throbber
Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 1 of 7 PageID #: 3998
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`C.A. No. 1:14-1171-GMS
`(CONSOLIDATED)
`
`STIPULATION AND [PROPOSED] ORDER
`CONCERNING CLAIM CONSTRUCTION DISPUTE
`
`Plaintiffs, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd.,
`
`Teva Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively
`
`“Plaintiffs” or “Teva”) and Defendants Mylan Pharmaceuticals Inc. and Mylan Inc.
`
`(collectively “Mylan”), Synthon Pharmaceuticals Inc., Synthon B.V., Synthon s.r.o. and
`
`Pfizer, Inc. (collectively “Synthon”), Sandoz Inc. and Momenta Pharmaceuticals, Inc.
`
`(“Sandoz”), Dr. Reddy’s Laboratories Ltd. (“DRL Ltd.”) and Dr. Reddy’s Laboratories,
`
`Inc. (“DRL Inc.”) (collectively, “DRL”); and Amneal Pharmaceuticals LLC and Amneal
`
`Pharmaceuticals Company GmbH (collectively, “Amneal”) (collectively, “Defendants”)
`
`hereby stipulate and agree, subject to the approval of the Court, as follows:
`
`1.
`
`Each of the following phrases constitutes a claim limitation, because the
`
`claimed invention is directed to patients already taking 20 mg glatiramer
`
`acetate daily by subcutaneous administration:
`
`U.S. Patent 9,155,776 patent (the “’776 patent”):
`
`
`
`“while inducing reduced severity of injection site reactions in the
`
`human patient relative to administration of 20 mg of glatiramer acetate
`
`1
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 2 of 7 PageID #: 3999
`
`s.c. daily” and “with reduced severity of injection site reactions
`
`relative to administration of 20 mg of glatiramer acetate s.c. daily”
`
`(claim 1);
`
`
`
`“induces reduced frequency and severity of immediate post injection
`
`reactions and injection site reactions in the human patient relative to
`
`administration of 20 mg of glatiramer acetate s.c. daily” (claim 2);
`
`
`
`“with reduced severity of
`
`injection site reactions
`
`relative to
`
`administration of 20 mg of glatiramer acetate s.c. daily” (claim 5);
`
`
`
`“induces reduced frequency and severity of immediate post injection
`
`reactions and injection site reactions in the human patient relative to
`
`administration of 20 mg of glatiramer acetate s.c. daily” (claim 9);
`
`
`
`“with reduced severity of
`
`injection site reactions
`
`relative to
`
`administration of 20 mg of glatiramer acetate s.c. daily” (claim 12);
`
`
`
`“with reduced frequency and severity of immediate post injection
`
`reactions and injection site reactions relative to administration of 20
`
`mg of glatiramer acetate s.c. daily” (claim 13);
`
`
`
`“with reduced severity of
`
`injection site reactions
`
`relative to
`
`administration of 20 mg of glatiramer acetate s.c. daily” (claim 16);
`
`
`
`“which treats the human patient with reduced frequency and severity
`
`of immediate post
`
`injection reactions and injection site reactions
`
`relative to administration of 20 mg of glatiramer acetate s.c. daily”
`
`(claims 21-24);
`
`2
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 3 of 7 PageID #: 4000
`
`
`
`“improving the tolerability of glatiramer acetate treatment” (claim 12);
`
`and
`
`
`
`“improving the tolerability of glatiramer acetate therapy” (claim 16);
`
`U.S. Patent 8,232,250 (the “’250 patent”)
`
`
`
`“wherein the frequency of an immediate post injection reaction or the
`
`frequency of an injection site reaction is reduced relative to daily
`
`subcutaneous administration of 20 mg glatiramer acetate” (claim 14);
`
`
`
`
`
`“increasing the tolerability of GA treatment” (claim 15);
`
`“so as to thereby increase the tolerability of GA treatment in the
`
`patient” (claim 15);
`
`
`
`“wherein increasing the tolerability of glatiramer acetate treatment in
`
`the human patient suffering from a relapsing form of multiple sclerosis
`
`comprises reducing the frequency of an immediate post
`
`injection
`
`reaction” (claim 16); and
`
`
`
`“wherein increasing the tolerability of glatiramer acetate treatment in
`
`the human patient suffering from a relapsing form of multiple sclerosis
`
`comprises reducing the frequency of an injection site reaction” (claim
`
`17);
`
`U.S. Patent 8,399,413 (the “’413 patent”):
`
`
`
`“wherein the frequency of an immediate post injection reaction or the
`
`frequency of an injection site reaction is reduced relative to daily
`
`subcutaneous administration of 20 mg glatiramer acetate” (claim 7).
`
`3
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 4 of 7 PageID #: 4001
`
`1.
`
`Regarding the ’776 patent and the construction of the terms “reduced
`
`severity of injection site reactions” and “reduced frequency and severity of
`
`immediate post injection reactions and injection site reactions”:
`
`
`
`“Frequency” means the rate of occurrence of a patient’s ISRs and/or
`
`IPIRs; and
`
`
`
`“Severity” means the intensity of a patient’s ISRs and/or IPIRs.
`
`SO AGREED AND STIPULATED
`
`Date: February 10, 2016
`
`4
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 5 of 7 PageID #: 4002
`
`BAYARD, P.A.
`
`SHAW KELLER LLP
`
`/s/ Stephen B. Brauerman
`Richard D. Kirk (No. 922)
`Stephen B. Brauerman (No. 4952)
`Vanessa R. Tiradentes (No. 5398)
`Sara E. Bussiere (No. 5725)
`222 Delaware Avenue, Suite 900
`Wilmington, DE 19801
`(302) 655-5000
`rkirk@bayardlaw.com
`sbrauerman@bayardlaw.com
`vtiradentes@bayardlaw.com
`sbussiere@bayardlaw.com
`
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James
`GOODWIN PROCTER LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 346-4000
`
`Attorneys for Plaintiffs Teva
`Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries, Ltd., Teva
`Neuroscience, Inc. and Yeda
`
`/s/ John W. Shaw
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James
`GOODWIN PROCTER LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 346-4000
`
`Attorneys for Plaintiffs Teva
`Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries, Ltd., Teva
`Neuroscience, Inc. and Yeda
`
`5
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 6 of 7 PageID #: 4003
`
`RICHARDS, LAYTON & FINGER, P.C.
`
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`
`/s/ Arun J. Mohan
`Frederick L. Cottrell, III (No. 2555)
`Arun J. Mohan
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`Shannon M. Bloodworth
`PERKINS COIE LLP
`700 13th Street, NW
`Washington, DC 20005
`(202) 654-6204
`Attorneys for Mylan Inc., Mylan
`Pharmaceuticals Inc. and Natco Pharma Ltd.
`
`/s/ John C. Phillips, Jr.
`John C. Phillips, Jr. (No. 110)
`David A. Bilson (No. 4986)
`1200 North Broom Street
`Wilmington, DE 19806
`jcp@pgslaw.com
`dab@pgslaw.com
`
`Constance S. Huttner
`Beshoy M. Sharoupim
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`(973) 315-4430
`
`Attorneys for DRL Defendants
`
`SMITH KATZENSTEIN & JENKINS LLP
`
`PROCTOR HEYMAN LLP
`
`/s/ Dominick T. Gattuso
`Dominick T. Gattuso (No. 3630)
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(308) 472-7300
`DGattuso@proctorheyman.com
`William A. Rakoczy
`Deanne M. Mazzochi
`Rachel Pernic Waldron
`RAKOCZYMOLINOMAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`(312) 222-7543
`wrakoczy@rmmslegal.com
`dmazzochi@rmmslegal.com
`rwaldron@rmmslegal.com
`
`Attorneys for Defendants Sandoz Inc.
`and Momenta Pharmaceuticals, Inc.
`
`/s/ Eve H. Ormerod
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`P.O. Box 410
`Wilmington, DE 19899 (courier 19801)
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`E. Anthony Figg
`Sharon L. Davis
`R. Elizabeth Brenner-Leifer
`Seth E. Cockrum
`Jennifer Nock
`ROTHWELL, FIGG, ERNST &
`MANBECK, P.C.
`607 14th Street, NW, Suite 800
`Washington, DC 20005
`(202) 783-6040
`
`Attorneys for Synthon Pharmaceuticals Inc.,
`Synthon B.V, Synthon s.r.o., and Pfizer, Inc.
`
`6
`
`

`
`Case 1:14-cv-01171-GMS Document 190 Filed 02/10/16 Page 7 of 7 PageID #: 4004
`
`DUANE MORRIS LLP
`
`/s/ Richard L. Renck
`Richard L. Renck (No. 3893)
`222 Delaware Avenue, Suite 1600
`Wilmington, DE 19801-1659
`(302) 657-4900
`
`Anthony J. Fitzpatrick
`Vincent L. Capuano
`Christopher S. Kroon
`Carolyn A. Alenci
`DUANE MORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110-1724
`(857) 488-4200
`
`Attorneys for Amneal Pharmaceuticals LLC
`
`IT IS SO ORDERED this ___ day of February, 2016.
`
`_________________________
`United States District Judge
`
`7

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket