Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 8.0

4 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

biosimilar  application  constitutes  an  act  of  infringement.
§§271(e)(2)(C)(i),  (ii).    We  will  refer  to  this  kind  of  preap-
proval  infringement  as  “artificial”  infringement.  Section 
271(e)(4)  provides  remedies  for  artificial  infringement, 
including injunctive relief and damages. 

C 
The  BPCIA  sets  forth  a  carefully  calibrated  scheme  for 
preparing  to  adjudicate,  and  then  adjudicating,  claims  of 
infringement.  See  42  U. S. C.  §262(l).  When  the  FDA 
accepts an application for review, it notifies the applicant,
who within 20 days “shall provide” to the sponsor a copy of
the  application  and  information  about  how  the  biosimilar 
is  manufactured.  §262(l)(2)(A).  The  applicant  also  “may
provide” the sponsor with any additional information that 
it  requests.  §262(l)(2)(B).  These  disclosures  enable  the 
sponsor  to  evaluate  the  biosimilar  for  possible  infringe-
ment of patents it holds on the reference product (i.e., the 
corresponding  biologic).  §262(l)(1)(D).  The  information 
the  applicant  provides  is  subject  to  strict  confidentiality 
rules,  enforceable  by  injunction.    See  §262(l)(1)(H).  The 
first  question  presented  by  these  cases  is  whether 
§262(l)(2)(A)’s requirement—that the applicant provide its
application  and  manufacturing  information  to  the  spon-
sor—is itself enforceable by injunction.

After the applicant makes the requisite disclosures, the 
parties  exchange  information  to  identify  relevant  patents 
and to flesh out the legal arguments that they might raise 
in future litigation.  Within 60 days of receiving the appli-
cation  and  manufacturing  information,  the  sponsor  “shall
provide”  to  the  applicant  “a  list  of  patents”  for  which  it
believes  it  could  assert  an  infringement  claim  if  a  person 
without  a  license  made,  used,  offered  to  sell,  sold,  or  im-
ported  “the  biological  product  that  is  the  subject  of  the 
[biosimilar]  application.”  §262(l)(3)(A)(i).  The  sponsor
must also identify any patents on the list that it would be