Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 13.0

Cite as:  582 U. S. ____ (2017) 

9 

Opinion of the Court 

396,  304  P. 3d  181,  185  (2013).    Amgen  alleged  that 
Sandoz  engaged  in  “unlawful”  conduct  when  it  failed  to
provide  its  application  and  manufacturing  information
under  §262(l)(2)(A),  and  when  it  provided  notice  of  com-
mercial marketing under §262(l)(8)(A) before, rather than
after,  the  FDA  licensed  its  biosimilar.    Amgen  sought
injunctions to enforce both requirements.  Sandoz counter-
claimed  for  declaratory  judgments  that  the  asserted  pat- 
ent  was  invalid  and  not  infringed  and  that  it  had  not 
violated the BPCIA. 

While  the  case  was  pending  in  the  District  Court,  the
FDA  licensed  Zarxio,  and  Sandoz  provided  Amgen  a  fur-
ther  notice  of  commercial  marketing.    The  District  Court 
subsequently granted partial judgment on the pleadings to 
Sandoz  on 
its  BPCIA  counterclaims  and  dismissed 
Amgen’s  unfair  competition  claims  with  prejudice.    2015 
WL  1264756,  *7–*9  (ND  Cal.,  Mar.  19,  2015).    After  the 
District  Court  entered  final  judgment  as  to  these  claims,
Amgen appealed to the Federal Circuit, which granted an
injunction pending appeal against the commercial market-
ing of Zarxio.

A  divided  Federal  Circuit  affirmed  in  part,  vacated  in
part, and remanded.  First, the court affirmed the dismis-
sal  of  Amgen’s  state-law  claim  based  on  Sandoz’s  alleged 
It  held  that  Sandoz  did  not 
violation  of  §262(l)(2)(A). 
violate the BPCIA in failing to disclose its application and 
manufacturing information.  It further held that the rem-
edies  contained  in  the  BPCIA  are  the  exclusive  remedies 
for an applicant’s failure to comply with §262(l)(2)(A).  794 
F. 3d 1347, 1357, 1360 (2015). 

Second,  the  court  held  that  an  applicant  may  provide
effective  notice  of  commercial  marketing  only  after  the 
FDA  has  licensed  the  biosimilar.  Id.,  at  1358.    Accord-
ingly, the 180-day clock began after Sandoz’s second, post- 
licensure  notice.  The  Federal  Circuit  further  concluded 
that the notice requirement is mandatory and extended its