SUPREME COURT DECLINES TO HEAR ZOLOFT CASE
The U.S. Supreme Court has declined to review Teva Pharmaceutical's long-running patent challenge to Pfizer's antidepressant Zoloft -- a case that hinges on the crucial declaratory judgment issue.
Teva asked the nation's highest court to review a Jan. 21 appeals court decision that dismissed the generic firm's motion for a declaratory judgment of noninfringement against Pfizer. The case has been closely watched by both brand and generic firms because the declaratory judgment provision, which was established by the 2003 Medicare Modernization Act (MMA), is a vital component of patent infringement cases.
Some legal experts had speculated that the Supreme Court was likely to hear Teva's appeal because it raised strong constitutional issues, but the court announced recently that it would not review the Federal Circuit's decision. The court did not comment on why Teva's appeal was declined. Three judges -- Chief Justice John Roberts and Justices Sandra Day O'Connor and Stephen Breyer -- recused themselves from the case.
The Supreme Court's decision not to weigh in on the case is a blow to the generic industry, which contends that the Federal Circuit's decision is a step backward because it eliminates the provisions set forth by the MMA. The declaratory judgment provision allows generic firms to seek a declaratory judgment of noninfringement on a patent if a brand firm fails to bring a patent lawsuit within a 45-day notification period. But since the law's passage, brand firms have elected not to sue generic firms that challenge brand drug patents within the 45-day window, thereby undercutting the rationale for a declaratory judgment.
That tactic has worked successfully for Pfizer, which elected not to sue Teva for infringement of its patent on Zoloft (sertraline HCl). Teva later filed a motion for declaratory judgment against Pfizer in the U.S. District Court for the District of Massachusetts, but the court ruled in December 2003 that because Pfizer did not sue Teva for patent infringement within the 45-day notification period, the generic firm failed to establish a "reasonable apprehension" of suit, which is needed to establish court jurisdiction under Article III of the Constitution. The Federal Circuit upheld the district court's ruling in its Jan. 21 decision.