In Re Tamoxifen Citrate Antitrust Litigation
MEMORANDUM AND ORDER
SUMMARY
Plаintiffs Caroline Marks (“Marks”), Maxine Blonstein (“Blonstein”), and Lois Steward (“Steward”), on behalf of themselves and those similarly situated, represent classes of consumers and indirect purchasers of tamoxifen citrate (“tamoxifen”) in California, Florida, and Kansas, respectively. Plaintiffs originally filed suits in state courts against defendants Zeneca, Inc., AstraZeneca Pharmaceuticals LP, As-traZeneca LP, AstraZeneca PLC (collectively “Zeneca”) and Barr Laboratories, Inc. (“Barr”), alleging stаte antitrust and consumer protection claims. Defendants subsequently removed the cases to federal court based on federal question and/or diversity jurisdiction.
Now before the Court are plaintiffs’ two motions to remand, including the Marks and Blonstein plaintiffs’ joint motion, see Marks v. Barr Labs., Inc (transferred from the Northern District of California) and Blonstein v. Barr Labs., Inc. (transferred from the Southern District of Florida), and the Steward plaintiffs’ motion, see Steward v. Barr Labs, (transferred from the District of Kansas). Because there is substantial overlap of the arguments raised in the parties’ briefs, the Court will consider the motions together.
BACKGROUND 1
These actions involve the drug tamoxifen, a critical drug for the treatment of breast cancer. In 1993, Zeneca acquired United States Patent 4,536,516 (the “ ’516 Patent”) for tamoxifen from its predecessor, Imperial Chemical Industries, PLC (“ICI”). The ’516 Patent will expire on August 20, 2002. Until that time, Zeneca owns the exclusive right in the United States to manufacture, sell, and license tamoxifen. Zeneca markets tamoxifen under the trade name Nolvadex.®
In December 1985, Barr filed an Abbreviated New Drug Applicatiоn (“ANDA”) with the Food and Drug Administration (“FDA”), requesting approval to sell a generic bioequivalent version of the “pioneer” drug tamoxifen. An ANDA filing is governed by the Hatch-Waxman Act,
ICI’s pаtent infringement suit against Barr was tried before the late Judge 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. Indus., PLC v. Barr Labs., Inc.,
The Settlement Agreement was to become effective only upon entry of an order by the Federal Circuit directing the district court to vacate its finding of patent invalidity. Barr and Zenеca filed a Joint Motion to Dismiss the Appeal as Moot and to Vacate the Judgment Below. On March 19, 1993, the Federal Circuit granted the motion to dismiss and vacated the judgment below, pursuant to its practice at the time to honor settlement agreements.
See
*329
Imperial Chem. Indus., PLC v. Heumann Pharma GmbH & Co.,
The Settlement Agreement has spawned thirty lawsuits around the country, all of which have been transferred to this Court, pursuant to
As noted above, these actions were filed in state courts, and were then removed by defendants to federal courts. Plaintiffs now seek to remand the actions, arguing that the federal courts lack subject matter jurisdiction. The Steward plaintiffs argue, in the alternative, that removal was improper based on a procedural defect in the notice of removal. In support of removal, defendants argue that federal question jurisdiction exists, pursuant to
DISCUSSION
In a multidistrict litigation, such as this one, the law of the circuit where the transferee court sits governs in deciding questions of federal law.
See Menowitz v. Brown,
I. Legal Standard for Remand
A state court action may be removed to federal court “if it qualifies as a ‘dril action ... of which the district courts of the United States have original jurisdiction ....’”
Rivet v. Regions Bank of La.,
II. The Actions “Arise Under” Federal Patent Law
A federal court has original jurisdiction of all civil actions “arising under the Constitution, laws, or treaties of the United States.”
District courts hаve original jurisdiction over claims relating to patents.
See
[J]urisdiction ... extend[s] only to those cases in which a well-pleaded complaint establishes either [1] that federal patent law creates the cause of action or [2] that the plaintiffs right to relief necessarily depends on resolution of a substantial question of federal patent law, in that patent law is a necessary elеment of one of the well-pleaded claims.
Id.
at 808-09. The Court made clear that to be a “necessary element” of one of the well-pleaded claims, the patent law question must be essential to every theory upon which the claim relies.
Id.
at 810,
Defendants concede that federal patent law does not create plaintiffs’ сauses of action, and, therefore, the first prong of Christianson is not implicated. Instead, defendants argue that plaintiffs’ claims necessarily require resolution of a substan *331 tial question of federal patent law. They argue that Zeneca, as a patent holder, can exclude generic competition and legitimately license Barr to market Zeneca-sup-plied tamoxifen. Thus, to show that the Settlement Agreement was an illegal restraint on trade, plaintiffs must prove that the ’516 Pаtent was invalid or unenforceable. Plaintiffs argue that they do not seek to litigate the validity of the patent, and that any mention of patent law is merely tangential to their claims.
The majority of district courts to consider the question in similar contexts have ruled in favor of remand.
See, e.g., Ciprofloxacin Hydrochloride Antitrust Litig. (“Cipro”),
The holder of a lawfully obtained patent maintains a monopoly over his product and may “prevent other[s] from utilizing his discovery without his consent.”
SCM Corp. v. Xerox Corp.,
Plaintiffs argue that the Settlement Agreement was anti-competitive, because Zeneca paid Barr to stay out of the market until the expiration of Zeneca’s patent. Plaintiffs assume that Barr would have begun producing its own generic version of Novladex® when Barr proved successful on appeal at the Federal Circuit, and that the Settlement Agreement effectively eliminated that outcome. At oral argument, the Court questioned whether it was possible that Barr settled to avoid the risk that Judge Broderick’s determination of patent invalidity would be overturned on appeal, and that Zeneca settled to avoid the risk that the decision would be affirmed. Although counsel ultimately conceded that it was possible, he persisted that the Settlement Agreement was anti-comрetitive based on the amount of money Zeneca paid to Barr. Without passing on the merits of plaintiffs’ claims, the Court is compelled to note that the Federal Circuit has since reviewed a similar challenge to the ’516 Patent based on inequitable conduct, the precise basis upon which Judge Broderick found the ’516 Patent to be in
*332
valid, and concluded that the ’516 Patent was still valid.
Zeneca Ltd.,
While the owner of a valid patent does not have carte blanche to engage in any conduct it wishes and cannot assume that its pаtent will always immunize it from antitrust liability, this is not a situation, for example, where defendants are alleged to have engaged in sham patent infringement litigation for the purpose of delaying generic drug competition. Proof of sham litigation would certainly seem to be outside the scope of protected activity under a valid patent.
The specific references in the complaints to the enforceability of the ’516 Patent preclude avoiding the conclusion that the validity of the patent is the sine qua non of the Settlement Agreement which, in turn, goes to the heart of the plaintiffs’ grievance. For example, the complaints set out a portion of the Distribution and Supply Agreement which was executed simultaneously with the Settlement Agreement as follows:
(2) In the event that the ’516 Patent is held invalid and/or unenforceable in a final, unappealable judgment, Barr may terminate this Agreement immediately, provided, however, that Barr shall pay ZENECA for the inventory of the Product which ZENECA, or its designee, has manufactured or has in the manufacturing process ....
Distribution and Supply Agreement ¶ 24(b).
(Blonstein Compl. ¶ 41; Marks Compl. ¶ 64; Steward Compl. ¶ 43.) In addition, the plaintiffs allege that the Settlement Agreement enabled Zeneca and Barr “to revive a patent that Barr had established was invalid and unenforceable.” (Blon-stein Compl. ¶ 57; Marks Compl. ¶ 79; Steward Compl. ¶ 57.) They also allege that Barr would have marketed its own generic drug prior to the expiration of Zeneca’s patent, assuming that the invalidity of the pаtent would have been affirmed on appeal. For example, two of the complaints state: “If the appeal of the patent suit against Barr had run its course and resulted in an affirmance of Judge Broder-ick’s finding of invalidity, Zeneca’s patent would have been removed from the FDA Orange Book and any applicable 180-day exclusivity period would have begun to run.” (Blonstein Compl. ¶ 60; Marks Compl. ¶ 82.) The third complaint includes similar language: “If Barr had prevailed [on appeаl], the FDA would have *333 been permitted to grant final approval to Barr’s generic version of tamoxifen, allowing Barr to offer generic competition to Zeneca.” 6 (Steward Compl. ¶ 58.) To prove these allegations, which appear on the face of plaintiffs’ complaints, it appears beyond doubt that a court will have to determine the validity, enforceability or scope of Zeneca’s patent.
The policy behind Christianson is that the patent law is intended to be appliеd uniformly by the Federal Courts. If state courts were able to make rulings on any anti-competitive theory that could nullify patent rights, uniformity of the patent law would be a mirage. Thus, the Court concludes that plaintiffs’ claims necessarily depend upon the resolution of a substantial question of federal patent law.
On a final note, the Court finds that
Cipro, supra,
a case upon which plaintiffs most heavily rely, is distinguishable.
Cipro
involved a similar settlement agreement, in which Barr agreed to discontinue its challenge to Bayer’s patent in exchange for monetary compensation. However, the
Cipro
plaintiffs alleged that they could prevail, regardless of the patent’s invalidity, by demonstrating that Bayer would have granted a license or otherwise authorized Barr to distribute Cipro had Bayer and Barr not entered into the agreement.
Cipro,
For all of these reasons, the Court finds that these actions “arise under” federal patent law, and, accordingly, that the motions for remand must be denied.
III. The Removal Procedure in the Steward Action Was Proper
The Steward plaintiffs also challengе the removal of the action as procedurally defective. Because plaintiffs timely raised their objection within thirty days after the notice of removal was filed, the issue is properly before the Court.
See
Pursuant to
As noted above, the majority of courts apply the “first-served rule.” A minority of courts apply the “last-served rule” or the “later-served rule,” which restarts the thirty-day clock each time a defendant is served.
See, e.g., Brierly v. Alusuisse Flexible Packaging, Inc.,
Neither the Seсond Circuit nor the Supreme Court has weighed in on the question of which rule of timing should apply. In considering a different question, the Supreme Court held that
The Court concludes that application of the “first-served rule” would not be fair to the defendants, nor does it seem appropriate in light of
Murphy Brothers
and the language of
CONCLUSION
For the foregoing reasons, the motions to remand are denied.
SO ORDERED.
Notes
. The following background is taken from the three class action complaints, which include virtually identical factual allegations.
. Zeneca’s patent infringement lawsuit also named as a defendant Heumann Pharma GmbH & Company ("Heumann”), Barr’s supplier of tamoxifen. While the lawsuit was pending, Heumann was dismissed, in accordance with the terms of a stipulation of settlement. As part of that settlement agreеment, Zeneca promised to pay Heumann a sum of cash over a ten year period in exchange for Heumann’s promise to discharge all claims related to the '516 Patent.
. In light of two recent district court decisions,
TorPharm v. Shalala,
No. 97-1925,
. Since that time, the Supreme Court has ruled that federal appellate courts may not direct the
vacatur
of district court orders based solely on a settlement agreement between the parties. See
United States Bancorp Mortgage Co. v. Bonner Mall P’ship,
. At oral argument, the Marks and Blonstein plаintiffs presented the alternative theory that, under the Hatch-Waxman Act, Barr could have begun producing its generic drug after thirty months, even if Zeneca's appeal was still pending at the Federal Circuit. However, plaintiffs do not allege, nor does Barr concede, that it would have begun marketing its product during the pendency of Zeneca’s appeal and risk having to pay hefty penalties for infringing Zeneca’s patent.
See In the Matter of Schering-Plough,
. It should again be noted that the Federal Circuit recently decided that the '516 Patent was still valid, thus providing a reasonable and justifiable basis for the Settlement Agreement.
See Zeneca Ltd.,
. Courts in other circuits have taken different аpproaches with respect to the "first-served rule” since
Murphy Brothers. Compare, Griffith v. Am. Home Prods. Corp.,