Teva v. FDA
Here is the intro from the FDA brief:
INTRODUCTION
This case reflects the efforts of plaintiff Teva Pharmaceutical Industries, Ltd. (“Teva”) to extend its monopoly for Copaxone (glatiramer acetate injection), a blockbuster multiple sclerosis drug. The Food and Drug Administration (“FDA”) has not yet approved any generic products, and Teva does not know if or when, or on what basis, such an approval will occur. In preemptively seeking to eliminate competition by enjoining the Food and Drug Administration (“FDA”) from approving a generic drug, Teva asks this Court to review decisions that have not yet been made and to find injury where none exists.
Over the last six years, Teva has filed no less than six citizen petitions with its various legal and scientific assertions and requests, each time making the same demand: that FDA not approve any generic competitor’s product without requiring, among other things, a full set of clinical trials. FDA responded each time, repeatedly explaining to Teva that, because Teva’s petitions relate to specific issues of approvability, FDA cannot issue a substantive response to the petitions without first completing the scientific analysis necessary to make the approval decision.
FDA’s responses to Teva’s requests reflect that the agency’s scientific evaluations are ongoing and must be completed in the context of generic applications. Teva has no right to a final, merits decision about potential competitors’ approvals before FDA’s review of their applications is complete. Teva’s request that this Court decide whether an abbreviated new drug application (“ANDA”) may be approved in the first instance without first meeting Teva’s additional “conditions” for approval – conditions above and beyond what Congress has set forth in the statute – is absolutely unprecedented, extrastatutory, and extrajudicial. The agency will take appropriate action to approve any generic applications if and when any such applications are ready for approval, as Congress has mandated, and as FDA does for all other generic drug approvals.
Courts are justifiably reluctant to second guess FDA’s scientific determinations, and FDA is not aware of any instance in which a court has overturned an FDA decision approving a generic drug on scientific grounds. Nor has Teva cited any case in which a court has blocked generic approval before it has occurred – much less taken it upon itself to determine the scientific issues bearing upon the approval of an ANDA before the agency itself has done so. But that is precisely what Teva asks this Court to do. This Court should decline Teva’s remarkable invitation and dismiss this premature and ill-considered lawsuit.
Not only are Teva’s claims unripe and unjusticiable for want of standing, but Teva has not established that it will suffer certain, great, and irreparable injury in the absence of a preliminary injunction. If Teva ever suffers the loss that it claims it will here, such loss will be a small percentage of its multibillion dollar portfolio of generic and brand drugs, and thus would not threaten or even seriously injure the business. And finally, the balance of harms weighs against the entry of preliminary relief because Teva’s desire to further delay generic competition does not outweigh FDA’s interest in the thoughtful and careful exercise of its generic approval decisions without premature judicial interference.
For these reasons, this Court should dismiss Teva’s complaint and deny Teva’s motion for a preliminary injunction.
AI
