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

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

11 

Opinion of the Court 

proval  of  a  biological  product”).    Failing  to  disclose  the
information  under 
application  and  manufacturing 
§262(l)(2)(A) does not.

In reaching the opposite conclusion, the Federal Circuit
relied  on  §271(e)(2)(C)(ii),  which  states  that  “[i]t  shall  be
an act of infringement to submit[,] if the applicant for the 
application  fails  to  provide  the  application  and  infor-
mation  required  under  [§262(l)(2)(A)],  an  application
seeking  approval  of  a  biological  product  for  a  patent  that 
(Em-
could  be  identified  pursuant  to  [§262(l)(3)(A)(i)].” 
phasis  added.)  The  court  appeared  to  conclude,  based  on
the italicized language, that an applicant’s noncompliance 
with  §262(l)(2)(A)  is  an  element  of  the  act  of  artificial 
infringement  (along  with  the  submission  of  the  applica-
tion).  794  F. 3d,  at  1356.    We  disagree.  The  italicized 
language  merely  assists  in  identifying  which  patents  will
be  the  subject  of  the  artificial  infringement  suit.  It  does 
not define the act of artificial infringement itself.

the 

This 

from 

follows 

conclusion 

structure  of 
§271(e)(2)(C).    Clause  (i)  of  §271(e)(2)(C)  defines  artificial
infringement  in  the  situation  where  the  parties  proceed 
through the list exchange process and the patents subject 
to  suit  are  those  contained  in  the  §262(l)(3)  lists,  as  sup-
plemented under §262(l)(7).  That clause provides that it is
an act of artificial infringement to submit, “with respect to 
a patent that is identified in the list of patents described in 
[§262(l)(3)]  (including  as  provided  under  [§262(l)(7)]),  an 
application  seeking  approval  of  a  biological  product.”
(Emphasis added.)  Clause (ii) of §271(e)(2)(C), in contrast,
defines  artificial  infringement  in  the  situation  where  an 
applicant fails to disclose its application and manufactur-
ing  information  altogether  and  the  parties  never  prepare 
the §262(l)(3) lists.  That clause provides that the submis-
sion  of  the  application  represents  an  act  of  artificial  in-
fringement  with  respect  to  any  patent  that  could  have 
been included on the lists.