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EXHIBIT 1
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Vern Winters/SV/WGM/US 03/20/2008 10:25 AM To [email protected] cc Subject Re: PDL v. Alexion
Dear Gerald: We write in response to Alexion's request that PDL BioPharma stipulate that Alexion does not infringe claims that PDL has not asserted, which you correctly refer to as the "unasserted claims." The request is not appropriate. PDL has not asserted the unasserted claims against Alexion, and there is no case or controversy between the parties with respect to those claims. Best regards, Vern ***************** Vernon M. Winters Weil, Gotshal & Manges LLP Silicon Valley Office 201 Redwood Shores Parkway Redwood Shores, CA 94065 t: 650.802.3005 f: 650.802.3100 m.: 650.339.5037 w: www.weil.com "Gerald J Flattmann Jr"
"Gerald J Flattmann Jr "
To [email protected] cc Subject PDL v. Alexion
Dear Vern: Thanks for talking this morning about PDL's pending motion to dismiss Alexion's counterclaim of invalidity as to "unasserted claims." I asked you whether PDL would be willing to stipulate to Alexion's non-infringement of the claims of the three patents-in-suit that have yet to be specifically asserted by PDL. I would be grateful if PDL would consider that question and get back to us with an answer in the next day or two. Best regards, Gerald ***********************************************************
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The information contained in this communication is confidential, may be attorney-client privileged, may constitute inside information, and is intended only for the use of the addressee. It is the property of Kirkland & Ellis LLP or Kirkland & Ellis International LLP. Unauthorized use, disclosure or copying of this communication or any part thereof is strictly prohibited and may be unlawful. If you have received this communication in error, please notify us immediately by return e-mail or by e-mail to [email protected], and destroy this communication and all copies thereof, including all attachments. ***********************************************************
< END >
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EXHIBIT 2
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AUSTIN BOSTON
BRUSSELS BUDAPEST DALLAS FRANKFURT
WEll, GOTSHAl& MANGES LLP
SILICON VALLEY OFFICE
201 REDWOOD SHORES PARKWAY
REDWOOD SHORES, CALIFORNIA 94065
(650) 802-3000 FAX: (650) 802-3100
HOUSTON LONDON
MIAMI
MUNICH
NEW YORK
PARIS PRAGUE PROVIDENCE SHANGHAI SINGAPORE WARSAW WASHINGTON, D.C.
VERNON M. WINTERS
DIRECT LINE (650) 802-3005 E-MAIL: vern.winters(gweil.com
Februar 27, 2008
VI
EMAI
Gerald Flattman, Esq.
Kirkland & Ellis LLP 153 E. 53rd Street New York, NY 10022-461 1 GFlattmannØ)kirkland. com
Re: PDL BioPharma, Inc. v. Alexion Pharmaceuticals, Inc. D. Del. Case No. 07-156
Dear Gerald:
Plaintiff, PDL BioPhara, Inc., provides the following list of claim term or phrases for, absent agreement by the paries, construction by the Court with respect to the asserted claim ofPDL's U.S. Patents Nos. 5,693,761,5,693,762, and 6,180,370.
PDL's investigation is ongoing and the defendant, Alexion
Pharmaceuticals, Inc., has not yet disclosed to PDL its list of term and claim elements
for construction. In addition, and in violation of an agreement between the paries,
defendant has failed to identify with any sort of reasonable specificity its invalidity contentions. Accordingly, PDL reserves its right to supplement, amend, or modify this disclosure.
1. "acceptor immunoglobulin";
2. "complementarity determning regions (CDRs) from a (the) donor
immunoglobulin" ;
(#289548)
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Gerald Flattmann, Esq.
Februar 27,2008
Page 2
3. "donor immunoglobulin";
4. "variable region framework"; and
5. "is at least 65% (70%) identical to the (sequence of the) donor
imunoglobulin heavy (light) chain variable region framework."
cc: Josy Ingersoll, Esq. (via email) Karen Jacobs Louden, Esq. (via email) Wendy Adam (via email)
(JlngersollØ)ycst.com) (KLoudenØ)NAT.com) (WAdamØ)kikland.com)
(#289548)
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EXHIBIT 3
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EXHIBIT 4
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PDL BIOPHARMA, INC., Plaintiff,
V.
C.A. NO. 07-156-JJF
ALEXION PHARMACEUTICALS, INC., ) Defendant.
)
ALEXION PHARMACEUTICALS, INC.'S FIRST SUPPLEMENTAL RESPONSE TO PDL BIOPHARMA, INC.'S INTERROGATORY NO. 3
Pursuant to Federal Rule of Civil Procedure 33 and Local Rule 26.1, Defendant Alexion Pharmaceuticals, Inc. ("Alexion") hereby submits its first supplemental response to Plaintiff PDL BioPharma, Inc.'s ("PDL's") Interrogatory No. 3 to Alexion Pharmaceuticals, Inc. Pursuant to Federal Rule of Civil Procedure 26(e), Alexion reserves the right to supplement its responses to these interrogatories if it learns of additional information.
GENERAL OBJECTIONS
Alexion hereby incorporates by reference its General Objections set forth in Alexion Pharmaceuticals, Inc.'s Objections And Responses To PDL Biopharma, Inc.'s First Set Of Interrogatories and makes said General Objections part of its response to each interrogatory.
SPECIFIC OBJECTIONS AND RESPONSES INTERROGATORY NO. 3:
Separately for each claim in each of the Patents-In-Suit, please state all facts, and identify all witnesses to any facts, that You contend support Your second defense set forth in paragraph 33 of Alexion's Answer and Counterclaims that the Patents-In-Suit are invalid.
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RESPONSE TO INTERROGATORY NO. 3:
Alexion objects to this interrogatory to the extent that it seeks information, documents or things that are protected by the attorney-client privilege, attorney work product doctrine, or any other applicable privilege or immunity. Alexion objects to this interrogatory as premature and unduly burdensome because it purports to require Alexion to set forth separate invalidity defenses for over 85 claims prior to PDL's identification of the asserted claims. Alexion further objects to this interrogatory as premature in that it seeks expert opinions prior to the time set for expert discovery by the proposed August 21,2007 Scheduling Order. Alexion will supplement its response in accordance with the Scheduling Order or as otherwise allowed by the Court or Federal or Local Rules. Subject to the foregoing objections and its General Objections, Alexion responds as follows. Each of the claims of the patents in suit are invalid for failure to meet the patentability requirements of one or more of 35 U.S.C. 5 101, 102, 103, and 112. For example, several claims of the patents-in-suit are invalid because they do not meet the patentability requirements of 35 U.S.C.
5 112. The specifications of the '762, '763 and
'370 patents do not provide an adequate written description to support the patentability of each claim of the respective patents. Similarly, the specifications of the '762, '763 and '370 patents do not fully enable the scope of the purported inventions claimed. Several claims of the patents-in-suit are invalid under 35 U.S.C. 5 101 because the claims are inoperable. The majority, if not all, of t'he claims of the patents-in-suit are invalid because they are anticipated by or obvious in view of the prior art andlor the knowledge of one of ordinary skull in the art. Examples of prior art references that render the patents invalid, either alone or in combination, include but are not limited to, Chothia & Lesk, The Relation Between
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the Divergence o Sequence and Structure in Proteins, EMBO Journal 5(4):823-26 (1986); Jones f et al., Replacing the Complementarity Determining Regions in a Human Antibody With Those From a Mouse, Nature 321 522-25 (1986); Riechrnann et al., Reshaping Human Antibodiesfor Therapy, Nature 322:323-27 (1988); and Winter, EP 0239400.
SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 3
Alexion objects to this interrogatory as improperly requiring Alexion to "state all facts" and "identify all witnesses to any facts'' in support of its invalidity defenses before PDL has provided its contentions as to Alexion's i&ingement. Alexion further objects to this interrogatory as premature given that it seelts expert opinion testimony prior to the disclosure dates set forth in the Federal Rules of Civil Procedure 26(a)(2)(C) and the Court's August 21, 2007 Scheduling Order. Alexion further objects to this interrogatory as premature given that PDL has not yet provided any claim construction contentions and the Court has not yet issued any claim construction decision. Alexion further objects to this interrogatory to the extent that it seeks information that is protected from disclosure under the attorney-client privilege andlor the attorney work product doctrine. Subject to these specific objections and its General Objections, Alexion further responds to this interrogatory as follows. Alexion states that Claims 1-19 and 26-3 7 of the '76 1 patent, Claims 1-20 of the '762 patent, and Claims 1-30 of the '370 patent are invalid for at least the following reasons. Alexion reserves the right to supplement its contentions in accordance with Federal Rule of Civil Procedure 26(e). Alexion states that Claims 1-19 and 26-37 of the '761 patent, Claims 1-20 of the '762 patent, and Claims 1-30 of the '370 patent are invalid for lack of utility under 35 U.S.C.
g 101.
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Alexion states that Claims 1-1 9 and 26-37 of the '761 patent, Claims 1-20 of the
'762 patent, and Claims 1-30 of the '370 patent are invalid under 35 U.S.C.
5 102(a),(b) andlor
5 103 over at least the following prior art:
1. 2.
Jones et al. "Replacing the Complementarity Determining Regions In A Human Antibody With Those From A Mouse." Nature, 321 :522-25 (1986); Riechrnann et al. "Reshaping Human Antibodies For Therapy." Nature, 322:32327 (1988);
6. 7. 8.
Chothia et al. "Cannonical Structures For The Hypervariable Regions of Immunoglobulins."J. Mol. Biol., 196:901-17 (1987); Verhoeyen et al. "Reshaping Human Antibodies: Grafting An Antilysozyme Activity." Science, 239:1534-36 (1988); De la Paz et al. "Modelling Of The Combining Sites Of Three Anti-Lysozyme Monoclonal Antibodies And Of The Complex Between One Of The Antibodies And Its Epitope." EMBO Journal, 5:2,415-25 ( 1 986); Alzari et al. "Three-Dimensional Structure Of Antibodies." Ann. Rev. Immunol., 6:555-80 (1988);
9.
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10. 11.
Amit et al. "Three-dimensional Structure Of An Antigen-Antibody Complex at 2.8 8+ Resolution." Science, 233:747-53 (1986); and Poljak et al. "Amino Acid Sequence Of The Vh Region of a Human Myeloma Immunoglobulin (IgG New)." Biochemistry, 16:3412-20 (1977). Alexion states that Claims 1-19 and 26-37 of the '76 1 patent, Claims 1-20 of the
'762 patent, and Claims 1-30 of the '370 patent are invalid under 35 U.S.C. !j 112 as the specifications of the '762, '763 and '370 patents do not provide an adequate written description to support the patentability of each claim of the respective patents. Alexion states that Claims 1-19 and 26-37 of the '761 patent, Claims 1-20 of the '762 patent, and Claims 1-30 of the '370 patent are invalid under 35 U.S.C. !j 112 as the specifications of the '762, '763 and '370 patents do not fully enable the scope of the purported inventions claimed. Alexion states that Claims 1-19 and 26-37 of the '761 patent, Claims 1-20 of the '762 patent, and Claims 1-30 of the '370 patent are invalid as indefinite under 35 U.S.C.
5 112 for
failing to particularly point out and distinctly claim the subject matter applicant regards as his invention.
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DATED: February 18,2008
YOUNG CONAWAY STARGATT & TAYLOR, LLP
Josy W. Ingersoll (No. ldB8) Andrew A. Lundgren (No. 4429) 1000 West Street, 17thFloor P.O. Box 391 Wilrnington, DE 19899 (302) 57 1-6600 [email protected]
.
Attorneys for Defendant Of Counsel:
John M. Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS 153 East 53rdStreet New York, NY 1002 Telephone: (212) 446-4800 Facsimile: (2 12) 446-4900
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CERTIFICATE OF SERVICE
I, Andrew A. Lundgren, hereby certify that on February 18,2008, I caused a copy of the foregoing document to be served on the following in the manner indicated:
BY E-MAIL AND HAND DELIVERY
Jack B. Blurnenfeld, Esquire Karen Jacobs Louden, Esquire Morris Nichols Arsht & Tunnel1 LLP 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347
BY E-MAIL
Matthew D. Powers, Esquire Vernon M. Winters, Esquire John D. Beynon, Esquire Weil, Gotshal & Manges LLP 201 Redwood Shores Parlcway Redwood Shores, CA 94065 YOUNG CONAWAY STARGATT & TAYLOR, LLP Josy W. Ingersoll N o . 1088) Andrew A. Lundgren (No. 4429) 1000 West Street, 17th Floor Wilmington, Delaware 1980 1 (302) 571-6600 [email protected]
Attorneys for Defendant.
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