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Page Number: 16.0

12 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

In  this  way,  the  two  clauses  of  §271(e)(2)(C)  work  in
tandem.  They both treat submission of the application as
the  act  of  artificial  infringement  for  which  §271(e)(4) 
provides the remedies.  And they both identify the patents 
subject to suit, although by different means depending on
whether the applicant disclosed its application and manu-
facturing information under §262(l)(2)(A).  If the applicant 
made the disclosures, clause (i) applies; if it did not, clause 
(ii) applies.  In neither instance is the applicant’s failure to
provide its application and manufacturing information an
element of the act of artificial infringement, and in neither
instance does §271(e)(4) provide a remedy for that failure.
See  Brief  for  Amgen  Inc.  et al.  66–67  (conceding  both 
points).

A  separate  provision  of  §262,  however,  does  provide  a
remedy  for  an  applicant’s  failure  to  turn  over  its  applica-
tion  and  manufacturing  information.    When  an  applicant 
fails  to  comply  with  §262(l)(2)(A),  §262(l)(9)(C)  authorizes
the sponsor, but not the applicant, to bring an immediate 
declaratory-judgment  action  for  artificial  infringement  as
defined in §271(e)(2)(C)(ii).  Section 262(l)(9)(C) thus vests
in the sponsor the control that the applicant would other-
wise  have  exercised  over  the  scope  and  timing  of  the
patent  litigation. 
It  also  deprives  the  applicant  of  the 
it  could  have  obtained  by  bringing
certainty  that 
a  declaratory-judgment  action  prior  to  marketing  its 
product.

The remedy provided by §262(l)(9)(C) excludes all other
federal  remedies,  including  injunctive  relief.    Where,  as 
here, “a statute expressly provides a remedy, courts must
be  especially  reluctant  to  provide  additional  remedies.” 
Karahalios  v.  Federal  Employees,  489  U. S.  527,  533 
(1989).  The  BPCIA’s  “carefully  crafted  and  detailed  en-
forcement scheme provides strong evidence that Congress
did  not  intend  to  authorize  other  remedies  that  it  simply
forgot to incorporate expressly.”  Great-West Life & Annu-