By Diane Bartz and Ransdell Pierson
WASHINGTON/NEW YORK, July 26 Teva Pharmaceutical
Industries' $4 billion-a-year multiple sclerosis drug Copaxone
will lose its patent protection in 2014 rather than 2015 because
of a ruling from a U.S. appeals court on Friday, making it
potentially prey to cheaper generics next May.
The U.S. Court of Appeals for the Federal Circuit issued its
decision in a patent fight that pits Teva against two
teams developing cheaper generic forms of Copaxone: one with
Novartis AG and Momenta Pharmaceuticals Inc
and another between Mylan Inc and Natco Pharma Ltd
The court upheld some claims, or portions, of nine patents
involved in the drug but declared several invalid, shortening
patent protection for the drug.
"We are very pleased with today's ruling and we expect that
it will allow Mylan to launch its generic version of Copaxone on
May 25, 2014," Mylan Chief Executive Heather Bresch said in a
Teva said in a release that it plans to appeal the court
decision. Novartis did not immediately comment on the ruling.
The lawsuit was filed after the Sandoz generic division of
Novartis and Mylan notified the U.S. Food and Drug
Administration that they wanted to bring out generic versions of
Copaxone. Teva sued to block them and protect its patents.
Patents on Copaxone, which accounts for about 20 percent of
Teva's sales and about 50 percent of its profit, had been set to
expire in September 2015.
Shares of Teva slipped 0.6 percent to $41.00 on the New York
Stock Exchange, while Mylan shares rose 1.7 percent to $33.16 on
the Nasdaq. Momenta shares rose 12.8 percent to $17.51 on the
Nasdaq. Novartis shares slipped 0.7 percent to $71.73.
Morningstar analyst Michael Waterhouse said Teva shares were
little affected by the unfavorable court ruling because many
analysts and investors had already assumed that Copaxone, which
had sales of $4 billion last year, would face competition from
at least one generic in 2014.
"So a lot of that pessimism was priced into the stock,"
Waterhouse said one or both generics could be introduced by
2014 or 2015. But he said there is a good chance neither generic
will be ready for launch next year because of difficulty making
the complicated molecule.
In any case, the analyst said he expects Copaxone sales to
fall to about $3.8 billion this year because of competition from
new oral treatments for multiple sclerosis, including Biogen
Idec's Tecfidera and Sanofi SA's Aubagio, and
to fall to $3.4 billion in 2014 for the same reason, even if no
generics are introduced.
Once one or more generics arrive, either in 2014 or later,
Waterhouse said they could be expected to quickly erase 40
percent of Copaxone sales.