Supreme Court Asks Solicitor General for Views on Whether Orange Book Listing Creates Justiciable Controversy
Generic drug companies may finally hear from the Supreme Court on whether merely listing a patent in the Orange Book creates a sufficient basis for a declaratory judgment action. Last October, the Supreme Court denied cert in Teva v. Pfizer, in which the Federal Circuit held that listing a patent in the Orange Book does not create a justiciable controversy. On Monday, in a move that may foreshawdow a grant of certiorari, the Supreme Court asked the Solicitor General for his views on a similar case, Apotex v. Pfizer. Both cases concern generic challenges to Pfizer's patent on Zoloft.
In its cert petition, Apotex framed the question for review as follows: whether, in cases where a generic drug maker seeks a declaratory judgment of noninfringement, a justiciable controversy is presented when "the failure to secure a court judgment prohibits the federal government from approving the generic equivalent and the prospect of massive patent liability deters the generic manufacturer from entering the marketplace." Apotex argued in its petition that Teva v. Pfizer was wrongly decided because the Federal Circuit improperly elevated its "reasonable apprehension" test for declaratory judgment jurisdiction to a "constitutional requirement"--in direct conflict with Supreme Court precedents. Apotex further argued that cert should be granted because the Federal Circuit's decision to deny declaratory judgment jursidiction "effectively nullifies an entire statutory scheme," the Hatch-Waxman Amendments.
In its opposition brief, Pfizer argued that the petition should be denied because: (a) the case is so fact-intensive that it doesn't raise a recurring issue; (b) the reasonable apprehension test is consistent with Supreme Court precedents and creates no split among the circuits; and (c) the lower court decision is correct on the merits. Apotex answered each of these arguments in its reply brief.
The Generic Pharmaceutical Association filed an amicus brief in support of Apotex.
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