Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 4

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SANDOZ INC. v. AMGEN INC. 

Syllabus 

ly works on the facts of this case: Sandoz failed to disclose the requi-
site  information  under  §262(l)(2)(A),  and  was  accordingly  subject  to
the consequence specified in §262(l)(9)(C).  As a result, there is noth-
ing  to  decide  on  this  point  as  a  matter  of  federal  law.    The  court  on 
remand  should  determine  whether  California  law  would  treat  non-
compliance with §262(l)(2)(A) as “unlawful,” and whether the BPCIA 
pre-empts any additional state-law remedy for failure to comply with
§262(l)(2)(A).  Pp. 13–15. 

(c) An applicant may provide notice of commercial marketing before
obtaining  a  license.    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 marketing of the bio-
logical product licensed under subsection (k).”  Because the phrase “of
the  biological  product  licensed  under  subsection  (k)”  modifies  “com-
mercial  marketing”  rather  than  “notice,”  “commercial  marketing”  is
the point in time by which the biosimilar must be “licensed.”  Accord-
ingly,  the  applicant  may  provide  notice  either  before  or  after  receiv-
ing FDA approval.  Statutory context confirms that §262(l)(8)(A) con-
tains  a  single  timing  requirement  (180  days  before  marketing), 
rather than the two requirements posited by the Federal Circuit (af-
ter  licensing,  and  180  days  before  marketing).    “Had  Congress  in-
tended  to”  impose  two  timing  requirements  in  §262(l)(8)(A),  “it  pre-
sumably  would  have  done  so  expressly  as  it  did  in  the”  adjacent  
provision,  §262(l)(8)(B).  Russello  v.  United  States,  464  U.  S.  16,  23. 
Amgen’s contrary arguments are unpersuasive, and its various policy
arguments cannot overcome the statute’s plain language.  Pp. 15–18. 

794 F. 3d 1347, vacated in part, reversed in part, and remanded. 

THOMAS, J., delivered the opinion for a unanimous Court.  BREYER, J., 

filed a concurring opinion.