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Nycomed Us Inc., et al v. Tolmar

April 28, 2011

NYCOMED US INC., ET AL., PLAINTIFFS,
v.
TOLMAR, INC.,
DEFENDANT.



The opinion of the court was delivered by: Shwartz, United States Magistrate Judge

NOT FOR PUBLICATION

OPINION

I. INTRODUCTION

This matter comes before the Court by way of the parties' joint letter, dated April 6, 2011, seeking a ruling as to whether Defendant Tolmar's Paragraph IV Notice Letter ["Paragraph IV Notice Letter"] is a confidential document that should be protected from unrestricted disclosure under the Discovery Confidentiality Order. For reasons stated herein, the Court finds that the Paragraph IV Notice Letter, including the appended Detailed Statement, is not subject to the Discovery Confidentiality Order.

II. BACKGROUND

Plaintiff Nycomed US Inc. ["Nycomed"] was the applicant for the New Drug Application ["NDA"] for Solaraze, a pharmaceutical product approved by the Food and Drug Administration ["FDA"]. (Compl. ¶ 24, May 24, 2010, ECF No. 1; Redacted Compl. ¶ 24, May 28, 2010, ECF No. 14.) Plaintiff Jagotec AG ["Jagotec"] owns the patents and Nycomed holds the exclusive licenses to these patents. (Compl. ¶ 26; Redacted Compl. ¶ 26.) The patents are listed in the FDA's "Orange Book" of Approved Drug Products with Therapeutic Equivalence Evaluations. (Compl. ¶ 28; Redacted Compl. ¶ 28.)

Defendant Tolmar, Inc. ["Tolmar"] filed an Abbreviated New Drug Application ["ANDA"] seeking approval for a generic version of Solaraze. (Compl. ¶ 47; Redacted Compl. ¶ 47.) On April 8, 2010, Tolmar sent a letter, known as its Paragraph IV Notice Letter, to Nycomed and Jagotec pursuant to Section 505(j)(2)(b) of the Federal Food, Drug, and Cosmetic Act ["FDCA"], codified at 21 U.S.C. § 355(j)(2)(b). (Compl. ¶ 48; Redacted Compl. ¶ 48.) The Paragraph IV Notice Letter notified the plaintiffs that Tolmar had filed its ANDA contending that its generic version of Solaraze would not infringe the Solaraze patents. (Joint Letter, Ex. B at 2, Apr. 6, 2011.) In pertinent part, the Paragraph IV Notice Letter states that "[a] Detailed Statement of the factual and legal basis of TOLMAR's opinion is appended hereto." (Id.) The Paragraph IV Notice Letter also states that an Offer of Confidential Access ["OCA"], pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III), was attached. (Id.; Compl. ¶¶ 56--57; Redacted Compl. ¶¶ 56--57.) Notably, the four-page OCA is followed by the twenty-three-page Detailed Statement and these two documents are one consecutively paginated attachment. (See Joint Letter, Ex. C.)

The plaintiffs found the OCA's restrictions unreasonable and unsuccessfully negotiated with Tolmar to amend those restrictions. (See Compl. ¶¶ 57, 59--65; Redacted Compl. ¶¶ 57, 59--65.) The parties dispute whether the plaintiffs ever requested access to the ANDA before this action was filed. (See, e.g., Compl. ¶ 62; Redacted Compl. ¶ 62; Tr. 15:10--14; May 28, 2010, ECF No. 17; Joint Letter 4 n.5, Apr. 6, 2011). At some point during this case, the parties exchanged the ANDA and NDA as required by the Court's Orders (see Am. Pretr. Sched. Order, Oct. 19, 2010, ECF No. 42) and the local patent rules. See L. Pat. R. 3.6(a).

On May 21, 2010, the plaintiffs filed a Complaint seeking declaratory and injunctive relief and alleging that Tolmar's Paragraph IV Notice Letter was ineffective and its ANDA infringed the Solaraze patents.*fn1 (Compl. ¶¶ 83--120; Redacted Compl. ¶¶ 83--120.) On May 25, 2010, Tolmar filed an "emergency motion" to seal portions of the Complaint that allegedly contained confidential information. (Mot. to Seal, May 25, 2010, ECF No. 8; see also Am. Mot. to Seal, May 26, 2010, ECF No. 9.) On May 28, 2010, the Court granted in part and denied in part this motion (Order, May 28, 2010, ECF No. 15), and the plaintiffs filed a Redacted Complaint. (Redacted Compl., May 28, 2010, ECF No. 14.) On June 16, 2010, the Court entered an additional Order to seal attachments that were also the subject of the May 28, 2010 Order. (Order, June 16, 2010, ECF No. 20.)

On July 26, 2010, Tolmar filed an Answer and a Counterclaim (Answer, July 26, 2010, ECF No. 22) and sought to seal portions of its Answer. (Mot. to Seal, July 27, 2010, ECF No. 23). The Court entered an Order sealing certain parts of the Answer. (Order, July 29, 2010, ECF No. 26.) On August 16, 2010, the plaintiffs filed a reply to Tolmar's Counterclaim. (Answer, Aug. 16, 2010, ECF No. 30.) On October 19, 2010, the Court held a scheduling conference and thereafter issued a Pretrial Scheduling Order. (Pretr. Sched. Order, Oct. 19, 2010, ECF No. 42.) On November 9, 2010, the Court entered a Discovery Confidentiality Order. (Disc. Confidentiality Order, Nov. 9, 2010, ECF No. 59.)

During a telephone conference on March 31, 2011, the parties advised the Court that a dispute had arisen concerning whether Tolmar's Paragraph IV Notice Letter should be subject to the restrictions of the Discovery Confidentiality Order. By Order dated March 31, 2011, the Court directed the parties to file a joint letter setting forth their positions on whether the Paragraph IV Notice Letter is a confidential document restricted under the terms of the Discovery Confidentiality Order. (3d Am. Pretr. Sched. Order, Mar. 31, 2011, ECF No. 102.) The Court ordered the parties to submit the letter directly to Chambers, rather than filing it on the public docket, because Tolmar asserted that the contents of the Paragraph IV Notice Letter are confidential. (See id.)

III. ARGUMENTS

A. Plaintiffs

Nycomed and Jagotec argue that all paragraph IV notice letters are public disclosures under FDA regulations and determinations. Specifically, they contend that: (1) paragraph IV notice letters provided to an NDA holder and patent owner are public disclosures; (2) paragraph IV certifications are subject to disclosure under the Freedom of Information Act ["FOIA"]; (3) the Court should defer to an FDA letter ruling on this subject; (4) this ruling is consistent with industry custom; (5) Tolmar made the notice letter public by sending it to ...


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