Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 9

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

5 

Opinion of the Court 

willing to license.  §262(l)(3)(A)(ii). 

Next,  within  60  days  of  receiving  the  sponsor’s  list,  the 
applicant may provide to the sponsor a list of patents that 
the  applicant  believes  are  relevant  but  that  the  sponsor 
omitted  from  its  own  list,  §262(l)(3)(B)(i),  and  “shall  pro-
vide” to the sponsor reasons why it could not be held liable 
for  infringing  the  relevant  patents,  §262(l)(3)(B)(ii).    The 
applicant may argue that the relevant patents are invalid, 
unenforceable,  or  not  infringed,  or  the  applicant  may 
agree  not  to  market  the  biosimilar  until  a  particular  pat- 
ent  has  expired.  Ibid.    The  applicant  must  also  respond 
to  the  sponsor’s  offers  to  license  particular  patents.
§262(l)(3)(B)(iii).  Then,  within  60  days  of  receiving  the
applicant’s  responses,  the  sponsor  “shall  provide”  to  the
applicant  its  own  arguments  concerning  infringement, 
enforceability,  and  validity  as  to  each  relevant  patent. 
§262(l)(3)(C).

Following  this  exchange,  the  BPCIA  channels  the  par-
ties into two phases of patent litigation.  In the first phase, 
the parties collaborate to identify patents that they would
like to litigate immediately.  The second phase is triggered
by  the  applicant’s  notice  of  commercial  marketing  and 
involves  any  patents  that  were  included  on  the  parties’ 
§262(l)(3) lists but not litigated in the first phase.

At  the  outset  of  the  first  phase,  the  applicant  and  the
sponsor  must  negotiate  to  determine  which  patents  in-
cluded on the §262(l)(3) lists will be litigated immediately. 
See  §§262(l)(4)(A),  (l)(6).    If  they  cannot  agree,  then  they 
must engage in another list exchange.  §262(l)(4)(B).  The 
applicant  “shall  notify”  the  sponsor  of  the  number  of  pat-
ents  it  intends  to  list  for  litigation,  §262(l)(5)(A),  and,
within  five  days,  the  parties  “shall  simultaneously  ex-
change”  lists  of  the  patents  they  would  like  to  litigate
immediately. 
§262(l)(5)(B)(i).    This  process  gives  the
applicant  substantial  control  over  the  scope  of  the  first 
phase of litigation: The number of patents on the sponsor’s