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Re: Medeva Pharma Suisse A.G., et al. v. Roxane Laboratories

August 25, 2011

RE: MEDEVA PHARMA SUISSE A.G., ET AL.
v.
ROXANE LABORATORIES, INC.



The opinion of the court was delivered by: Tonianne J. Bongiovanni United States Magistrate Judge

(609) 989-2040

CHAMBERS OF U.S. COURTHOUSE TONIANNE J. BONGIOVANNI 402 E. STATE STREET, RM 6052 TRENTON, NJ 08608 UNITED STATES MAGISTRATE JUDGE

LETTER OPINION AND ORDER

Dear Counsel:

Pending before the Court is Plaintiffs Medeva Pharma Suisse A.G., Warner Chilcott Company, LLC, and Warner Chilcott (US) LLC's (collectively, "Medeva") application to modify the Discovery Confidentiality Order (the "DCO") [Docket Entry No. 31] entered in this matter on May 21, 2008 at the request of the parties. Specifically, Medeva requests permission to submit, or require Defendant Roxane Laboratories, Inc. ("Roxane") to submit, various expert reports and in vivo testing generated by Roxane in connection with this litigation to the Food and Drug Administration (the "FDA"). This information includes:

1. The expert report of Dr. Erik Sandefer, dated December 21, 2009 and all associated exhibits;

2. The expert report of Dr. Larry Augsburger, dated December 21, 2009 and all associated exhibits;

3. The expert report of Dr. Alan Safdi, dated December 21, 2009 and all associated exhibits;

4. The expert report of Dr. Carmello Cuffari, dated December 21, 2009 and all associated exhibits; and

5. Roxane's protocol for A Scintigraphic Evaluation of a Radiolabeled and NonRadiolabeled Delayed Release Mesalamine (DRM) Formulation in Healthy Male Subjects, dated February 10, 2010.

The Court has reviewed all arguments made in support of and in opposition to Medeva's request.*fn1 For the reasons stated below, Medeva's request to modify the DCO is DENIED.

I. Background and Procedural History

The Court first addressed Medeva's request to make the aforementioned modification to the DCO in its Letter Order dated July 8, 2008 (the "July 8th Order") [Docket Entry No. 161] in which It denied Medeva's request. The July 8th Order was vacated by the District Court's Opinion and Order dated January 24, 2011 (the "January 24th Order"). In the January 24th Order, the District Court found that it was "unclear what standard the [undersigned] applied in denying [Medeva's] request for modification of the DCO." (January 24th Order at 7; Docket Entry No. 220]. As a result, the District Court vacated the July 8th Order and remanded the issue concerning Medeva's request to modify the DCO "for further consideration with instructions to not apply the burden shifting or compelling need tests and, instead, to apply the entirety of the Third Circuit's balancing test." (Id.)

After the District Court entered the January 24th Order, the parties submitted additional correspondence regarding Medeva's request to modify the DCO. The Court reviewed same and after considering all arguments made in support of and in opposition to Medeva's request, determined that, under the Third Circuit's balancing test, modification of the DCO was not warranted. However, the Court did not enter an order to that effect. Instead, in an effort to efficiently and economically resolve the parties' dispute, the Court informally relayed Its decision to counsel via e-mail and while not explicitly saying so, the Court anticipated that Medeva would seek a formal order should it be deemed necessary. Instead, Medeva filed an appeal of the Court's informal decision denying its request. The Court struck that appeal, finding that it was unviable because no order was entered denying Medeva's request to modify the DCO and, as such, there was no appealable ...


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