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CLOSED, PATENT

U.S. District Court District of Delaware (Wilmington) CIVIL DOCKET FOR CASE #: 1:03-cv-01160-GMS

Genentech Inc., et al v. Wyeth, et al Assigned to: Judge Gregory M. Sleet Demand: $0 Cause: 35:0146 Review of Board of Patent Appeals Decision Plaintiff Genentech Inc.

Date Filed: 12/23/2003 Date Terminated: 10/13/2005 Jury Demand: None Nature of Suit: 830 Patent Jurisdiction: Federal Question

represented by Rudolf E. Hutz Connolly, Bove, Lodge & Hutz The Nemours Building 1007 North Orange Street P.O. Box 2207 Wilmington, DE 19899 (302) 658-9141 Fax: (302) 658-5614 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED

Plaintiff Bayer Healthcare LLC represented by Rudolf E. Hutz (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

V. Defendant Wyeth represented by Josy W. Ingersoll Young, Conaway, Stargatt & Taylor The Brandywine Building 1000 West Street, 17th Floor P.O. Box 391 Wilmington, DE 19899-0391 (302) 571-6600 Email: [email protected] LEAD ATTORNEY ATTORNEY TO BE NOTICED

Defendant

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Genetics Institute, LLC

represented by Josy W. Ingersoll (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Date Filed 12/23/2003 12/23/2003 12/23/2003 12/29/2003 12/29/2003 01/06/2004 01/07/2004 01/09/2004 01/13/2004 01/14/2004

# 1

Docket Text COMPLAINT filed. Magistrate Consent Notice to Pltf. FILING FEE $ 150.00 RECEIPT # 135417 (dab) (Entered: 12/29/2003) SUMMONS(ES) issued for Wyeth, Genetics Inst LLC (dab) (Entered: 12/29/2003)

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Report to Commissioner of Patents and Trademarks. Exit original. RE 4,868,112 (dab) (Entered: 12/29/2003) RETURN OF SERVICE executed as to Wyeth 12/24/03 Answer due on 1/13/04 for Wyeth (dab) (Entered: 12/29/2003) RETURN OF SERVICE executed as to Genetics Inst LLC 12/24/03 Answer due on 1/13/04 for Genetics Inst LLC (dab) (Entered: 12/29/2003) Disclosure Statement pursuant to Rule 7.1 by Bayer Healthcare LLC (dab) (Entered: 01/07/2004) CASE assigned to Judge Gregory M. Sleet . Notice to all parties. (rjb) (Entered: 01/07/2004) Disclosure Statement pursuant to Rule 7.1 by Genentech Inc. (gp) (Entered: 01/09/2004) 1ST STIPULATION extending time for defts to answer or respond to complaint (gp) (Entered: 01/13/2004) So Ordered granting [8-1] stipulation extending time through 02/12/04 for defts to move or answer complaint( signed by Judge Gregory M. Sleet ) Notice to all parties. (gp) (Entered: 01/16/2004) Deadline updated; reset Answer deadline to 2/12/04 for Genetics Inst LLC, for Wyeth (gp) (Entered: 01/16/2004)

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MOTION by Genentech Inc. for Coe A. Bloomberg, Lois M. Kwasigroch and Jerrold B. Reilly of Jones Day to Appear Pro Hac Vice (gp) (Entered: 01/20/2004) So Ordered granting [9-1] motion for Coe A. Bloomberg, Lois M. Kwasigroch and Jerrold B. Reilly of Jones Day to Appear Pro Hac Vice ( signed by Judge Gregory M. Sleet ) Notice to all parties. (gp) (Entered: 01/20/2004)

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MOTION by Wyeth, Genetics Inst LLC for Timothy B. Donaldson, gregory A. Chopskie, and Robert D. Bajefsky of Finnegan, Henderson, Farabow, Garrett & Dunner to Appear Pro Hac Vice re: [10-1] motion (gp) (Entered: 02/04/2004) So Ordered granting [10-1] motion for Timothy B. Donaldson, gregory A.

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Chopskie, and Robert D. Bajefsky of Finnegan, Henderson, Farabow, Garrett & Dunner to Appear Pro Hac Vice ( signed by Judge Gregory M. Sleet ) Notice to all parties. (gp) (Entered: 02/05/2004) 02/11/2004 02/13/2004 02/13/2004 02/20/2004 02/20/2004 02/20/2004 02/23/2004 03/02/2004 03/03/2004 03/04/2004 13 14 15 16 17 11 12 ANSWER to Complaint by Wyeth, Genetics Inst LLC (Attorney Josy Ingersol), (gp) (Entered: 02/17/2004) NOTICE from Judge Sleet of initial 16.2a telecnf. scheduled for 02/20/04 at 10:00 (gp) (Entered: 02/17/2004) Deadline updated; set Telephone Conference for 10:00 2/20/04 (gp) (Entered: 02/17/2004) Tele-conference held (rpt. Gaffigan) 16 conf. scheduled for 3/11/04 at 10:00 (gp) (Entered: 02/20/2004) Deadline updated; set Scheduling Conference for 10:00 3/11/04 (gp) (Entered: 02/20/2004) Steno Notes for 02/20/04 (rpt. Gaffigan) (gp) (Entered: 02/20/2004) NOTICE of Scheduling Conf for 3/11/04, at 10:00 am (lg) (Entered: 03/02/2004) FIRST AMENDED ANSWER to Complaint by Wyeth, Genetics Inst LLC (lg) (Entered: 03/03/2004) JOINT STATUS REPORT for the 3/11/04 Scheduling Conf (lg) (Entered: 03/04/2004) CERTIFICATE OF SERVICE by Genentech Inc., Bayer Healthcare LLC Copies of Interrogs Nos. 1-3; Requests for Productions of Docs Nos. 1-22 and Requests for Admission Nos. 1-2 (asw) (Entered: 03/05/2004) MOTION by Genentech Inc. with Proposed Order for Allan W. Jansen to Appear Pro Hac Vice (lg) (Entered: 03/09/2004) So Ordered granting [18-1] motion for Allan W. Jansen to Appear Pro Hac Vice ( signed by Judge Gregory M. Sleet ) Notice to all parties. (lg) (Entered: 03/10/2004) Scheduling conference held; Judge Sleet presiding; Ct Rptr Maurer; Cnsl for Pltfs will file a Motion by 3/22/04; All Briefing due by the end of April; Court will issue an order referring the case to the Magistrate Judge; the Court will have another conf at a later date to impose a schedule (lg) (Entered: 03/12/2004) So Ordered ( signed by Judge Gregory M. Sleet ) Notice to all parties. (asw) (Entered: 03/16/2004) 19 ORDER referring the case matter to the U.S. Magistrate for the purpose of exploring the possibility of a settlement ( signed by Judge Gregory M. Sleet ) copies to: cnsl (asw) (Entered: 03/16/2004) Steno Notes for 3/11/04 RE: Scheduling Conference (asw) (Entered:

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03/16/2004) 03/22/2004 03/22/2004 21 22 MOTION by Genentech Inc., Bayer Healthcare LLC with Proposed Order to Strike Defts' Affirmative Defense (asw) (Entered: 03/24/2004) SEALED Opening Brief Filed by Genentech Inc., Bayer Healthcare LLC [21-1] motion to Strike Defts' Affirmative Defense - Answer Brief due 4/5/04 (asw) (Entered: 03/24/2004) SEALED Declaration of Coe A. Bloomberg (asw) (Entered: 03/24/2004) CERTIFICATE OF SERVICE by Bayer Healthcare LLC, Wyeth copies of Initial Disclosure Statement and this Notice (asw) (Entered: 03/24/2004) Declaration of Coe A. Bloomberg (with an original signature page - the Declaration previously filed has a facsimile signature page) (asw) (Entered: 03/24/2004) CERTIFICATE OF SERVICE by Genentech Inc., Bayer Healthcare LLC copies of Initial Disclosures (asw) (Entered: 03/24/2004) TRANSCRIPT filed for dates of 3/11/04 Scheduling Conf (lg) (Entered: 03/26/2004) CERTIFICATE OF SERVICE by Bayer Healthcare LLC, Wyeth copies First Set of Requests for Docs and Things (1-28) (asw) (Entered: 03/29/2004) CERTIFICATE OF SERVICE by Wyeth, Genetics Inst LLC copies Objections and Responses to Interrogs Nos. 1-3; Objections and Responses Requests for Production of Docs Nos. 1-22; and Objections and Responses to Requests for Admissions Nos. 1-2 (lg) (Entered: 04/05/2004) Answer Brief Filed by Wyeth, Genetics Inst LLC in Opposition to [21-1] motion to Strike Defts' Affirmative Defense - Reply Brief due 4/12/04 (lg) (Entered: 04/06/2004) Declaration of Josy W. Ingersoll (lg) (Entered: 04/06/2004) Reply Brief Filed by Genentech Inc., Bayer Healthcare LLC [21-1] motion to Strike Defts' Affirmative Defense (asw) (Entered: 04/14/2004) CERTIFICATE OF SERVICE by Genentech Inc. copies Responses and Objections to First Set of Requests for Docs and Things (1-28) (lg) (Entered: 04/28/2004) CERTIFICATE OF SERVICE by Bayer Healthcare LLC copies Responses and Objections to First Set of Requests for Docs and Things (1-28) (lg) (Entered: 04/28/2004) CERTIFICATE OF SERVICE by Wyeth, Genetics Inst LLC copies First Set of Interrogs (1-2) (lg) (Entered: 04/28/2004) NOTICE OF SERVICE by Genentech Inc., Bayer Healthcare LLC re: Plaintiff's Supplemental Rule 26(a)(1) Initial Disclosures, Responses and Objections to Wyeth's First Set of Interrogatories (1-2) and Genentech's

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Responses and Objections to Wyeth's First Set of Interrogatories (asw) (Entered: 05/28/2004) 06/15/2004 37 NOTICE OF SERVICE by Wyeth, Genetics Inst LLC re: Wyeth's Second Set of Requests for Documents and Things (Nos. 29-41) (asw) (Entered: 06/17/2004) NOTICE OF SERVICE by Genentech Inc., Bayer Healthcare re: Responses and Objections to Wyeth's 2nd Set of Requests for Documents and Things LLC (asw) (Entered: 07/19/2004) NOTICE OF SERVICE by Genentech Inc., Bayer Healthcare LLC re: Plaintiff's Interrogatories Nos. 4-9 (asw) (Entered: 08/10/2004) NOTICE OF SERVICE by Wyeth, Genetics Inst LLC re: Supplemental Objections and Responses to Plaintiff's Requests for Admissions (Nos. 1-2) (asw) (Entered: 08/11/2004) ORDER that a teleconference has been scheduled for 9/7/04 at 9:30 a.m. to discuss the scheduling of, the procedures involved and the types of alternative dispute resolutions available, including mediation conferences ( signed by Judge Mary P. Thynge ) copies to: Counsel (asw) (Entered: 08/23/2004) NOTICE OF SERVICE by Genentech Inc. re: Supplemental Responses to Defendant's First Set of Interrogatories (asw) (Entered: 08/27/2004) STIPULATED ORDER Governing the Protection and Exchange of Confidential Material with proposed order (asw) (Entered: 09/13/2004) So Ordered granting [43-1] stipulation ( signed by Judge Gregory M. Sleet ) Notice to all parties. (asw) (Entered: 09/14/2004) 44 NOTICE OF SERVICE by Wyeth, Genetics Inst LLC re: Objections and Responses to Plaintiffs' Interrogatories Nos. 4-9, and this Notice of Service (asw) (Entered: 09/23/2004) ORDER that the mediation conference has been scheduled for 2/28/05 at 10:00 a.m. ( signed by Judge Mary P. Thynge ) copies to: Counsel (asw) (Entered: 10/07/2004) ORDER canceling the mediation conference scheduled for 2/28/05 at 10:00 a.m. Signed by Judge Mary Pat Thynge on 2/14/05. (mmm, ) (Entered: 02/14/2005) Letter to Counsel from Marie McDavid, Case Manager, regarding request for status report. Status report due 4/22/05. (mmm) (Entered: 04/08/2005) Set/Reset Deadlines: Status Report due by 4/22/2005. (mmm) (Entered: 04/08/2005) 48 49 Joint STATUS REPORT by Genentech Inc., Bayer Healthcare LLC. (DiGiovanni, Francis) (Entered: 04/22/2005) ORDER directing counsel to file a Stipulation of Dismissal or a Status Report regarding settlement within ten (10) days of the date of this Order. Signed by

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Judge Gregory M. Sleet on 8/11/05. (mmm) (Entered: 08/11/2005) 08/25/2005 10/03/2005 50 51 Joint STATUS REPORT by Genentech Inc., Bayer Healthcare LLC, Wyeth, Genetics Institute, LLC. (DiGiovanni, Francis) (Entered: 08/25/2005) ORDER directing counsel to file a status report, or a stipulation of dismissal within ten (10) days of the date of this Order. Signed by Judge Gregory M. Sleet on 10/3/05. (mmm) (Entered: 10/03/2005) STIPULATION of Dismissal by Genentech Inc., Bayer Healthcare LLC, Wyeth, Genetics Institute, LLC. (DiGiovanni, Francis) (Entered: 10/12/2005) CASE CLOSED (asw ) (Entered: 10/13/2005) 53 ORDER (including procedural letter and docket sheet), directing the return of sealed documents to the parties. Signed by Judge Gregory M. Sleet on 7/7/06. (Attachments: # 1 Letter to counsel # 2 Partial Docket Sheet)(rpg, ) (Entered: 07/10/2006) Acknowledgment of Receipt for sealed documents, D.I. 22 & 23 by Rudolf E. Hutz Esq. ( rpg, ) (Entered: 07/11/2006)

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UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS MARSHALL DIVISION

NOVARTIS VACCINES AND DIAGNOSTICS, INC., Plaintiff, CIVIL ACTION NO. 2:08-CV-67 v. WYETH and WYETH PHARMACEUTICALS INC., Defendants.

DEFENDANTS WYETH AND WYETH PHARMACEUTICALS INC.'S ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS IN RESPONSE TO PLAINTIFF'S COMPLAINT

Defendants Wyeth and Wyeth Pharmaceuticals Inc. (collectively, "Wyeth") hereby respond to the Complaint for Patent Infringement of Plaintiff Novartis Vaccines and Diagnostics, Inc. ("Novartis"). Wyeth denies each and every allegation contained in the Complaint that is not expressly admitted below. Any factual allegation below is admitted only as to the specific admitted facts, not as to any purported conclusions, characterizations, implications or speculations that arguably follow from the admitted facts. Wyeth denies that Plaintiff is entitled to the relief requested or any other relief. ANSWER 1. On information and belief, Wyeth admits that Novartis is a Delaware corporation,

having its principal place of business at 4560 Horton Street, Emeryville, California 94608-2916.

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2.

Wyeth admits that Defendant Wyeth is a Delaware corporation with a principal

place of business at Five Giralda Farms, Madison, New Jersey 07940. 3. Wyeth admits that Defendant Wyeth Pharmaceuticals, Inc. is a Delaware

corporation having its principal place of business at 500 Arcola Road, Collegeville, Pennsylvania 19426. Wyeth denies that Defendant Wyeth Pharmaceuticals Inc. is a division of Defendant Wyeth. Wyeth admits that ReFacto® is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. Wyeth admits that Defendant Wyeth sells ReFacto® in the United States and that ReFacto® has been sold within the Eastern District of Texas. Wyeth denies the remaining allegations and characterizations of paragraph 3. 4. Wyeth denies some or all of "the acts set forth below" and, on at least that basis,

denies the allegations of this paragraph. 5. Wyeth admits that Novartis's claim for patent infringement purports to arise

under the patent laws of the United States, 35 U.S.C. § 100, et seq. but denies that such claim has merit. Wyeth admits that this Court has subject matter jurisdiction over this case under 28 U.S.C. §1338(a). 6. For the purposes of this action only, Wyeth does not contest that personal

jurisdiction in this district is proper. Wyeth admits that Defendant Wyeth has conducted and conducts business in the State of Texas. Wyeth admits that Defendant Wyeth offers for sale, sells and advertises products within the United States, the State of Texas and the Eastern District of Texas. Wyeth denies the remaining allegations and characterizations of paragraph 6.

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7.

For the purposes of this action only, Wyeth does not contest that venue is proper

in the Eastern District of Texas. 8. Wyeth reasserts and incorporates by reference each of the answers to paragraphs

1-7 above, as if fully set forth herein. 9. Wyeth admits that U.S. Pat. No. 6,060,447 ("the '447 patent"), entitled "Protein

Complexes Having Factor VIII:C Activity and Production Thereof" purports on its face to have been issued by the United States Patent and Trademark Office ("USPTO") on May 9, 2000, to Chiron Corporation and Novo Nordisk A/S as the named assignees. Wyeth is without specific knowledge or information sufficient to form a belief as to the remaining allegations in this paragraph and, on that basis, denies them. 10. Wyeth admits that Defendant Wyeth imports and sells a pharmaceutical

composition encompassing a recombinant form of the human factor VIII protein under the trade name ReFacto®. Wyeth further admits that ReFacto® is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. Wyeth denies the remaining allegations and characterizations of paragraph 10. 11. 12. 13. 14. Denied. Denied. Denied. Wyeth reasserts and incorporates by reference each of the answers to paragraphs

1-13 above, as if fully set forth herein. 15. Wyeth admits that U.S. Pat. No. 6,228,620 ("the '620 patent"), entitled "Protein

Complexes Having Factor VIII:C Activity and Production Thereof" purports on its face to have

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been issued by the USPTO on May 8, 2001, to Chiron Corporation and Novo Nordisk A/S as the named assignees. Wyeth is without specific knowledge or information sufficient to form a belief as to the remaining allegations in this paragraph and, on that basis, denies them. 16. Wyeth admits that Defendant Wyeth imports and sells a pharmaceutical

composition encompassing a recombinant form of the human factor VIII protein under the trade name ReFacto®. Wyeth further admits that ReFacto® is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. Wyeth denies the remaining allegations and characterizations of paragraph 16. 17. 18. 19. Denied. Denied. Denied. DEFENSES FIRST DEFENSE 20. Wyeth has not infringed any claim of the '447 patent, either literally or under the

doctrine of equivalents. SECOND DEFENSE 21. Novartis is estopped from asserting that Wyeth has infringed the '447 patent as a

result of arguments made to the USPTO during the prosecution of the '447 patent. THIRD DEFENSE 22. The claims of the '447 patent are invalid for failure to meet the requirements of

patentability under 35 U.S.C. § 101 et seq., including, without limitation, §§ 101, 102, 103, 112, and/or the judicially-created doctrine of double-patenting.

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FOURTH DEFENSE 23. Wyeth has not infringed any claim of the '620 patent, either literally or under the

doctrine of equivalents. FIFTH DEFENSE 24. Novartis is estopped from asserting that Wyeth has infringed the '620 patent as a

result of arguments made to the USPTO during the prosecution of the '620 patent. SIXTH DEFENSE 25. The claims of the '620 patent are invalid for failure to meet the requirements of

patentability under 35 U.S.C. § 101 et seq., including, without limitation, §§ 101, 102, 103, 112, and/or the judicially-created doctrine of double-patenting. SEVENTH DEFENSE 26. Novartis, and its predecessor in interest in the `447 and `620 patents, Chiron

Corporation, knew or should have known about Wyeth's ReFacto® product since at least 2000. By unjustifiably waiting at least seven years from the issuance of the '447 and '620 patents, Novartis's requested relief is barred by the doctrine of laches. Moreover during the 1990s and early 2000s, Chiron and Wyeth had repeated dealings and communications relating to ReFacto® and/or related subject matter. Based on these dealings and communications Novartis's requested relief is also barred by the doctrine of equitable estoppel. EIGHTH DEFENSE 27. this suit. Novartis is barred by 35 U.S.C. § 288 from recovering any costs associated with

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COUNTERCLAIMS Without admitting any of the allegations of the Complaint other than those expressly admitted herein, and without prejudice to Wyeth's right to plead additional counterclaims as the facts of the matter warrant, Wyeth hereby asserts the following counterclaims against Novartis: 1. Wyeth is a Delaware corporation having its principal place of business at Five

Giralda Farms, Madison, New Jersey 07940. 2. Wyeth Pharmaceuticals, Inc. is a Delaware corporation having its principal place

of business at 500 Arcola Road, Collegeville, Pennsylvania 19426. 3. On information and belief, Novartis Vaccine and Diagnostics, Inc. is a Delaware

Corporation having its principal place of business at 4560 Horton Street, Emeryville, California 94608. JURISDICTION AND VENUE 4. These counterclaims arise under the Federal Declaratory Judgment Act and the

Patent Laws of the United States and, more particularly, under Title 28 U.S.C. §§ 2201 and 2202, and Title 35 U.S.C. § 100, et seq., respectively. Jurisdiction is based on Title 28 U.S.C. §§ 1338 and 2201. Venue is proper in this Court under 28 U.S.C. § 1391(b) and (c) and § 1400(b). 5. patents. 6. Novartis alleges that Wyeth infringes the '447 and '620 patent and has filed suit Novartis alleges it is the owner of all right, title, and interest in the '447 and '620

against Wyeth in this Court alleging infringement. 7. There exists an actual justiciable controversy between Wyeth and Novartis

concerning the validity and infringement of the '447 and '620 patents based upon Novartis's allegations that Wyeth infringes the '447 and '620 patents.

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CLAIM I 8. Wyeth incorporates by reference paragraphs 1-7 of these counterclaims as though

fully repeated here. 9. The claims of the '447 patent are invalid for failure to meet the requirements of

the United States patent laws, 35 U.S.C. § 100 et seq., including but not limited to 35 U.S.C. §§ 101, 102, 103, 112, and/or the judicially-created doctrine of double-patenting. CLAIM II 10. Wyeth incorporates by reference paragraphs 1-9 of these counterclaims as though

fully repeated here. 11. The claims of the '620 patent are invalid for failure to meet the requirements of

the United States patent laws, 35 U.S.C. § 100 et seq., including but not limited to 35 U.S.C. §§ 101, 102, 103, 112, and/or the judicially-created doctrine of double-patenting. CLAIM III 12. Wyeth incorporates by reference paragraphs 1-11 of these counterclaims as

though fully repeated here. 13. Wyeth has not infringed, induced infringement or contributed to the infringement

of any valid claim, if any, of the '447 patent, either literally or under the doctrine of equivalents. CLAIM IV 14. Wyeth incorporates by reference paragraphs 1-13 of these counterclaims as

though fully repeated here. 15. Wyeth has not infringed, induced infringement or contributed to the infringement

of any valid claim, if any, of the '620 patent, either literally or under the doctrine of equivalents.

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CLAIM V 16. Wyeth incorporates by reference paragraphs 1-15 of these counterclaims as

though fully repeated here. 17. Novartis, and its predecessor in interest in the `447 and `620 patents, Chiron

Corporation, knew or should have known about Wyeth's ReFacto® product since at least 2000. By unjustifiably waiting at least seven years from the issuance of the '447 and '620 patents, Novartis's requested relief is barred by the doctrine of laches. Moreover during the 1990s and early 2000s, Chiron and Wyeth had repeated dealings and communications relating to ReFacto® and/or related subject matter. Based on these dealings and communications Novartis's requested relief is also barred by the doctrine of equitable estoppel. CLAIM VI 18. Wyeth incorporates by reference paragraphs 1-17 of these counterclaims as

though fully repeated here. 19. For having brought this action, Novartis is liable under 35 U.S.C. § 285, making

this case exceptional and Wyeth seeks recovery of its attorney fees under that statute as part of this counterclaim.

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REQUEST FOR RELIEF Wherefore, premises considered, Wyeth respectfully requests that the Court grant the following relief: (a) Novartis is not entitled to recover any of its requested relief, and Novartis's Complaint be dismissed with prejudice and costs; (b) (c) (d) a declaration that the claims of the '447 patent are invalid; a declaration that the claims of the '620 patent are invalid; a declaration that Wyeth does not infringe any claim of the '447 patent and that Wyeth is not liable for inducing or contributing to the infringement of any claim of the '447 patent; (e) a declaration that Wyeth does not infringe any claim of the '620 patent and that Wyeth is not liable for inducing or contributing to the infringement of any claim of the '620 patent; (f) estoppel; (g) (h) (i) a declaration that this case is exceptional; an award of costs and attorney fees to Wyeth; and such other and further relief as this Court deems just and proper. a declaration that Novartis's requested relief is barred by laches and equitable

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Dated: August 1, 2008

Respectfully submitted,

By:

/s/ Stephen M. Hash Jones & Jones, Inc., P.C. Franklin Jones, Jr. 201 W Houston St., PO Drawer 1249 Marshall, TX 75671-1249 Tel: (903) 938-4395 Fax: (903) 938-3360 William B. Dawson Willem G. Schuurman Robert M. Schick Stephen M. Hash VINSON & ELKINS, L.L.P. 2801 Via Fortuna, Suite 100 Austin, Texas 78701 Tel : (512) 542-8504 Fax : (512) 236-3278 [email protected] [email protected] [email protected] [email protected] Attorneys for Defendants Wyeth and Wyeth Pharmaceuticals Inc.

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CERTIFICATE OF SERVICE

The undersigned certifies that the foregoing document was filed electronically in compliance with Local Rule CV-5(a). As such, this document was served on all counsel who are deemed to have consented to electronic service. Local Rule CV-5(a)(3)(A). Pursuant to Fed. R. Civ. P. 5(d) and Local Rule CV-5(d) and (e), all other counsel of record not deemed to have consented to electronic service were served with a true and correct copy of the foregoing by email and/or fax, on this the 1st day of August, 2008.

/s/ Stephen M. Hash Stephen M. Hash

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Alberta Telecommunications Research Centre v. Rambus, Inc. N.D.Cal.,2006. Only the Westlaw citation is currently available. United States District Court, N.D. California, San Jose Division. ALBERTA TELECOMMUNICATIONS RESEARCH CENTRE, d/b/a TR Labs, a Canadian Corporation, Plaintiff, v. RAMBUS INC., a California Corporation, Defendant. No. C-06-02595 RMW. [Docket No. 21]. Oct. 24, 2006. Dana Duane McDaniel, Hugh McCoy Fain, Sotts Fain PC, Richmond, VA, Bernard Hon-Wei Chao, Chao Hadidi Stark & Barker LLP, Menlo Park, CA, George C. Summerfield, Stadheim & Grear, Ltd., Chicago, IL, for Plaintiff. Thomas G. Slater, Jr., Hunton & Williams, Richard, VA, Benjamin Lucas Hatch, Hunton & Williams LLP, Richmond, VA, Jeannine Y. Sano, Saxon S. Noh, Dewey Ballantine LLP, East Palo Alto, CA, Thomas E. Anderson, Tyler Maddry, Hunton & Williams, Washington, DC, for Defendant. ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO DISMISS RONALD M. WHYTE, District Judge. *1 Defendant Rambus moves to dismiss plaintiff complaint for lack of subject matter jurisdiction and failure to state a claim. Alberta Telecommunications Research Centre's, doing business as TR Labs, ("Alberta") opposes the motion. The court has read the moving papers and considered the arguments of counsel. For the reasons set forth below, the court grants in part and denies in part defendant's motion to dismiss as follows: (1) Rambus's motion to dismiss count one is granted with prejudice as to the '703 patent; (2) Rambus's motion to dismiss count one is granted as to the '804 patent; (3) Rambus's motion to dismiss count two is denied as to the '703 patent and

granted as to the '804 patent; (4) Rambus's motion to dismiss count three is granted; and (5) Alberta has twenty (20) days from the date of this order to amend its complaint. I. BACKGROUND Alberta is a non-profit research consortium with a principal place of business in Edmonton, Alberta, Canada and offices throughout western Canada. It alleges that it is the owner by assignment of U.S. Patent No. 5,361,277, entitled "Methods and Apparatus for Clock Distribution and for Clock Synchronization" ("the '277 patent"). Compl. ¶ 3. The '277 patent issued on November 1, 1994 and purports to claim a priority date from a Canadian patent application filed April 27, 1988. Id. ¶ 5. The named inventor on the '277 patent is Dr. Wayne Grover, Alberta's Chief Scientist in Network Systems Research. Id. ¶ 4. According to the complaint, Dr. Grover "had conceived of the invention of the ['277 patent] by at least May 1987, and had reduced that invention to practice by July 1987." Id. ¶ 7. Alberta alleges that the '277 patent is cited as prior art in thirty-three of Rambus's patents. Id. ¶ 6. Rambus is a "pure-play licensing company" and derives its revenues by licensing its technologies to others. Id. ¶ 24.According to the complaint, Rambus has entered into license agreements for its patented technology with a number of integrated circuit chip manufacturers worldwide. Id. ¶ 32.The complaint alleges, inter alia, that Rambus infringes by making available know-how and other technical assistance, such as a validation program performed at third party laboratories, to its licensees. Id. ¶ 15.Rambus owns by assignment U.S. Patent No. 5,243,703, entitled "Apparatus for Synchronously Generating Clock Signals in a Data Processing System" ("the '703 patent").Id. ¶ 17.The '703 patent issued on September 7, 1993 and claims a priority date of April 18, 1990. Id. Alberta alleges that the named inventors of Rambus's '703 patent, Drs. Farmwald and Horowitz, "did not have a complete set of ideas for addressing the problems allegedly solved by the subject matter of the [April 1990 patent application] until early 1990."Id. ¶ 23.

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Alberta alleges that the '703 patent is part of the portfolio from which Rambus derives its royalty income. Id. ¶ 30.Alberta also alleges that Rambus's licensing portfolio also includes U.S. Patent No. 5,954,804 ("the ' 804 patent").Id. ¶ 31. *2 The complaint alleges three causes of action. In Count I, Alberta claims an action for interference under 35 U.S.C. § 291 between claims in Rambus's '703 patent and Alberta's '277 patent and between claims in Rambus's '804 patent and Alberta's '277 patent. The complaint sets forth a tabular comparison of claims in Rambus's '703 patent and claim one of Alberta's '277 patent, which Alberta alleges demonstrate how claim one of its '277 patent anticipates or renders obvious the listed claims of Rambus's '703 patent, and vice versa. Id. ¶ 37.In Count II, Alberta asserts willful patent infringement based on Rambus's licensing of its technology and provision of know-how and other technical assistance in connection with its licensing activities. Id. ¶ 42.The complaint sets forth a tabular presentation of certain claim limitations in Alberta's '277 patent compared against a purported description of "Rambus Operations" apparently based on various Rambus documents and patents. Id. ¶ 41.In Count III, Alberta claims unjust enrichment based on the revenues Rambus has derived from licensing the '703 and '804 patents because it contends those patents interfere with the more senior '277 patent. Id. ¶¶ 4648. II. ANALYSIS A. Interference Under 35 U.S.C. § 291 1. Rambus's '703 Patent Rambus asserts that the court lacks subject matter jurisdiction over a section 291 claim as to the '703 patent and that Alberta lacks standing to bring the claim. Specifically, Rambus argues that Alberta has not and cannot allege any interference-in-fact since Rambus's '703 patent has expired. Section 291"is solely the basis for an action to eliminate interference between patents."Albert v. Kevex Corp., 729 F.2d 757, 761 (Fed.Cir.1984). A district court does not have jurisdiction under § 291 unless interference is established. Id. at 760-61;see also Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928,

930 (Fed.Cir.2003) (Section 291"provides a cause of action to one patent owner against another patent owner where the inventions claimed by their respective patents interfere with one another.").FN1 In Albert, the plaintiff filed suit under § 291, asserting that defendant's patent interfered with plaintiff's patent. 729 F.2d at 760. The defendant subsequently disclaimed under 35 U.S.C. § 253 and 37 C.F.R. § 1.321 all allegedly interfering claims of its patent. Id. at 760.The Federal Circuit held that this disclaimer rendered moot the interfering patent suit and deprived the court of subject-matter jurisdiction to pass on the validity of one of the patents originally alleged to interfere. Id. Judge Giles Rich, writing for the panel, stated: FN1.Section 291 provides in full: The owner of an interfering patent may have relief against the owner of another by civil action, and the court may adjudge the question of the validity of any of the interfering patents, in whole or in part. The provisions of the second paragraph of section 146 of this title shall apply to actions brought under this section. 35 U.S.C. § 291. Under any construction of § 291, it is impossible to conceive how it could be any clearer that interference between patents is a sine qua non of an action under § 291. Absent interference, a court has no power under § 291 to adjudicate the validity of any patent. We hold that the court has no jurisdiction under § 291 unless interference is established. Mere citation of that statute or recitation in a pleading as a basis for suit is not enough. *3Id. at 760-61 (emphasis in original). Alberta's arguments in opposition are unpersuasive. Alberta argues that an expired patent may still be the subject of an interference action under § 291. However, Alberta has not shown that "interference does in fact exist" with the expired '703 patent. See id. at 760-61 ("When challenged, the pleader must establish that interference does in fact exist."). Here, Alberta's complaint relies in part on its allegation that Rambus's '703 patent "is part of the portfolio from which Rambus derives its royalty income."Compl. ¶ 30. However, Alberta does not now dispute that the

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'703 patent has expired. Although the Albert case involved claims that were disclaimed by the patent holder, the reasoning in Albert nevertheless supports that expiration of the alleged interfering patent likewise moots the claim of interference. Given the stringent requirement of an interference "in fact" from Albert, the court concludes that an expired patent cannot form the basis of an interference under § 291. See also Engler v. Gen'l Elec. Co., 144 F.2d 191 (2d Cir.1944) (observing that under 35 U.S.C. § 66, a prior version of section 291, "the owner of an expired patent cannot maintain [an interference] suit since the claims of an expired patent are no longer of any force or effect and cannot be interference with those of any other patent"); Regents of University of California v. Eli Lilly & Co., 777 F.Supp. 779, 782 (N.D.Cal.1991) (Jensen, J.) ("An action under section 291 is only possible if two or more parties are claiming the same or substantially the same subject matter."). As this means there is no live controversy regarding the interference of the '277 and '703 patents, Albert mandates dismissal of Alberta's § 291 action as to Rambus's '703 patent for lack of subject matter jurisdiction. Alberta attempts to distinguish the present action on the grounds that (1) Rambus purposely allowed the '703 patent to expire after Alberta put Rambus on notice of its interference claim FN2, and (2) "the remedy sought by [Alberta] in this case is the assignment of the claims of the '703 patent and disgorgement of Rambus'[s] licensing royalties, as opposed to a declaration that such claims are invalid." Alberta's Opp. at 2:8-19. The allegation that Rambus purposefully permitted its patent to lapse does not change the jurisdictional analysis under § 291. In Albert, the Federal Circuit noted that "[a] claim under § 291, however, depends so completely on the existence of interference that lack of it, whenever it becomes apparent, must be deemed fatal to jurisdiction."Id. at 762 n. 4 (emphasis added). In addition, Judge Rich emphasized that § 291 was not a vehicle for determining patent validity outside of the context of an actual case or controversy. Id. at 761.An argument that the remedy sought is assignment of the interfering claims rather than a declaration of invalidity does not save a claim for which subject matter jurisdiction is lacking.FN3 FN2. The parties do not dispute that the '703 patent expired because of failure to pay the

maintenance fees. See Rambus's Mot. Dismiss at 5:16-17; Alberta's Opp. at 2:9-12. FN3. In so concluding, the court does not take a position on whether a request for assignment to the complaining party of the alleged interfering claims is a proper remedy under § 291. Alberta argues that if it secures the assignment of the lapsed Rambus claims, it can later revive those claims pursuant to 35 U.S.C. § 41(c). The court notes that this argument does not support a conclusion that interference-in-fact is established or that jurisdiction under § 291 otherwise exists. In particular, Rambus's argument that assignment would be pointless since the premise of interference is that the plaintiff already possesses the allegedly interfering claims is well taken. 2. Rambus's '804 Patent *4 Rambus argues that Alberta's allegations of interference by the Rambus ' 804 patent are insufficient because the complaint makes "passing reference only" to the '804 patent. The complaint alleges: (1) "Third-party intellectual property analyses have shown the similarities between the subject matter of the [Alberta] ... patents on the one hand, and the subject matter of the Rambus '703 and '804 patents, on the other hand," compl. ¶ 35; (2) "In a similar fashion to the Rambus '703 patent, claim 1 of the [Alberta] patent anticipates and/or renders obvious the claims of the Rambus '804 patent, and vice versa.As such, there is an interference-in-fact between those claims as well,"id. ¶ 38; and (3) Rambus's licensing portfolio also includes the ' 804 patent, id. ¶ 31.Alberta's allegations are too conclusory and vague to plead a cause of action under § 291. "Without first identifying an interference-in-fact under the two-way test, a court has no jurisdiction to make a priority determination between two patents under § 291."Medichem, 353 F.3d at 932. "An interference-in-fact exists when at least one claim of a party that is designated to correspond to a count and at least one claim of an opponent that is designated to correspond to the count define the same patentable invention."Id. at 932 (emphasis in original) (quoting 37 C.F.R. § 1.601(j)). The conclusory allegations in the complaint are insufficient to show that an interference-in-fact

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exists between any particular claim in the ' 277 patent and any particular claim in the '804 patent. B. Patent Infringement Rambus first argues that mere licensing of its patents cannot constitute direct infringement FN4 because (1) a patent grants the right to exclude other from making, using, or selling the patented invention, but does not confer the right to practice the claimed invention, and (2) licenses are considered nothing more than the licensor's promise not to sue the licensee. Therefore, Rambus argues, its licenses do not infringe because they do not confer an affirmative right to practice the subject matter licensed. In opposition, Alberta concedes that there is no case law supporting the proposition that the mere licensing of a patent can be the basis of an infringement claim, but argues that it nevertheless states a patent infringement claim under a broad interpretation of the term "use" under 35 U.S.C. § 271(a). The court need not reach this issue in the present motion to dismiss. As discussed below, because Alberta has also alleged that Rambus does more than merely license patents, the court finds that Alberta has otherwise stated a claim for patent infringement. See Kumar v. Ovonic Battery Co., Inc., 351 F.3d 1364, 1372 (Fed.Cir.2003) (choosing not to decide the issue of whether mere licensing constitutes direct infringement because "Kumar also argues that Ovonic is liable for infringement because it did more than merely license patents"). FN4. Rambus clarifies in its reply brief that, as to the patent infringement claim, "Rambus is not moving to dismiss the claim for inducing infringement of the '703 patent."Rambus's Reply 11:8-10. Rather, Rambus contends "to the extent Alberta is arguing that the act of licensing of a patent or patents itself can constitute a form of infringement, Alberta has failed to state a claim for infringement and that aspect of its allegations should be dismissed."Id. at 11:12-15. *5 Here, Alberta also argues that it has alleged patent infringement based on both Rambus's indirect infringement (including inducing infringement), activities such as product testing by Rambus, and other non-licensing products and services allegedly

offered along with Rambus's licenses. Alberta's complaint alleges, inter alia, (1) that aspects of Rambus's technology and operations, including claims in the '703 patent, infringe upon specific claims of the '277 patent, (2) that Rambus's licensing of this described subject matter, and the accompanying know-how and other activities, directly and indirectly infringed claims of the '277 patent, and (3) that Intel has used the licensed Rambus technology to infringe the claims of the '277 patent. Alberta's allegations regarding Rambus's '804 patent are limited and conclusory. These allegations, even if accepted as true and viewed in the light most favorable to plaintiff, are too vague to adequately state a claim that Rambus's '804 patent infringes the '277 patent. As to the '703 patent, the court notes that the complaint's comparison of aspects of Rambus's technology and operations to claims of the '277 patent does not clearly identify what aspect of the described technology Rambus allegedly makes, uses, offers to sell, or sells. Nevertheless, the court finds that Alberta's allegations as to the '703 patent are sufficient to meet the pleading requirements of Rule 8 in stating a claim of patent infringement. C. Unjust Enrichment Alberta's unjust enrichment claim is premised on its assertion that Rambus's ' 703 and '804 patents interfere with the '277 patent. As noted above, the complaint has not sufficiently pled such interference. Accordingly, Rambus's motion is granted as to Alberta's unjust enrichment claim. D. Leave to Amend Leave to amend is to be freely granted when justice so requires. SeeFed.R.Civ.P. 15(a). Fed.R.Civ.P. 15(a)'s edict that "leave shall be freely given when justice so requires" is "to be applied with extreme liberality."Eminence Capital, LLC v. Aspeon, Inc., 316 F.3d 1048, 1051 (9th Cir.2003) (quoting Owens v. Kaiser Found. Health Plan, Inc., 244 F.3d 708, 712 (9th Cir.2001) (citations omitted)). Absent prejudice or a strong showing of undue delay, bad faith, dilatory motive, repeated failure to cure deficiencies by amendment, or futility of amendment, "there exists a presumption under Rule 15(a) in favor of granting leave to amend."Id. at 1052. Rambus argues that leave to amend count one should

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not be granted as to the ' 804 patent because a review of the claims in the patent makes clear that the '804 patent does not interfere with Alberta's '277 patent. A motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of the claims asserted in the complaint. Dismissal can be based on the "lack of a cognizable legal theory" or "the absence of sufficient facts alleged under a cognizable legal theory."Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988). A court must not dismiss a complaint for failure to state a claim unless "it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief."Conley v. Gibson, 355 U.S. 41, 45-46 (1957). As noted above, the court dismisses the claim because it finds that the complaint does not set forth sufficient allegations to establish interference-in-fact as between the '804 and '277 patents. However, the court cannot conclude at this point that amendment would be futile. III. ORDER *6 For the foregoing reasons, the court grants Rambus's motion in part and denies it in part as follows: 1. Rambus's motion to dismiss count one is granted with prejudice as to the ' 703 patent; 2. Rambus's motion to dismiss count one is granted as to the '804 patent; 3. Rambus's motion to dismiss count two is denied as to the '703 patent and granted as to the '804 patent; 4. Rambus's motion to dismiss count three is granted; and 5. Alberta has twenty (20) days from the date of this order to amend its complaint. N.D.Cal.,2006. Alberta Telecommunications Research Centre v. Rambus, Inc. Slip Copy, 2006 WL 3041075 (N.D.Cal.) END OF DOCUMENT

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EXHIBIT 7

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Manual of PATENT EXAMINING PROCEDURE
Original Eighth Edition, August 2001 Latest Revision September 2007

U.S. DEPARTMENT OF COMMERCE United States Patent and Trademark Office

Rev. 6, Sept. 2007

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The U.S. Patent and Trademark Office does not handle the sale of the Manual, distribution of notices and revisions, or change of address of those on the subscription list. Correspondence relating to existing subscriptions should be sent to the Superintendent of Documents at the following address: Superintendent of Documents Mail List Section Washington, DC 20402 Inquiries relating to purchasing the Manual should be directed to: Superintendent of Documents United States Government Printing Office Washington, DC 20402 Telephone: 202-512-1800 Telephone: 202-512-2267

Orders for reproduced copies of individual replacement pages or of previous revisions of the Manual should be sent to the following address: Mail Stop Document Services Director of the U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450 Telephone: 1-800-972-6382 or 571-272-3150

Previous editions and revisions of the Manual are available on microfilm in the Patent Search Room. The Manual is available on CD-ROM and on diskette from: U.S. Patent and Trademark Office Office of Electronic Information Products MDW 4C18, P.O. Box 1450 Alexandria, VA 22313-1450 Telephone: 571-272-5600

Employees of the U.S. Patent and Trademark Office should direct their requests for the Manual, replacement pages, notices, and revisions to the Office of Patent Training. Telephone: 571-272-7222 Pursuant to the Patent and Trademark Office Efficiency Act (PTOEA) (Pub. L. 106-113, 113 Stat. 1501A-572), the head of the United States Patent and Trademark Office (USPTO) is the "Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office." The Director is assisted by the "Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office." The patent operations of the USPTO are now headed by the "Commissioner for Patents." The trademark operations of the USPTO are now headed by the "Commissioner for Trademarks." Under section 4741(b) of the PTOEA, any reference to the Commissioner of Patents and Trademarks, the Assistant Commissioner for Patents, or the Assistant Commissioner for Trademarks is deemed to refer to the Director, the Commissioner for Patents, or the Commissioner for Trademarks, respectively. See "Reestablishment of the Patent and Trademark Office as the United States Patent and Trademark Office" published in the Federal Register at 65 FR 17858 (Apr. 5, 2000), and in the Official Gazette of the United States Patent and Trademark Office at 1234 O.G. 41 (May 9, 2000). Additions to the text of the Manual are indicated by arrows (><) inserted in the text. Deletions are indicated by a single asterisk (*) where a single word was deleted and by two asterisks (**) where more than one word was deleted. The use of three or five asterisks in the body of the laws, rules, treaties, and administrative instructions indicates a portion of the law, rule, treaty, or administrative instruction which was not reproduced. First Edition, November 1949 Second Edition, November 1953 Third Edition, November 1961 Fourth Edition, June 1979 Fifth Edition, August 1983 Sixth Edition, January 1995 Seventh Edition, July 1998 Eighth Edition, August 2001 Revision 1, February 2003 Revision 2, May 2004 Revision 3, August 2005 Revision 4, October 2005 Revision 5, August 2006 Revision 6, September 2007

Rev. 6, Sept. 2007

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Chapter 2700 Patent Terms and Extensions
2701 2710 Patent Term Term Extensions or Adjustments for Delays Within the USPTO Under 35 U.S.C. 154 Applications Filed Between June 8, 1995, and May 28, 2000 Applications Filed On or After May 29, 2000; Grounds for Adjustment Period of Adjustment Reduction of Period of Adjustment of Patent Term Determination of Patent Term Adjustment Application for Patent Term Adjustment; Due Care Showing Request for Reconsideration of Patent Term Adjustment Determination Third Party Papers< Patent Term Extension for Delays at other Agencies Under 35 U.S.C. 156 Eligibility Requirements Patent Term Extension Applicant Application Contents Filing Date Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) Filing Window for an Application Under 35 U.S.C. 156(d)(5) Filing of a Request for an Extension Under 35 U.S.C. 156(e)(2) Eligibility Determination Interim Extension of Patent Term During the Processing of the Application Interim Extension of Patent Term Before Product Approval Correspondence Between the USPTO and the Regulatory Agency Regulatory Agency Determination of the Length of the Regulatory Review Period Due Diligence Determination Notice of Final Determination - Calculation of Patent Term Extension Certificate of Extension of Patent Term Trade Secret, Confidential, and Protective Order Material Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period for a Product Duty of Disclosure in Patent Term Extension Proceedings 2763 2764 Limitation of Third Party Participation Express Withdrawal of Application for Extension of Patent Term

2701

Patent Term [R-2]

2720 2730 >2731 2732 2733 2734 2735 2736 2750 2751 2752 2753 2754 2754.01 2754.02 2754.03 2755 2755.01 2755.02 2756 2757 2757.01 2758 2759 2760 2761

35 U.S.C. 154. Contents and term of patent; provisional rights.
(a) IN GENERAL.-- ***** (2) TERM.--Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, or 365(c) of this title, from the date on which the earliest such application was filed. (3) PRIORITY.--Priority under section 119, 365(a), or 365(b) of this title shall not be taken into account in determining the term of a patent. ***** (c) CONTINUATION.-- (1) DETERMINATION.--The term of a patent that is in force on or that results from an application filed before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act shall be the greater of the 20-year term as provided in subsection (a), or 17 years from grant, subject to any terminal disclaimers. (2) REMEDIES.--The remedies of sections 283, 284, and 285 of this title shall not apply to acts which -- (A) were commenced or for which substantial investment was made before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act; and (B) became infringing by reason of paragraph (1). (3) REMUNERATION.--The acts referred to in paragraph (2) may be continued only upon the payment of an equitable remuneration to the patentee that is determined in an action brought under chapter 28 and chapter 29 (other than those provisions excluded by paragraph (2)) of this title. *****

2762

For applications filed on or after June 8, 1995, Section 532(a)(1) of the Uruguay Round Agreements Act (Pub. L. 103-465, 108 Stat. 4809 (1994)) amended 35 U.S.C. 154 to provide that the term of a patent (other than a design patent) begins on the date the patent issues and ends on the date that is twenty years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under 35 U.S.C. 120, 121, or 365(c), twenty years from the filing date of the

2700-1

Rev. 2, May 2004

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MANUAL OF PATENT EXAMINING PROCEDURE

should make plans for another to take over his or her work so that it is completed and filed in the Office within the three-month period. Thus, failure to reply within the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) due to preoccupation with other matters (e.g., an inter partes lawsuit or interference) given priority over the application, or vacation or other non-attention to an application, cannot be relied upon to show that applicant was unable to reply "in spite of all due care" under 35 U.S.C. 154(b)(3)(C).< >

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Request for Reconsideration of Patent Term Adjustment Determination [R-2]
*****

term adjustment indicated in the notice of allowance, the patent will indicate the revised patent term adjustment. 37 CFR 1.705(d) also provides that if the patent indicates or should have indicated a revised patent term adjustment, any request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued and must comply with the requirements of 37 CFR 1.705(b). The two month period is not extendable. 37 CFR 1.705(e). Any request for reconsideration under 37 CFR 1.705(d) that raises issues that were raised, or could have been raised, in an application for patent term adjustment under 37 CFR 1.705(b) shall be dismissed as untimely as to those issues.< >

37 CFR 1.705. Patent term adjustment determination.

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Third Party Papers [R-2]
*****

(d) If there is a revision to the patent term adjustment indicated in the notice of allowance, the patent will indicate the revised patent term adjustment. If the patent indicates or should have indicated a revised patent term adjustment, any request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued and must comply with the requirements of paragraphs (b)(1) and (b)(2) of this section. Any request for reconsideration under this section that raises issues that were raised, or could have been raised, in an application for patent term adjustment under paragraph (b) of this section shall be dismissed as untimely as to those issues. (e) The periods set forth in this section are not extendable. *****

37 CFR 1.705. Patent term adjustment determination.

(f) No submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office. Any such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office. *****

Since the Office is obligated to provide a determination of patent term adjustment under 35 U.S.C. 154(b) in the notice of allowance (i.e., before the actual patent issue date), the Office must project (or estimate) the actual patent issue date and base its patent term adjustment determination on that projection. Additionally, there are a number of papers which if submitted by an applicant after the mailing of the notice of allowance will result in a reduction of any patent term adjustment, and there may be Office delays occurring after mailing the notice of allowance resulting in an increase in the amount of patent term adjustment. Thus, 37 CFR 1.705(d) provides for a revision of the patent term adjustment when revision is necessitated by events occurring after the mailing of the notice of allowance. 37 CFR 1.705(d) specifically provides that if there is a revision to the patent

37 CFR 1.705(f) implements the provisions of 35 U.S.C. 154(b)(4)(B) and provides that no submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office, and that any such submission or petition will be returned to the third party, or otherwise disposed of, at the convenience of the Office.<

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Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156 [R-2]

The right to a patent term extension based upon regulatory review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156, 271, 282)(Hatch-Waxman Act). The act sought to eliminate two distortions to the normal "patent term produced by the requirement that certain products must receive premarket regulatory approval." Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 669, 15 USPQ2d

Rev. 2, May 2004

2700-26

Case 1:08-cv-00290-SLR

Document 10

Filed 08/12/2008

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PATENT TERMS AND EXTENSIONS

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1121, 1126 (1990). The first distortion was that the patent owner loses patent term during the early years of the patent because the product cannot be commercially marketed without approval from a regulatory agency. The second distortion occurred after the end of the patent term because competitors could not immediately enter the market upon expiration of the patent because they were not allowed to begin testing and other activities necessary to receive FDA approval before patent expiration. The part of the act codified as 35 U.S.C. 156 was designed to create new incentives for research and development of certain products subject to premarket government approval by a regulatory agency. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket government approval from a regulatory agency. The rights derived from extension of the patent term are limited to the approved product (as defined in 35 U.S.C. 156(a)(4) and (a)(5)). See 35 U.S.C. 156(b). Accordingly, if the patent claims other products in addition to the approved product, the exclusive patent rights to the additional products expire with the original expiration date of the patent. In exchange for extension of the term of the patent, Congress legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and provided that it shall not be an act of infringement, for example, to make and test a patented drug solely for the purpose of developing and submitting information for an Abbreviated New Drug Application (ANDA). 35 U.S.C. 271(e)(1). See Donald O. Beers, Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Fifth Edition, Aspen Law & Business, 1999, 4.3[2] for a discussion of the Hatch-Waxman Act and infringement litigation. Furthermore, Congress provided that an ANDA cannot be filed until five years after the approval date of the product if the active ingredient or a salt or ester of the active ingredient had not been previously approved under section 505(b) of the Federal Food, Drug and Cosmetic Act. 21 U.S.C. 355(j)(4)(D)(ii). See also Lourie, Patent Term Restoration: History,

Summary, and Appraisal, 40 Food, Drug and Cosmetic L. J. 351, 353-60 (1985). See also Lourie, Patent Term Restoration, 66 J. Pat. Off. Soc'y 526 (1984). On November 16, 1988, 35 U.S.C. 156 was amended by Public Law 100-670, essentially to add animal drugs and veterinary biologics to the list of products that can form the basis of patent term extension. Animal drug products which are primarily manufactured through biotechnology are excluded from the provisions of patent term extension. On December 3, 1993, 35 U.