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Janssen Pharmaceutica N.V. v. Mylan Pharmaceuticals

February 14, 2006


The opinion of the court was delivered by: Lifland, District Judge


Before the Court is the appeal of Defendant Mylan Pharmaceuticals Inc. ("Mylan") from the June 29, 2005 Order of former United States Magistrate Judge Haneke denying Mylan's motion to compel discovery and granting Plaintiffs Janssen Pharmaceutica N.V. and Janssen Pharmaceutica Products, L.P. ("Janssen") a protective order. For the reasons stated herein, the Court will vacate the Order denying Mylan's motion to compel and granting Janssen a protective order.


This is a Hatch-Waxman*fn1 case involving risperidone, an anti-psychotic drug.

Janssen owns the patent for risperidone (the "'663 patent") which it sells in the United States under the trade name of Risperdal. Mylan*fn2 filed both an Abbreviated New Drug Application ("ANDA") with the United States Food and Drug Administration ("FDA") to market generic versions of Risperdal, and a Paragraph IV Notice[s] certifying that the '663 patent is invalid and would not be infringed by the proposed generic product. In response, Janssen filed a patent infringement suit against Mylan on December 29, 2003.

The dispute that is the subject of this appeal centers on whether Janssen must produce the Investigational New Drug Application ("IND") and the New Drug Application ("NDA")*fn3 which Janssen filed with the FDA to demonstrate that Risperdal was safe and effective. Mylan argues that Janssen must produce these applications because they are relevant to Mylan's defenses of invalidity and inequitable conduct.

In its initial production requests of March 22, 2004, Mylan requested the following two documents:

62. All documents and things relating to communications between Janssen and the FDA or any other regulatory Authority regarding Risperidone, Compound 11, Pirenperone or Ketanserin.

75. All documents relating to any NDA for any oral tablet containing Risperidone.

Janssen made standard objections to these requests under Fed. R. Civ. P. 34, and agreed to "produce responsive documents to the extent they have not already been produced to Mylan."

Discovery proceeded, and Mylan was only able to find a small, redacted portion of the NDA and no IND or DMFs. After failed attempts to acquire complete copies of the applications from Janssen, Mylan petitioned Magistrate Judge Haneke via letter dated March 16, 2005 for assistance in resolving the discovery dispute. Judge Haneke instructed Janssen to produce the portions of the NDA and the IND that were relevant to Mylan's defenses. Nevertheless, Mylan continued to be unsuccessful in its efforts to obtain copies of the relevant portions of the NDA and the IND.

At a status conference on June 15, 2005 Judge Haneke reversed his earlier instructions and ruled that Mylan could not have any access to the NDA and the IND. An Order of June 29, 2005 memorializes this ruling. As part of this Order, Judge Haneke also granted Janssen a protective order, and denied Mylan's motion to compel production of missing "clinical investigation documents" on pirenperone, or to have Janssen explain these documents' disposition. Pirenperone is another anti-psychotic drug and prior art of which Janssen advised the Patent and Trademark Office when it was prosecuting the '663 patent. Janssen does not dispute the relevancy of this discovery, but asserts that it has produced every document it was able to locate regarding pirenperone. Mylan now appeals Judge Haneke's order.


The parties dispute the appropriate standard of review in this case. Under the Federal Magistrates Act of 1968, a Magistrate Judge may decide certain nondispositive pretrial matters which a district court may reconsider and then reverse if it finds the ruling to be "clearly erroneous or contrary to law." 28 U.S.C. § 636(b)(1)(A); Fed. R. Civ. P. 72(a); L. Civ. R. 72.1(c)(1)(A); see also Haines v. Liggett Group, Inc., 975 F.2d 81, 92 (3d Cir.1992). Where a Magistrate Judge has ruled on a non-dispositive discovery order, some courts apply a third "abuse of discretion" standard of review. In re Gabapentin Patent Lit., 312 F. Supp. 2d 653, 661 (D.N.J. 2004). In contrast, a district court's review of a Magistrate's ruling that is ...

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