This document summarizes a presentation about DNA patent law and the Supreme Court's 2013 decision in Association for Molecular Pathology v. Myriad Genetics, Inc. regarding the patent eligibility of isolated DNA sequences. The presentation discusses how Myriad Genetics discovered and patented the BRCA1 and BRCA2 genes linked to breast cancer. It describes the technical principles of DNA, genes, and mutations. It then summarizes the legal proceedings that challenged Myriad's patents and the Supreme Court's unanimous ruling that isolated genomic DNA is not patent eligible but cDNA is. The ruling leaves many existing gene patents vulnerable to invalidation while still allowing other types of DNA-related claims.

1. DNA Patent Law 101:
The Myriad Decision and its Impact on
Patenting Genes
© 2014 Michael A. Cicero
Southern Polytechnic State U.
EE 3903 – Introduction to BME
April 9, 2014

2. Who is this guy, and what does he know
about patent law?
• Juris Doctor (law degree), U. of SC, 1990
• Member, GA & SC Bars
• Registered to practice before U.S. Pat. &
TM Office, Apr. 1991, Reg. No. 34,562
• Worked 22+ years as an IP attorney

3. Why should I care about patents?
• “One study demonstrated that biotech firms expect to earn
between 45–79% more on patented inventions than they would
earn on those inventions if they had not been patented.” Buck,
Nikki, “Greed is Good, for Patients: How the Biotechnology Industry
Saves Lives, One Gene Patent at a Time,” 11 NW. J. TECH. &
INTELL. PROP. 61, 78 (2013).
• Between 1997 and 2013, Myriad Genetics, Inc. earned more
than $2 BILLION from sales of its patented test for presence of
mutations in BRCA1 and BRCA2 genes. In re BRCA1- and
BRCA2- Based Hereditary Cancer Test Patent Litig., 2014
U.S.Dist.LEXIS 31345, at *9 (D. Utah Mar. 14, 2014).

4. Patent Basics
“The patent system added the fuel of interest to the fire
of genius.” - Abraham Lincoln

5. What is a patent?
A grant from the federal government to an inventor, conveying
the right to exclude others in the U.S. from making, using,
selling, offering for sale, or importing into the U.S., the
invention for a term of years. 35 U.S.C. 154(a)(1).
Term of U.S. utility patent = 20 years from earliest effective
filing date. (Design patents: 14 years from patent issue date.)

6. What does a patent protect?
• “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.
• Put another way: “anything under the sun that is made by
man.” Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
• Examples: computer programs, golf balls, medical devices.

7. § 101 – General Principles
• “[T]his provision [ 101] contains an important implicit
exception. „[L]aws of nature, natural phenomena, and
abstract ideas‟ are not patentable.” Mayo Collaborative
Svcs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012).
• “„[T]hey are the basic tools of scientific and technological
work‟ that lie beyond the domain of patent protection.”
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133
S.Ct. 2107, 2116 (2013) (Myriad) (quoting Gottschalk v.
Benson, 409 U.S. 63, 67 (1972)).

8. § 101 – General Principles
“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.‟” Myriad, 133 S.Ct. at 2116 (citations omitted)).

9. Technical Principles
Underlying Myriad
Patent Litigation

10. Transcription (Fig. 2 from Myriad Appellate Opinion)
Exons:
DNA sequence
necessary for
protein creation
Introns:
DNA sequence
interspersed b/t
exons; they do
not code for a
protein

11. Translation (EE 3903 PowerPoint #5, Slide 10)

12. Translation (Fig. 3 from Myriad Appellate Opinion)
(Genetic Code Table - annotated excerpt from
EE 3903 PowerPoint #5, Slide 11)

13. SNP (EE 3903 PowerPoint #7, Slide 12)

14. Genomic DNA
“Genomic DNA can be extracted from its cellular environment
using a number of well-established laboratory techniques. A
particular segment of DNA, such as a gene, can then be
excised or amplified from the DNA to obtain the isolated DNA
segment of interest.” Ass’n for Molecular Pathology v. Myriad
Genetics, Inc., 689 F.3d 1303, 1313 (Fed. Cir. 2012).

15. Complementary DNA (“cDNA”)
Source: http://blogs.scientificamerican.com/guest-blog/2013/07/09/new-supreme-court-decision-
rules-that-cdna-is-patentablewhat-it-means-for-research-and-genetic-testing/

16. Facts in Myriad Case

17. Discovery of BRCA-1 & -2 Genes
• 1980s: Breast cancer patients mobilize to raise awareness of
breast cancer epidemic. This caused the federal gov‟t to
increase funding for breast cancer research, which would
grow from $90M in 1990 to $2.1 billion by 2008.
In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *49.
• 1990: Group from U. of Cal., Berkeley announces that the
Breast Cancer Susceptibility Gene (BRCA1) was located on
chromosome 17. “With this discovery, research teams from
around the world intensified efforts to be the first to sequence
the BRCA1 gene.”

18. Discovery of BRCA-1 & -2 Genes
• Sept. 1994: Group led by Dr. Mark Skolnick, co-founder of
Myriad, announces that it had sequenced the BRCA1 gene.
Myriad files patent applications related to that gene.
In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *50-52.
• Dec. 1995: Dr. Skolnick‟s group announces that it found the
sequence of a BRCA2 gene, which had recently been located
on chromosome 13. That gene was linked to ovarian cancer,
as well as female and male breast cancer. Myriad files patent
applications regarding the BRCA2 gene in the U.S. and in
Europe.

19. Significance of BRCA-1 & -2 Genes
• “The sequencing of the BRCA1 and BRCA2 genes were
landmark events in genetics, as mutations in these genes are
responsible for many breast and ovarian cancer cases.” In re
BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *52.
• “Before Myriad‟s discovery of the BRCA1 and BRCA2 genes,
scientists knew that heredity played a role in establishing a
woman‟s risk of developing breast and ovarian cancer, but they
did now know which genes were associated with those
cancers.” Myriad, 133 S.Ct. at 2112.

20. Statistics Regarding BRCA-1 & -2 Genes
Normal risk (breast cancer): 12% - 13%
Risk with BRCA mutations:
• Breast cancer: 50% - 80%
• Ovarian cancer: 20% - 50%
Source: Myriad, 689 F.3d at 1314.

21. Myriad‟s Patents
• Myriad‟s applications issued as patents, owned by Univ. of Utah
Research Foundation, and exclusively licensed to Myriad. Myriad,
689 F.3d at 1324.
• Nine “composition” claims at issue before Supreme Court. Examples:
• Claim 1 of “the „282 Patent” asserts a claim on the DNA code that
tells a cell to produce the 1,863 amino acids that the typical BRCA1
gene encodes. Myriad, 133 S.Ct. at 2113.
• Claim 2 asserts a sequence of cDNA that codes those amino acids.
• Method claims - Myriad, 689 F.3d at 1333-37.
• Methods of “comparing” and “analyzing” BRCA sequences
• Method of screening potential cancer therapeutics via “changes
in cell growth rates of transformed cells.”

22. Myriad Threatens Lawsuit, Gets Hit with
Preemptive Strike
• 1998-99: Myriad sends cease-and-desist letters to U. of PA‟s
Genetic Diagnostic Laboratory (“GDL”), claiming that GDL‟s BRCA1/2
diagnostic services for women violated Myriad‟s patents. Sends
similar letter to Dr. Harry Ostrer, NYU researcher. Ostrer had sent
patient samples to GDL for testing. Myriad, 689 F.3d at 1314-15.
• Sept. 1999: GDL informs Dr. Ostrer that GDL can no longer accept
patient samples for BRCA testing, due to Myriad‟s threats. This made
Myriad the only provider of such services in the U.S. Id. at 1315.
• 2009: Dr. Ostrer, other researchers, and the ACLU file a declaratory
judgment action vs. Myriad, alleging that 15 claims in 7 Myriad
patents were invalid as drawn to patent-ineligible matter under 101.

23. Procedural History and
Judicial Rulings

24. 2010: U.S. District Ct. for Southern District of NY: Invalidates all of
Myriad‟s challenged claims under 101.
Myriad files appeal
2012: U.S. Court of Appeals for the Federal Circuit: Mostly reverses
district court; upholds validity of all claims except for the “comparing and
analyzing” method claims.
Researchers file petition for
Supreme Court review
2012: Supreme Court of the United States: Grants the petition,
agreeing to review the Federal Circuit‟s decision.

25. The Supreme Court‟s Decision
• Authored by Justice Clarence Thomas
• “Groundbreaking, innovative, or even brilliant
discovery does not by itself satisfy the 101 inquiry.”
Myriad, 133 S.Ct. at 2117.
• Issued by the Court on June 13, 2013
• Unanimous decision – no dissenting opinions
• “[E]xtensive effort alone is insufficient to meet the demands of 101.”
Id. at 2117.
• “Myriad found the location of the BRCA1 and BRCA2 genes, but that
discovery, by itself, does not render the BRCA genes „new . . .
composition[s] of matter,‟ 101, that are patent eligible.” Id.

26. The Supreme Court‟s Decision
• “cDNA does not present the same obstacles to
patentability as naturally occurring, isolated DNA
segments.” Myriad, 133 S.Ct. at 2119.
• “[T]he lab technician unquestionably creates
something new when cDNA is made.” Id.
• “As a result, cDNA is not a „product of nature‟ and is patent eligible
under 101, except insofar as very short series of DNA may have no
intervening introns to remove when creating cDNA. In that situation,
a short strand of cDNA may be indistinguishable from natural
DNA.” Id. (emphasis added).

27. The Aftermath of the
Supreme Court‟s
Myriad Decision

28. Thousands of Unexpired Genomic DNA
Patents Vulnerable to Invalidity Attack . . .
• “It is estimated that the PTO has issued 2,645 patents claiming
„isolated DNA‟ over the past [29] years . . . and by 2005, had
granted 40,000 DNA-related patents relating to, in non-native
form, genes in the human genome.” Myriad, 689 F.3d at 1333.
• “Existing patents that claim only isolated genes are „probably
pretty worthless‟ now, according to Thomas Engellenner of
Pepper Hamilton LLP, but the ruling did not broadly foreclose
any patents involving genes, leaving applicants plenty of
options.” Davis, Ryan, “High Court‟s Ruling Will Spur Novel
Patent Claims,” LAW360 (June 13, 2013).

29. . . . But Door to DNA Patents Not Totally Closed . . .
“Leaving the door open to other types of claims ensures that
patent protection will remain available for inventions involving
natural products that cannot themselves be patented, according to
Dalila Argaez Wendlandt of Ropes & Gray LLP.
„The Myriads of the world still have the incentive to do this
research because there are other types of claims that are still out
there,‟ she said.
The thousands of patents that have already been issued on
isolated DNA are now vulnerable to invalidation, but many of them
may include the types of claims that the Supreme Court found
acceptable, [Mark] Janis said.” Davis, R., supra.

30. . . . But Just How Narrow Might that Opening Be?
“[T]he [Supreme] Court well understood that isolated DNA could
encompass synthetic DNA, as the lower court opinion made
clear.”
* * *
For these reasons, this court concludes that Plaintiffs are incorrect
in contending that the [Supreme] Court found all synthetic DNA to
be patent eligible. Rather, this court interprets [Myriad] to stand
for the proposition that even synthetic, non-cDNA , isolated DNA is
patent ineligible where it reflects the same nucleotide sequence
as the genomic DNA.”
In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *140.

31. USPTO Memo to its Examiners – March 4, 2014

32. ANY
QUESTIONS?
32

33. THE END