Near term, other than a short term overreaction to an ANDA being approved, all I can see is green. An injunction will be granted, I beg someone to give me reason why it wouldn't. So AMRN continues as if the ruling never happened for the next year in which the EU approval would offset an unfavorable appeal outcome.
The district court made extensive factual findings, detailing
the likelihood of irreparable harm to Indivior in
the absence of an injunction while the issues are litigated.
D.N.J. Op. at *12. The district court found that “[e]ntry of
a generic would cause Indivior to lose market share and
the [S]uboxone film’s advantageous formulary status, and
would impair research and development.” Id. at *1. The
district court cited precedent that the “right to exclude
direct competition in a limited sphere, a right inherent in
the grant of a patent, is irreparably harmed by the loss of
sales and the competitive foothold that the infringer will
gain.” Id. at *12 (internal quotation marks and citation
“Price erosion, loss of goodwill, damage to reputation,
and loss of business opportunities are all valid grounds for
finding irreparable harm.” Celsis in Vitro, Inc. v. CellzDirect,
Inc., 664 F.3d 922, 930 (Fed. Cir. 2012). The district
court found this case to fit these conditions:
It comports with common sense, and Indivior has
shown, that Indivior will likely lose market share
to DRL’s ANDA product once it is launched and
will be unlikely to recover that share, even if that
product is pulled from the market. Courts have
found that a reduction of market share due to the
loss of formulary status and a change in tier pricing,
constitutes irreparable harm.
D.N.J. Op. at *12.
The district court determined that the balance of equities
“appears to favor Indivior.” D.N.J. Op. at *1, *13.
The district court found that Dr. Reddy’s “knowingly
invested ‘at risk,’” id. at *1, and its projected “losses stem
from a market it seeks to enter, not one that it is already
in.” Id. at *13. As in Sanofi-Synthelabo v. Apotex, Inc.,