FURTHER UPDATE Monday 4:52 p.m. The generic companies have now filed their reply brief, arguing that Teva has not actually taken any significant step — and may not be able to do so — in the trial court, so the Supreme Court should go ahead and send down its ruling.
UPDATE: This new dispute will be submitted initially to Justice Stephen G. Breyer, instead of to the Chief Justice. Breyer was the author of the Court’s Teva decision.
The high-dollar feud between drug companies over the rights to sell a hugely profitable drug for treating multiple sclerosis patients has reopened in the Supreme Court, just days after the Justices ruled in favor of the brand-name company. The new dispute centers on the timing of lower-court actions that are to follow the Justices’ decision last Tuesday in Teva Pharmaceuticals USA, Inc., v. Sandoz.
Sandoz, Inc., and other makers of generic versions of Teva’s brand-name Copaxone drug want the Justices to quickly release the formal document implementing last week’s ruling so that a federal appeals court can move ahead quickly on a new round, but Teva is seeking to protect its existing monopoly to continue selling the drug without generic competition while additional proceedings unfold.
Specifically, Sandoz and three other generics on Friday asked the Court not to wait the usual twenty-five days to put its new decision into effect, saying that each day is important with the last remaining Teva patent on Copaxone due to expire next September 1. Any delay, those firms said in their application, may mean that the case loses any remaining significance on the question of when the generics could enter the market with their version of Copaxone.
For its part, Teva told the Court in its response Monday that it has already asked a federal trial judge in New York City to put back into effect a formal court order that bars the generic firms from putting their substitute on the market until after the remaining Teva patent has expired. Teva argued that the Justices should not issue their implementing order until after the New York judge has a chance to act on the plea to restore the marketing injunction order. If the case returns swiftly to the U.S. Court of Appeals for the Federal Circuit, the New York judge would lose jurisdiction to put that order back into effect, Teva contended. The generics, the company added, will not be harmed, because they still have not obtained government clearance to sell their generic versions.
As the case went to the Supreme Court, the Federal Circuit had ruled that the Teva patent on Copaxone was invalid. Last week, the Justices overturned that decision by a seven-to-two vote, but in doing so they did not rule on the question of the validity of the Teva patent. Instead, the Court ordered the case back to the Federal Circuit, saying it had overstepped its reviewing powers in overturning the trial judge’s ruling in Teva’s favor.
When the case does get back to the Federal Circuit, that court is to analyze the trial judge’s decision to see if it was clearly in error; if not, then it must uphold that ruling. The Federal Circuit had overturned the judge’s decision by undertaking, on its own, an independent review of the factual dispute underlying the fight over the Teva patent’s validity.
The new filings in the Supreme Court were submitted to Chief Justice John G. Roberts, Jr., who handles emergency legal matters from the Federal Circuit. He has the authority to act on his own, or to refer it to his colleagues for action. With the timing issue front and center, the Chief Justice or the full Court presumably will act quickly.