of Schering's claims directed to the Copley product itself. For the reasons stated below, the Court finds that preliminary injunctive relief is not warranted on the present record.
When deciding a motion for a preliminary injunction, the Court must consider four criteria: (1) whether plaintiff is likely to prevail on the merits; (2) whether plaintiff has shown irreparable injury absent interim relief; (3) whether injunctive relief would significantly harm other interested parties; and (4) whether the public interest would be served by granting or denying preliminary relief. Washington Metropolitan Area Transit Commission v. Holiday Tours, 182 App. D.C. 220, 559 F.2d 841 (D.C. Cir. 1977). The greatest difficulty with Schering's impromptu suggestion that it is entitled to preliminary relief even under a broad application of the statute is that it has not demonstrated a likelihood of success on the merits of a future factual challenge to the FDA's determination that the Copley drug is bioequivalent to the Schering pioneer drug.
Although Schering claims its challenge is "limited in scope" to FDA's asserted departure from what Schering believes to be the statutory definition of bioequivalence, Reply Memorandum in Support of Motion for Preliminary Injunction at 6, Schering also suggests that, in any event, there is no adequate explanation underlying the FDA's finding or inference of bioequivalence. Id. at 8. However, the agency did purport to make such a finding or inference that the Copley drug is bioequivalent to the Schering drug, see Defendant's Opposition to Motion for Preliminary Injunction, Exhibit 2(c) at 1, and the FDA's affidavit -- which is pertinent at the preliminary injunction stage -- premises this determination on standards set forth by the 1977 regulations for drugs "administered by inhalation as a gas or vapor." Id., Exhibit 2, para. 9; 21 C.F.R. § 320.22(b)(4). Apart from its statutory challenge, Schering has not yet offered an adequate basis for challenging the support for or the application of that regulation in this case.
Equally significant to the question of preliminary relief is Schering's failure to offer any affirmative evidence that there is reason for suspecting that the Copley drug would pose a threat to public safety. While much has been made about the general hazards of permitting non-bioequivalent generic drugs to be substituted for pioneer drugs, there is nothing before the Court, in the partial "administrative record"
or elsewhere, to suggest that the drug in question is such a drug and would have immediate harmful effects on the public. At the same time, the FDA's affidavit does describe the extensive review conducted by the FDA with the safety issue in mind. Here again, acknowledging the undoubted importance of the Congressional mandate for safe generic drugs, the Court cannot find on the present record that Schering would be likely to succeed on the merits of a future factual challenge to the Copley approval.
A preliminary injunction nonetheless might be warranted if the Court could find that Schering had "made a substantial case on the merits," and that the equities of the case "strongly favor interim relief." Holiday Tours, 559 F.2d at 843. However, as discussed, there is no evidence that the public interest would be served by issuance of an injunction, while delay in the marketing of Copley's drug could easily be against the public interest in reduced prices. See Mead Johnson Pharmaceutical Group v. Bowen, 655 F. Supp. 53, 56 (D.D.C. 1986), aff'd, 267 App. D.C. 382, 838 F.2d 1332 (D.C. Cir. 1988). Further, the Court finds that the equitable balance of harms between the parties is inconclusive at best. Schering argues that it will suffer great economic losses due to competition from the Copley product. This claim is speculative as to amount, see id. at 56, and in any event falls short of showing the immediate irreparable harm necessary to justify emergency injunctive relief.
Similarly, while Copley makes a credible showing that its economic interests could be irreparably damaged by an injunction, it is hard to accord great weight to this outcome where the facts suggest that Copley willingly assumed this risk when deciding to bring its product to market in the face of Schering's pending lawsuit. In sum, the Court concludes that the equities of the case do not warrant injunctive relief at this time.
Since the Court has ruled on the merits of Schering's original complaint, and concluded that there presently is no basis for the issuance of emergency injunctive relief, Schering's complaint will be dismissed. The dismissal will permit Schering to seek immediate appellate review on the legal issue that both it and the FDA agree to be ripe. At the same time, this dismissal is without prejudice to any future suit that Schering chooses to bring for the purpose of challenging the Copley approval itself on a full administrative record.
In accordance with this Memorandum Opinion, an Order will be entered this date, granting defendants' motion for summary judgment and dismissing this case, without prejudice to Schering's right to file a new action seeking judicial review of the Copley approval.
United States District Judge
EDITOR'S NOTE: The following court-provided text does not appear at this cite in 782 F. Supp. 645.
ORDER - January 17, 1992, Filed
Upon consideration of the defendants' motion to dismiss, the parties' cross-motions for summary judgment, plaintiff's motion for a preliminary injunction, and the opposition and reply memoranda thereto, and for the reasons set forth in the Court's Memorandum Opinion of this same date, it is hereby
ORDERED, that defendants' motion to dismiss is DENIED AS MOOT, and defendants' motion for summary judgment is GRANTED. Plaintiffs' motions for summary judgment and for a preliminary injunction are DENIED. Accordingly, judgment is hereby entered in favor of the defendants, and this case is DISMISSED, but without prejudice to plaintiff's right to file a new action seeking judicial review of defendants' approval of the Copley product itself on the basis of a full administrative record.
IT IS SO ORDERED.
United States District Judge