`
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., and SUN PHARMA GLOBAL FZE,
`Petitioners,
`v.
`NOVARTIS AG,
`Patent Owner.
`______________________
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`PATENT OWNER NOVARTIS’S SUPPLEMENTAL
`MOTION TO EXCLUDE
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`
`joined with this proceeding.
`
`
`
`
`
`
`
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`The parties agreed that Novartis could object to and serve a supplemental
`
`motion to exclude on evidence submitted with Petitioners sur-reply on Novartis’s
`
`motion to amend. (Paper 74.) Novartis filed objections on April 23, 2018 (Paper
`
`87), and hereby moves to exclude the Exhibits 1065-1069 cited in the sur-reply as
`
`untimely under the Board’s rules, and for lack of any relevance foundation under
`
`Fed. R. Evid. 401-403.
`
`First, Petitioners submitted these five Exhibits for the first time with their sur-
`
`reply, without any expert testimony or other evidence to lay any foundation
`
`whatsoever. Petitioners’ offer only new attorney argument about the purported
`
`content of these documents in their sur-reply, which is improper and too late. The
`
`Exhibits should be excluded on this basis alone. 37 C.F.R. 42.23(b).
`
`Second, these Exhibits are five patents or patent applications, two of which
`
`are not even prior art to the ’405 Patent. (Exhibits 1069 and 1068.) Exhibit 1069
`
`was published on September 8, 2017, and Exhibit 1068 was published on December
`
`24, 2008, both years after the priority date of the ’405 patent. These two Exhibits
`
`should be excluded as irrelevant for this reason alone.
`
`All of the Exhibits are also outside the field of multiple sclerosis and thus
`
`irrelevant. Exhibit 1065 is a U.S. Patent directed to “methods and products for
`
`stimulating hematopoiesis.” (Ex. 1065, Abstract.) Exhibit 1066 is a publication of
`
`a U.S. patent application directed to methods for treating individuals having a
`
`1
`
`
`
`
`
`hepatitis C virus infection. (Ex. 1066, Abstract.) Exhibit 1067 is a PCT publication
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`directed to methods of reducing liver fibrosis, and methods of increasing liver
`
`function and methods of reducing the incidence of complications associated with
`
`HCV and cirrhosis of the liver. (Ex. 1067, Abstract.) Exhibit 1068 is a PCT
`
`publication directed to methods and drug products for treating inflammatory joint
`
`disease. (Ex. 1068, Abstract.) And, Exhibit 1069 is a PCT publication directed to a
`
`method combining a checkpoint inhibitor and a glucocorticoid receptor modulator
`
`to treat cancer. (Ex. 1069, Abstract.) None of the documents even mention
`
`fingolimod, and no expert or other evidence purports to link these documents to the
`
`therapeutic field at issue here, i.e., treatments for multiple sclerosis using
`
`fingolimod. These documents are therefore irrelevant.
`
`Third, Petitioners argue that these patent documents show that “[m]ethods of
`
`treatment routinely employ more than one dosing regimen for a given active at
`
`different times.” (Paper 85 at 10.) From this, Petitioners say that the close-ended
`
`dosing regimen described in the proposed amended claims as “consisting of” daily
`
`0.5 fingolimod doses allegedly still leaves open the possibility of other dosing
`
`regimens for the drug.
`
`The point Petitioners say these documents make is irrelevant—if anything, the
`
`documents prove Novartis’s point. In these documents, each separate dosing
`
`regimen is discussed as a separate thing, typically separated by time. Each dosing
`
`
`
`2
`
`
`
`
`
`
`
`regimen is modified with an adjective such as “first” or “second” or “induction” or
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`“maintenance.” (Paper 85 at 10.) No such language appears in the ’405 Patent
`
`specification or the proposed amended claims. Rather, the Patent and the proposed
`
`amended claims speak of only one dosing regimen for fingolimod, and the claim
`
`amendments make clear that any such regimen would be limited solely to 0.5 mg
`
`daily. That would exclude a loading dose or any other dosing scheme. Thus, the
`
`Exhibits proffered by Petitioners are prejudicial in that they distract from the
`
`appropriate time period and from the relevant factual language used in the
`
`specification at issue in this case.
`
`These new documents accordingly are irrelevant, prejudicial, without
`
`foundation, and should be excluded under Fed. R. Evid. 401–403.
`
`Dated: April 30, 2018
`
`Respectfully submitted,
`
`
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`
`
`3
`
`
`
`
`
`
`
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on April 17, 2018, true and
`
`accurate copies of the foregoing MOTION TO EXCLUDE for IPR2017-00854 were
`
`served via electronic mail, on the following counsel of record for Petitioners:
`
`For Apotex:
`
`For Argentum:
`
`For Sun:
`
`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`Winston & Strawn LLP
`35 W. Wacker Drive
`
`4
`
`
`
`
`
`
`For Teva:
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: greg.springsted@kirkland.com
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
`
`Respectfully submitted,
`
`
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`Dated: April 30, 2018
`
`
`
`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
