Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 19

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

15 

Opinion of the Court 

the 

whether  §262(l)(2)(A)  is  mandatory  or  conditional;  the 
court need only determine whether the applicant supplied
the  sponsor  with 
information  required  under 
§262(l)(2)(A).  If the applicant failed to provide that infor-
mation,  then  the  sponsor,  but  not  the  applicant,  could 
bring an immediate declaratory-judgment action pursuant 
to  §262(l)(9)(C).  The  parties  in  these  cases  agree—as  did 
the  Federal  Circuit—that  Sandoz  failed  to  comply  with
§262(l)(2)(A),  thus  subjecting  itself  to  that  consequence.
There is no dispute about how the federal scheme actually 
works,  and  thus  nothing  for  us  to  decide  as  a  matter  of
federal  law.  The  mandatory  or  conditional  nature  of  the 
BPCIA’s  requirements  matters  only  for  purposes  of  Cali-
fornia’s  unfair  competition  law,  which  penalizes  “unlaw-
ful”  conduct.  Whether  Sandoz’s  conduct  was  “unlawful” 
under  the  unfair  competition  law  is  a  state-law  question, 
and  the  court  below  erred  in  attempting  to  answer  that
question by referring to the BPCIA alone.

On  remand,  the  Federal  Circuit  should  determine 
whether  California  law  would  treat  noncompliance  with
§262(l)(2)(A) as “unlawful.”  If the answer is yes, then the 
court  should  proceed  to  determine  whether  the  BPCIA
pre-empts  any  additional  remedy  available  under  state 
law  for  an applicant’s  failure  to  comply  with  §262(l)(2)(A)
(and  whether  Sandoz  has  forfeited  any  pre-emption  de-
fense,  see  794  F. 3d,  at  1360,  n. 5).    The  court  is  also  of 
course  free  to  address  the  pre-emption  question  first  by
assuming that a remedy under state law exists. 

IV 

The  second  question  at  issue  in  these  cases  is  whether 
an applicant must provide notice after the FDA licenses its 
biosimilar, or if it may also provide effective notice before
licensure.  Section  262(l)(8)(A)  states  that  the  applicant 
“shall  provide  notice  to  the  reference  product  sponsor  not 
later than 180 days before the date of the first commercial