Zeneca Ltd. v. Pharmachemie B.V.

16 F. Supp. 2d 112, 1998 U.S. Dist. LEXIS 12823, 1998 WL 514108
CourtDistrict Court, D. Massachusetts
DecidedAugust 10, 1998
DocketCivil Action 96-12413-RCL
StatusPublished
Cited by6 cases

This text of 16 F. Supp. 2d 112 (Zeneca Ltd. v. Pharmachemie B.V.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zeneca Ltd. v. Pharmachemie B.V., 16 F. Supp. 2d 112, 1998 U.S. Dist. LEXIS 12823, 1998 WL 514108 (D. Mass. 1998).

Opinion

ORDER ON REPORT AND RECOMMENDATION ON ZENECA’S MOTION TO EXTEND THE 30-MONTH STATUTORY BAR

LINDSAY, District Judge.

Upon consideration of the Report and Recommendation of Magistrate Judge Collings in this action, and the submissions of the parties in response, the Court determines as follows. The Court accepts the Report and Recommendation. The Court does not intend to suggest, however, that a party may not violate its affirmative duty to “reasonably cooperate in expediting the action,” under 21 U.S.C. § 355(j)(5)(B)(iii), even when it pursues a non-frivolous assertion of its rights. In this case, however, the record shows that the defendant has cooperated reasonably in expediting this action including giving its consent to a prompt trial of the case before Magistrate Judge Collings.

SO ORDERED.

REPORT AND RECOMMENDATION ON ZENECA’S MOTION TO EXTEND THE 30-MONTH STATUTORY BAR (# 66)

COLLINGS, United States Magistrate Judge.

I. Introduction

The plaintiff Zeneca Limited (hereinafter “Zeneca”) has filed a motion seeking to extend the 30-month statutory bar provided under Title 21 U.S.C. § 355(j)(5)(B)(iii) which at present forestalls any action by the Food and Drug Administration to grant final approval to an Abbreviated New Drug Application filed by the defendant Pharmachemie B.V. (hereinafter “Pharmachemie”). Such final approval would allow the defendant to manufacture and market a generic version of tamoxifen, a drug used in treating breast cancer for which Zeneca holds the patent. Absent an extension, the statutory bar will expire in mid-August, 1998, prior to October 19, 1998, the date on which the patent infringement trial in this case is scheduled to begin before the District Judge to whom this case is assigned. Pharmachemie opposes the plaintiffs motion.

II. The Facts

An abbreviated review of the historical facts will serve to place this controversy in context. In and of themselves, the facts are basically not disputed. 1 Zeneca is the owner of U.S. Patent 4,536,516 (“the ’516 patent”) directed to the cancer drug tamoxifen which the plaintiff markets in the United States under the trademark NOLVADEX. Phar-machemie, a generic drug manufacturer, wants to sell a generic version of NOLVA-DEX in this country during the life of the ’516 patent, i.e., before August, 2002. To that end, Pharmachemie has submitted an Abbreviated New Drug Application (“ANDA”) for tamoxifen to the Food and Drug Administration (“FDA”) for approval. Additionally, in accordance with the applicable statutory scheme set forth in the Hateh-Waxman Act, 2 the defendant filed a so-called “Paragraph IV” certification contending that the ’516 patent is invalid and/or unenforceable. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). The act of submitting the ANDA and the Paragraph IV certification to the FDA in order to obtain approval to make and sell a generic drug constitutes an act of patent infringement under 35 U.S.C. § 271(e)(2)(A). 3

*114 Pharmaehemie duly complied with another statutory mandate: the defendant notified Zeneca that the Paragraph IV certification had been submitted and provided its factual and legal basis for alleging that the ’516 patent is not valid. See 21 U.S.C. § 355(j)(2)(B)(ii). On or about March 22, 1996, in response to the notification, Zeneca filed a patent infringement suit against Phar-machemie in the United States District Court for the District of Maryland within the forty-five day period provided by statute thereby automatically invoking the 30-month stay against action by the FDA with respect to Pharmachemie’s ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii). To be more precise, the statute provides that

(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined under the following:
* * * * * *
(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the termination of the thirty-month period beginning on the date' of the receipt of the notice provided under (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action ...

Title 21 U.S.C. § 355(j)(5)(B)(iii) (emphasis added).

It is pursuant to this provision that Zeneca is moving for an extension of the 30-month bar on the grounds that Pharmaehemie has “failed to reasonably cooperate in expediting the action.”

At the time that Zeneca commenced suit against Pharmaehemie, it was already engaged in comparable 4 ongoing litigation with another generic drug company, Novopharm Limited, in the federal court in Maryland. Indeed, approximately one month after the Pharmaehemie case was filed, the Novop-harm Limited case was decided. Following a non-jury trial, not having been persuaded by the mouse data defense or any other defense presented, the district judge determined that the ’516 patent was valid and had been infringed. 5 Consequently, Novopharm Limited was enjoined from pursuing approval of its ANDA or from distributing tamoxifen until the ’516 patent expired.

In May of 1996 when the time came for Pharmaehemie to answer or otherwise response to Zeneca’s complaint, Pharmaehemie moved to dismiss for lack of personal jurisdiction or, in the alternative, to transfer. On June 17, 1996, the district judge concluded that the government contacts rule foreclosed predicating personal jurisdiction over Phar-machemie upon the filing of the ANDA and Paragraph IV certification in Maryland. Zeneca was, however, granted a sixty-day period during which to undertake discovery to probe other possible bases for jurisdiction. Two days later on June 19th the district judge consolidated the Pharmaehemie case with two other pending actions involving the ’516 patent,

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Bluebook (online)
16 F. Supp. 2d 112, 1998 U.S. Dist. LEXIS 12823, 1998 WL 514108, Counsel Stack Legal Research, https://law.counselstack.com/opinion/zeneca-ltd-v-pharmachemie-bv-mad-1998.