Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 6.0

2 

SANDOZ INC. v. AMGEN INC. 

Opinion of the Court 

the  requirement  that  an  applicant  provide  its  application 
and manufacturing information to the manufacturer of the 
biologic is enforceable by injunction.  We conclude that an 
injunction  is  not  available  under  federal  law,  but  we  re-
mand for the court below to decide whether an injunction
is  available  under  state  law.  The  second  question  is
whether  the  applicant  must  give  notice  to  the  manufac- 
turer after, rather than before, obtaining a license from the
FDA  for  its  biosimilar.    We  conclude  that  an  applicant 
may provide notice before obtaining a license. 

I 
The  complex  statutory  scheme  at  issue  in  these  cases
establishes  processes  both  for  obtaining  FDA  approval  of 
biosimilars  and  for  resolving  patent  disputes  between
manufacturers  of  licensed  biologics  and  manufacturers  of 
biosimilars.  Before turning to the questions presented, we 
first explain the statutory background. 

A 
A biologic is a type of drug derived from natural, biologi-
cal sources such as animals or microorganisms.  Biologics
thus  differ  from  traditional  drugs,  which  are  typically
synthesized from chemicals.1  A manufacturer of a biologic
may market the drug only if the FDA has licensed it pur-
suant  to  either  of  two  review  processes  set  forth  in  §262.
The default pathway for approval, used for new biologics, 
is  set  forth  in  §262(a).  Under  that  subsection,  the  FDA 
may  license  a  new  biologic  if,  among  other  things,  the
manufacturer  demonstrates  that  it  is  “safe,  pure,  and 
potent.”  §262(a)(2)(C)(i)(I).    In  addition  to  this  default 
route,  the  statute  also  prescribes  an  alternative,  abbrevi-
ated  route  for  FDA  approval  of  biosimilars,  which  is  set 

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1FDA, What Are “Biologics” Questions and Answers (Aug. 5, 2015), http://
www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/
ucm133077.htm (as last visited June 6, 2017).