Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc.

629 F. Supp. 2d 416, 2009 WL 1833874
CourtDistrict Court, D. New Jersey
DecidedJuly 6, 2009
DocketCivil Action 05-5727 (HAA), 07-5489(HAA)
StatusPublished
Cited by45 cases

This text of 629 F. Supp. 2d 416 (Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eisai Co., Ltd. v. Teva Pharmaceuticals USA, Inc., 629 F. Supp. 2d 416, 2009 WL 1833874 (D.N.J. 2009).

Opinion

OPINION & ORDER

ACKERMAN, Senior District Judge:

This matter comes before the Court on appeals (Doc. Nos. 157 and 201) filed by Defendants Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries, Ltd., and Gate Pharmaceuticals (hereinafter collectively “Defendants” or “Teva”) from two orders of Magistrate Judge Esther Salas, as well as the motion for summary judgment (Doc. No. 214) filed by Plaintiffs Eisai Co., Ltd. and Eisai, Inc. (hereinafter collectively “Plaintiffs” or “Eisai”). The Complaints in these consolidated cases assert patent infringement against Teva with *419 regard to Teva’s applications for approval to market its own generic version of Eisai’s product Aricept®, a prescription drug medication covered by U.S. Patent No. 4,895,841 (“the '841 patent”).

In a February 13, 2008 Order, Magistrate Judge Salas granted Eisai’s motion to strike portions of Teva’s Amended Answers. Eisai Co. v. Teva Pharms. USA, Inc., 557 F.Supp.2d 490 (D.N.J.2008) (hereinafter “February Order”). Teva filed the instant appeal (Doc. No. 157) from this February Order. The February Order relied on the Magistrate Judge’s December 6, 2007 Order that granted in part and denied in part Teva’s motion to amend its Answer. Eisai Co. v. Teva Pharms. USA, Inc., 247 F.R.D. 445 (D.N.J.2007) (hereinafter “December Order”). Importantly, Teva did not file an appeal from the December Order.

Teva also appeals (Doc. No. 201) from two portions of a subsequent bench Order issued by Magistrate Judge Salas on May 29, 2008 (“May Bench Order”) that denied some of Teva’s discovery requests. These discovery requests concern the matters that Magistrate Judge Salas ordered to be stricken from Teva’s Amended Answers, as well as related issues.

For the following reasons, this Court will reverse the February Order, vacate the appealed portions of the May Bench Order, and refer this matter to the Magistrate Judge for further proceedings consistent with this Opinion. This Court will stay consideration of Eisai’s motion for summary judgment pending completion of any additional discovery allowed by Magistrate Judge Salas in accordance with this Opinion.

Background

I. Litigation History and Teva’s Motion to Amend its Answer

In the late 1980s, Eisai developed a new drug called donepezil hydrochloride that it would eventually market as Aricept®, which is the drug claimed in Eisai’s '841 patent. The '841 patent was issued on January 23,1990, and arose from the prosecution of U.S. Patent Application No. 07/207,339 (“the '339 application”). The '841 patent expires in November 2010.

In October 2004, Teva filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (FDA), seeking approval to market its own generic version of Aricept®. Teva’s ANDA contained a Paragraph III certification with regard to the '841 patent, indicating that it would not distribute its generic version prior to the patent’s expiration in November 2010. See 21 U.S.C. § 355(j)(2)(A)(vii)(III). 1 One year after filing this ANDA, in October 2005, Teva amended its ANDA to include a Paragraph IV certification claiming that the '841 patent is invalid for obviousness. Shortly thereafter, Eisai filed this patent infringement suit (No. 05-5727) against Teva pursuant to 35 U.S.C. § 271(e)(2), based on Teva’s Paragraph IV certification.

Eisai’s second Complaint in this matter arose in a similar fashion. In November 2005, Defendant Gate Pharmaceuticals (“Gate”), an unincorporated division of *420 Teva, filed an ANDA for a generic version of Aricept® with no Paragraph IV certification attacking the '841 patent. Nearly two years later, Gate amended its ANDA to include a Paragraph IV certification with the same claim that the '841 patent is invalid for obviousness. Eisai then filed a second Complaint against Defendants for patent infringement (No. 07-5489).

In Teva’s initial Answer to Eisai’s first Complaint, filed in early 2006, it asserted the affirmative defense of patent invalidity for obviousness. The parties extensively litigated the obviousness defense and engaged in substantial discovery relating to that defense. 2 More than a year later, in May 2007, Teva filed a motion to amend its Answer to add the affirmative defense of inequitable conduct. This defense amounts to an argument that the '841 patent is unenforceable because Eisai failed to disclose known material information to the Patent and Trademark Office (“PTO”) during the prosecution of its patent with an intent to deceive the PTO.

In its Proposed Amended Answer submitted in conjunction with the motion to amend, Teva alleged that Eisai failed to disclose four sets of its own co-pending patent applications to the PTO examiner of the '339 application. The majority of the inequitable conduct allegations in Teva’s Proposed Amended Answer concerned Eisai’s alleged failure to disclose a family of patent applications known as “the '459 application.” Eisai initially filed the '459 application in December 1986. While this application was pending, Eisai filed the '339 application in June 1988. The applications were assigned to different PTO examiners. The '459 application resulted in the issuance of U.S. Patent No. 4,849,-431 (“the '431 patent”) in July 1989. The '339 application resulted in the issuance of the patent-in-suit, the '841 patent, in January 1990. Teva chiefly alleged in its Proposed Amended Answer that Eisai, in prosecuting the '339 application that led to the patent-in-suit, failed to disclose the co-pending '459 application, the '431 patent that issued from that application, and the existence of a 1984 article in the Journal of Medicinal Chemistry authored by Richard A. Kenley. Teva alleged that these materials, to which the Court will refer collectively as the “'459 application,” were material to consideration of the '339 application and were withheld with the intent to deceive the PTO.

In addition to the inequitable conduct allegations regarding the '459 application, Teva’s Proposed Amended Answer also alleged similar inequitable conduct in Eisai’s failure to disclose to the PTO examiner for the '339 application three other sets of its co-pending patent applications, all under consideration by different PTO examiners: the '035 application, the '662 application, and the '971 application (collectively the “other co-pending applications”). Eisai opposed Teva’s motion to amend its Answer. 3

II. The December Order

In the December Order, Magistrate Judge Salas granted Teva’s motion to amend only with respect to inequitable conduct based on failure to disclose the '459 application. In the analysis relevant *421

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