United States District Court, Eastern District of New York
May 15, 2003
IN RE TAMOXIFEN CITRATE ANTITRUST LITIGATION.
The opinion of the court was delivered by: I. Leo Glasser, Senior District Judge
MEMORANDUM AND ORDER
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 for service of process in the United
States. (Id., at 3.)
• the 1998 annual report from Zeneca Group PLC
describing the structure of supervision by its board
over the activities of its subsidiaries through a
"Zeneca Executive Council" comprised of Executive
Directors and Business Chief Executive Officers, the
latter of which "are responsible for the management
and performance of their respective businesses
within the framework of Group policies. . . .
supported by business audit committees. . . ." (Hart
Dec., Ex. 3, at 62.) The report states that Zeneca
Group PLC's system of internal control "is designed
to provide reasonable assurance of effective and
efficient operations and compliance with laws and
regulations," and then describes the various
procedures used. (Id., at 63.)
• AstraZeneca PLC's website
(http://www.astrazeneca.com) which states that David
Brennan (the President and CEO of US-subsidiary
AstraZeneca Pharmaceuticals L.P.) is a member of
AstraZeneca PLC's Senior Executive Team and "is in
charge of all North American commercial operations."
(Id., Ex. 5, at 4-6.)*fn3
• The website for AstraZeneca's US operations
(http://www/astrazeneca-us.com) also states that
AstraZeneca PLC "is headquartered in London with its
U.S. headquarters located in Wilmington, Delaware."
(Hart Dec., Ex. 6.)*fn4
• AstraZeneca PLC's 2001 annual report (located on
its website) identifies the company's business
strategy as follows: "We are committed to creating
enduring shareholder value by delivering a flow of
innovative medicines which meet the needs of
patients and healthcare professionals in important
areas of medicine. As a prescription pharmaceutical
company focused on the introduction of new
medicines, we are transforming our portfolio from
successful but mature brands to a
range of exciting
new products." (Id., at 15 (AstraZeneca Annual
Report and Form 20-F 2002, at 8).) According to the
Annual Report, one of AstraZeneca PLC's six key
priorities is to "Win in the US" (Id., at 16.)
• AstraZeneca PLC's website also indicates that its
"largest market is the US," (id., at 25), and that
AstraZeneca PLC maintains an investor relations
office in Wilmington, Delaware. (Id., at 57.)
It is undisputed for purposes of this motion that AstraZeneca PLC's subsidiaries were doing business at the relevant times in this district.
Plaintiffs bear the burden of establishing that the court has jurisdiction over the defendant. Robinson v. Overseas Military Sales Corp., 21 F.3d 502, 507 (2d Cir. 1994). However, when a motion to dismiss is brought before any discovery has been conducted, only a prima facie showing of personal jurisdiction is required to defeat the motion, Ball v. Metallurgie Hoboken-Overpelt, S.A., 902 F.2d 194, 197 (2d Cir. 1990), and plaintiffs may rely on the complaint, affidavits, and other supporting materials to satisfy their burden. Marine Midland Bank N.A. v. Miller, 664 F.2d 899, 904 (2d Cir. 1981). Such pleadings and affidavits must be construed in the light most favorable to the plaintiffs, and all doubts must be resolved in plaintiffs' favor. Hoffritz for Cutlery, Inc. v. Amajac. Ltd., 763 F.2d 55, 57 (2d Cir. 1985).
I. Personal Jurisdiction Under the Clayton Act
Section 12 of the Clayton Act provides:
Any suit, action or proceeding under the antitrust
laws against a corporation may be brought not only in
the judicial district whereof it is an inhabitant,
but also in any district wherein it may be found or
transacts business; and all process in such cases may
be served in the district of which it is an
inhabitant, or wherever it may be found.
15 U.S.C. § 22.
This section thus provides both bases for venue and personal jurisdiction that supplement the general venue and service of process provisions in the United States Code and Federal Rules of Civil Procedure. Although the parties vigorously dispute whether venue under Section 12 must be satisfied before plaintiffs may avail themselves of its worldwide service of process, and courts in this Circuit are split over this issue,*fn5 this Court need not reach that issue.
The Supreme Court has construed the term "transacts business" to mean "the practical and broader business conception of engaging in any substantial business operations." United States v. Scophony Corp., 333 U.S. 795, 807 (1948). In so doing, the Court condemned a restrictive interpretation that overly relied upon the "artful arrangement of agents' authority, or of their comings and goings, or of the geography of minute incidents in contracting" if that would bar an aggrieved person from establishing venue locally. Id. at 808 n. 19.
When facing suit under the antitrust laws in that case, Scophony (a British company) argued that it "became concerned solely with creating and protecting an `investment,' namely, in . . . shares [of its American subsidiary]" and thus it was no longer transacting business after its subsidiary was formed. Id. at 812. However, the Court found that Scophony continued to transact business in the United States by virtue of the ongoing monitoring of the subsidiary:
[I]n view of the agreements' continuing and pervasive
effects. . . . they set the pattern for a regular and
continuing program of patent exploitation requiring,
as we have said, Scophony's constant supervision and
intervention. That necessity was shown, among other
ways, by the contractual provisions for interchange
of data and information, and further by the fact that
there was sustained interchange of correspondence
between Levey [a director of Scophony and President
and director of American Scophony] and Scophony
devoted to Scophony's affairs and interests in this
country. Levey kept Scophony informed fully of all
that went on here, and in turn received and carried
out its instructions respecting American Scophony's
affairs and its own.
Id. at 814-15. Based on these facts, the Court had little difficulty concluding that venue was proper because Scophony was transacting business in the United States.
As plaintiffs note the facts in this case are almost impossible to distinguish from those in Waldron v. British Petroleum Co., 149 F. Supp. 830, 832 (S.D.N.Y. 1957). In Waldron, plaintiffs sought to establish venue pursuant to Section 12 over the Standard Oil Company of California ("Secal") in New York, where California Commercial Company and California Oil Company, two of Socal's wholly owned subsidiaries, were based and did business. Id at 831. Although Socal did business in other states, with respect to operations in New York it was solely a holding company that "produce[d] and market[ed] petroleum products in various areas of this country and in foreign countries" through its subsidiaries. Id. In holding that Socal was transacting business within the Southern District of New York the court noted:
A person would have to be blind to the economic facts
of business life if he did not recognize that the
activities of Commercial and California Oil in this
District are activities which in another less
elaborate corporate set-up would be conducted
directly by branch offices or agents within the
District. It is Social, and not the subsidiaries,
which is the defendant in the present action. What is
Social? It is a large aggregation of invested capital
which transacts its business through officers,
agents, employees, and through subsidiaries, which in
the drilling, production and marketing of oil operate
as agents, employees or branch
offices would operate.
Does the fact that this large business entity, for
tax reasons or otherwise, decides to tragmentize its
operations into numerous corporate subsidiarires,
make the resulting operations of the subsidiaries any
the less a part of transaction of business by Socal?
A corporation may be a fiction of the law but there
is no reason to carry the fiction to the extreme of
saying that a corporation which has wholly owned
subsidiaries performing services in the local
jurisdiction which ordinarily would be performed by
service employees or making sales which ordinarily
would be made by a sales department, is in fact not
transacting business in that jurisdiction,
particularly when the entire corporate set-up of the
defendant shows that it is designed to operate to a
substantial degree through separate corporate
entities responding to the wishes and directions of
the parent and providing the revenues sought by the
parent. We would be exalting fiction over fact if we
were to conclude that under those circumstances the
parent company was not in fact transacting business
in this District through the instrumentality of its
wholly owned subsidiaries.
Id. at 834-35.
Given Scophony's understanding that transacting business consists of the "practical and broader business conception of engaging in any substantial business operations," 333 U.S. at 807, plaintiffs here have sufficiently alleged facts to sustain personal jurisdiction over AstraZeneca PLC under Section 12 of the Clayton Act. First, plaintiffs allege that AstraZeneca PLC succeeded to Zeneca Limited's interests in the Settlement Agreement. Although AstraZeneca PLC denies that it was the successor in interest (Kemp Dec. ¶ 3), other statements in that declaration are contradicted by AstraZeneca PLC's own marketing material. Compare Kemp Dec. ¶ 6 (stating that AstraZeneca PLC keeps no offices in the United States) with Holt Dec., Ex. 5, at 57 (listing a Wilmington, Delaware address for AstraZeneca PLC's Investor Relations office) and Ex. 6, at 2 ("AstraZeneca PLC is headquartered in London with its U.S. headquarters located in Wilmington. Delaware").*fn6 At the very least, plaintiffs' allegations that AstraZeneca PLC succeeded in interest to Zeneca Limited's role in the Settlement Agreement have set forth a prima facie case on successor liability.
Second, much like the holding company in Waldron, the activities taken by AstraZeneca PLC's subsidiaries here are those that AstraZeneca PLC would have to undertake directly if the subsidiary did not exist to perform them. Cf. Buloya Watch Co. v. K. Hattori & Co., 508 F. Supp. 1322, 1344 (E.D.N.Y. 1981) (personal jurisdiction existed over Japanese parent under New York long-arm statute where evidence established that "subsidiaries do for the parent everything that the parent would have to do if it were here directly"). Taken as a whole, the complaint and exhibits suffice to set forth a prima facie case that if no American subsidiary existed, AstraZeneca PLC would need to act directly in order to achieve its goals marketing pharmaceuticals in the United States.
In its reply memorandum, AstraZeneca PLC contends that it is simply a holding company and that therefore its subsidiaries are not performing any activity that it would undertake itself. (Reply Mem. at 20-21.) However, given the self-proclaimed focus of AstraZeneca PLC on the research, development, marketing and sales of pharmaceuticals as evidenced by its website and annual report and the emphasis on success in the United States marketplace, this argument is not persuasive once all inferences are drawn in favor of plaintiff.
II. The Due Process Clause
In addition to the prior discussion, however, a court must examine whether the defendant has "certain minimum contacts . . . such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice." Calder v. Jones, 465 U.S. 783, 788 (1984). Because the claims are based upon federal question jurisdiction, the Court must analyze AstraZeneca PLC's contacts with the United States as a whole. Chew v. Dietrich, 143 F.3d 24, 28 n. 4 (2d Cir. 1998).
As noted above, plaintiffs allege that AstraZeneca PLC succeeded in interest to the signatory of the Settlement Agreement which settled an appeal of a judgment entered by a federal district court in New York. Moreover, AstraZeneca PLC maintains an Investors Relations Office in Wilmington, Delaware (where it claims that its "US Headquarters" also is located), and its Executive Vice President for North American operations is the President and CEO of one of its American subsidiaries. Based on the current state of the record, AstraZeneca PLC has sufficient minimum contacts with the United States to satisfy due process.
In addition to minimum contacts, however, a court must determine whether the assertion of personal jurisdiction "comports with traditional notions of `fair play and substantial justice' — that is, whether it is reasonable under the circumstances of a particular case." Metropolitan Life Ins. Co. v. Robertson-Ceco Corp., 84 F.3d 560, 568 (2d Cir. 1996) (quoting International Shoe v. State of Washington, 326 U.S. 310, 316 (1945)). "Whether it is reasonable to exercise jurisdiction in a particular case depends on (1) the burden that the exercise of jurisdiction will impose on the defendant; (2) the interests of the forum state in adjudicating the case; (3) the plaintiffs interest in obtaining convenient and effective relief; (4) the interstate judicial system's interest in obtaining the most efficient resolution of the controversy; and (5) the shared interest of the states in furthering substantive social policies." U.S. Titan, Inc. v. Guangzhou Zhen Hua Shipping Co., Ltd., 241 F.3d 135, 152 (internal quotations omitted).
In the present case, none of the factors weigh in favor of finding the exercise of personal jurisdiction reasonable. Given that AstraZeneca PLC maintains an office in the United States, is alleged to have succeeded in interest to the signatory of the Settlement Agreement, and openly claims to seek the advantages of the United States market, the burden of defending this action simply is not so overwhelming that it would otherwise be unreasonable or fail to comport with traditional notions of fair play and substantial justice.
Finally, although it probably need not be said, the Court is well aware of the point made repeatedly throughout AstraZeneca PLC's briefs (Def. Mem. at 15-16; Def. Reply Mem. at 3-6, 13-14) that a higher showing is necessary to sweep aside the corporate veil between it and its subsidiaries. See e.g., United States v. Bestfoods, 524 U.S. 51 (1998) (noting that "owner or operator" test for substantive liability under CERCLA did not abolish traditional notion of corporate separateness between parent and subsidiary). Whether the liability of AstraZeneca PLC's subsidiaries may be imputed to it, however, is not the issue before this Court. See Buloya, 508 F. Supp. at 1342. Rather, the question presented by this motion is whether AstraZeneca PLC might be amenable to suit id., and that question, once all inferences are resolved in favor of plaintiffs as they must under Rule 12(b)(2), must be answered in the affirmative.
For the foregoing reasons, the motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(2) is denied.