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10 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

injunction  pending  appeal  to  bar  Sandoz  from  marketing 
Zarxio until 180 days after the date it provided its second 
notice.  Id., at 1360–1361. 

We  granted  Sandoz’s  petition  for  certiorari,  No.  15–
1039, and Amgen’s conditional cross-petition for certiorari,
No. 15–1195,  and  consolidated  the  cases.    580  U. S.  ___ 
(2017). 

III

first  question  we  must  answer 

is  whether 
  The 
§262(l)(2)(A)’s  requirement  that  an  applicant  provide  the 
sponsor  with  its  application  and  manufacturing  infor-
mation is enforceable by an injunction under either federal 
or state law. 

A 
We  agree  with  the  Federal  Circuit  that  an  injunction
under federal law is not available to enforce §262(l)(2)(A),
though  for  slightly  different  reasons  than  those  provided 
by  the  court  below.    The  Federal  Circuit  held  that  “42 
U. S. C.  §262(l)(9)(C)  and  35  U. S. C.  §271(e)  expressly 
provide the only remedies” for a violation of §262(l)(2)(A),
794 F. 3d, at 1357, and neither of those provisions author-
izes  a  court  to  compel  compliance  with  §262(l)(2)(A).  In 
concluding  that  the  remedies  specified  in  the  BPCIA  are 
exclusive,  the  Federal  Circuit  relied  primarily  on 
§271(e)(4),  which  states  that  it  provides  “ ‘the  only  reme-
dies which may be granted by a court for an act of [artifi-
cial] infringement.’ ”  Id., at 1356 (emphasis deleted).

The  flaw  in  the  Federal  Circuit’s  reasoning  is  that
Sandoz’s  failure  to  disclose  its  application  and  manufac-
turing  information  was  not  an  act  of  artificial  infringe-
ment,  and  thus  was  not  remediable  under  §271(e)(4).
Submitting  an  application  constitutes  an  act  of  artificial
infringement.  See §§271(e)(2)(C)(i), (ii) (“It shall be an act 
of  infringement  to  submit  . . .  an  application  seeking  ap-