Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 21

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

17 

Opinion of the Court 

We  are  not  persuaded  by  Amgen’s  arguments  to  the 
contrary.  Amgen points out that other provisions refer to 
“ ‘the biological product that is the subject of ’ ” the applica-
tion,  rather  than  the  “ ‘biological  product  licensed  under 
subsection (k).’ ”  Brief for Amgen  Inc. et al. 28 (emphasis 
added).  In  its  view,  this  variation  “is  a  strong  textual
indication  that  §262(l)(8)(A),  unlike  the  other  provisions, 
refers to a product that has already been ‘licensed’ by the 
FDA.”  Ibid. 

Amgen’s  interpretation  is  not  necessary  to  harmonize
Congress’ use of the two different phrases.  The provision 
upon which Amgen primarily relies (and that is generally 
illustrative  of  the  other  provisions  it  cites)  requires  the
applicant to explain why the sponsor’s patents are “ ‘inva-
lid, unenforceable, or will not be infringed by the commer-
cial marketing of the biological product that is the subject 
of  the  subsection  (k)  application.’ ”    Id.,  at  29–30  (quoting
§262(l)(3)(B)(ii)(I); emphasis deleted).  This provision uses
the  phrase  “subject  of  the  subsection  (k)  application”
rather  than  “product  licensed  under  subsection  (k)”  be-
cause  the  applicant  can  evaluate  validity,  enforceability, 
and infringement with respect to the biosimilar only as it
exists  when  the  applicant  is  conducting  the  evaluation, 
which it does before licensure.  The applicant cannot make
the  same  evaluation  with  respect  to  the  biosimilar  as  it
will  exist  after  licensure,  because  the  biosimilar’s  specifi-
cations  may  change  during  the  application  process.    See, 
e.g.,  794  F. 3d,  at  1358. 
In  contrast,  nothing  in 
§262(l)(8)(A) turns on the precise status or characteristics
of the biosimilar application. 

Amgen  also  advances  a  host  of  policy  arguments  that 
prelicensure  notice  is  undesirable.  See  Brief  for  Amgen
Inc.  et al.  35–42.    Sandoz  and  the  Government,  in  turn, 
respond  with  their  own  bevy  of  arguments  that  Amgen’s
concerns  are  misplaced  and  that  prelicensure  notice  af-
firmatively  furthers  Congress’  intent.    See  Brief  for