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8 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

with  respect  to  any  patent  included  on  the  sponsor’s 
§262(l)(3)(A)  list  of  patents  (as  well  as  those  it  acquired 
later and added to the list).  As noted, it is an act of artifi-
cial  infringement,  with  respect  to  any  patent  on  the
§262(l)(3) lists, to submit an application to the FDA.  See 
§271(e)(2)(C)(i). 

II 
These cases concern filgrastim, a biologic used to stimu-
late  the  production  of  white  blood  cells.    Amgen,  the  re-
spondent  in  No.  15–1039  and  the  petitioner  in  No.  15–
1195, has marketed a filgrastim  product called Neupogen
since 1991 and claims to hold patents on methods of man-
ufacturing and using filgrastim.  In May 2014, Sandoz, the 
petitioner  in  No.  15–1039  and  the  respondent  in  No. 15–
1195,  filed an  application  with  the  FDA  seeking  approval 
to  market  a  filgrastim  biosimilar  under  the  brand  name 
Zarxio, with Neupogen as the reference product.  The FDA 
informed Sandoz on July 7, 2014, that it had accepted the
application  for  review.  One  day  later,  Sandoz  notified
Amgen both that it had submitted an application and that
it  intended  to  begin  marketing  Zarxio  immediately  upon 
receiving FDA approval, which it expected in the first half 
of  2015.  Sandoz  later  confirmed  that  it  did  not  intend  to 
provide  the  requisite  application  and  manufacturing
information under §262(l)(2)(A) and informed Amgen that 
Amgen  could  sue  for  infringement  immediately  under 
§262(l)(9)(C).

In  October  2014,  Amgen  sued  Sandoz  for  patent  in-
fringement.  Amgen  also  asserted  two  claims  under  Cali-
fornia’s  unfair  competition  law,  which  prohibits  “any 
unlawful  . . .  business  act  or  practice.”    Cal.  Bus.  &  Prof. 
Code  Ann.  §17200  (West  2008).  A  “business  act  or  prac-
tice”  is  “unlawful”  under  the  unfair  competition  law  if  it
violates  a  rule  contained  in  some  other  state  or  federal 
statute.  Rose  v.  Bank  of  America,  N. A.,  57 Cal.  4th  390,