Tafas v. Dudas et al

Filing 39

MOTION for Leave to File Amicus Brief in Support of the "GSK" Plaintiffs' Motion for A temporary Restraining Order and Preliminary Injunction by Elan Pharmaceuticals, Inc.. (Attachments: # 1 Exhibit Memorandum in Support of Motion for Leave# 2 Exhibit Elan's Amicus Brief# 3 Exhibit Battle Declaration to Amicus Brief# 4 Proposed Order)Associated Cases: 1:07-cv-00846-JCC-TRJ, 1:07-cv-01008-JCC-TRJ(Carr, Rebecca) Modified on 10/31/2007 to reflect the title of docket entry (klau, ).

Tafas v. Dudas et al

Doc. 39 Att. 1

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 1 of 6

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA (Alexandria Division) ____________________________________ TRIANTAFYLLOS TAFAS, ) ) Plaintiff, ) ) v. ) Civil Action No. 1:07cv846 (JCC/TRJ) ) JON W. DUDAS, et al. ) ) Defendants. ) ____________________________________) CONSOLIDATED WITH ____________________________________ ) SMITHKLINE BEECHAM ) CORPORATION, et al. ) ) Plaintiffs, ) ) v. ) ) JON W. DUDAS, et al. ) ) Defendants. ) ____________________________________)

Civil Action No. 1:07cv1008 (JCC/TRJ)

MEMORANDUM IN SUPPORT OF AMICUS CURIĆ ELAN PHARMACEUTICAL CORPORATION'S MOTION FOR LEAVE TO FILE ITS BRIEF IN SUPPORT OF THE "GSK" PLAINTIFFS' MOTION FOR A TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION Elan Pharmaceuticals, Inc., on behalf of itself and its parent and affiliates (herein collectively referred to as "Elan") submits this memorandum in support of its Motion for leave to file its brief as amicus curić in support of SmithKline Beecham Corporation, SmithKline Beecham PLC and Glaxo Group Limited's Motion for a Temporary Restraining Order and Preliminary Injunction ("Brief").

Dockets.Justia.com

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 2 of 6

Elan is a biotechnology company that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain. Elan wishes to submit its amicus Brief addressing the likelihood of success on the merits, irreparable harm, and public interest prongs of the pending Motion for Temporary Restraining Order and Preliminary Injunction. Allowing a non-party to file an amicus curić brief is within the discretion of the Court. DeJulio v. Georgia, 127 F. Supp. 2d 1274, 1284 (N.D. Ga. 2001). The filing of an amicus brief should be allowed where the amicus curić can "offer insights not available from the parties" or can provide "unique information or perspective that can help the court beyond the help that the lawyers for the parties are able to provide." Citizens Against Casino Gambling in Erie County v. Kempthorne, 471 F. Supp. 2d 295, 311 (W.D.N.Y. 2007). Here, while Elan concurs with GSK's assertion that the "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications," 72 Fed. Reg. 46716 (Aug. 21, 2007) (to be codified at 37 C.F.R. pt. 1) (hereinafter "Final Rules") are ultra vires, Elan's Brief expands on GSK's position that the Final Rules improperly shift the burden of examining a patent application from the U.S. Patent and Trademark Office ("PTO") to the applicant. This burden shifting is contrary to law and serves as a basis to overturn the Final Rules. Similarly, Elan's Brief supports the irreparable harm prong and provides additional insight into how Elan and other patent applicants would suffer irreparable harm through the implementation of the Final Rules. Some of this harm would result from Elan and other pharmaceutical companies' reluctance to invest heavily in research and development of new drugs since the patent protection on drugs will not be as effective and will not allow Elan to

2

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 3 of 6

recoup its development costs. This would in turn, lead to fewer life saving drugs and higher prices for any drugs that are developed. This argument also supports the public interest prong of the preliminary injunction test as it establishes that the public interest would be harmed if an injunction did not issue. Elan's Motion is filed a mere 14 days after GSK initially filed its Motion for Preliminary Injunction and is therefore timely. As Elan's Brief includes unique and special information not otherwise available to this Court, the Court should exercise its discretion to allow the filing of Elan's Brief. Elan also requests that the Court deem Elan's Brief filed upon the granting of this motion without requiring a separate filing. Elan has contacted counsel for plaintiffs GSK and Tafas who consent to the filing of Elan's Brief. Counsel for defendants John Dudas and the PTO oppose Elan's Motion and the filing of its Brief.

Dated: October 29, 2007 By:

Respectfully submitted, /s/ Rebecca M. Carr (VSB # 70874) PILLSBURY WINTHROP SHAW PITTMAN, LLP 2300 N Street, N.W. Washington, D.C. 20037 Tel: [phone] Fax: [phone] e-mail: [e-mail]

3

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 4 of 6

Of Counsel Vincent J. Napoleon PILLSBURY WINTHROP SHAW PITTMAN, LLP 2300 N Street, N.W. Washington, D.C. 20037

Scott J. Pivnick (VSB # 48022) PILLSBURY WINTHROP SHAW PITTMAN, LLP 1650 Tysons Boulevard McLean, Virginia 22102-4856 Tel: [phone] Fax: [phone] e-mail: [e-mail] ATTORNEYS FOR AMICUS CURIĆ ELAN PHARMACEUTICALS, INC.

4

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 5 of 6

CERTIFICATE OF SERVICE I hereby certify that on this 29th day of October 2007, I electronically filed in Case Nos. 1:07cv1008 and 1:07cv846 (JCC/TRJ) the foregoing "MEMORANDUM IN SUPPORT OF AMICUS CURIĆ ELAN PHARMACEUTICAL CORPORATION'S MOTION FOR LEAVE TO FILE ITS BRIEF IN SUPPORT OF THE `GSK' PLAINTIFFS' MOTION FOR A TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION" using the CM/ECF system and that service was thereby accomplished on: Elizabeth M. Locke, Esq. KIRKLAND & ELLIS LLP 655 15th Street, NW ­ Suite 1200 Washington, DC 20005 e-mail: [e-mail] and Craig C. Reilly, Esq. RICHARD MCGETTIGAN REILLY & WEST PC 1725 Duke Street, Suite 600 Alexandria, VA 22314 e-mail: [e-mail] Attorneys for Plaintiffs in Civil Action No. 1:07cv1008 (JCC/TRJ) and Lauren A. Wetzler, Esq. United States Attorney's Office 2100 Jamison Ave. Alexandria, VA 22314 e-mail: [e-mail] Attorney for Defendants in Civil Action Nos. 1:07cv1008 (JCC/TRJ) and 1:07cv846 (JCC/TRJ)

Case 1:07-cv-00846-JCC-TRJ

Document 39-2

Filed 10/29/2007

Page 6 of 6

I further certify that on this 29th day of October 2007, I caused a copy of the foregoing to be served by U.S. Mail, postage prepaid, upon: Joseph Dale Wilson, III, Esq. KELLEY DRYE & WARREN LLP Washington Harbour 3050 K Street NW, Suite 400 Washington, DC 2007 E-mail: [e-mail] Counsel for Plaintiff in Civil Action No. 1:07cv846 (JCC/TRJ)

/s/ Rebecca M. Carr (VSB # 70874) PILLSBURY WINTHROP SHAW PITTMAN, LLP 2300 N Street, N.W. Washington, D.C. 20037 Tel: [phone] Fax: [phone] e-mail: [e-mail]