Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 17

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

13 

Opinion of the Court 

ity Ins. Co. v. Knudson, 534 U. S. 204, 209 (2002) (internal 
quotation  marks  omitted).  The  presence  of  §262(l)(9)(C),
coupled  with  the  absence  of  any  other  textually  specified 
remedies, indicates that Congress did not intend sponsors
to  have  access  to  injunctive  relief,  at  least  as  a  matter  of 
federal law, to enforce the disclosure requirement. 

Statutory  context  further  confirms  that  Congress  did 
not authorize courts to enforce §262(l)(2)(A) by injunction.
Section 262(l)(1)(H) provides that “the court shall consider
immediate  injunctive  relief  to  be  an  appropriate  and  nec-
essary remedy for any violation or threatened violation” of
the  rules  governing  the  confidentiality  of  information
disclosed  under  §262(l).  We  assume  that  Congress  acted 
intentionally  when  it  provided  an  injunctive  remedy  for 
breach  of  the  confidentiality  requirements  but  not  for
breach  of  §262(l)(2)(A)’s  disclosure  requirement.  Cf. 
Touche Ross & Co. v. Redington, 442 U. S. 560, 572 (1979) 
(“[W]hen  Congress  wished  to  provide  a  private  damage
remedy,  it  knew  how  to  do  so  and  did  so  expressly”).2 
Accordingly, the Federal Circuit properly declined to grant 
an injunction under federal law. 

B 
The  Federal  Circuit  rejected  Amgen’s  request  for  an
injunction under state law for two reasons.  First, it inter-
preted California’s unfair competition law not to provide a 
remedy when the underlying statute specifies an “expressly
. . .  exclusive”  remedy.    794  F. 3d,  at  1360  (citing  Cal. 
—————— 

2 In holding that §262(l)(9)(C) represents the exclusive remedy for an
applicant’s  failure  to  provide  its  application  and  manufacturing  infor-
mation, we express no view on whether a district court could take into
account  an  applicant’s  violation  of  §262(l)(2)(A)  (or  any  other  BPCIA 
procedural  requirement)  in  deciding  whether  to  grant  a  preliminary
injunction  under  35  U. S. C.  §271(e)(4)(B)  or  §283  against  marketing 
the biosimilar.  See Winter v.  Natural Resources Defense Council, Inc., 
555  U. S.  7,  20  (2008)  (court  should  consider  “balance  of  equities”  in
deciding whether to grant a preliminary injunction).