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Page Number: 2.0

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SANDOZ INC. v. AMGEN INC. 

Syllabus 

scope of both phases of litigation.

Failure to comply with these procedural requirements may lead to
two consequences relevant here.  Under §262(l)(9)(C), if an applicant 
fails to provide its application and manufacturing information to the 
sponsor under §262(l)(2)(A), then the sponsor, but not the applicant,
may  immediately  bring  an  action  “for  a  declaration  of  infringement, 
validity,  or  enforceability  of  any  patent  that  claims  the  biological
product or a use of the biological product.”  And under §262(l)(9)(B), if
an applicant provides the application and manufacturing information
but  fails  to  complete  a  subsequent  step  in  the  process,  the  sponsor,
but not the applicant, may bring a declaratory-judgment action with
respect  to  any  patent  included  on  the  sponsor’s  list  of  relevant  pa-
tents. 
  Neupogen  is  a  filgrastim  product  marketed  by  Amgen,  which 
claims  to  hold  patents  on  methods  of  manufacturing  and  using  fil-
grastim.    Sandoz  sought  FDA  approval  to  market  a  biosimilar  fil-
grastim product under the brand name Zarxio, with Neupogen as the 
reference product.  A day after the FDA informed Sandoz that its ap-
plication had been accepted for review, Sandoz notified Amgen that it
had  submitted  an  application  and  that  it  intended  to  market  Zarxio 
immediately upon receiving FDA approval.  It later informed Amgen 
that  it  did  not  intend  to  provide  the  application  and  manufacturing
information  required  by  §262(l)(2)(A)  and  that  Amgen  could  sue  im-
mediately for infringement under §262(l)(9)(C).

Amgen sued Sandoz for patent infringement and also asserted that 
Sandoz engaged in “unlawful” conduct in violation of California’s un-
fair competition law.  This latter claim was predicated on two alleged
violations  of  the  BPCIA:  Sandoz’s  failure  to  provide  its  application 
and manufacturing information under §262(l)(2)(A), and its provision
of notice of commercial marketing under §262(l)(8)(A) prior to obtain-
ing  licensure  from  the  FDA.    Amgen  sought  injunctions  to  enforce 
both  BPCIA  requirements.    Sandoz  counterclaimed  for  declaratory
judgments that the asserted patent was invalid and not infringed and
that it had not violated the BPCIA. 

While the case was pending, the FDA licensed Zarxio, and Sandoz 
provided Amgen a further notice of commercial marketing.  The Dis-
trict  Court  subsequently  granted  partial  judgment  on  the  pleadings 
to Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair 
competition  claims  with  prejudice.    The  Federal  Circuit  affirmed  in 
part, vacated in part, and remanded.  The court affirmed the dismis-
sal of Amgen’s state-law claim based on Sandoz’s alleged violation of 
§262(l)(2)(A),  holding  that  Sandoz  did  not  violate  the  BPCIA  in  fail-
ing  to  disclose  its  application  and  manufacturing  information  and
that the BPCIA provides the exclusive remedies for failure to comply