B. Irreparable Harm
With respect to irreparable harm, plaintiff contends that if preliminary relief is not granted, the safety and effectiveness data in the Desyrel NDA file will be released to the public pursuant to 21 U.S.C. § 355(l)(5). Plaintiff maintains that this data have significant trade secret and confidential commercial value during the exclusivity periods provided for under the FFDCA. Once this material is released to the public, plaintiff argues, it is "forever public" and there is no means by which plaintiff could seek to recover damages in the event the release is found to have been improper. As further evidence of irreparable harm, plaintiff claims that if ANDAs are approved for generic copies of Desyrel, plaintiff will suffer the loss of sales of its product.
As our Court of Appeals recently stated, the party seeking injunctive relief must show that the injury complained of is of such imminence that there is a "clear and present need" for equitable relief to prevent irreparable harm. Wisconsin Gas Company v. Federal Energy Regulatory Commission, 244 U.S. App. D.C. 349, 758 F.2d 669, 674 (D.C. Cir. 1985). Plaintiff has not demonstrated the existence of imminent injury. As defendants assert, disclosure of safety and effectiveness data is not available to the public as a matter of course but can only be made available pursuant to requests from interested individuals. Should there be such a request, FDA's own regulations provide the NDA holder an opportunity to object to disclosure where there is an issue as to its confidentiality. The regulations further provide for a period within which the NDA holder may seek judicial review of any agency decision to release the data. See 21 C.F.R. §§ 20.45, 20.46. Hence, the concerns expressed by plaintiff regarding the immediacy of alleged irreparable harm are not persuasive.
Turning next to plaintiff's claims of economic injury, it is "well-settled that economic loss does not, in and of itself, constitute irreparable harm." Wisconsin Gas, supra, at 674. Moreover, plaintiff's claim that it will suffer a loss of sales should an ANDA be approved and drug product marketed before this case is disposed of on the merits is pure speculation. Plaintiff has also failed to provide any proof of economic loss and merely states that it would probably lose 20 to 30 percent of its market during the first year. The Court finds that plaintiff has not adequately demonstrated that it will suffer irreparable harm if this extraordinary relief is not issued.
C. Other Criteria for Preliminary Injunctive Relief
Plaintiff has also failed to demonstrate that the granting of injunctive relief will not significantly harm other interested parties. Other potential ANDA holders may have relied on official information published by the FDA that the Desyrel NDA had been approved on December 24, 1981, and that there was no non-patent exclusivity periods that applied to the product. If the Court were to grant the requested relief, these ANDA holders suffer delay from obtaining approval and marketing generic copies of Desyrel. They would, presumably, lose profits from not being able to sell their products. Although plaintiff states that any delay would likely be insignificant, it offers no support for its assertion.
With regard to the public interest, plaintiff contends that any delay of the date of ANDA approvals would not deny any member of the public drug therapy because Desyrel would remain available for purchase. Plaintiff's argument misses the mark. Any delay in the approval and marketing of generic copies of Desyrel appears to run counter to the public interest. One of the primary reasons Congress enacted the 1984 Amendments was to increase the availability of generic copies of marketed drug products in order to increase competition and save money for the American consumer. Thus, plaintiff has not demonstrated that the public interest will be served by a grant of the relief sought.
Accordingly, the motion of plaintiff for a preliminary injunction must be denied. An Order consistent with this Memorandum Opinion will be entered this date.
DATED: February 5, 1986
Upon consideration of the motion of plaintiff for preliminary injunction, the supporting and opposing memoranda, the argument of counsel, and the entire record herein, and consistent with the Memorandum Opinion of even date, it is this 5th day of February, 1986,
ORDERED that the motion of plaintiff for preliminary injunction be, and hereby is, denied.
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