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- Wikipedia

Association for Molecular Pathology v.

Myriad Genetics, Inc.
Association for Molecular Pathology v. Myriad Genetics,[1] No. 12-
398 (569 U.S. ___ June 13, 2013), was a case challenging the validity of gene
Association for Molecular
patents in the United States, specifically challenging certain claims in issued
Pathology v. Myriad
patents owned or controlled by Myriad Genetics that cover isolated DNA Genetics, Inc.
sequences, methods to diagnose propensity to cancer by looking for mutated
DNA sequences, and methods to identify drugs using isolated DNA sequences.
Prior to the case, the U.S. Patent Office accepted patents on isolated DNA
sequences as a composition of matter. Diagnostic claims were already under
question through the In re Bilski and Mayo v. Prometheus cases. Drug
screening claims were not seriously questioned prior to this case. Supreme Court of the United
States
The case was originally heard in Southern District Court of New York, which Argued April 15, 2013
ruled that all the challenged claims were not patent eligible. Myriad then Decided June 13, 2013
appealed to the United States Court of Appeals for the Federal Circuit. The Full case Association for
circuit court overturned the previous decision in part, ruling that isolated DNA name Molecular Pathology,
which does not exist alone in nature can be patented and that the drug et al. v. Myriad
screening claims were valid, and confirmed in part, finding the diagnostic Genetics, Inc., et al.
claims unpatentable. The plaintiffs appealed to the Supreme Court, which Docket nos. 12-398 (https://www.
granted certiorari and remanded the case to the Federal Circuit. The Federal supremecourt.gov/S
earch.aspx?FileNam
Circuit did not change its opinion, so on September 25, 2012, the American
e=/docketfiles/12-39
Civil Liberties Union and the Public Patent Foundation filed a petition for
8.htm)
certiorari with the Supreme Court with respect to the Second Federal Circuit
Citations 569 U.S. ___ (more)
decision. 133 S.Ct. 2107

On November 30, 2012, the Supreme Court agreed to hear the plaintiffs' appeal Prior history The District Court for
the Southern District
of the Federal Circuit's ruling. On June 13, 2013, in a unanimous decision, the
of New York found
Supreme Court invalidated Myriad's claims to isolated genes. The Court held that patents were
that merely isolating genes that are found in nature does not make them ineligible. 702
patentable. F.Supp. 2d 181,
192–211 (SDNY
Proponents of the validity of these patents argued that they encourage 2010). On appeal,
investment in biotechnology and promote innovation in genetic research by the Federal Circuit
not keeping technology shrouded in secrecy. Opponents argued that these reversed the
patents stifle innovation by preventing others from conducting cancer
decision and found
2-1 in favor of
research, limit options for cancer patients in seeking genetic testing, and are
Myriad (689 F.3d
not valid because they claim genetic information that is not inventive, but is 1303).
rather produced by nature.
Holding
Naturally occurring DNA sequences,
even when isolated from the body,
cannot be patented, but artificially
Contents
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Background created DNA is patent eligible

Litigants because it is not naturally occurring.
Arguments Court membership
Decision of the District Court Chief Justice
First hearing in the Court of Appeals for the Federal Circuit John Roberts
First petition to the Supreme Court Associate Justices
Second hearing in the Court of Appeals for the Federal Circuit Antonin Scalia · Anthony Kennedy
Clarence Thomas · Ruth Bader
Second petition to the Supreme Court
Ginsburg
Decision of the Supreme Court Stephen Breyer · Samuel Alito
Reactions to the decision Sonia Sotomayor · Elena Kagan
References Case opinions
Further reading Majority Thomas, joined by
External links
Roberts, Kennedy,
Ginsburg, Breyer,
Alito, Sotomayor,
Kagan; Scalia (all
Background but part 1-A)
Concurrence Scalia
The global search for a genetic basis for breast and ovarian cancer began in
Laws applied
earnest in 1988. In 1990, at an American Society of Human Genetics meeting, a
team of scientists led by Mary-Claire King, from University of California,
U.S. Const. Article I, Section 8,
Clause 8, 35 U.S.C. § 101 (https://w
Berkeley announced the localization through linkage analysis of a gene
ww.law.cornell.edu/uscode/text/35/1
associated with increased risk for breast cancer (BRCA1) to the long arm of 01)
chromosome 17.[2] It was understood at the time that a test for these mutations
would be a clinically important prognostic tool. Myriad Genetics was founded in 1994 as a startup company out of
University of Utah, by scientists involved in the hunt for the BRCA genes. In August 1994, Mark Skolnick, a founder of
Myriad and scientist at University of Utah, and researchers at Myriad, along with colleagues at the University of Utah, the
National Institutes of Health (NIH), and McGill University published the sequence of BRCA1, which they had isolated.[3]
In that same year, the first BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental
Health Sciences (NIEHS), and Myriad.[4] Over the next year, Myriad, in collaboration with University of Utah, isolated and
sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by the University of Utah and other
institutions in 1995.[5] In 1996, Myriad launched their BRACAnalysis product, which detects certain mutations in the
BRCA1 and BRCA2 genes that put women at high risk for breast cancer and ovarian cancer.[6]

Myriad's business model has been to exclusively offer diagnostic testing services for the BRCA genes. It was on the basis of
the premium price that the patents would allow Myriad to set during the 20 year life of the patents, that investors put
money into Myriad.[7] These were the funds that allowed Myriad to rapidly sequence the BRCA2 gene and finalize a robust
diagnostic test. The business model meant that Myriad would need to enforce its patents against competitors, which
included diagnostic labs at universities, which function very much like for-profit businesses in addition to educating
pathologists-in-training.[7] The patents expire, starting in 2014. In 2012, Myriad—just a startup in 1994—employed about
1200 people, had revenue of around $500 million, and was a publicly traded company.[8]

About 2000 isolated human genes had been patented in the United States before this case started.[9][10] Gene patents have
generated a great deal of controversy, especially when their owners or licensees have aggressively enforced them to create
exclusivity. Clinical pathologists have been especially concerned with gene patents, as their medical practice of offering
clinical diagnostic services is subject to patent law, unlike the practices of other doctors which are exempt from patent
law.[11] For example, in 1998, University of Pennsylvania's Genetic Diagnostic Laboratory received cease and desist letters

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on the basis of patent infringement from Myriad, which requested clinical pathologists to stop testing patient samples for
BRCA.[7] Because of these kinds of legal threats to its members' medical practices, the Association for Molecular Pathology
has actively lobbied against the existence of, and exclusive licensing of, gene patents and was the lead plaintiff in this
litigation.[12][13]

Litigants
Along with the AMP (Association for Molecular Pathology) and the University of Pennsylvania, other plaintiffs in the suit
included researchers at Columbia, NYU, Emory, and Yale; several patient advocacy groups; and several individual
patients.

The defendants in the suit were originally Myriad, the trustees of the University of Utah, and the U.S. Patent and
Trademark Office (USPTO), but the USPTO was severed from the case by the district court.[7]

The American Civil Liberties Union (ACLU) and Public Patent Foundation represented the plaintiffs, with attorney Chris
Hansen arguing the case, and Jones Day represented Myriad.

Arguments
The complaint challenged specific claims on isolated genes, diagnostic methods, and methods to identify drug candidates,
in seven of Myriad's 23 patents on BRCA1 and BRCA2.[14]

The specific claims that were challenged were:[7]

claims 1, 2, 5, 6, 7, and 20 of U.S. patent 5,747,282;[4]

claims 1, 6, and 7 of U.S. patent 5,837,492;[5]
claim 1 of U.S. patent 5,693,473;[15]
claim 1 of U.S. patent 5,709,999;[16]
claim 1 of U.S. patent 5,710,001;[17]
claim 1 of U.S. patent 5,753,441;[18] and
claims 1 and 2 of U.S. patent 6,033,857[19]
The plaintiffs wanted these claims declared invalid on the grounds that they are not patentable subject matter under §101
of Title 35 of the United States Code—that the isolated genes are unpatentable products of nature, and that the diagnostic
method claims are mere thought processes that do not yield any real world transformations, and that the drug screening
claims were just describing the basic processes of doing science.[7] This part of US law describes what is patent-eligible:
"any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement
thereof". If the invention falls under one of several excluding categories, however, including a "naturally occurring article"
(a defined term in the law), then it is not patent eligible.[7]

Plaintiffs argued that Myriad's use of these patents—and the patents' very existence—restricted research for clinicians and
limited scientific progress. They further argued that from a patient's perspective, Myriad's use of the patents not only
made it impossible to obtain a second opinion on a patient's genetic predisposition to breast and ovarian cancer, but also
kept the cost of BRCA1/2 testing high by preventing competition.[7]

Myriad defended their patents to be valid because the USPTO issues patents for genes as "isolated sequences" in the same
way it issues patents for any other chemical compound, since the isolation of the DNA sequence renders it different in
character from that present in the human body, and they argued that their diagnostic tests were patentable subject
matter.[7]

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Decision of the District Court

On March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York
declared all of the contested claims invalid.[7]

With respect to claims to isolated DNA sequences, Judge Sweet's 152 page decision stated: "DNA's existence in an
'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes.
Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a
matter of law and are deemed unpatentable under 35 U.S.C. §101."[7] The decision also found that comparisons of DNA
sequences involved in these patents are abstract mental processes under the recent In re Bilski decision, therefore also not
patent eligible, and that the drug screening claims were unpatentable as they merely cover a "basic scientific
principle".[7][14][20]

On June 16, 2010, Myriad filed its Notice of Appeal.[9][10]

First hearing in the Court of Appeals for the Federal

Circuit
Myriad's appeal was granted, and the case was heard in United States Court of Appeals for the Federal Circuit. Myriad, the
defendant-appellant, was supported by at least 15 amicus briefs and the plaintiff-appellees' position received support from
12 amicus briefs.[21][22] The Department of Justice provided a surprising and unsolicited brief that in part supported the
appellees but also suggested that claims covering isolated naturally occurring human genetic sequences are not properly
patentable.[23][24] Oral arguments were held on April 4, 2011.[25]

On July 29, 2011, the Federal Circuit overturned the district court's decision in part (reversing that an isolated DNA
sequence is patent-ineligible, and the district court's decision that methods for screening cancer therapeutics is patent-
ineligible) and affirmed its ruling in part (agreeing that the district court's decision that Myriad's claims for comparing
DNA sequences are patent-ineligible). Judge Alan Lourie, who wrote the majority ruling, reasoned that isolated DNA is
chemically distinct from the natural state of a gene in the body.[26] Judge Lourie cited the Supreme Court case Diamond v.
Chakrabarty, which used the test of whether a genetically modified organism was "markedly different" from those found
in nature to rule that genetically modified organisms are patent eligible. Thus, he concluded that since Myriad's patents
describe DNA sequences that do not alone exist in nature, they are patent eligible.[27]

First petition to the Supreme Court

After the Federal Circuit ruling, the Association for Molecular Pathology petitioned for a writ of certiorari to the Supreme
Court, asking it to review this case.[28] The Supreme Court granted the writ, and on March 26, 2012, it vacated the Federal
Circuit decision, and remanded the case back to the Federal Circuit.[29] In other words, the Supreme court revoked the
original ruling of the Federal Circuit, and asked the lower court to re-hear the entire case again. These Supreme Court
actions were made in light of its recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., where
the Court ruled that certain kinds of claims in medical diagnostics patents, including natural phenomena, were not
patentable. The Supreme Court expected the Federal Circuit to take this precedent into account in its new ruling.

Second hearing in the Court of Appeals for the Federal

Circuit

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On August 16, 2012, the Federal Circuit held its ground, ruling again in a 2–1 decision in favor of Myriad. The new court
opinion was nearly identical to the original.[30] The Federal Circuit again reversed the district court's decision on isolated
DNA molecules; the Federal Circuit found that such molecules are patent-eligible under § 101 because they are
nonnaturally occurring compositions of matter. It also reversed the district court's decision concerning assays to find
drugs to treat cancer; the Federal Circuit again found that these assays are patentable. And again—now reinforced by the
Mayo decision—the Federal Circuit affirmed the lower court's decision, that method claims directed to "comparing" or
"analyzing" DNA sequences are patent ineligible. Such claims were held to include no transformative steps and therefore
to cover only patent-ineligible abstract, mental steps.

With respect to the patentability of isolated genes, the majority opinion stated that the Mayo precedent was not
particularly relevant to this case, because it did not deal with the patent eligibility of gene patents.[31] Judge Lourie stated:
"The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the
composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man
reflects and is consistent with a law of nature."[32]

Judge William Bryson wrote a dissent with respect to the non-patentability of isolated DNA sequences, applying the
reasoning of the Supreme Court in the Mayo case, with respect to methods involving "natural laws", to products of nature:

In Mayo, which involved method claims…the [Supreme] Court found that the method was not directed to
patent-eligible subject matter because it contributed nothing "inventive" to the law of nature that lay at the
heart of the claimed invention…In concluding that the claims did not add "enough" to the natural laws, the
Court was particularly persuaded by the fact that "the steps of the claimed processes…involve well-
understood, routine, conventional activity previously engaged in by researchers in the field."

Just as a patent involving a law of nature must have an "inventive concept" that does "significantly more
than simply describe…natural relations,"… a patent involving a product of nature should have an inventive
concept that involves more than merely incidental changes to the naturally occurring product. In cases such
as this one, in which the applicant claims a composition of matter that is nearly identical to a product of
nature, it is appropriate to ask whether the applicant has done "enough" to distinguish his alleged invention
from the similar product of nature. Has the applicant made an "inventive" contribution to the product of
nature? Does the claimed composition involve more than "well-understood, routine, conventional"
elements? Here, the answer to those questions is no.

Neither isolation of the naturally occurring material nor the resulting breaking of covalent bonds makes the
claimed molecules patentable….The functional portion of the composition—the nucleotide sequence—
remains identical to that of the naturally occurring gene.[33]

Second petition to the Supreme Court

On September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed another petition for
certiorari with the Supreme Court with respect to the second Federal Circuit Decision.[34] On November 30, 2012, the
Supreme Court agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling.[35]

Oral arguments were heard before the Supreme Court on April 15, 2013.[36]

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Decision of the Supreme Court

Justice Clarence Thomas, on June 13, 2013, delivered the opinion of the Court,[37][38][39] in which all other members of the
Supreme Court joined, except Justice Antonin Scalia, who concurred in part and concurred in the judgment. The majority
opinion delivered by Thomas held, "A naturally occurring DNA segment is a product of nature and not patent eligible
merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring."[40] In Part III of the
majority opinion, Thomas wrote:

It is important to note what is not implicated by this decision. First, there are no method claims before this
Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and
BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate
DNA at the time of Myriad's patents "were well understood, widely used, and fairly uniform insofar as any
scientist engaged in the search for a gene would likely have utilized a similar approach," 702 F. Supp. 2d, at
202–203, and are not at issue in this case.

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2
genes. Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2]
sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its
unchallenged claims are limited to such applications." 689 F. 3d, at 1349.

Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has
been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion
about the application of §101 to such endeavors. We merely hold that genes and the information they encode
are not patent eligible under §101 simply because they have been isolated from the surrounding genetic
material.[40]

In his concurring opinion, which relates to the scientific details in the majority opinion,[39] Scalia wrote:

I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the
opinion going into fine details of molecular biology. I am unable to affirm those details on my own
knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the
expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is
identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic
creation not normally present in nature.[40]

Reactions to the decision

Molecular Pathology v. Myriad Genetics was a landmark case on the practice of gene patenting. The District Court's
decision was received as an unexpected ruling, because it contradicted the generally accepted practice of gene
patents.[41][42] The Federal Circuit's decision was a return to the status quo, in which the U.S. Patent Office issues patents
for isolated gene sequences. However, it still ignited much controversy and interest from the public. The plaintiff's
argument that DNA should be excluded from patent eligibility was widely echoed in popular media.[43][44] Jim Dwyer, a
reporter for The New York Times, wrote: "But for many people, it is impossible to understand how genes—the traits we
inherit from our parents and pass along to our children—could become a company's intellectual property."[45] James

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Watson, one of the discoverers of the structure of DNA, agreed and submitted a brief in the case. He argued that DNA
conveys special genetic information, that human genetic information should not be the private property of anyone, and
that developing a patent thicket of gene sequences could prevent easy commercialization of genetic diagnostics.[46]

In terms of the emotional impact of this case as it was portrayed in the media—the exclusive offering of a diagnostic test
and the high price of the test—the real legal force on that issue arose from the outcome of other cases, In re Bilski and
Mayo v. Prometheus. These cases rendered most diagnostic claims unpatentable, making it difficult for Myriad's business
model (as described above in the Background section) to work going forward—difficult for R&D driven business and
investors and thus potentially bad for patients as there may be fewer diagnostic tests brought to market, but also
potentially better for patients in that prices for tests may be lower and it will be easier to have a test re-done by an
alternate lab.[47][48]

The same issue, namely the patentability of the DNA sequence in the BRCA1 gene, was considered in a February 2013 case
in the Federal Court of Australia where the validity of Myriad's patent was upheld.[49] This was also a landmark ruling, and
an appeal to the Full Court of the Federal Court of Australia was to be heard in August 2013.[50] The submissions for that
appeal were due on June 14, 2013, the day after the U.S. Supreme Court ruling was published, and the appellants in the
Australian case stated that the U.S. ruling was referenced within their submission.[51] In a unanimous decision in October
2015, the High Court of Australia, Australia's final court of appeal, found that an isolated nucleic acid, coding for a BRCA1
protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer was
not a "patentable invention".[52]

References
1. USSC 12-398 (https://supreme.justia.com/cases/federal/us/569/12-398/)
2. Hall, J.; Lee, M.; Newman, B.; Morrow, J.; Anderson, L.; Huey, B.; King, M. (1990). "Linkage of early-onset familial
breast cancer to chromosome 17q21". Science. 250 (4988): 1684–1689. doi:10.1126/science.2270482 (https://doi.or
g/10.1126%2Fscience.2270482). PMID 2270482 (https://www.ncbi.nlm.nih.gov/pubmed/2270482).
3. Miki, Y.; Swensen, J.; Shattuck-Eidens, D.; Futreal, P. A.; Harshman, K.; Tavtigian, S.; Liu, Q.; Cochran, C.; Bennett,
L. M.; Ding, W.; Et, A. (1994). "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1".
Science. 266 (5182): 66–71. doi:10.1126/science.7545954 (https://doi.org/10.1126%2Fscience.7545954).
PMID 7545954 (https://www.ncbi.nlm.nih.gov/pubmed/7545954).
4. US5747282 (http://www.google.com/patents/US5747282)
5. US5837492 (http://www.google.com/patents/US5837492)
6. "Myriad Marketed Products" (http://www.myriad.com/products/). Retrieved October 10, 2012.
7. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683
(S.D.N.Y. March 29, 2010). District Court Decision. (http://graphics8.nytimes.com/packages/pdf/national/20100329_p
atent_opinion.pdf?scp=3&sq=Myriad%20Genetics&st=cse) Retrieved October 10, 2012.
8. Myriad Investor Page—see "Myriad at a glance" (http://investor.myriad.com/index.cfm) accessed October 2012.
9. Shipman, Joan (March 30, 2010). "BRCA1/2 patents ruled invalid in PUBPAT/ACLU lawsuit" (https://web.archive.org/
web/20120313090714/http://nysbar.com/blogs/healthlaw/2010/03/brca12_patents_ruled_invalid_i.html).
Supraspinatus, Official Blog of the New York State Bar Association Health Law Section. Archived from the original (htt
p://nysbar.com/blogs/healthlaw/2010/03/brca12_patents_ruled_invalid_i.html) on 2012-03-13. Retrieved 2012-06-28.
10. "ACLU Challenges Patents On Breast Cancer Genes: BRCA" (https://www.aclu.org/free-speech-womens-rights/aclu-c
hallenges-patents-breast-cancer-genes-0). American Civil Liberties Union. June 26, 2012. Retrieved 2012-06-28.
11. USC § 287(c) (https://www.law.cornell.edu/uscode/text/35/287#c) Quote: "This subsection (exemptions of patent
infringement for doctors) does not apply to the activities of any person...who is engaged in ...the provision of ... clinical
laboratory services".

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