
`typically files the transcript with the Board. In this instance, the Petitioner's Reply
`
`cites to the transcript as Exhibit 1052. Patent Owner does not cite to either exhibit.
`
`In response to the Patent Owner’s rejection, Petitioner suggested Patent Owner
`
`should delete Exhibit 2304, which they apparently refused.
`
`
`
`Date: November 10, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`Christopher Casieri
`
`
`
`
`
`
`
`4
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
` The undersigned hereby certifies that the foregoing PETITIONER’S
`
`OPPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`list for this proceeding were served on November 10, 2016 by delivering copies via
`
`electronic mail on the following attorneys of record for the Patent Owner.
`
`Lead Counsel
`William G. James
`(Reg. No. 55,931)
`GOODWIN PROCTER LLP
`901 New York Avenue NW
`Washington, DC 20001
`Tel: 202-346-4046
`Fax:202-346-4444
`wjames@goodwinprocter.com
`
`Backup Counsel
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109-2881
`Tel: 617-570-1913
`Fax:617-523-1231
`nmitrokostas@goodwinprocter.com
`
`Cynthia Lambert Hardman
`(Reg. No. 53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-459-7295
`Fax:212-355-3333
`chardman@goodwinprocter.com
`
`
`
`Date: November 10, 2016
`
`Respectfully Submitted,
`
`/Gregory J. Gonsalves/
`Dr. Gregory J. Gonsalves (Reg. No. 43,639)
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`
`
`5
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
