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16 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

marketing of the biological product licensed under subsec-
tion  (k).”  The  Federal  Circuit  held  that  an  applicant’s
biosimilar  must  already  be  “licensed”  at  the  time  the
applicant gives notice.  794 F. 3d, at 1358. 

We  disagree.  The  applicant  must  give  “notice”  at  least 
180 days  “before the date of the first commercial market-
ing.” 
“[C]ommercial  marketing,”  in  turn,  must  be  “of
the  biological  product  licensed  under  subsection  (k).” 
§262(l)(8)(A).  Because  this  latter  phrase  modifies  “com-
mercial  marketing”  rather  than  “notice,”  “commercial 
marketing”  is  the  point  in  time  by  which  the  biosimilar 
must  be  “licensed.”  The  statute’s  use  of  the  word  “li-
censed”  merely  reflects  the  fact  that,  on  the  “date  of  the 
first  commercial  marketing,”  the  product  must  be  “li-
censed.”  See  §262(a)(1)(A).    Accordingly,  the  applicant
may  provide  notice  either  before  or  after  receiving  FDA
approval.

Statutory  context  confirms  this  interpretation.    Section 
262(l)(8)(A)  contains  a  single  timing  requirement:  The
applicant  must  provide  notice  at  least  180  days  prior  to
marketing  its  biosimilar.    The  Federal  Circuit,  however, 
interpreted  the  provision  to  impose  two  timing  require-
ments:  The  applicant  must  provide  notice  after  the  FDA 
licenses  the  biosimilar  and  at  least  180  days  before  the 
applicant  markets  the  biosimilar.    An  adjacent  provision 
expressly  sets  forth  just  that  type  of  dual  timing  require-
ment.  See  §262(l)(8)(B)  (“After  receiving  notice  under
subparagraph  (A)  and  before  such  date  of  the  first  com-
mercial marketing of such biological product, the reference 
product  sponsor  may  seek  a  preliminary  injunction”  (em-
phasis added)).  But Congress did not use that structure in 
“Had  Congress  intended  to”  impose  two 
§262(l)(8)(A). 
timing  requirements  in  §262(l)(8)(A),  “it  presumably
would have done so expressly as it did in the immediately 
following”  subparagraph.    Russello  v.  United  States,  464 
U. S. 16, 23 (1983).