Document ID: ./input/supremecourt_opinions/opinions/16pdf/15-1039_1b8e.pdf
Page Number: 7.0

Cite as:  582 U. S. ____ (2017) 

3 

Opinion of the Court 

forth in §262(k).

To  obtain  approval  through  the  BPCIA’s  abbreviated 
process, the manufacturer of a biosimilar (applicant) does 
not  need  to  show  that  the  product  is  “safe,  pure,  and  po-
tent.”  Instead, the applicant may piggyback on the show-
ing  made  by  the  manufacturer  (sponsor)  of  a  previously 
licensed biologic (reference product).  See §262(k)(2)(A)(iii).
An  applicant  must  show  that  its  product  is  “highly  simi-
lar”  to  the  reference  product  and  that  there  are  no  “clini-
cally meaningful differences” between the two in terms of 
“safety,  purity,  and  potency.”  §§262(i)(2)(A),  (B);  see  also
§262(k)(2)(A)(i)(I).  An applicant may not submit an appli-
cation  until  4  years  after  the  reference  product  is  first
licensed,  and  the  FDA  may  not  license  a  biosimilar  until 
12  years  after  the  reference  product  is  first  licensed.
§§262(k)(7)(A), (B).  As a result, the manufacturer of a new 
biologic  enjoys  a  12-year  period  when  its  biologic  may  be
marketed without competition from biosimilars. 

B 
A  sponsor  may  hold  multiple  patents  covering  the  bio-
logic, its therapeutic uses, and the processes used to man-
ufacture  it.  Those  patents  may  constrain  an  applicant’s
ability to market its biosimilar even after the expiration of 
the 12-year exclusivity period contained in §262(k)(7)(A).

The  BPCIA  facilitates  litigation  during  the  period  pre-
ceding  FDA  approval  so  that  the  parties  do  not  have  to
wait  until  commercial  marketing  to  resolve  their  patent
It  enables  the  parties  to  bring  infringement 
disputes. 
actions at certain points in the application process, even if
the  applicant  has  not  yet  committed  an  act  that  would 
traditionally  constitute  patent  infringement. 
See  35 
U. S. C.  §271(a)  (traditionally  infringing  acts  include 
making,  using,  offering  to  sell,  or  selling  any  patented
invention within the United States without authority to do
so).  Specifically, it provides that the mere submission of a