Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 3

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

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Syllabus 

with  this  requirement.    The  court  also  held  that  under  §262(l)(8)(A)
an  applicant  must  provide  notice  of  commercial  marketing  after  ob-
taining  licensure,  and  that  this  requirement  is  mandatory.   It  thus 
enjoined Sandoz from marketing Zarxio until 180 days after the date
it provided its second notice. 

Held: Section 262(l)(2)(A) is not enforceable by injunction under federal 
law, but the Federal Circuit on remand should determine whether a 
state-law  injunction  is  available.    An  applicant  may  provide  notice 
under §262(l)(8)(A) prior to obtaining licensure.  Pp. 10–18.

(a) Section 262(l)(2)(A)’s requirement that an applicant provide the 
sponsor  with  its  application  and  manufacturing  information  is  not
enforceable by an injunction under federal law.  The Federal Circuit 
reached the proper result on this point, but its reasoning was flawed.
It  cited  §271(e)(4),  which  expressly  provides  the  “only  remedies”  for
an act of artificial infringement.  In light of this language, the court
reasoned that no remedy other than those specified in the text—such 
as  an  injunction  to  compel  the  applicant  to  provide  its  application
and  manufacturing  information—was  available.    The  problem  with
this  reasoning  is  that  Sandoz’s  failure  to  disclose  was  not  an  act  of 
artificial  infringement  remediable  under  §271(e)(4).    Submitting  an
application constitutes an act of artificial infringement; failing to dis-
close  the  application  and  manufacturing  information  required  by 
§262(l)(2)(A) does not.  

Another  provision,  §262(l)(9)(C),  provides  a  remedy  for  an  appli-
cant’s  failure  to  turn  over  its  application  and  manufacturing  infor-
mation.  It authorizes the sponsor, but not the applicant, to bring an 
immediate  declaratory-judgment  action  for  artificial  infringement, 
thus vesting in the sponsor the control that the applicant would oth-
erwise have exercised over the scope and timing of the patent litiga-
tion  and  depriving  the  applicant  of  the  certainty  it  could  have  ob-
tained by  bringing a declaratory-judgment action prior to marketing
its product.  The presence of this remedy, 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.    See 
Great-West  Life  &  Annuity  Ins.  Co.  v.  Knudson,  534  U. S.  204,  209. 
Statutory  context  further  confirms  that  Congress  did  not  authorize 
courts to enforce §262(l)(2)(A) by injunction.  Pp. 10–13.

(b) The  Federal  Circuit  should  determine  on  remand  whether  an 
injunction  is  available  under  state  law  to  enforce  §262(l)(2)(A).
Whether  Sandoz’s  conduct  was  “unlawful”  under  California’s  unfair 
competition statute is a question of state law, and the Federal Circuit 
thus erred in attempting to answer that question by referring only to
the BPCIA.  There is no dispute about how the federal scheme actual-