Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 11

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

7 

Opinion of the Court 

timing of the second phase of litigation.  The second ques-
tion  presented  is  whether  notice  is  effective  if  an  appli- 
cant  provides  it  prior  to  the  FDA’s  decision  to  license  the 
biosimilar. 

In  this  second  phase  of  litigation,  either  party  may  sue 
for declaratory relief.  See §262(l)(9)(A).  In addition, prior 
to the date of first commercial marketing, the sponsor may
“seek a preliminary injunction prohibiting the [biosimilar] 
applicant  from  engaging  in  the  commercial  manufacture 
or sale of [the biosimilar] until the court decides the issue
of  patent  validity,  enforcement,  and  infringement  with 
respect to any patent that” was included on the §262(l)(3)
lists but not litigated in the first phase.  §262(l)(8)(B). 

D 
If  the  parties  comply  with  each  step  outlined  in  the
BPCIA,  they  will  have  the  opportunity  to  litigate  the 
relevant  patents  before  the  biosimilar  is  marketed.  To 
encourage  parties  to  comply  with  its  procedural  require-
ments,  the  BPCIA  includes  various  consequences  for 
failing  to  do  so.  Two  of  the  BPCIA’s  remedial  provisions
are at issue here.  Under §262(l)(9)(C), if an applicant fails
to  provide  its  application  and  manufacturing  information 
to  the  sponsor—thus  effectively  pretermitting  the  entire
two-phase  litigation  process—then  the  sponsor,  but  not 
the  applicant,  may  immediately  bring  an  action  “for  a 
declaration  of  infringement,  validity,  or  enforceability  of
any  patent  that  claims  the  biological  product  or  a  use  of
the  biological  product.”  Section  271(e)(2)(C)(ii)  facilitates 
this  action  by  making  it  an  artificial  act  of  infringement, 
with  respect  to  any  patent  that  could  have  been  included 
on  the  §262(l)(3)  lists,  to  submit  a  biosimilar  application.
Similarly, when an applicant provides the application and 
manufacturing  information  but  fails  to  complete  a  subse-
quent step, §262(l)(9)(B) provides that the sponsor, but not
the  applicant,  may  bring  a  declaratory-judgment  action