Case :0-cv-0-MRP-MLG Document Filed //00 Page of California Street San Francisco, CA -0 0 Gail J. Standish (SBN: gstandish@winston.com Peter E. Perkowski (SBN: pperkowski@winston.com WINSTON & STRAWN LLP Los Angeles, CA 00- Telephone: ( -00 Facsimile: ( -0 Don J. Mizerk (SBN: 0 don.mizerk@huschblackwell.com HUSCH BLACKWELL SANDERS WELSH & KATZ 0 S. Riverside Plaza, nd Floor Chicago, IL 00 Telephone: ( -00 Facsimile: ( -0 Attorneys for Defendants ANCHEN PHARMACEUTICALS, INC. and ANCHEN, INC. ELAN PHARMA INTERNATIONAL LIMITED and JAZZ PHARMACEUTICALS, INC., vs. Plaintiffs, UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA ANCHEN PHARMACEUTICALS, INC. and ANCHEN, INC., Defendants. SOUTHERN DIVISION Case No. SACV0-0 CJC (MLGx The Honorable Cormac J. Carney ANSWER AND AFFIRMATIVE DEFENSES OF ANCHEN PHARMACEUTICALS, INC. AND ANCHEN, INC. Defendants Anchen Pharmaceuticals, Inc. ( Anchen Pharmaceuticals and Anchen, Inc. ( Anchen Holding, by and through the undersigned attorneys, respond by way of Answer and Affirmative Defenses to the Complaint of Plaintiffs Elan Pharma International Limited and Jazz Pharmaceuticals, Inc.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 ANSWER AS TO JURISDICTION:. This is an action for infringement of United States Patent No.,, (the Patent. This action is based upon the Patent Laws of the United States, U.S.C. 0 et seq. This Court has jurisdiction over the subject matter of this action pursuant to U.S.C. and (a. ANSWER: Anchen Pharmaceuticals and Anchen Inc. admit that the Complaint purports to be a patent infringement action arising under the Patent Laws of the United States, U.S.C. 0 et seq. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph. AS TO THE PARTIES:. Elan is an Irish corporation having its principal place of business at Monksland, Athlone County, Westmeath, Ireland. ANSWER: Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph.. Jazz Pharmaceuticals is a Delaware corporation having its principal place of business at 0 Porter Drive, Palo Alto, CA 0. ANSWER: Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the allegations of this paragraph.. On information and belief, Anchen Pharmaceuticals is a California corporation having a principal place of business at 0 Jeronimo Road, Irvine, CA -0, and is engaged in the manufacture and sale of generic drug products.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 ANSWER: Anchen Pharmaceuticals admits that it is a specialty pharmaceutical company focused on the development and commercialization of extended release and niche generic pharmaceuticals. Anchen Pharmaceuticals further admits that its state of incorporation is California and its principal place of business is Irvine, California. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, Anchen is a Delaware corporation having a principal place of business at 0 Jeronimo Road, Irvine, CA -0, and is engaged in the manufacture and sale of generic drug products. On information and belief, Anchen Pharmaceuticals is a wholly-owned subsidiary of Anchen. ANSWER: Anchen Holding admits that its state of incorporation is Delaware and its principal place of business is Irvine, California. Anchen Holding further admits that it is the parent corporation of Anchen Pharmaceuticals. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, the Defendants closely coordinate their commercial activities and hold themselves out to the marketplace as one company. For example, during prosecution of Anchen Pharmaceuticals s trademark application for the word mark ANCHEN with respect to pharmaceutical products (serial no. 0, representatives for Anchen Pharmaceuticals stated that, Anchen Pharmaceuticals, Inc. and Anchen Incorporated, though separate legal entities, constitute a single source to the relevant public, and there is unity of control with respect to the nature and quality of the goods. On information and belief, the Defendants have also simultaneously shared senior corporate officers with the same titles, including Margaret Choy, Senior Vice President of Regulatory Affairs. Ms.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 Choy is the contact person listed in the Defendants Paragraph IV Notice Letter to Plaintiffs, which is discussed below. ANSWER: Anchen Pharmaceuticals admits that Margaret Choy is identified in Anchen Pharmaceuticals s ANDA No. - as the contact person for that company for purposes of FDA communications. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, Anchen Pharmaceuticals is in the business of preparing generic pharmaceuticals that it distributes in the State of California and throughout the United States. On information and belief, Anchen Pharmaceuticals conducts its North American operations, in part, through its parent company Anchen. On information and belief, together, the Defendants collaborate in the manufacture, marketing, and sale of many pharmaceutical products (including generic drug products manufactured and sold pursuant to approved abbreviated new drug applications within the United States generally, and the State of California specifically. ANSWER: Anchen Pharmaceuticals admits that it is headquartered in Irvine, California, and further that it is a specialty pharmaceutical company focused on the development and commercialization of extended release and niche generic products. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph. AS TO PERSONAL JURISDICTION AND VENUE:. Based on the facts and causes alleged herein, and for additional reasons to be further developed through discovery, this Court has personal jurisdiction over the Defendants. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that they are each subject to personal jurisdiction in this Court. Except as expressly
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, this Court has personal jurisdiction over Anchen Pharmaceuticals by virtue of its systematic and continuous contacts with the State of California, and within this judicial district, including inter alia the supply of generic pharmaceutical drugs to the State of California including this judicial district. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that they are each subject to personal jurisdiction in this Court. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, Anchen Pharmaceuticals plans to continue to maintain continuous and systematic contacts with the State of California and within this judicial district, including but not limited to its aforementioned business of preparing generic pharmaceuticals that it distributes in the State of California, including this judicial district. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that they are each subject to personal jurisdiction in this Court. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. On information and belief, this Court has personal jurisdiction over Anchen Pharmaceuticals because Anchen Pharmaceuticals is a California corporation, and because Anchen Pharmaceuticals has had continuous and systematic contacts within this judicial district, including inter alia the supply of generic pharmaceutical drugs to the State of California.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that they are each subject to personal jurisdiction in this Court. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph. and 00(b.. Venue is proper in this judicial district pursuant to U.S.C. (c ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that venue is proper in this district under U.S.C. 00(b. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph. AS TO ALLEGED FACTS:. On December, 00, the patent, entitled Multiparticulate Controlled Release Selective Serotonin Reuptake Inhibitor Formulations, was duly and legally issued to Elan as assignee. Jazz Pharmaceuticals is the exclusive licensee under the patent. A true and correct copy of the patent is attached as Exhibit A. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that the U.S. Patent and Trademark Office issued U.S. Patent No.,, ( the patent on December, 00, and that Elan Pharma International Limited is listed on the face of the patent as Assignee. Anchen Pharmaceuticals and Anchen Holding further admit that a document purporting to be a copy of the patent is attached to the Complaint as Exhibit A. Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the allegations that Jazz Pharmaceuticals is the exclusive licensee under the patent. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0. On February, 00, the United States Food and Drug Administration ( FDA approved an new drug application ( NDA, No. -0, for LUVOX CR extended release capsules, which contain fluvoxamine maleate, under 0(a of the Federal Food, Drug and Cosmetic Act, U.S.C. (a, for the treatment of social anxiety disorder and obsessive compulsive disorder. The patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book for LUVOX CR capsules. Jazz Pharmaceuticals is the holder of NDA No. -0. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that the patent is listed in the Orange Book in reference to LUVOX CR. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the remaining allegations of this paragraph.. On information and belief, Defendants submitted to the FDA an ANDA, No. -, under 0(j of the Federal Food, Drug and Cosmetic Act, U.S.C. (j, seeking approval to engage in the commercial manufacture, use, and sale of Fluvoxamine Maleate Extended-Release Capsules in the 0 and 0 mg strengths, as generic versions of the LUVOX CR 0 and 0 mg capsules. ANSWER: Anchen Pharmaceuticals admits that it submitted ANDA No. - to FDA under 0(j of the Federal Food, Drug and Cosmetic Act, U.S.C. (j, seeking approval to engage in the commercial manufacture, use, and sale of Fluvoxamine Maleate Extended-Release Capsules in the 0 and 0 mg strengths, as generic versions of the LUVOX CR 0 and 0 mg capsules. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0. The filing of ANDA No. - by Defendants constituted an act of infringement pursuant to U.S.C. (e((a. ANSWER: The allegation of this paragraph state a legal conclusion to which no response is required. To the extent a response is required, Anchen Pharmaceuticals and Anchen Holding deny the allegation.. By letter dated September, 00 (the Anchen Letter, Defendants advised Plaintiffs that they had submitted ANDA No. - seeking approval to manufacture, use, or sell generic Fluvoxamine Maleate Extended-Release Capsules prior to the expiration of the patent. ANSWER: Anchen Pharmaceuticals admits that, by letter dated September, 00, it advised Plaintiffs that it submitted ANDA No. - seeking approval to manufacture, use, or sell Fluvoxamine Maleate Extended-Release Capsules prior to the expiration of the patent. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. The Anchen Letter advised Plaintiffs that Defendants ANDA included a certification under U.S.C. (j((a(vii(iv that, in the Anchen Defendants opinion, the manufacture, use or sale of the proposed generic Fluvoxamine Maleate Extended-Release Capsules described in their ANDA will not infringe any valid claim of the patent. ANSWER: Anchen Pharmaceuticals admits that its letter dated September, 00, included notice that ANDA No. - included a certification that each claim of the patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the drug product described in ANDA No. -. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0. Under the Hatch-Waxman Act of, an owner of a patented drug must file an action in federal court within days of receiving a letter such as the Anchen Letter ( -day window in order to receive certain benefits under the Act, including a stay of approval of the generic drug for up to 0 months during the pendency of litigation, as appropriate. U.S.C. (c((c. ANSWER: The allegations of this paragraph state legal conclusions to which no response is required. To the extent a response is required, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph. 0. On October, 00, within the -day window, Plaintiffs filed and served an action against Defendants for infringement of the patent-in-suit in the United States District Court for the District of Delaware, Civil Action No. 0- (the Delaware Action. A copy of the Complaint in the Delaware Action is attached hereto as Exhibit B. ANSWER: Anchen Pharmaceuticals and Anchen Holding admit that Plaintiffs filed a complaint against them and another party in the United States District Court for the District of Delaware, Civil Action No. 0-cv-00. Anchen Pharmaceuticals and Anchen Holding further admit that the document attached to the complaint filed in this case purports to be a copy of the complaint filed in Delaware and assigned case number 0-cv-00. Except as expressly admitted, Anchen Pharmaceuticals and Anchen Holding deny the allegations of this paragraph.. Defendants are both properly subject to personal jurisdiction in the District of Delaware. Upon information and belief, Plaintiffs understand that Defendants may nevertheless contest personal jurisdiction in Delaware. The Hatch- Waxman Act does not squarely address the consequences of the grant of a motion to dismiss for lack of personal jurisdiction in a plaintiff s chosen forum. It is possible
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 that such a dismissal could result in a plaintiff losing the benefit of the 0-month stay of ANDA approval even if the plaintiff refilled the action in another jurisdiction, since the refilling would occur after the -day window. Therefore, district courts have countenanced the filing of additional protective suits within the -day window to ensure a plaintiff will not lose the benefits of the 0-month stay should the court in the chosen forum dismiss the action for lack of personal jurisdiction. See, e.g., Adams Respiratory Therapeutics, Inc. v. Perrigo Co., No. :0-cv-, 00 WL (W.D. Mich. Dec., 00; see also PDL Biopharma, Inc. v. Sun Pharm. Indus., Ltd., No. 0-0, 00 WL (E.D. Mich. Aug,, 00; Celgene Corp. v. Abrika Pharms., Inc., No. 0- (SDW, 00 WL (D.N.J. May, 00. ANSWER: Anchen Pharmaceuticals and Anchen Holding deny that they are both subject to personal jurisdiction in the District of Delaware. Anchen Pharmaceuticals and Anchen Holding also deny that Plaintiffs are entitled to file a protective suit as alleged. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin Ltd., 0 F. Supp. d, (E.D. Va. 00 ( If the Maryland forum is in any way questionable in order to necessitate a protective filing as Plaintiffs maintain, then this Court is clearly the better forum, as all of the parties agree that both jurisdiction and venue lie here.. Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the allegation concerning Plaintiffs understanding or belief. The remaining allegations of this paragraph state legal conclusions to which no response is required.. Accordingly, although Plaintiffs believe the District of Delaware has personal jurisdiction over Defendants, and Delaware is their preferred choice of forum to litigate the claims for relief set forth in this Complaint, Plaintiffs seek the Court s indulgence and file this Complaint as a protective suit to protect Plaintiffs rights under the Hatch-Waxman Act in the event the District of Delaware were to determine that there is no personal jurisdiction over one or both Defendants in Delaware.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 ANSWER: Anchen Pharmaceuticals and Anchen Holding deny that they are both subject to personal jurisdiction in the District of Delaware. Anchen Pharmaceuticals and Anchen Holding also deny that Plaintiffs are entitled to file a protective suit as alleged. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin Ltd., 0 F. Supp. d, (E.D. Va. 00 ( If the Maryland forum is in any way questionable in order to necessitate a protective filing as Plaintiffs maintain, then this Court is clearly the better forum, as all of the parties agree that both jurisdiction and venue lie here.. Anchen Pharmaceuticals and Anchen Holding are without knowledge or information sufficient to form a belief as to the truth of the allegation concerning Plaintiffs understanding or belief. The remaining allegations of this paragraph state legal conclusions to which no response is required. AS TO COUNT I:. Plaintiffs incorporate each of the preceding paragraphs to as if fully set forth herein. ANSWER: Anchen Pharmaceuticals and Anchen Holding incorporate their answers to paragraphs to as if fully set forth herein.. By submitting ANDA No. - to the FDA for the purpose of obtaining approval to engage in the commercial manufacture, use or sale of its generic Fluvoxamine Maleate Extended-Release Capsules prior to the expiration of the patent, the Defendants, acting jointly in submitting ANDA No. - and both being actively involved in that submission, have committed an act of infringement of the patent under U.S.C. (e(. ANSWER: Denied.. The commercial manufacture, use or sale of the Anchen Defendants proposed generic Fluvoxamine Maleate Extended-Release Capsules in the United
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0 States before the expiration of the patent would infringe one or more claims of that patent. ANSWER: Denied.. On information and belief, the Defendants were aware of the existence of the patent and was aware that the filing of their ANDA and certification with respect to the patent constituted infringement of that patent. This is an exceptional case. ANSWER: Denied. AS TO COUNT II:. Plaintiffs incorporate each of the preceding paragraphs to as if fully set forth herein. ANSWER: Anchen Pharmaceuticals and Anchen Holding incorporate their answers to paragraphs to as if fully set forth herein.. On information and belief, Anchen jointly filed and/or was actively involved in submitting ANDA No. - to the FDA to obtain approval to engage in the commercial manufacture, use, or sale throughout the United States, including the State of California, of the Defendants generic Fluvoxamine Maleate Extended- Release Capsules prior to the expiration of the patent. Upon information and belief, Anchen will participate in the manufacture, marketing, and sale of the Defendants generic Fluvoxamine Maleate Extended-Release Capsules if they are approved by the FDA. Anchen thus actively induced Anchen Pharmaceuticals to submit ANDA No. - to the FDA. ANSWER: Denied.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Los Angeles, CA 00-0. The commercial manufacture, use or sale of the Anchen Defendants proposed generic Fluvoxamine Maleate Extended-Release Capsules in the United States before the expiration of the patent would infringe one or more claims of that patent. ANSWER: Denied. 0. By actively inducing submission of ANDA No. -, Anchen has committed an act of infringement with respect to the patent under U.S.C. (b. ANSWER: Denied. AS TO THE PRAYER FOR RELIEF: The allegations contained in the Plaintiffs Prayer for Relief do not require a response, but to the extent that their Prayer for Relief contains additional allegations, Anchen Pharmaceuticals and Anchen Holding deny them all and deny that Elan Pharma International Limited and Jazz Pharmaceuticals, Inc. are entitled to any relief from either Anchen Pharmaceuticals or Anchen Holding. AFFIRMATIVE DEFENSES Further answering the Complaint, Anchen Pharmaceuticals and Anchen Holding assert the following defenses in response to the allegations of the Complaint, undertaking the burden of proof only as to those defenses required by law, regardless of how such defenses are denominated below. Anchen Pharmaceuticals and Anchen Holding each reserve the right to amend this answer with additional defenses as further information is obtained. First Affirmative Defense The manufacture, use, or sale of Anchen Pharmaceuticals s proposed ANDA product has not infringed, does not infringe, and would not infringe any claims of the patent.
Case :0-cv-0-MRP-MLG Document Filed //00 Page of Second Affirmative Defense The asserted claims of the patent are invalid under one or more provisions of U.S.C., et seq. WHEREFORE, Anchen Pharmaceuticals and Anchen Holding respectfully request that Elan Pharma International Limited and Jazz Pharmaceuticals, Inc. take nothing by way of their Complaint, that judgment be entered in favor of Anchen Pharmaceuticals and Anchen Holding, that Anchen Pharmaceuticals and Anchen Holding be awarded their attorneys fees and costs, and that the Court award Anchen Pharmaceuticals and Anchen Holding all other just and proper relief. Los Angeles, CA 00-0 Dated: October, 00 Respectfully submitted, WINSTON & STRAWN LLP By: /s/ Peter E. Perkowski Gail J. Standish (SBN: gstandish@winston.com Peter E. Perkowski (SBN: pperkowski@winston.com WINSTON & STRAWN LLP Los Angeles, CA 00- Telephone: ( -00 Facsimile: ( -0 Don J. Mizerk (SBN: 0 don.mizerk@huschblackwell.com HUSCH BLACKWELL SANDERS WELSH & KATZ 0 S. Riverside Plaza, nd Floor Chicago, IL 00 Telephone: ( -00 Facsimile: ( Attorneys for Defendants Anchen Pharmaceuticals, Inc. and Anchen, Inc.