Free Stipulation - District Court of Delaware - Delaware

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EXHIBIT A

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EXHIBIT B

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PDL BIOPHARMA, INC., Plaintiff, v. ALEXION PHARMACEUTICALS, INC., Defendant. DEFENDANT ALEXION PHARMACEUTICALS, INC.'S AMENDED ANSWER AND COUNTERCLAIMS Defendant Alexion Pharmaceuticals, Inc. ("Alexion"), for its Amended Answer to the Complaint of Plaintiff PDL Biopharma, Inc. ("PDL"), hereby states as follows: 1. On information and belief, Alexion admits that PDL is a biopharmaceutical C.A. No. 07-CV-156 -***

company headquartered in Fremont, California. Alexion is without knowledge or information sufficient to form a belief as to the remaining allegations of Paragraph 1 of PDL's Complaint. 2. Alexion admits that it has obtained FDA approval for its humanized antibody

product, SolirisTM for the treatment of paroxysmal nocturnal hemoglobinuria ("PNH"), that it has launched SolirisTM, and that it does not have a license with PDL. Except as expressly admitted herein, Alexion denies all averments of Paragraph 2 of PDL's Complaint. 3. Alexion admits that its Form 10-K submitted to the United States Securities and

Exchange Commission for the year ending December 31, 2006 contains statements about certain third party patents, which statements speak for themselves. Alexion also admits that SolirisTM for the treatment of PNH is projected by some to become a blockbuster drug. Except as expressly admitted herein, Alexion denies all averments of Paragraph 3 of PDL's Complaint. 4. 5. Alexion denies all averments of Paragraph 4 of PDL's Complaint. Alexion denies that PDL is entitled to injunctive relief. Alexion further denies all

averments of Paragraph 5 of PDL's Complaint.

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6.

Upon information and belief, Alexion admits that PDL is a corporation organized

and existing under the laws of Delaware, with its principal place of business in Fremont, California. Alexion is without knowledge or information sufficient to form a belief as to the nature, scope or parties to any alleged PDL licenses. Except as expressly admitted herein, Alexion denies all averments of Paragraph 6 of PDL's Complaint. 7. 8. Alexion admits the averments of Paragraph 7 of PDL's Complaint. Alexion neither admits nor denies the averments of Paragraph 8 of PDL's

Complaint because they are legal conclusions to which no response by Alexion is required. To the extent that any response by Alexion is required, Alexion does not contest subject matter jurisdiction in this action. 9. Alexion admits that it is incorporated in the State of Delaware and that it conducts

business in the State of Delaware. Alexion does not contest personal jurisdiction in this action. Except as expressly admitted herein, Alexion denies all averments of Paragraph 9 of PDL's Complaint. 10. Alexion neither admits nor denies the averments of Paragraph 10 of PDL's

Complaint because they are legal conclusions to which no response by Alexion is required. To the extent that any response by Alexion is required, Alexion does not contest venue in this action. 11. Alexion repeats and incorporates by reference its answers to Paragraphs 1 through

10 above as if fully set forth herein. 12. Alexion admits that U.S. Patent No. 5,693,761 ("the '761 patent"), attached as

Exhibit A to PDL's Complaint, is entitled "Polynucleotides Encoding Improved Humanized Immunoglobulins," names on its face PDL as assignee, and purports to have been issued on December 2, 1997. Alexion denies that the '761 patent was duly and legally issued. Except as expressly admitted herein, Alexion denies all averments of Paragraph 12 of PDL's Complaint. 13. 14. Alexion denies all averments of Paragraph 13 of PDL's Complaint. Alexion admits that it was aware of the '761 patent prior to the filing of PDL's 2

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Complaint. Except as expressly admitted herein, Alexion denies all averments of Paragraph 14 of PDL's Complaint. 15. 16. 17. Alexion denies all averments of Paragraph 15 of PDL's Complaint. Alexion denies all averments of Paragraph 16 of PDL's Complaint. Alexion repeats and incorporates by reference its answers to Paragraphs 1 through

10 above as if fully set forth herein. 18. Alexion admits that U.S. Patent No. 5,693,762 ("the '762 patent"), attached as

Exhibit B to PDL's Complaint, is entitled "Humanized Immunoglobulins," names on its face PDL as assignee, and purports to have been issued on December 2, 1997. Alexion denies that the '762 patent was duly and legally issued. Except as expressly admitted herein, Alexion denies all averments of Paragraph 18 of PDL's Complaint. 19. 20. Alexion denies all averments of Paragraph 19 of PDL's Complaint. Alexion admits that it was aware of the '762 patent prior to the filing of PDL's

Complaint. Except as expressly admitted herein, Alexion denies all averments of Paragraph 20 of PDL's Complaint. 21. 22. 23. Alexion denies all averments of Paragraph 21 of PDL's Complaint. Alexion denies all averments of Paragraph 22 of PDL's Complaint. Alexion repeats and incorporates by reference its answers to Paragraphs 1 through

10 above as if fully set forth herein. 24. Alexion admits that U.S. Patent No. 6,180,370 B1 ("the '370 patent"), attached as

Exhibit C to PDL's Complaint, is entitled "Humanized Immunoglobulins and Methods of Making the Same," names on its face PDL as assignee, and purports to have been issued on January 30, 2001. Alexion denies that the '370 patent was duly and legally issued. Except as expressly admitted herein, Alexion denies all averments of Paragraph 24 of PDL's Complaint. 25. 26. Alexion denies all averments of Paragraph 25 of PDL's Complaint. Alexion admits that it was aware of the '370 patent prior to the filing of PDL's

Complaint. Except as expressly admitted herein, Alexion denies all averments of Paragraph 26 3

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of PDL's Complaint. 27. 28. Alexion denies all averments of Paragraph 27 of PDL's Complaint. Alexion denies all averments of Paragraph 28 of PDL's Complaint. Response To PDL's Prayer for Relief 29. Alexion denies that PDL is entitled to any relief whatsoever from Alexion or the

Court, either as prayed for in its Complaint or otherwise. 30. Alexion further denies each and every averment contained in PDL's Complaint

that was not specifically admitted, denied, or otherwise responded to in its Answer and Counterclaims. DEFENSES Alexion asserts the defenses set forth below, undertaking the burden of proof on such defenses only to the extent required by law, and specifically reserves the right to amend its Answer and Counterclaims with additional defenses and/or counterclaims: Noninfringement 31. Alexion has not infringed any claim of the '761 patent, the '762 patent or the '370

patent, either directly, indirectly, literally, or under the doctrine of equivalents. 32. To the extent that PDL asserts infringement of any claim of the '761 patent, the

'762 patent or the '370 patent based on any act of making, using, offering to sell, or selling within the United States, or importing into the United States, any accused product solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products or medical devices, that activity cannot constitute infringement under 35 U.S.C. § 271(e)(1). Patent Invalidity 33. Each claim of the '761 patent, the '762 patent and the '370 patent is invalid for

failure to comply with one or more of the conditions of patentability and/or requirements specified in Part II of Title 35 of the United States Code, including 35 U.S.C. §§ 101, 102, 103 4

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and/or 112. Unenforceability Due To Inequitable Conduct 34. Upon information and belief, each of the '761, '762, and '370 patents are

unenforceable due to inequitable conduct in their procurement. 35. All three patents, the '761 patent, the '762 patent, and the '370 patent, stem from

the same parent application, U.S. Application No. 07/634,278 ("the '278 application"). Upon information and belief, one or more of the named inventors and/or other individuals subject to the requirements of 37 C.F.R. § 1.56 engaged in inequitable conduct during the prosecution of the '278 parent application before the United States Patent and Trademark Office ("USPTO"). Because the inequitable conduct had occurred during the prosecution of the '278 parent application, it materially affected and tainted the prosecution of the '761 patent, the '762 patent, and the '370 patent, all of which stem from that application. See, e.g., Consolidated Aluminum Corp. v. Foseco Int'l Ltd., 910 F.2d 804 (Fed. Cir. 1990). 36. One or more of the named inventors and/or other individuals subject to the

requirements of 37 C.F.R. § 1.56 engaged in a pattern of inequitable conduct during the prosecution of the '761 patent before the USPTO, rendering '761 patent completely and permanently unenforceable, including the inequitable conduct as follows: a) Upon information and belief, during prosecution of the '278 application,

co-inventor Dr. Cary L. Queen, filed a declaration with the USPTO dated November 4, 1992 that included false and misleading material information. The false and misleading information included, but was not limited to: (1) misleading statements regarding the appropriate definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding the disclosures of Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in his declaration, Queen stated that "The hypervariable regions or CDRs were originally defined by

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Kabat et al. . . . . . More recently Chothia et al. have given an alternate definition of the hypervariable regions or CDRs." (¶ 5) Queen further stated, for instance, that "although [amino acids at positions 27 and 30] are part of the Kabat framework (i.e., not in a Kabat CDR), these amino acids are in CDR H1 as defined by Chothia . . . . Hence, the final humanized antibody of Riechmann et al. contains the Kabat CDRs and the Chothia CDR H1 from the mouse antibody . . . . The double mutation was simply to transfer the whole Chothia CDR H1 to the humanized antibody . . . . The authors had evidently concluded that they had simply used the wrong definition of CDR H1 (Kabat rather than Chothia) in designing the humanized antibody, and they corrected the error by also transferring Chothia CDR H1. The extra amino acids 27, and 30, while part of Chothia CDR H1, are not in Kabat CDR H1, and are therefore part of the Kabat framework." (¶¶ 9, 25-26) This false and misleading material declaration was deliberately used to overcome rejections over the prior art, which disclosed back mutations outside the CDR as that term was used in the original patent application, and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO. b) Upon information and belief, during prosecution of the '278 application,

Applicants submitted Amendments and Responses that included false and misleading material information, including, without limitation, those dated November 12, 1992 and October 4, 1993. The false and misleading information included, but was not limited to: (1) misleading statements regarding the appropriate definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding the disclosures of Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in October 4, 1993 Amendment, at *11, the applicants stated: "The authors [Riechmann et al.] made changes only within the hypervariable loop

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(Chothia CDR H1), and did not modify any framework residues outside the loop . . . indicating that Riechmann et al. does not teach that framework residues outside the CDR loop are important for maintaining binding affinity . . . . Overall, Riechmann et al. teaches that it is only important to change residues within the CDR loop and does not suggest alternatives." This false and misleading material representation was deliberately used to overcome rejections over the prior art and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO. c) The false and material statements submitted during prosecution of the '278

patent application, the parent of the '761 patent, is part of the '761 file history and taints the prosecution of the '761 patent. Moreover, during the prosecution of the '761 patent, Applicants specifically resubmitted the November 4, 1992 Queen Declaration in support of the patentability of the claims of the '761 patent. d) Upon information and belief, during prosecution of the '761 patent, PDL

counsel filed a Petition To Make Special under 37 C.F.R. § 1.102(d) ("Petition To Make Special") with the USPTO on January 16, 1992 that contained false and misleading information. For example, this Petition to Make Special was filed together with a Detailed Discussion of Most Closely Related References ("Detailed Discussion"), which purported to distinguish PDL's claims by mischaracterizing prior art references, including but not limited to, Riechmann et al.; Winter, European Patent No. 0 239 400 (filed March 23, 1987) ("Winter"); and Verhoeyen et al., Reshaping Human Antibodies: Grafting an Antilysozyme Activity, 239 Science 1534 (1988) ("Verhoeyen et al."). For example, in the Detailed Discussion, at *6-*7, *11, the applicants stated that "Riechmann et al. . . . did not modify or replace any framework residues outside of the [CDR] loop . . . . Riechmann taught that it is only important to change residues within the CDR

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loop . . . none of the cited references taught or suggested the presently claimed polynucleotides which encode humanized immunoglobulins." This false and misleading Petition To Make Special was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO into improperly issuing the '761 patent. 37. One or more of the named inventors and/or other individuals subject to the

requirements of 37 C.F.R. § 1.56 engaged in a pattern of inequitable conduct during the prosecution of the '762 patent before the United States Patent and Trademark office ("USPTO"), rendering the '762 patent completely and permanently unenforceable, including the inequitable conduct as follows: a) Upon information and belief, during prosecution of the '278 application,

co-inventor Dr. Cary L. Queen, filed a declaration with the USPTO dated November 4, 1992 that included false and misleading material information. The false and misleading information included, but was not limited to: (1) misleading statements regarding the definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding the disclosures of Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in his declaration, Queen stated that "The hypervariable regions or CDRs were originally defined by Kabat et al. . . . . More recently Chothia et al. have given an alternate definition of the hypervariable regions or CDRs." (¶ 5) Queen further stated, for instance, that "although [amino acids at positions 27 and 30] are part of the Kabat framework (i.e., not in a Kabat CDR), these amino acids are in CDR H1 as defined by Chothia . . . . Hence, the final humanized antibody of Riechmann et al. contains the Kabat CDRs and the Chothia CDR H1 from the mouse antibody . . . . The double mutation was simply to transfer the whole Chothia CDR H1 to the humanized antibody . . . . The authors had evidently concluded that they had simply used the 8

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wrong definition of CDR H1 (Kabat rather than Chothia) in designing the humanized antibody, and they corrected the error by also transferring Chothia CDR H1. The extra amino acids 27, and 30, while part of Chothia CDR H1, are not in Kabat CDR H1, and are therefore part of the Kabat framework." (¶¶ 9, 25-26) This false and misleading material declaration was deliberately used to overcome rejections over the prior art, which disclosed back mutations outside the CDR as that term was used in the original patent application, and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO. b) Upon information and belief, during prosecution of the '278 application,

Applicants submitted Amendments and Responses that included false and misleading material information, including, without limitation, those dated November 12, 1992 and October 4, 1993. The false and misleading information includes, but is not limited to: (1) misleading statements regarding the definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in October 4, 1993 Amendment, at *11, the applicants stated: "The authors [Riechmann et al.] made changes only within the hypervariable loop (Chothia CDR H1), and did not modify any framework residues outside the loop . . . indicating that Riechmann et al. does not teach that framework residues outside the CDR loop are important for maintaining binding affinity . . . . Overall, Riechmann et al. teaches that it is only important to change residues within the CDR loop and does not suggest alternatives." This false and misleading material representation was deliberately used to overcome rejections over the prior art and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO.

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c)

The false and material statements submitted during prosecution of the '278

patent application, the parent of the '762 patent, is part of the '762 file history and taints the prosecution of the '762 patent. Moreover, during the prosecution of the '762 patent, Applicants specifically resubmitted the November 4, 1992 Queen Declaration in support of the patentability of the claims of the '762 patent. d) Upon information and belief, during prosecution of '762 patent, PDL

counsel filed a Petition To Make Special under 37 C.F.R. § 1.102(d) ("Petition To Make Special") with the USPTO on January 16, 1992 that contained false and misleading information. For example, this Petition to Make Special was filed together with a Detailed Discussion of Most Closely Related References ("Detailed Discussion"), which purported to distinguish PDL's claims by mischaracterizing prior art references, including but not limited to, Riechmann et al., Winter, and Verhoeyen et al. For example, in the Detailed Discussion, at *6-7, 11, the applicants stated that "Riechmann et al . . . did not modify or replace any framework residues outside of the [CDR] loop . . . . Riechmann taught that it is only important to change residues within the CDR loop . . . none of the cited references taught or suggested the presently claimed polynucleotides which encode humanized immunoglobulins." This false and misleading Petition To Make Special was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO into improperly issuing the '762 patent. 38. Upon information and belief, one or more of the named inventors and/or other

individuals subject to the requirements of 37 C.F.R. § 1.56 engaged in a pattern of inequitable conduct during the prosecution of the '370 patent before the United States Patent and Trademark office ("USPTO"), rendering '370 patent completely and permanently unenforceable, including the inequitable conduct as follows:

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a)

Upon information and belief, during prosecution of the '278 application,

co-inventor Dr. Cary L. Queen, filed a declaration with the USPTO dated November 4, 1992 that included false and misleading material information. The false and misleading information included, but was not limited to: (1) misleading statements regarding the definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding the disclosures of Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in his declaration, Queen stated that "The hypervariable regions or CDRs were originally defined by Kabat et al. . . . . More recently Chothia et al. have given an alternate definition of the hypervariable regions or CDRs." (¶ 5) Queen further stated, for instance, that "although [amino acids at positions 27 and 30] are part of the Kabat framework (i.e., not in a Kabat CDR), these amino acids are in CDR H1 as defined by Chothia . . . . Hence, the final humanized antibody of Riechmann et al. contains the Kabat CDRs and the Chothia CDR H1 from the mouse antibody . . . . The double mutation was simply to transfer the whole Chothia CDR H1 to the humanized antibody . . . . The authors had evidently concluded that they had simply used the wrong definition of CDR H1 (Kabat rather than Chothia) in designing the humanized antibody, and they corrected the error by also transferring Chothia CDR H1. The extra amino acids 27, and 30, while part of Chothia CDR H1, are not in Kabat CDR H1, and are therefore part of the Kabat framework." (¶¶ 9, 25-26) This false and misleading material declaration was deliberately used to overcome rejections over the prior art, which disclosed back mutations outside the CDR as that term was used in the original patent application, and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO.

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b)

Upon information and belief, during prosecution of the '278 application,

Applicants submitted Amendments and Responses that included false and misleading material information, including, without limitation, those dated November 12, 1992 and October 4, 1993. The false and misleading information includes, but is not limited to: (1) misleading statements regarding the definition of complementarity determining regions ("CDR") as set forth in the original patent specification; and (2) misleading statements regarding Riechmann et al., Reshaping Human Antibodies for Therapy, 332 Nature 323 (1988) ("Riechmann et al."). For example, in October 4, 1993 Amendment, at *11, the applicants stated: "The authors [Riechmann et al.] made changes only within the hypervariable loop (Chothia CDR H1), and did not modify any framework residues outside the loop . . . indicating that Riechmann et al. does not teach that framework residues outside the CDR loop are important for maintaining binding affinity . . . . Overall, Riechmann et al. teaches that it is only important to change residues within the CDR loop and does not suggest alternatives." This false and misleading material representation was deliberately used to overcome rejections over the prior art and was submitted to the USPTO knowingly, willfully, and with the intent to deceive the USPTO. c) The false and material statements submitted during prosecution of the '278

patent application, the parent of the '370 patent, is part of the '370 file history and taints the prosecution of the '370 patent. d) Upon information and belief, during prosecution of the '370 patent, one or

more of the named inventors and/or other individuals subject to the requirements of 37 C.F.R. § 1.56 made false and misleading statements material to the USPTO concerning the prior art references of Verhoeyen et al. and Winter. The false and misleading material statements included, but were not limited to, sequence identity calculations and the availability in the prior

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art of the donor sequence used in these references. For example, PDL through its attorneys stated the following to the USPTO in response to a November 18, 1997 Official Action during the prosecution of the '370 patent: Recently, it has been brought to Applicants' attention during the course of prosecution of the corresponding application in Japan that the framework of the humanized heavy chain described in Verhoeyen et al. (1988) Science 239:15341536, (which is of record in the present application) may be 65.5% identical to the donor heavy chain variable region. This was not observed previously because the sequence of the donor antibody was not presented in Verhoeyen et al., and apparently was not published at the time, nor even at the priority dates of the present application. That statement was not true. The complete murine D1.3 sequence was shown in Figure 7 of Winter, which was published in 1987, more than one year before the earliest potential priority date of PDL's application. The mischaracterization of these prior art references was knowing, willful, and done with the intent to deceive the USPTO into improperly issuing the '370 patent. COUNTERCLAIMS Defendant Alexion Pharmaceuticals, Inc. ("Alexion"), in Counterclaim against Plaintiff PDL Biopharma, Inc. ("PDL"), hereby alleges and avers as follows: 1. This is a declaratory judgment counterclaim for a declaration of noninfringement and invalidity of all of the asserted claims of U.S. Patent No. 5,693,761 ("the '761 patent"), U.S. Patent No. 5,693,762 ("the '762 patent"), and U.S. Patent No. 6,180,370 B1 ("the '370 patent"). This counterclaim arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202, and the Patent Laws of the United States, 35 U.S.C. § 1 et seq. 2. Counterclaim Plaintiff Alexion is a corporation incorporated under the laws of the State of Delaware, with its principal place of business at 352 Knotter Drive, Cheshire, Connecticut 06410. 3. On information and belief, Counterclaim Defendant PDL is a corporation incorporated under the laws of the State of Delaware with its principal place of business at 34801 13

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Campus Drive, Fremont, California 94555. 4. This Court has subject matter jurisdiction over this Counterclaim pursuant to the

Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202, and 28 U.S.C. §§ 1331 and 1338(a). As demonstrated by, inter alia, the Complaint filed by PDL in this action and Alexion's Answer and Counterclaims to that Complaint, an actual and justiciable controversy exists between PDL and Alexion regarding the noninfringement and invalidity of the '761, '762 and '370 patents. 5. Counterclaim Defendant PDL is subject to personal jurisdiction in this Court, as

evidenced by, inter alia, its consent to jurisdiction in this Court and its existence as a corporation incorporated under the laws of the State of Delaware. 6. Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 because,

inter alia, PDL has consented to venue in this judicial district, PDL resides in this district and PDL is subject to personal jurisdiction in this district. 7. On March 16, 2007, PDL initiated a civil action by filing a Complaint against

Alexion in this Court alleging that Alexion has infringed the '761, '762 and '370 patents. COUNT I Declaratory Judgment Counterclaim for a Declaration of Patent Noninfringement and Invalidity 8. 9. Alexion incorporates and realleges Paragraphs 1-7 as if set forth herein. PDL has created an actual and justiciable controversy between itself and Alexion

regarding whether Alexion has infringed any valid and enforceable claim of the '761 patent. 10. Alexion has not infringed any claim of the '761 patent, either directly, indirectly,

literally, or under the doctrine of equivalents. 11. To the extent that PDL asserts infringement of any claim of the '761 patent based

on any act of making, using, offering to sell, or selling within the United States, or importing into the United States, any accused product solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products or medical devices, that activity cannot constitute

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infringement under 35 U.S.C. § 271(e)(1). 12. Each claim of the '761 patent is invalid for failure to comply with one or more of

the conditions of patentability and/or requirements specified in Part II of Title 35 of the United States Code, including 35 U.S.C. §§ 101, 102, 103 and/or 112. 13. A judicial declaration of noninfringement of the '761 patent is necessary and

appropriate to resolve this controversy. 14. A judicial declaration of invalidity of the '761 patent is necessary and appropriate COUNT II Declaratory Judgment Counterclaim for a Declaration of Patent Noninfringement and Invalidity 15. 16. Alexion incorporates and realleges Paragraphs 1-14 as if set forth herein. PDL has created an actual and justiciable controversy between itself and Alexion

to resolve this controversy.

regarding whether Alexion has infringed any valid and enforceable claim of the '762 patent. 17. Alexion has not infringed any claim of the '762 patent, either directly, indirectly,

literally, or under the doctrine of equivalents. 18. To the extent that PDL asserts infringement of any claim of the '762 patent based

on any act of making, using, offering to sell, or selling within the United States, or importing into the United States, any accused product solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products or medical devices, that activity cannot constitute infringement under 35 U.S.C. § 271(e)(1). 19. Each claim of the '762 patent is invalid for failure to comply with one or more of

the conditions of patentability and/or requirements specified in Part II of Title 35 of the United States Code, including 35 U.S.C. §§ 101, 102, 103 and/or 112. 20. A judicial declaration of noninfringement of the '762 patent is necessary and

appropriate to resolve this controversy.

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21.

A judicial declaration of invalidity of the '762 patent is necessary and appropriate COUNT III Declaratory Judgment Counterclaim for a Declaration of Patent Noninfringement and Invalidity

to resolve this controversy.

22. 23.

Alexion incorporates and realleges Paragraphs 1-21 as if set forth herein. PDL has created an actual and justiciable controversy between itself and Alexion

regarding whether Alexion has infringed any valid and enforceable claim of the '370 patent. 24. Alexion has not infringed any claim of the '370 patent, either directly, indirectly,

literally, or under the doctrine of equivalents. 25. To the extent that PDL asserts infringement of any claim of the '370 patent based

on any act of making, using, offering to sell, or selling within the United States, or importing into the United States, any accused product solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products or medical devices, that activity cannot constitute infringement under 35 U.S.C. § 271(e)(1). 26. Each claim of the '370 patent is invalid for failure to comply with one or more of

the conditions of patentability and/or requirements specified in Part II of Title 35 of the United States Code, including 35 U.S.C. §§ 101, 102, 103 and/or 112. 27. A judicial declaration of noninfringement of the '370 patent is necessary and

appropriate to resolve this controversy. 28. A judicial declaration of invalidity of the '370 patent is necessary and appropriate PRAYER FOR RELIEF WHEREFORE, Defendant and Counterclaim Plaintiff Alexion prays for entry of judgment: A. Dismissing PDL's Complaint, and all claims therein, with prejudice;

to resolve this controversy.

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B. C. D. E. F. G. H. procuring it; I. procuring it; J. procuring it; K.

Declaring that Alexion has not infringed any claim of the '761 patent; Declaring that Alexion has not infringed any claim of the '762 patent; Declaring that Alexion has not infringed any claim of the '370 patent; Declaring that each claim of the '761 patent is invalid; Declaring that each claim of the '762 patent is invalid; Declaring that each claim of the '370 patent is invalid; Holding that the '761 patent is unenforceable due to PDL's inequitable conduct in

Holding that the '762 patent is unenforceable due to PDL's inequitable conduct in

Holding that the '370 patent is unenforceable due to PDL's inequitable conduct in

Enjoining PDL, its officers, agents, servants, employees and attorneys, and all

persons in active concert or participation with any of them, and its parents, successors, and assigns, from directly or indirectly charging infringement, or instituting any further action for infringement of the '761 patent against Alexion and/or any of its affiliates, customers, licensees, or potential customers or licensees, in connection with any product accused of infringement in this action, including Alexion's SolirisTM; L. Enjoining PDL, its officers, agents, servants, employees and attorneys, and all

persons in active concert or participation with any of them, and its parents, successors, and assigns, from directly or indirectly charging infringement, or instituting any further action for infringement of the '762 patent against Alexion and/or any of its affiliates, customers, licensees, or potential customers or licensees, in connection with any product accused of infringement in this action, including Alexion's SolirisTM; M. Enjoining PDL, its officers, agents, servants, employees and attorneys, and all

persons in active concert or participation with any of them, and its parents, successors, and assigns, from directly or indirectly charging infringement, or instituting any further action for 17

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infringement of the '370 patent against Alexion and/or any of its affiliates, customers, licensees, or potential customers or licensees, in connection with any product accused of infringement in this action, including Alexion's SolirisTM ; N. Declaring this case to be exceptional within the meaning of 35 U.S.C. § 285 and

awarding Alexion the attorney fees, costs, and expenses that it incurs in connection with any of the issues raised by PDL's Complaint and/or Alexion's Answer and Counterclaims to that Complaint; O. proper. Awarding Alexion such other and further relief as the Court deems just and

18

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EXHIBIT C

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DATED: June 4,December 7, 2007

YOUNG CONAWAY STARGATT & TAYLOR LLP

___________________________________________ Josy W. Ingersoll (I.D. #1088) Andrew Lundgren (I.D. #4429) The Brandywine Building 1000 West Street, 17th Floor P.O. Box 391 Wilmington, Delaware 19801 Telephone: (302) 571-6600 Attorneys for Alexion Pharmaceuticals, Inc. Of Counsel: John M. Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS LLP 153 East 53rd Street New York, NY 10022 Telephone: (212) 446-4800 Facsimile: (212) 446-4900

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