Free Notice (Other) - District Court of Delaware - Delaware

Case 1:07-cv-00754-GMS

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ABBOTT LABORATORIES, an Illinois corporation, Plaintiff, v. BANNER PHARMACAPS, INC., a Delaware corporation, Defendant. ABBOTT'S NOTICE OF SUPPLEMENTARY AUTHORITY In further support of its Motion to Dismiss Banner's Unfair Competition Counterclaim (D.I.11&12), Plaintiff Abbott Laboratories respectfully states that: 1. Exhibit A to this Notice of Supplemental Authority is a July 17, 2008 decision Civil Action No. 07-CV-00754-GMS

from the District of New Jersey in the matter of Celgene Corp. v. KV Pharmaceutical Co. that bears directly on the issues presented in Abbott's motion to dismiss. 2. Banner's unfair competition claim alleges that ­ even though Banner admittedly

submitted a new drug application to FDA that contained a paragraph IV certification directed to Abbott's patents, and it provided notice of this submission to Abbott ­ Abbott nevertheless committed a wrongful act by initiating this lawsuit without first reviewing the actual text of Banner's application or testing its product. (See Answer (D.I.7).) As pointed out in Abbott's motion to dismiss, however, the Hatch-Waxman Act provides that it is an act of infringement for an applicant, like Banner, to submit a new drug application containing a paragraph IV certification. (See Brief in Support of Motion to Dismiss (D.I.12) at 8-9.) No more is required to justify a patent infringement action by the patent holder. (Id. (citing Merck & Co. v. Apotex Inc., 488 F. Supp. 2d 418, 429 (D. Del. 2007).)

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3.

The District of New Jersey's recent decision in Celgene is squarely on point. In

that matter, defendant KV submitted a drug application to FDA containing a paragraph IV certification directed to certain patents owned by Celgene, and it subsequently gave notice to Celgene of this submission. (Ex. A at 1-2.) Celgene filed suit against KV under the HatchWaxman Act without first reviewing KV's application or conducting product testing. (Id.) KV responded by filing a motion for sanctions under Rule 11, espousing the very same arguments made by Banner in support of its unfair competition claim. (Id. at 2-3.) 4. The New Jersey court denied KV's Rule 11 motion, with prejudice, finding as a

matter of law that a patent holder is fully justified in instituting a patent infringement action under the Hatch-Waxman Act when it receives notice that an application has been submitted to FDA containing a paragraph IV certification directed to its patents. (Id. at 3-8.) The patent holder has no obligation to review the application or to conduct product testing prior to filing suit. (Id.) 5. Abbott respectfully submits that, like this Court's decision in Merck, the New

Jersey court's recent decision in Celgene completely undermines Banner's unfair competition claim as a matter of law. On the basis of this additional authority, and that relied upon in Abbott's original briefing, Abbott renews its request that this counterclaim be dismissed, with prejudice. Dated: July 28, 2008 Respectfully submitted, CONNOLLY BOVE LODGE & HUTZ LLP

By: /s/ Paul E. Crawford Paul E. Crawford (DE Bar No. 0493) E-mail: [email protected] 1007 N. Orange St. P.O. Box 2207

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Wilmington, DE 19899 (T) 302.658.9141 (F) 302.658.5614 Attorneys for Abbott Laboratories Of Counsel Daniel E. Reidy; Bar No. 2306948 E-mail: [email protected] James R. Daly; Bar No. 6181714 Email: [email protected] Jason G. Winchester; Bar No. 6238377 Email: [email protected] Melissa B. Hirst; Bar No. 6282498 Email: [email protected] JONES DAY 77 West Wacker Drive, Suite 3500 Chicago, Illinois 60601-1692 (T): 312.782.3939 (F): 312.782.8585 Perry C. Siatis ABBOTT LABORATORIES 100 Abbott Park Road Abbott Park, Illinois 60064-6034

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CERTIFICATE OF SERVICE I hereby certify that, on July 28, 2008, a true and correct copy of the foregoing document, entitled Notice of Supplemental Authority, was served on the following persons via the following methods: VIA ELECTRONIC MAIL Charles J. Raubicheck FROMMER, LAWRENCE & HOAG LLP 745 Fifth Avenue New York, NY 10151 [email protected] VIA ECF FILING: George Pazuniak Anna Martina Tyreus WOMBLE CARLYLE SANDRIDGE & RICE, PLLC 222 Delaware Avenue, Suite 1501 Wilmington, DE 19801 [email protected] [email protected] /s/ Paul E. Crawford Paul E. Crawford, Esquire (#493) [email protected]

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EXHIBIT A

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