Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 1.0

(Slip Opinion) 

OCTOBER  TERM,  2016 

1 

Syllabus 

NOTE:  Where  it  is  feasible,  a  syllabus  (headnote)  will  be  released,  as  is
being  done  in  connection  with  this  case,  at  the  time  the  opinion  is  issued.
The  syllabus  constitutes  no  part  of  the  opinion  of  the  Court  but  has  been
prepared  by  the  Reporter  of  Decisions  for  the  convenience  of  the  reader. 
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337. 

SUPREME COURT OF THE UNITED STATES 

Syllabus 

SANDOZ INC. v. AMGEN INC. ET AL. 

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR 
THE FEDERAL CIRCUIT 

No. 15–1039.  Argued April 26, 2017—Decided June 12, 2017* 

The Biologics Price Competition and Innovation Act of 2009 (BPCIA or 
Act)  provides  an  abbreviated  pathway  for  obtaining  Food  and  Drug
Administration (FDA) approval of a drug that is biosimilar to an al-
ready  licensed  biological  product  (reference  product).    42  U. S. C. 
§262(k).  It also provides procedures for resolving patent disputes be-
tween  biosimilar  manufacturers  (applicants)  and  manufacturers  of
reference products (sponsors).  §262(l).  The Act treats the mere sub-
mission  of  a  biosimilar  application  as  an  “artificial”  act  of  infringe-
ment,  enabling  parties  to  bring  patent  infringement  actions  at  cer-
tain  points  in  the  application  process  even  if  the  applicant  has  not 
committed  a  traditional  act  of  patent  infringement.    See  35  U. S. C. 
§§271(e)(2)(C)(i), (ii). 
  Under  §262(l)(2)(A),  an  applicant  seeking  FDA  approval  of  a  bio-
similar  must  provide  its  application  and  manufacturing  information
to the sponsor within 20 days of the date the FDA notifies the appli-
cant that it has accepted the application for review.  This triggers an
exchange of information between the applicant and sponsor designed
to create lists  of relevant patents and flesh out potential legal  argu-
ments.  §262(l)(3).  The  BPCIA  then  channels  the  parties  into  two
phases  of  patent  litigation.    In  the  first,  the  parties  collaborate  to 
identify  patents  on  the  lists  for  immediate  litigation.    The  second 
phase—triggered when the applicant, pursuant to §262(l)(8)(A), gives
the  sponsor  notice  at  least  180  days  before  commercially  marketing 
the  biosimilar—involves  any  listed  patents  not  litigated  in  the  first 
phase.    The  applicant  has  substantial  control  over  the  timing  and 

—————— 

* Together with No. 15–1195, Amgen Inc. et al. v. Sandoz Inc., also on 

certiorari to the same court.