Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 10

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SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

list  is  limited  to  the  number  contained  in  the  applicant’s 
list,  though  the  sponsor  always  has  the  right  to  list  at
least one patent.  §262(l)(5)(B)(ii).

The  parties  then  proceed  to  litigate  infringement  with
respect  to  the  patents  they  agreed  to  litigate  or,  if  they 
failed  to  agree,  the  patents  contained  on  the  lists  they
simultaneously exchanged under §262(l)(5).  §§262(l)(6)(A), 
(B).  Section  271(e)(2)(C)(i)  facilitates  this  first  phase  of 
litigation  by  making  it  an  act  of  artificial  infringement,
with  respect  to  any  patent  included  on  the  parties’ 
§262(l)(3) lists, to submit an application for a license from 
the  FDA.  The  sponsor  “shall  bring  an  action”  in  court
within 30 days of the date of agreement or the simultane-
ous  list  exchange.    §§262(l)(6)(A),  (B).    If  the  sponsor 
brings  a  timely  action  and  prevails,  it  may  obtain  a  rem- 
edy provided by §271(e)(4). 

The  second  phase  of  litigation  involves  patents  that 
were  included  on  the  original  §262(l)(3)  lists  but  not  liti-
gated in the first phase (and any patents that the sponsor
acquired after the §262(l)(3) exchange occurred and added 
to  the  lists,  see  §262(l)(7)).  The  second  phase  is  com-
menced by the applicant’s notice of commercial marketing, 
which  the  applicant  “shall  provide”  to  the  sponsor  “not 
later than 180 days before the date of the first commercial 
marketing of the biological product licensed under subsec-
tion  (k).”  §262(l)(8)(A).  The  BPCIA  bars  any  declaratory
judgment action prior to this notice.  §262(l)(9)(A) (prohib-
iting,  in  situations  where  the  parties  have  complied  with 
each step of the BPCIA process, either the sponsor or the 
applicant  from  seeking  a  “declaration  of  infringement, 
validity, or enforceability of any patent” that was included
on  the  §262(l)(3)  lists  but  not  litigated  in  the  first  phase
“prior  to  the  date  notice  is  received  under  paragraph
(8)(A)”).  Because  the  applicant  (subject  to  certain  con-
straints) chooses when to begin commercial marketing and
when to give notice, it wields substantial control over the