The opinion of the court was delivered by: I. Leo Glasser, Senior District Judge
Defendant AstraZeneca PLC appears specially to move to dismiss the claims against it for lack of personal jurisdiction pursuant to Rule 12(b)(2) of the Federal Rules of Civil Procedure. Plaintiffs allege that AstraZeneca PLC (by its purported predecessor in interest Zeneca Limited and with its subsidiaries and co-defendants Zeneca, Inc. and Astrazeneca Pharmaceuticals L.P.) entered into an agreement with co-defendant Barr Laboratories, Inc. ("Barr")*fn1 that monopolized and allocated the United States market for the drug tamoxifen citrate ("tamoxifen").
For the reasons stated below, AstraZeneca PLC's motion is denied.
According to the Corrected Consolidated Class Action Complaint ("Complaint"), these actions involve the drug tamoxifen, the most essential drug for treatment of breast cancer. Breast cancer is the most common malignancy and is one of the leading causes of death among women. During the 1990's, more than 1.5 million women in the United States were newly diagnosed with breast cancer. Tamoxifen is a synthetic hormone developed in the 1970's that is used to treat both early and advanced-stage breast cancer and to prevent recurrence. Tamoxifen has become the most widely prescribed treatment for breast cancer, and indeed is the single most-prescribed drug in the world for any cancer. The World Health Organization lists tamoxifen as an "Essential Drug." and tamoxifen is the standard of comparison in most relevant clinical trials.
On August 20, 1985, Imperial Chemical Industries, PLC ("ICI") obtained United States Patent 4,536,516 (the `516 Patent) for tamoxifen. In December 1985 Barr filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration ("FDA"), requesting approval to sell a generic bioequivalent version of the pioneer drug tamoxifen.*fn2 Barr's ANDA application, as amended in September 1987, certified that the `516 Patent was invalid and unenforceable. ICI promptly sued Barr for patent infringement, which was tried before the late Honorable Vincent L. Broderick. On April 20, 1992, Judge Broderick held that the `516 Patent was invalid and unenforceable because ICI wrongfully withheld relevant material from the United States Patent and Trademark Office. Imperial Chem. Industries, PLC v. Barr Labs., Inc., 795 F. Supp. 619 (S.D.N.Y. 1992). ICI appealed that determination to the Federal Circuit.
In 1993, while the appeal was pending, Zeneca Limited (which had recently succeeded to ICI's rights in the `516 Patent) and Barr entered into a settlement agreement (the "Settlement Agreement"). Pursuant to the Settlement Agreement, Barr withdrew its challenge to the validity of the `516 Patent and amended its ANDA application to certify that it would not seek to market its generic version of tamoxifen until the patent expired. In return, Zeneca paid Barr $21 million and licensed Barr to sell tamoxifen manufactured by Zeneca in the United States, including Puerto Rico and the District of Columbia. The Settlement Agreement was conditioned upon the Federal Circuit vacating the Judgement declaring the `516 Patent invalid. The Settlement Agreement was executed by ICI, Zeneca Limited and Barr. On the same day, a Distribution and Supply Agreement was executed between Zeneca, Inc. and Barr.
On March 19, 1993 the Federal Circuit granted Barr and ICI's Joint Motion to Dismiss the Appeal as Moot and to Vacate the Judgment Below. On March 23, 1993 Judge Broderick vacated the judgement and entered a Stipulation of Dismissal and Order. Consequently, the `516 Patent remained valid, and Zeneca's brand and Barr's licensed version of tamoxifen were the only products on the market. Although Barr could produce tamoxifen at a lower cost than the price at which Zeneca licensed it, the price charged by Barr was restrained by that higher cost.
Allegations Regarding AstraZeneca PLC
AstraZeneca PLC is a British corporation based in the United Kingdom. (Compl. ¶ 19.) With its subsidiaries, it is one of the largest pharmaceutical companies in the world. (Id.) The largest portion of its revenues come from sales in the United States. (Id.) American Depository Receipts of AstraZeneca PLC are traded on the New York Stock Exchange. (Id.) AstraZeneca PLC is alleged to control its subsidiaries and their directors, officers, employees and agents. (Id.) AstraZeneca PLC is also alleged to be the successor in interest to Zeneca Limited (a signatory to the Settlement Agreement). (Id.)
However, according to Adrian Charles Noel Kemp, Assistant Secretary of AstraZeneca PLC, its sole business is that of a parent holding company. (Kemp Aff., ¶ 4.) AstraZeneca PLC was created on April 6, 1999 by the merger of Zeneca Group PLC and Astra AB. (Id., ¶ 2.) Kemp states that Zeneca Limited, a subsidiary of Zeneca Group PLC, was not a predecessor in interest to AstraZeneca PLC. (Id., 3.) (However, he offers no explanation as to who succeeded to Zeneca Limited's interest after the Astra — Zeneca merger.) Kemp also states that subsidiaries like co-defendants Zeneca Inc. and AstraZeneca Pharmaceuticals L.P. do not hold the authority to act as agents for AstraZeneca PLC (id., ¶ 4), that AstraZeneca PLC does not manufacture, design, advertise, market, package, sell, distribute, or place into the stream of commerce any products, including tamoxifen, nor does it establish the prices for any products. (Id., ¶ 5.) According to Kemp, AstraZeneca PLC is not authorized to, nor does it, do any business, keep any offices, engage in any service or solicitation with respect to any product, maintain distributors, wholesalers, or other representatives, rent or own property, have any employees, hold any bank accounts, have any telephone listing or pay taxes in the United States. (Id., ¶ 6.)
In response to Kemp's affidavit, plaintiffs submit publicly available documents to refute these claims. These documents include:
• a Form F-4 filed by Zeneca Group PLC (AstraZeneca
PLC's direct predecessor) with the Securities and
Exchange Commission in 1995. (Hart Dec., Ex. 3.) In
the F-4, Zeneca Group PLC designated Zeneca Inc. as
its agent ...