This slide set was presented to the Introduction to Biotechnology class at UNCC--Go 49er's!

1. AMP v. Myriad
As an introduction to Patent Law
Smith, Parsons & Summa
www.smithparsons.com
© Philip Summa 2014

2. Introduction to
Biotech
Dr. Todd Steck
February 19, 2014

3. Amp v. Myriad is a case decided by the US
Supreme Court in June 2013. Because the
subject matter is human genetics and
because the decision arguably differs from
long-standing aspects of US patent law, the
case provides a worthwhile introduction to
Patent Law and related legal issues.

4. http://kintalk.org/genetics-101/
(Accessed February 12, 2014)

5. Mutations in the BRCA1 and BRCA2 genes have been discovered to dramatically increase an
individual’s risk of developing breast and ovarian cancers.

6. Myriad found the exact location of the BRCA1 and BRCA2 genes, which allowed Myriad to determine
their typical nucleotide sequence which enabled Myriad to better assess whether a patient has the
mutation.

7. Myriad obtained a number of patents after this discovery . . . including a claim for the list of amino
acids that the typical BRCA1 gene encodes.
“1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid
sequence set forth in SEQ ID NO:2.”

8. US Patent No.
5747282

9. The second claim recites the sequence of cDNA that codes for the BRCA1 amino acids listed in
claim 1.
“2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID
NO:1.”

10. Myriad’s patents would give it the exclusive right to isolate an individual’s BRCA1 and BRCA2
genes and synthetically create BRCA cDNA and exclude others from being able to make it.

11. Others began providing genetic testing based upon the
Myriad discoveries, so Myriad filed patent infringement
suits against other entities that performed BRCA testing,
resulting in settlements in which the defendants agreed to
cease all allegedly infringing activity and Myriad solidified
its position as the only entity providing BRCA testing.
Ostrer and others filed a lawsuit declaring that Myriad’s patents were invalid
because they covered products of nature.

12. There are four (4)
categories of
patentable subject
matter (§ 35 USC
101):
Processes
Machines
Manufactures
Compositions
of Matter
“Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of matter,
or any new and useful improvement thereof, may obtain a
patent therefor, subject to the conditions and requirements
of this title.” 35 U.S.C. 101

13. There are three (3)
exceptions (Case
Law Precedent):
Laws of Nature
Physical Phenomena
Abstract Ideas

14. There are three (3) further
requirements for patentability:
Novelty (§ 102)
Nonobviousness (§ 103)
A full and particular description (§ 112)

15. Novelty means “brand new.”
Most typically, it means that the
words of the claim recite
something that, in total, cannot
be found in any other single
item. In the sciences, the
relevant items are usually prior
patents, published patent
applications, and journal articles.
Novelty is an objective
standard.
35 U.S.C. Section 102

16. Obviousness is a subjective
standard based upon the
knowledge of a hypothetical
“person of ordinary skill in the art.”
35 U.S.C. Section 103

17. Obvious?
© Gary Larson, The Far Side

18. The District Court ruled that
Myriad’s patent claims were
invalid because isolated DNA and
cDNA were ineligible for patent
protection as covering products of
nature.
On appeal, the Federal Circuit
ruled oppositely (“reversed”) on
the grounds that isolating DNA or
cDNA is an “inventive act.”

19. The Supreme Court began by bracketing the conceptual aspects:
We have “long held that this provision contains an important implicit
exception[:] Laws of nature, natural phenomena, and abstract ideas
are not patentable.” … Rather, “ ‘they are the basic tools of scientific
and technological work’ ” that lie beyond the domain of patent protection.
(W)ithout this exception, there would be considerable danger that the
grant of patents would “tie up” the use of such tools and thereby “inhibit
future innovation premised upon them.” This would be at odds with the
very point of patents, which exist to promote creation. (Products of
nature are not created, and “ ‘manifestations ... of nature [are] free to all
men and reserved exclusively to none’ ”).
Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107,
2116, 186 L. Ed. 2d 124 (2013)

20. (Versus:)
The rule against patents on naturally occurring things is not without
limits, however, for “all inventions at some level embody, use, reflect,
rest upon, or apply laws of nature, natural phenomena, or abstract
ideas,” and “too broad an interpretation of this exclusionary
principle could eviscerate patent law.” As we have recognized
before, patent protection strikes a delicate balance between creating
“incentives that lead to creation, invention, and discovery” and
“imped[ing] the flow of information that might permit, indeed spur,
invention.” We must apply this well-established standard to determine
whether Myriad's patents claim any “new and useful ... composition of
matter,” § 101, or instead claim naturally occurring phenomena.
Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct.
2107, 2116, 186 L. Ed. 2d 124 (2013)

21. “It is undisputed that Myriad did not create or alter any of the
genetic information encoded in the BRCA1 and BRCA2
genes. The location and order of the nucleotides existed in
nature before Myriad found them. Nor did Myriad create or
alter the genetic structure of DNA. Instead, Myriad's
principal contribution was uncovering the precise
location and genetic sequence of the BRCA1 and
BRCA2 genes within chromosomes 17 and 13. The
question is whether this renders the genes patentable.”
Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133
S. Ct. 2107, 2116, 186 L. Ed. 2d 124 (2013)

22. An intermediate reminder:
1. An isolated DNA coding for a
BRCA1 polypeptide, said polypeptide
having the amino acid sequence set
forth in SEQ ID NO:2.
2. The isolated DNA of claim 1,
wherein said DNA has the nucleotide
sequence set forth in SEQ ID NO:1.”

23. The legal issue in chemistry
terms: you need to cleave the
gene from the DNA stand to
isolate it. Does this create
anything new in the patentable
sense?

24. Problem for Myriad--the claims are
written to cover information rather
than chemical composition (“the
claims undoubtedly focus on the
genetic information encoded in the
BRCA1 and BRCA2 genes”).
A molecule claim could be avoided
by isolating a slightly different
sequence; a result that wouldn’t
help Myriad commercially.

25. cDNA is a different issue.
Non-coding regions have
been removed, and thus the
sequence does not occur in
nature. Therefore cDNA is
patentable (unless it is
identical to a natural short
DNA that has no intervening
introns).

26. “Final Answer”
“Genes and the information
they encode are not patent
eligible under Section 101
simply because they have
been isolated from the
surrounding genetic material.”

27. Thank you very much
Smith, Parsons & Summa
www.smithparsons.com
© Philip Summa 2014