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Andrulis Pharmaceuticals Corp. v. Celgene Corp.

United States District Court, D. Delaware

July 16, 2015

ANDRULIS PHARMACEUTICALS CORP., Plaintiff,
v.
CELGENE CORP., Defendant.

REPORT AND RECOMMENDATION

MARY PAT THYNGE, Magistrate Judge.

I. INTRODUCTION

On October 2, 2013 Andrulis Pharmaceuticals Corp. ("plaintiff') filed this action against Celgene Corp. ("defendant"), alleging infringement of U.S. Patent No. 6, 140, 346 ("the 364 patent"), seeking declaratory judgment of defendant's willful and deliberate infringement, including enhanced damages, compensatory damages, and costs. On March 10, 2015, defendant amended its answer to include Count IV of its counterclaim, seeking declaratory judgment of the unenforceability of the 346 patent due to inequitable conduct, and a ninth affirmative defense, also alleging that the 346 patent is unenforceable due to inequitable conduct.[1]

Pending before the court is plaintiff's motion to dismiss Count IV of defendant's counterclaim for failure to state a claim of inequitable conduct under FED. R. CIV. P. 12(b)(6) and to strike defendant's ninth affirmative defense for asserting an insufficient defense of inequitable conduct under FED. R. CIV. P. 12(f).[2] The court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a) because this action arises under 35 U.S.C. § 1 et seq., [3] and personal jurisdiction over defendant, who is a Delaware corporation.[4] Venue is proper under 28 U.S.C. §§ 1391(c) and 1400(b).[5] This Report and Recommendation is issued pursuant to 28 U.S.C. § 636(b)(1)(B), FED. R. CIV. P. 72(b)(1), and D. DEL. LR 72.1.[6] For the reasons stated below, it is recommended that plaintiff's motion be denied.

II. BACKGROUND

A. Parties

Plaintiff is a corporation organized and existing under the laws of the State of Maryland, with its principal place of business in Rehoboth, Delaware.[7] Defendant is a Delaware corporation, with its principal place of business in Summit, New Jersey.[8]

B. Patent-in-suit

Plaintiff asserts that it currently holds and has held all rights to the patent-in-suit by assignment from inventors Peter J. Andrulis, Jr. ("Andrulis") and Murray W. Drulak ("Drulak") since the issuance of the 346 patent's from the United States Patent and Trademark Office ("PTO") on October 31, 2000.[9] The 346 patent, titled "Treatment of Cancer with Thalidomide Alone or in Combination with Other Anti-Cancer Agents, " claims a "novel method for the treatment of certain cancers, including multiple myeloma, which comprises administering therapeutically-effective amounts of the drug thalidomide in combination with an alkylating agent, " such as cisplatin or carboplatin.[10]

During the review of the corresponding application ("813 application") of the 346 patent, the examiner initially rejected claims "directed to a combination of thalidomide and cisplatin (an alkylating agent) as obvious over U.S. Patent No. 5, 399, 363 to Liversidge et al. (Liversidge'), " which disclosed that "anticancer agents can be used... in combination" and that thalidomide and cisplatin are among the anticancer agents.[11] The examiner concluded that evidence demonstrating a "greater than additive effect" was necessary to overcome the obviousness rejection.[12]

In response to the Office Action, the claims were amended to require an "enhanced effective amount" of thalidomide. Appendix A was attached to the Response to illustrate "the success of thalidomide in combination with anticancer agents" in a way not taught by the Liversidge Patent.[13] Appendix A included the following:

(1) 1996 NYU Proposed Study Concept Sheet, which proposed a Phase I/II study "to document [the] safety and potential efficacy of the combination" of thalidomide and carboplatin (an alkylating agent).[14]
(2) 1996 NYU Study Interim Report, which outlined the study's parameters and included both the interim data results[15] and a "Conclusions" heading appearing ...

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