Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 18

14 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

Bus. & Prof. Code Ann. §17205; Loeffler v. Target Corp., 58 
Cal.  4th  1081,  1125–1126,  324  P. 3d  50,  76  (2014)).    It 
further held that §271(e)(4), by its text, “provides ‘the only 
remedies’ ” for an applicant’s failure to disclose its applica-
tion  and  manufacturing  information.    794  F. 3d,  at  1360 
(quoting  §271(e)(4)).  The  court  thus  concluded  that  no 
state  remedy  was  available  for  Sandoz’s  alleged  violation 
of  §262(l)(2)(A)  under  the  terms  of  California’s  unfair 
competition law.

This  state-law  holding  rests  on  an  incorrect  interpreta-
tion of federal law.  As we have explained, failure to com-
ply  with  §262(l)(2)(A)  is  not  an  act  of  artificial  infringe-
ment.  Because  §271(e)(4)  provides  remedies  only  for 
artificial infringement, it provides no remedy at all, much
less  an  “expressly  . . .  exclusive”  one,  for  Sandoz’s  failure 
to comply with §262(l)(2)(A).

Second, the Federal Circuit held in the alternative that 
Sandoz’s  failure  to  disclose  its  application  and  manufac-
turing  information  was  not  “unlawful”  under  California’s
unfair  competition  law. 
In  the  court’s  view,  when  an 
applicant declines to provide its application and manufac-
turing information to the sponsor, it takes a path “expressly
contemplated  by”  §262(l)(9)(C)  and  §271(e)(2)(C)(ii)  and 
thus does not violate the BPCIA.  794 F. 3d, at 1357, 1360. 
In  their  briefs  before  this  Court,  the  parties  frame  this
issue  as  whether  the  §262(l)(2)(A)  requirement  is  manda-
tory  in  all  circumstances,  see  Brief  for  Amgen  Inc.  et al. 
58,  or  merely  a  condition  precedent  to  the  information 
exchange process, see Reply Brief for Sandoz Inc. 33.  If it 
is only a condition precedent, then an applicant effectively
has the option to withhold its application and manufactur-
ing information and does not commit an “unlawful” act in
doing so.

We decline to resolve this particular dispute definitively
because it does not present a question of federal law.  The 
BPCIA, standing alone, does not require a court to decide