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16 

ASSOCIATION FOR MOLECULAR PATHOLOGY v. 
MYRIAD GENETICS, INC.
 
Opinion of the Court 

Act may be used to issue patents on claims directed to or
encompassing a human organism”).

Further  undercutting  the  PTO’s  practice,  the  United
States argued in the Federal Circuit and in this Court that
isolated DNA was not patent eligible under §101, Brief for 
United  States  as  Amicus  Curiae  20–33,  and  that  the 
PTO’s  practice  was  not  “a  sufficient  reason  to  hold  that
isolated  DNA  is  patent-eligible.”  Id.,  at  26.   See  also  id., 
at  28–29.  These  concessions  weigh  against  deferring  to
the PTO’s determination.7 

C 
cDNA does not present the same obstacles to patentabil-
ity  as  naturally  occurring,  isolated  DNA  segments.    As 
already  explained,  creation  of  a  cDNA  sequence  from 
mRNA results in an exons-only molecule that is not natu-
rally  occurring.8   Petitioners  concede  that  cDNA  differs 
from  natural  DNA  in  that  “the  non-coding  regions  have 

—————— 

7 Myriad  also  argues  that  we  should  uphold  its  patents  so  as  not  to 
disturb  the  reliance  interests  of  patent  holders  like  itself.    Brief  for 
Respondents  38–39.    Concerns  about  reliance  interests  arising  from
PTO determinations, insofar as they are relevant, are better directed to
Congress.  See Mayo Collaborative Services v. Prometheus Laboratories, 
Inc., 566 U. S. ___, ___ (2012) (slip op., at 22–24). 

8 Some  viruses  rely  on  an  enzyme  called  reverse  transcriptase  to  re-
produce by copying RNA into cDNA.  In rare instances, a side effect of 
a viral infection of a cell can be the random incorporation of fragments 
of the resulting cDNA, known as a pseudogene, into the genome.  Such 
pseudogenes  serve  no  purpose;  they  are  not  expressed  in  protein 
creation  because  they  lack  genetic  sequences  to  direct  protein  expres-
sion.  See J. Watson et al., Molecular Biology of the Gene 142, 144, fig.
7–5  (6th  ed.  2008).    Perhaps  not  surprisingly,  given  pseudogenes’
apparently random origins, petitioners “have failed to demonstrate that
the  pseudogene  consists  of  the  same  sequence  as  the  BRCA1  cDNA.” 
Association  for  Molecular  Pathology  v.  United  States  Patent  and 
Trademark  Office,  689  F. 3d  1303,  1356,  n. 5  (CA  Fed.  2012).    The 
possibility  that  an  unusual  and  rare  phenomenon  might  randomly
create  a  molecule  similar  to  one  created  synthetically  through  human
ingenuity does not render a composition of matter nonpatentable.