Free Motion to Dismiss/Lack of Jurisdiction - District Court of California - California

Case 3:08-cv-01156-L-RBB

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DLA P IPER US LLP
SAN DIEGO

RICHARD T. MULLOY (Bar No. 199278) DLA PIPER US LLP 401 B Street, Suite 1700 San Diego, CA 92101-4297 [email protected] Tel: 619.699.2700 Fax: 619.699.2701 EDGAR H. HAUG (Pro Hac Vice) [email protected] THOMAS J. KOWALSKI (Pro Hac Vice) [email protected] VICKI FRANKS (Pro Hac Vice) [email protected] GINA M. BASSI (Pro Hac Vice) [email protected] ANNE-MARIE C. YVON (Pro Hac Vice) [email protected] FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue, New York, New York 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500 Attorneys for Defendants OXFORD BIOMEDICA PLC, BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD. UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA BAVARIAN NORDIC A/S., Plaintiff, v. OXFORD BIOMEDICA PLC, BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD., Defendants. CASE NO. 08cv1156-L-RBB OXFORD BIOMEDICA PLC'S AND OXFORD BIOMEDICA (UK) LTD.'S NOTICE OF MOTION AND MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM, AND LACK OF SUBJECTMATTER JURISDICTION Date: November 3, 2008 Time: 10:30 a.m. Courtroom: 14 Judge: The Hon. M. James Lorenz Complaint: June 30, 2008

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DLA P IPER US LLP
SAN DIEGO

PLEASE TAKE NOTICE that on November 3, 2008 at 10:30 a.m., or as soon thereafter as can be heard, in Courtroom 14 of the United States District Court for the Southern District of California, located at 940 Front Street, San Diego, California 92101-8900, Defendants Oxford BioMedica plc and Oxford BioMedica (UK) Ltd. (collectively, "the UK Defendants"), will and hereby do move the Court for an order dismissing Plaintiff Bavarian Nordic A/S's Complaint. The UK Defendants' motion is made pursuant to the Federal Rules of Civil Procedure, Rules 12(b)(1) and 12(b)(6), and on the grounds that the Court lacks subject-matter jurisdiction and that the Complaint fails to state a claim upon which relief can be granted. The UK Defendants' motion is based on this Notice, the Memorandum of Points and Authorities in support thereof, and the Declaration of Peter J. Nolan filed herewith, along with all pleadings and exhibits of record and such argument as the Court may entertain at any hearing. Dated: August 18, 2008 DLA PIPER US LLP

By: s/ Richard T. Mulloy Richard T. Mulloy Attorneys For Defendants, OXFORD BIOMEDICA PLC, BIOMEDICA, INC., AND OXFORD BIOMEDICA (UK) LTD. Of Counsel: Edgar H. Haug (PRO HAC VICE) [email protected] Thomas J. Kowalski (PRO HAC VICE) [email protected] Vicki Franks (PRO HAC VICE) [email protected] Gina M. Bassi (PRO HAC VICE) [email protected] Anne-Marie C. Yvon (PRO HAC VICE) [email protected] FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue, New York, New York 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500 Attorneys for Defendants, OXFORD BIOMEDICA PLC,; BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD. -2WEST\21495885.1 354423-000002 CASE NO. 08-CV-01156-L-RBB

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RICHARD T. MULLOY (Bar No. 199278) DLA PIPER US LLP 401 B Street, Suite 1700 San Diego, California 92101 Telephone: (619) 699-4787 Facsimile: (619) 699-2701 [email protected] EDGAR H. HAUG (Pro Hac Vice) [email protected] THOMAS J. KOWALSKI (Pro Hac Vice) [email protected] VICKI FRANKS (Pro Hac Vice) [email protected] GINA M. BASSI (Pro Hac Vice) [email protected] ANNE-MARIE C. YVON (Pro Hac Vice) [email protected] FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue, New York, New York 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500 Attorneys for Defendants, OXFORD BIOMEDICA PLC, BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD. UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA BAVARIAN NORDIC A/S., Plaintiff, vs. OXFORD BIOMEDICA PLC, BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD., Defendants. CASE NO. 08cv1156-L (RBB) MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF OXFORD BIOMEDICA PLC'S AND OXFORD BIOMEDICA (UK) LTD.'S MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM AND LACK OF SUBJECT-MATTER JURISDICTION Date: November 3, 2008 Time: 10:30 a.m. Courtroom: 14 Judge: The Hon. M. James Lorenz Complaint Filed: June 30, 2008

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DLA P IPER US LLP
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1 2 3 4 5 6 7 8 9 10 11 12 13 IV. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 B. III.

TABLE OF CONTENTS

TABLE OF AUTHORITIES...........................................................................................................ii I. II. INTRODUCTION AND SUMMARY OF ARGUMENT...................................... 1 FACTUAL BACKGROUND. ................................................................................ 2 A. B. The Parties................................................................................................... 2 Summary of the Complaint. ........................................................................ 2

THE COURT SHOULD DISMISS BN'S COMPLAINT AGAINST OXFORD BIOMEDICA PLC AND OXFORD BIOMEDICA (UK) LIMITED................................................................................................................. 3 A. BN Cannot State a Claim for Relief Because the Alleged Infringing Acts Are Protected By the Safe Harbor Provision of Section 271(e)(1)......................................................................................... 3 BN Cannot Establish Proper Subject-Matter Jurisdiction Because the TroVax® Vaccine Has Not Been Approved by the FDA. ..................... 6

CONCLUSION. ...................................................................................................... 7

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TABLE OF AUTHORITIES Cases Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336 (9th Cir. 1996)................................................................................................ 3 Classen Immunotherapies, Inc. v. Biogen IDEC, 381 F.Supp.2d 452 (D. Md. July 22, 2005).................................................................... 4, 5 Genentech, Inc. v. Insmed Inc., 436 F.Supp.2d 1080 (N.D. Cal. June 30, 2006). ................................................................ 5 MedImmune, Inc. v. Genentech, Inc., 549 S. Ct. 764 (2007). ........................................................................................................ 6 Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005). .......................................................................................................... 4 Navarro v. Block, 250 F.3d 729 (9th Cir. 2001) .............................................................................................. 3 Neitzke v. Williams, 490 U.S. 319 (1989). .......................................................................................................... 3 Shaunnessey v. Monteris Medical, Inc., 554 F.Supp.2d 1321 (M.D. Fla. May 8, 2008). .................................................................. 6 Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992). ..................................................................................... 4, 5 Statutes 35 U.S.C. § 271(a) (2006). ............................................................................................................. 4 35 U.S.C. § 271(e)(1) (2006). ........................................................................................................ 4 Other Authorities U.S. CONST. art. III, § 2, cl. 2......................................................................................................... 6 Rules Fed. R. Civ. P. 12(b)(1). ................................................................................................................. 6 Fed. R. Civ. P. 12(b)(6). ................................................................................................................. 3

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I.

INTRODUCTION AND SUMMARY OF ARGUMENT. The Court should dismiss Bavarian Nordic A/S's ("BN's") Complaint against Oxford

BioMedica plc ("OXB") and Oxford BioMedica (UK) Ltd. ("OBM UK") (collectively, "the UK Defendants") because BN has failed to allege any infringing acts committed by the UK Defendants. This is a patent infringement case. BN filed its Complaint against BioMedica, Inc., Oxford BioMedica (UK) Ltd., and Oxford BioMedica plc (collectively, "Defendants").1 (Compl. ¶¶ 5-7.) BN alleges that the UK Defendants have infringed, through the experimental research and testing of their TroVax® vaccine, three of BN's patents: (1) U.S. Patent No. 6,761,893 ("the '893 patent"); (2) U.S. Patent No. 6,913,752 ("the '752 patent"); and (3) U.S. Patent No. 7,335,364 ("the '364 patent") (collectively, the "asserted patents"), which generally concern a modified vaccinia Ankara ("MVA") virus variant. (Compl. ¶¶ 2, 36.) BN's Complaint should be dismissed because it is based on actions that fall well within the safe harbor protection of 35 U.S.C. § 271(e)(1). Even assuming that the UK Defendants engaged in the activities alleged in the Complaint, BN has failed to state a claim for relief because all of the alleged activities concerning the TroVax® vaccine are reasonably related to obtaining regulatory approval by the Food and Drug Administration ("FDA"). Such activities are protected by the safe harbor provision of Section 271(e)(1), and are therefore not infringing acts. BN apparently does not believe that the safe harbor provision applies to those actions because of an alleged commercial contract related to that product. This argument fails, however, because any alleged commercial activity involving the TroVax® vaccine was also reasonably related to the research and development of the TroVax® vaccine, and is therefore exempt from infringement. Because the research and development activities concerning the TroVax® vaccine cannot constitute infringement, the Complaint should be dismissed. ///// /////
1

BN also alleges that BioMedica, Inc. infringes the asserted patents. BioMedica, Inc. has concurrently filed a separate motion to dismiss.

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In addition, BN cannot satisfy its burden to establish that subject-matter jurisdiction exists. BN filed an infringement suit against the UK Defendants on the basis that the UK Defendants allegedly intend to eventually market the TroVax® vaccine, and are conducting clinical trials for that purpose. But the FDA has not yet approved the TroVax® vaccine, and there is no guarantee that FDA approval will ever be granted. Because no case or controversy exists between BN and the UK Defendants, the Court should dismiss the Complaint for lack of subject-matter jurisdiction. II. FACTUAL BACKGROUND. A. The Parties.

Bavarian Nordic A/S ("BN") is a Danish stock corporation (aktieselskab), with its principal place of business in Denmark. (Compl. ¶ 4.) BN is the assignee of the '893 patent, the '752 patent, and the '364 patent. (Compl. ¶¶ 13-19.) These patents relate to BN's MVA-BN® technology, an attenuated strain of MVA virus, which is used in human vaccines. (Compl. ¶¶ 13-19.) BioMedica, Inc. ("BioMedica") is a Delaware corporation with its principal place of business in San Diego, California. (Declaration of Peter J. Nolan ("Nolan Decl.") ¶ 4.) It is a wholly-owned subsidiary of Oxford BioMedica plc. (Nolan Decl. ¶ 4.) Oxford BioMedica plc is a public limited company incorporated in England and Wales, and is headquartered in Oxford, United Kingdom. (Nolan Decl. ¶ 2.) Oxford BioMedica (UK) Ltd. is a private limited company incorporated in England and Wales. (Nolan Decl. ¶ 3.) It is a wholly-owned subsidiary of Oxford BioMedica plc and has its principal place of business in Oxford, United Kingdom. (Nolan Decl. ¶ 3.) B. Summary of the Complaint.

BN's Complaint alleges that Defendants have directly infringed, contributorily infringed, or induced infringement of, various claims of the '893, '752, and '364 patents. (Compl. ¶¶ 1, 36-38.) BN seeks a judgment that the defendants have directly and indirectly infringed the asserted patents, a permanent injunction preventing the defendants from further infringing the asserted patents, damages, and attorneys' fees. (Compl. ¶¶ 1-5.) 2
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BN's Complaint draws no distinction between the three defendants in its infringement allegations, and alleges substantially all of the facts supporting its infringement claims against the Defendants based only "on information and belief." (Compl. ¶¶ 1-5, 25-38.) BN generally alleges that Defendants are developing an oncology product, the TroVax® vaccine, and are sponsoring FDA-approved clinical trials regarding that vaccine. (Compl. ¶¶ 25, 30-32.) BN also alleges that Defendants published reports concerning the TroVax® vaccine in clinical trials. (Compl. ¶ 28) BN further alleges, on information and belief, that Defendants have received payments through an agreement with a French pharmaceutical company, sanofi-aventis, regarding the development of the TroVax® vaccine. (Compl. ¶ 29.) Thus, each of the alleged acts of infringement in BN's complaint are directly related to development and clinical activities regarding the TroVax® vaccine. III. THE COURT SHOULD DISMISS BN'S COMPLAINT AGAINST OXFORD BIOMEDICA PLC AND OXFORD BIOMEDICA (UK) LIMITED. A. BN Cannot State a Claim for Relief Because the Alleged Infringing Acts Are Protected By the Safe Harbor Provision of Section 271(e)(1).

Rule 12(b)(6) of the Federal Rules of Civil Procedure requires a court to dismiss a complaint when the plaintiff has failed to state a claim upon which relief may be granted. Fed. R. Civ. P. 12(b)(6). Dismissal is proper where the complaint fails to allege sufficient facts to support a cognizable legal theory. See, e.g., Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001). "If as a matter of law `it is clear that no relief could be granted under any set of facts that could be proved consistent with the allegations,'" a claim must be dismissed "whether it is based on an outlandish legal theory or a close but ultimately unavailing one." Neitzke v. Williams, 490 U.S. 319, 327 (1989). In this inquiry, the court must accept the complaint's allegations as true and construe the complaint in the light most favorable to the plaintiff. See Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir. 1996). ///// ///// ///// 3
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It is an act of infringement to make, use, offer to sell, or sell any patented invention within the United States. 35 U.S.C. § 271(a) (2006). Under 35 U.S.C. § 271(e)(1), however, certain actions are exempt from infringement. Section 271(e)(1) provides: It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention ... 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. 35 U.S.C. § 271(e)(1) (2006) (emphasis added). The Supreme Court recently gave an expansive view to the exemption, stating that the statutory text of Section 271(e) "provides a wide berth for the use of patented drugs in activities related to the federal regulatory process." Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193, 202 (2005). The Court held that "§ 271(e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [Food, Drug, and Cosmetic Act]." Id.; see Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520, 152122 (Fed. Cir. 1992) (conducting clinical trials of an allegedly infringing device, displaying the device at seven medical conferences, and raising funds for the clinical trials by talking with investors, fall within Section 271(e)(1)). Classen Immunotherapies, Inc. v. Biogen IDEC, 381 F.Supp.2d 452 (D. Md. July 22, 2005) demonstrates that courts broadly construe the "safe harbor" provision of Section 271(e)(1). In Classen, two of the defendants conducted clinical studies for vaccines that had been approved by the FDA and were covered by the plaintiff's patents. Id. at 455. The defendants moved to dismiss the complaint under Rule 12(b)(6) based on the safe harbor provision of Section 271(e)(1). Id. The plaintiff argued that the safe harbor only applied to drugs that had not yet been approved by the FDA, as opposed to the post-approval activities at issue in that case. Id. at 455-56. The district court disagreed. Relying on the Supreme Court's broad interpretation of Section 271(e)(1) in Merck, the court determined that the defendants' clinical trial activities were reasonably related to the development and submission of information to the FDA, and thus granted the motion to dismiss. Id. at 456. 4
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Genentech, Inc. v. Insmed Inc., 436 F.Supp.2d 1080 (N.D. Cal. June 30, 2006) provides further insight into the circumstances that merit safe harbor protection under Section 271(e)(1). In that case, defendants hired a consulting company to conduct experiments for commercial purposes, as well as for FDA purposes, using an allegedly infringing product. Id. at 1095. The district court agreed with the defendants that the research conducted by the consulting company fell under the safe harbor protection, and granted defendants' motion for summary judgment. In doing so, the Court held that "even if the allegedly infringing experiments were conducted, in part, for commercial reasons, the experiments would produce information that would be given to the FDA in order to get FDA approval." Id. Even assuming the UK Defendants performed the activities alleged by BN, the Complaint fails to state a claim upon which relief may be granted. BN's allegations are based entirely on actions performed for uses reasonably related to the development of the TroVax® vaccine for FDA approval. (Nolan Decl. ¶¶ 5-6.) Participating in and sponsoring FDAapproved clinical trials for the TroVax® vaccine, and publishing reports about the clinical trial findings, all fall squarely within the safe harbor provision of Section 271(e)(1). See Genentech, 436 F.Supp.2d at 1095; Classen Immunotherapies, 381 F.Supp.2d at 456. Because BN only alleges acts that cannot constitute patent infringement, the Court should dismiss the Complaint. Moreover, the UK Defendants have not engaged in a commercial sale or offer to sell the TroVax® vaccine to sanofi-aventis or to any other person or entity. (Nolan Decl. ¶ 5.) BN's only attenuated assertion of commercial activity involving the TroVax® vaccine is a contract between "the defendants"--which apparently includes the UK Defendants and BioMedica--and sanofi-aventis. (Compl. ¶¶ 25, 29.) However, even if that contract could be characterized as having some commercial purpose, that does not eliminate the protection afforded by Section 271(e)(1). As in Genentech, seeking and receiving funds to conduct research and development for FDA approval is not patent infringement. Genentech, 436 F.Supp.2d at 1095; see Telectronics, 982 F.2d at 1525 ("using...the derived test data for fund raising and other business purposes" was protected activity and consistent with legislative intent behind Section 271(e)(1)); Classen Immunotherapies, 381 F.Supp. 2d at 456 (post-approval commercial 5
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research and development activities for purposes of FDA submissions were also protected under Section 271(e)(1)). Because BN does not--and cannot--allege any facts supporting its claim for patent infringement against the UK Defendants, the Court should dismiss the Complaint. B. BN Cannot Establish Proper Subject-Matter Jurisdiction Because the TroVax® Vaccine Has Not Been Approved by the FDA.

A complaint must be dismissed under Rule 12(b)(1) of the Federal Rules of Civil Procedure when the court lacks subject-matter jurisdiction. Fed. R. Civ. P. 12(b)(1). Under Article III of the United States Constitution, courts may only adjudicate "actual cases or controversies." U.S. CONST. art. III, § 2, cl. 2. To satisfy the requirements of Article III, the plaintiff must sufficiently demonstrate that the dispute is "definite and concrete, touching the legal relations of parties having adverse legal interests," and that the dispute is "real and substantial." MedImmune, Inc. v. Genentech, Inc., 127 S. Ct. 764, 771 (2007). In Shaunnessey v. Monteris Medical, Inc., 554 F.Supp.2d 1321, 1326 (M.D. Fla. May 8, 2008), the court granted a motion to dismiss under Rule 12(b)(1) for lack of subject-matter jurisdiction. Plaintiff Shaunnessey sued defendant Monteris for alleged infringement of a patent on an apparatus that moved a surgical laser to kill brain tumors. Id. Monteris was testing its allegedly infringing device and had exhibited its device in at least five separate locations in the United States to generate investment support to further its development for submission to the FDA for approval. Id. However, the district court granted the motion to dismiss and concluded that there was not sufficient immediacy and reality to provide subject-matter jurisdiction because any FDA approval was years away. Id. at 1324-25. In addition, the court noted that no party could know whether the approved device would be the same or substantially the same device that was currently being tested. Id. at 1324. Even assuming all the facts as pleaded by BN are true regarding the UK Defendants' actions, the Court lacks subject-matter jurisdiction to decide this case. Just as the allegedly infringing device in Shaunnessey had not yet received FDA approval, BN's complaint acknowledges that the TroVax® vaccine similarly has not been approved by the FDA. (Compl. ¶¶ 25-26, 28, 30, 37.) Moreover, there is no way to know for certain if, or when, the TroVax® 6
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vaccine will be approved or whether the approved vaccine will have the same composition as the version being tested in the FDA-approved clinical trials. Indeed, further administration of the TroVax® vaccine to patients has been halted, and there are no further plans to administer the TroVax® vaccine, in the TRIST trial. (Nolan Decl. ¶ 7.) Because BN's patent-infringement allegations lack the requisite immediacy to establish proper subject-matter jurisdiction, the Court should dismiss the Complaint. IV. CONCLUSION. Even if all the allegations in BN's Complaint are assumed to be true, BN cannot state any claim for relief because the alleged acts of infringement fall squarely within the safe harbor protection of Section 271(e)(1). Moreover, the Court does not have proper subject-matter jurisdiction because the TroVax® vaccine forming the basis for BN's Complaint has not been approved by the FDA. Accordingly, the UK Defendants respectfully request that the Court dismiss BN's complaint.

Dated: August 18, 2008

Respectfully submitted DLA PIPER US LLP

By: s/ Richard T. Mulloy Richard T. Mulloy Attorneys For Defendants, OXFORD BIOMEDICA PLC, BIOMEDICA, INC., AND OXFORD BIOMEDICA (UK) LTD.

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OF COUNSEL: Edgar H. Haug (PRO HAC VICE) [email protected] Thomas J. Kowalski (PRO HAC VICE) [email protected] Vicki Franks (PRO HAC VICE) [email protected] Gina M. Bassi (PRO HAC VICE) [email protected] Anne-Marie C. Yvon (PRO HAC VICE) [email protected] FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue, New York, New York 10151 Telephone: (212) 588-0800 Facsimile: (212) 588-0500 Attorneys for Defendants, OXFORD BIOMEDICA PLC, BIOMEDICA, INC., and OXFORD BIOMEDICA (UK) LTD.

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EXHIBIT A

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OXFORD BIOMEDICA SECURES AGREEMENT WITH FDA ON SPECIAL PROTOCOL ASSESSMENT FOR PHASE III TRIAL OF TROVAX IN RENAL CANCER
Oxford BioMedica (LSE: OXB), the leading gene therapy company, announced today that it has received a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA) for a Phase III trial of TroVax in renal cell carcinoma. The written agreement from the FDA specifies the design, conduct, analysis and endpoints of the trial, which, if successful, will support an efficacy claim in a regulatory submission for product registration. The SPA was received at the end of the FDA's first review period following Oxford BioMedica's application in March 2006. Oxford BioMedica plans to start the trial in the second half of 2006. The Phase III trial, referred to as TRIST (TroVax Renal Immunotherapy Survival Trial), will evaluate whether TroVax immunotherapy, added to first line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal adenocarcinoma. The trial will be a randomised, placebo-controlled, two-arm study of TroVax in combination with standard of care versus placebo with standard of care. Standard of care will be interleukin-2, interferon-alpha or Sutent® (sunitinib). Study treatment will be stratified between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced. Recruitment will be approximately 700 patients in about 120 centres in the USA, European Union and Eastern Europe. The primary endpoint will be survival improvement and secondary endpoints will include progression free survival, tumour response rates and quality of life scores. The protocol includes the appointment of a Safety and Efficacy Monitoring Board (SEMB) to assess the safety and potential efficacy of the drug combinations at various time points during the trial. Oxford BioMedica is also discussing the TRIST trial with regulatory authorities in Europe. In addition, the Company plans to seek `orphan drug' designation for TroVax in both the USA and Europe for renal cell carcinoma. The granting of orphan drug status would provide Oxford BioMedica and any prospective commercial partner with various benefits in terms of regulatory exclusivity, assistance with clinical development and a waiver of filing fees. Oxford BioMedica's Chief Medical Officer, Dr Mike McDonald, said: "We are delighted to have secured the SPA within such a short time period. We have worked closely with the FDA on the design of the TRIST study and they have been extremely supportive. We look forward to starting this pivotal trial of TroVax in a cancer setting where there are few treatment options and there is a need for new approaches that are both safe and effective." Commenting on the SPA, Oxford BioMedica's Chief Executive, Professor Alan Kingsman, said: "This is a significant milestone for the Company. It represents the successful achievement of the first of our major goals for 2006." - ends -

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Notes

1.

Oxford BioMedica plc Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in 2006, and four further preclinical candidates. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

2.

TroVax® TroVax is Oxford BioMedica's leading cancer immunotherapy product. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4. TroVax has attracted external support from Cancer Research UK and the US National Cancer Institute. Over 100 patients have now been treated with TroVax in six clinical trials (collectively over 400 doses). The Company is targeting colorectal cancer and renal cell carcinoma (RCC) as lead indications for the development of TroVax. Renal cell carcinoma is an indication where TroVax might achieve a rapid route to product registration. Renal Cell Carcinoma Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA. More than 150,000 people are newly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCC has metastasised to other organs at the time of first diagnosis, the five-year survival rate is less than 5%. In the USA and Europe, RCC accounts for more than 33,000 deaths each year. To date, neither radiation, chemotherapy, nor hormonal therapy prolongs the survival of metastatic RCC patients. Commonly used treatments for patients with metastatic RCC include cytokines such as interferon-alpha, which has limited efficacy, and interleukin-2, which is associated with severe side effects at high dose levels. Two new drugs have recently received US approval for the treatment of metastatic RCC, Nexavar® and Sutent®, although there are no published data showing that they offer a survival benefit. There are several reasons for considering that a cancer vaccine such as TroVax might be highly appropriate for this patient group. There is circumstantial evidence that immune responses may be important in dictating the outcome for RCC patients and a vaccine could potentiate this immune response. TroVax, in particular, may be the vaccine of choice since the expression of 5T4, the antigenic component of TroVax, is more prevalent in RCC than any other solid cancer analysed by Oxford BioMedica. 5T4 is present at high levels on a high proportion of cells in approximately 90% of tumours. Treatments for RCC generated sales of $600 million in 2004 according to Datamonitor.

3.

4.

Special Protocol Assessment (SPA) The FDA's SPA process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. Under the SPA process, the FDA assesses the protocol design, conduct and data analyses of a trial. Once the protocol is agreed in writing, then the assessment is binding on the review division of the FDA as long as the protocol is followed, unless substantial scientific issues essential to determining the safety or efficacy of the drug are identified later. Clinical protocols for Phase III trials that are assessed under the SPA process can form the primary basis of an efficacy claim in a marketing application submitted to the FDA. Further information on the SPA process is available at www.fda.gov

For further information please contact: Oxford BioMedica plc Professor Alan Kingsman, Chief Executive City/Financial Enquiries Lisa Baderoon/Mark Court/Mary-Jane Johnson

Tel: +44 (0)1865 783 000 Tel: +44 (0)20 7466 5000

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Buchanan Communications Scientific/Trade Press Enquiries Katja Stout/Gemma Bradley College Hill - Life Sciences Top of page
Website by College Hill - Life Sciences

Tel: +44 (0)20 7886 8150

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News 11 July 2008
2008/OB/21
2008 Archive

OXFORD BIOMEDICA ANNOUNCES DATA SAFETY MONITORING BOARD RECOMMENDATION FOR TROVAX® PHASE III TRIST STUDY
Oxford, UK - 11 July 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has recommended that the trial should continue but that further vaccinations be discontinued. TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis. Following its fourth interim review of the TRIST study, the DSMB advised that TroVax administered according to the protocol will not meet the predefined primary efficacy endpoint, but there is important scientific merit and more to be learned by additional follow up of all patients. Hence, the DSMB's recommendation is to continue the study but discontinue further vaccinations. Oxford BioMedica has implemented the DSMB's recommendation. In addition, the Company intends to amend the statistical plan of the study to determine whether patient outcome is dependent on the number of TroVax doses administered. Oxford BioMedica and, its partner, sanofi-aventis, will evaluate the available data and the implications on the development plan for TroVax, including the planned Phase III trials in colorectal cancer. The companies will discuss the proposed TRIST protocol amendments with the regulatory authorities. With these amendments, a focus of the ongoing TRIST study will be to explore the number of doses that provide optimal benefit. In particular, it may be that the optimal benefit-to-risk ratio is delivered without the requirement for as many vaccinations as specified in the original TRIST study protocol. It is unlikely that the TRIST study alone will support registration of TroVax in renal cancer, although the trial may ultimately demonstrate a survival advantage for TroVax, and the results may form part of a regulatory submission alongside an additional confirmatory trial. The role of the DSMB is to monitor, periodically, the data emerging from the study to determine whether there are issues arising that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis. The TRIST (TroVax Renal Immunotherapy Survival Trial) study is a randomised and placebo-controlled Phase III trial, designed to evaluate TroVax in combination with standard of care in locally advanced or metastatic clear cell renal carcinoma. The trial was initiated in November 2006 and completed recruitment of 733 patients in March 2008 in more than 100 sites in the USA, European Union and Eastern Europe. The original trial protocol, which was the subject of a Special Protocol Assessment by the US Food and Drug Administration (FDA), allowed for patients to receive up to 13 immunisations over 73 weeks. Dr Mike McDonald, Chief Executive of Oxford BioMedica, said: "This news is clearly disappointing. However, there is good reason to continue the study and potentially a late survival benefit for TroVax may still be demonstrated. The proposed trial amendment will assess whether the maximum benefit-to-risk ratio is dependent on an optimal number of doses.

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We remain optimistic that TroVax may show benefit in this population after these protocol amendments. With our partner, sanofi-aventis, we will provide an update on the TRIST study and the development plan for TroVax in due course." Dr McDonald added: "In addition to TroVax, we have a broad pipeline of innovative drug candidates and we will continue to focus our resources on deriving maximum value for both patients and shareholders, while maintaining the Company's financial strength. In particular, we look forward to reporting initial results from the Phase I/II trial of ProSavin in Parkinson's disease in September. In addition, we are working diligently towards the start of clinical trials of RetinoStat in neovascular age-related macular degeneration." - ends Conference Call and Audio Web Cast on Friday, 11 July at 10.00am BST Oxford BioMedica's management will host a conference call for analysts at 10.00am BST on Friday, 11 July 2008, to discuss the DSMB's recommendation for the TroVax Phase III TRIST study. The dial-in details for analysts are available from Buchanan Communications (+44 (0) 20 7466 5000). A live audio web cast of the conference call will be available through the website homepage. This will also be available for replay shortly after the conference call. Return to the News
Notes

1.

Oxford BioMedica plc Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer immunotherapy and gene-based therapies. The Company was established in 1995, as a spin-out from Oxford University, and is listed on the London Stock Exchange. The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. TroVax® is the Company's therapeutic vaccine, which is in clinical development for multiple solid cancers. The product is licensed to sanofi-aventis for global development and commercialisation. Oxford BioMedica has three other products in clinical development, including ProSavin®, a novel gene-based treatment for Parkinson's disease, in a Phase I/II trial. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 85. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk

2.

TroVax® TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a Modified Vaccinia Ankara vector, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 antigen.

For further information please contact: Oxford BioMedica plc Mike McDonald, Chief Executive Officer Nick Woolf, Chief Business Officer JPMorgan Cazenove Limited James Mitford/Gina Gibson City/Financial Enquiries Lisa Baderoon/Mark Court/Mary-Jane Johnson Buchanan Communications

Tel: +44 (0)1865 783 000

Tel: +44 (0)20 7588 2828 Tel: +44 (0)20 7466 5000

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Scientific/Trade Press Enquiries Holly Griffiths/Katja Stout/Claire Mosley College Hill US Enquiries Thomas Fechtner The Trout Group LLC Top of page
Website by College Hill - Life Sciences

Tel: +44 (0)20 7457 2020

Tel: +1 646 378 2900

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DLA P IPER US LLP
SAN DIEGO

RICHARD T. MULLOY (Bar No. 199278) DLA PIPER US LLP 401 B Street, Suite 1700 San Diego, CA 92101-3697 Tel: 619.699.4787 Fax: 619.699.2701 E-mail: [email protected] EDGAR H. HAUG THOMAS J. KOWALSKI VICKI FRANKS ANNE-MARIE C. YVON GINA M. BASSI FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue New York, NY 10151 Tel: (212) 588-0800 Fax: (212) 588-0500 Attorneys for Defendants OXFORD BIOMEDICA PLC, BIOMEDICA, INC., AND OXFORD BIOMEDICA (UK) LTD.

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA BAVARIAN NORDIC A/S, Plaintiff, v. OXFORD BIOMEDICA PLC, an English public limited company; BIOMEDICA, INC., a Delaware corporation; and OXFORD BIOMEDICA (UK) LTD., an English private limited company, Defendants. CV NO. 08 CV 1156 L (RBB) PROOF OF SERVICE Judge: Hon. M. James Lorenz Magistrate Judge: Hon. Ruben B. Brooks Complaint: June 30, 2008

-1WEST\21473726.1

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DLA P IPER US LLP
SAN DIEGO

PROOF OF SERVICE BAVARIAN NORDIC A/S v. OXFORD BIOMEDICA, PLD, et al. Case No. 08 CV 1156 L (RBB)

I am a resident of the State of California, over the age of eighteen years, and not a party to the within action. My business address is DLA Piper US LLP, 401 B Street, Suite 1700, San Diego, CA 92101-42907. I hereby certify that on August 18, 2008, I caused the following document(s) to be electronically filed with the Clerk of the Court and served on all parties to this action using the CM/ECF system: · OXFORD BIOMEDICA PLC'S AND OXFORD BIOMEDICA (UK) LTD.'S NOTICE OF MOTION AND MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM, AND LACK OF SUBJECT-MATTER JURISDICTION MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF OXFORD BIOMEDICA PLC'S AND OXFORD BIOMEDICA (UK) LTD.'S MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM AND LACK OF SUBJECTMATTER JURISDICTION DECLARATION OF PETER J. NOLAN IN SUPPORT OF OXFORD BIOMEDICA PLC'S AND OXFORD BIOMEDICA (UK) LTD.'S MOTION TO DISMISS

·

·

Michael L Kirby Kirby Noonan Lance and Hoge LLP Diamond View Towers 350 Tenth Avenue Suite 1300 San Diego, CA 92101 (619)231-8666 Fax: (619)231-9593 Email: [email protected] Christopher M. Morrison David C. Kravitz Theodore J. Folkman Hanify & King PC One Beacon Street Boston, MA 02108 (617)423-0400 Fax: (617)423-0498 Email: [email protected] Email: [email protected] Email: [email protected] -2WEST\21473726.1

Via CM/ECF Via Email (PDF) Via First Class Mail Via Overnight Mail Via Hand Delivery Overnight Mail Via Facsimile

Via CM/ECF Via Email (PDF) Via First Class Mail Via Overnight Mail Via Hand Delivery Overnight Mail Via Facsimile

CV NO. 08 CV 1156 L (RBB)

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DLA P IPER US LLP
SAN DIEGO

I declare that I am employed in the office of a member of the Bar of or permitted to practice before this Court at whose direction the service was made. Executed on August 18, 2008, at San Diego, California.

Virginia R. Gomez

-3WEST\21473726.1

CV NO. 08 CV 1156 L (RBB)