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Isis Pharmaceuticals, Inc., A Delaware v. Santaris Pharma A/S Corp.

April 23, 2013

ISIS PHARMACEUTICALS, INC., A DELAWARE CORPORATION,
PLAINTIFF,
v.
SANTARIS PHARMA A/S CORP., A DELAWARE CORPORATION, AND
SANTARIS PHARMA A/S, A DANISH CORPORATION,
DEFENDANTS.



The opinion of the court was delivered by: Hon. Gonzalo P. Curiel United States District Judge

ORDER GRANTING PLAINTIFF'S MOTION FOR LEAVE TO FILE FIRST AMENDED COMPLAINT (ECF NO. 95) AND RELATED COUNTERCLAIMS.

INTRODUCTION

Before the Court is Plaintiff's Motion for Leave to File a First Amended Complaint, (ECF No. 95), which has been fully briefed, (ECF Nos. 104, 109), and which the Court finds suitable for disposition without oral argument, see CivLR 7.1.d.1. After considering the parties' submissions and the record in this matter, and for the reasons that follow, the Court hereby GRANTS Plaintiff's Motion for Leave to File a First Amended Complaint.

BACKGROUND

Plaintiff filed suit on September 22, 2011, alleging infringement of two of its patents: U.S. Patent No. 6,326,199, "Gapped 2' Modified Oligonucleotides" ("'199 Patent") and U.S. Patent No. 6,066,500 "Antisense Modulation of Beta Catenin Expression" ("'500 Patent"). (ECF No. 1.) Both the '199 Patent and the '500 Patent cover methods and compounds related to the modification of genetic material.

Ribonucleic acid, or RNA, is a single-stranded molecule that carries genetic instructions. Messenger RNA, or mRNA, carries genetic instructions from a cell's nucleus to the cell's cytoplasm, where it provides instructions for the production of proteins. Nucleotides from the basic structural unit of nucleic acids like mRNA.

The '199 Patent covers the synthesis and use of short strands of nucleotides called oligonucleotides, antisense molecules, or -- very broadly -- macromolecules. The '199 Patent claims a method whereby antisense molecules are hybridized with complimentary strands of mRNA in a target cell to modify the target cell's behavior in some way.

To ensure successful hybridization, the antisense molecules covered by the '199 Patent possess features that make degradation of the molecule less likely and that make binding with the complimentary strand more likely.

If successfully hybridized, the antisense molecule modifies the target cell to, for example, decrease production of a certain protein. Indeed, the '500 Patent covers the synthesis and use of an antisense molecule that specifically reduces production of the protein Beta catenin -- a protein whose overproduction has been tied to certain cancers.

Plaintiff alleges in its Complaint that Defendants have used the molecules claimed by the '199 Patent, and the method of contacting cells with those molecules also claimed in the '199 Patent, to "identify [gene] targets and/or to screen gapmer ... antisense molecules for activity inhibiting a target." Plaintiff alleges Defendants sell and offer for sale in the U.S. the patented methods of the '199 Patent. Plaintiff further alleges that Defendants have infringed the '500 Patent by offering for sale and selling antisense compounds that inhibit Beta catenin production.

Plaintiff bases its infringement contentions on four agreements between Defendants and various U.S. pharmaceutical companies: a January 4, 2011 agreement with Pfizer, Inc.; a July 27, 2006 agreement with Enzon Pharmaceuticals, Inc.; an August 24, 2009 agreement with Shire PLC; and a December 19, 2007 agreement with GlaxoSmithKline. Plaintiff alleges each of the agreements infringe the '199 Patent (and that the Enzon agreement also infringes the '500 Patent) because the agreements require Defendants to supply the above pharmaceutical companies with antisense molecules that are covered by the '199 and '500 Patents for use in connection with therapeutic targets identified by the pharmaceutical companies.

On December 8, 2011, Defendants filed an answer and counterclaims against Plaintiff. (ECF No. 12.) On December 12, 2011, Plaintiff filed a reply to Defendants' counterclaims. (ECF NO. 14.)

Thereafter, before a case management conference was held (and thus before discovery commenced), Defendants filed a motion for summary judgment. (ECF No. 17.) Defendants asserted they are entitled to judgment as a matter of law pursuant to the safe harbor provision set forth in 35 U.S.C. § 271(e)(1).*fn1 Defendants claimed their use of the antisense technology falls within the safe harbor provision because the only purpose for Defendants' use of the technology is to develop antisense drugs that target conditions that have already been identified by Defendants' pharmaceutical partners in the U.S. That is, Defendants claimed their use of the antisense technology falls within the safe harbor provision because Defendants' pharmaceutical partners ultimately use Defendants' work in connection with seeking FDA approval of antisense drugs.

On September 19, 2012, prior to the case's transfer to this Court, Judge Moskowitz denied Defendants' Motion for Summary Judgment without prejudice. (ECF No. 53.) Judge Moskowitz found Defendants had offered insufficient evidence as to Defendants' specific uses of the infringing compounds, methods, and processes. Judge Moskowitz further found a dispute of material fact as to whether Defendants do not perform any antisense technology work until a therapeutic target has already been identified by a pharmaceutical partner. Judge Moskowitz concluded, stating, "To the extent [Defendants] [are] selling and/or licensing infringing 'platform' technology so that another company can 'discover and develop' drug candidates-rather than developing and/or licensing/selling ...


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