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

1 

Opinion of the Court 

NOTICE:  This opinion is subject to formal revision before publication in the
preliminary  print  of  the  United  States  Reports.  Readers  are  requested  to
notify the Reporter of Decisions, Supreme Court of the United States, Wash-
ington,  D. C.  20543,  of  any  typographical  or  other  formal  errors,  in  order
that corrections may be made before the preliminary print goes to press. 

SUPREME COURT OF THE UNITED STATES 

_________________ 

Nos. 15–1039 and 15–1195 
_________________ 

15–1039 

SANDOZ INC., PETITIONER 
v. 
AMGEN INC., ET AL. 

15–1195 

AMGEN INC., ET AL., PETITIONERS 
v. 
SANDOZ INC. 

ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF 
APPEALS FOR THE FEDERAL CIRCUIT 

[June 12, 2017] 

JUSTICE THOMAS delivered the opinion of the Court. 
These  cases  involve  42  U. S. C.  §262(l),  which  was  en-
acted as part of the Biologics Price Competition and Inno-
vation  Act  of  2009  (BPCIA),  124  Stat.  808.    The  BPCIA 
governs  a  type  of  drug  called  a  biosimilar,  which  is  a
biologic product that is highly similar to a biologic product 
that  has  already  been  approved  by  the  Food  and  Drug
Administration  (FDA).    Under  §262(l),  an  applicant  that 
seeks FDA approval of a biosimilar must provide its appli-
cation  materials  and  manufacturing  information  to  the 
manufacturer of the corresponding biologic within 20 days
of  the  date  the  FDA  notifies  the  applicant  that  it  has
accepted  the  application  for  review.    The  applicant  then
must  give  notice  to  the  manufacturer  at  least  180  days 
before marketing the biosimilar commercially. 

The  first  question  presented  by  these  cases  is  whether