Here's a little more color on NVS/MNTA/MYLs argument
Generic-Drug Makers Oppose Teva Bid to Delay Copaxone Rivals
2014-04-14 22:19:20.668 GMT
By Greg Stohr
April 14 (Bloomberg) -- Generic-drug makers including
Momenta Pharmaceuticals Inc. urged the U.S. Supreme Court to let
them introduce generic versions of Teva Pharmaceutical
Industries Ltd.’s Copaxone multiple-sclerosis drug next month.
In a court filing today, Momenta, Novartis AG’s Sandoz and
Mylan Inc. said they would suffer “immense harm” if barred
from selling generic Copaxone in the U.S. after some of the
drug’s patents expire May 24.
Teva is asking Chief Justice John Roberts to block generic
Copaxone while the high court considers a case involving a
different patent claim that may shield Copaxone from competition
until September 2015.
Momenta, Sandoz and Mylan haven’t explicitly said whether
they will press ahead with plans to sell generic Copaxone while
the Supreme Court fight plays out. They suggested in today’s
filing that they would do so, though they didn’t say so
directly.
The companies said a Supreme Court order blocking generic
versions would in effect “decide this litigation for Teva” by
giving it time to switch patients from a 20-milligram dose to a
40-milligram version covered by other patents before any generic
competition begins.
Copaxone brings in $3.2 billion in annual U.S. sales and
accounts for more than half of Teva’s profit. Should the
generic-drug companies start selling their versions in May, they
would be at risk of having to pay Teva for its lost profit in
the event that company ultimately wins the case.
Generic Version
Momenta has developed a generic version of Copaxone with
Sandoz, and Mylan is planning its own version.
A federal appeals court last year threw out the disputed
Teva patent, saying it didn’t clearly outline what the company
claimed was invented.
In November, Roberts refused to put the appeals court
ruling on hold while the justices decided whether to take up
Teva’s appeal. The Supreme Court later agreed to hear the case,
putting it on a timeline to be resolved early next year.
Roberts handles emergency matters from the appeals court
that handled the Copaxone case. Roberts can either act on the
Teva request himself or refer it to the full nine-member court.
The case is Teva v. Sandoz, 13-854.
