Transcript Castanias presentation

The Myriad Genetics Case
Gregory A. (Greg) Castanias
Jones Day—Washington, DC
September 22, 2011
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Disclaimer
Any views expressed here are my views only, offered in
order to advance the cause of thinking about some of
the issues presented in this case. The views
expressed here do not necessarily represent the
views of Myriad Genetics, Jones Day, or any of Jones
Day’s clients, and are not to be attributed to any of
those organizations or individuals.
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Section 101’s actual language
• “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.”
• No one in the case doubted that isolated DNA
molecules are “compositions of matter.”
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Judicially created exceptions
• “The [Supreme] Court’s precedents provide three
specific exceptions to § 101’s broad patent-eligibility
principles: ‘laws of nature, physical phenomena, and
abstract ideas.’” Bilski v. Kappos, 130 S. Ct. 3218,
3225 (2010) (quoting Diamond v. Chakrabarty, 447
U.S. 303, 308 (1980)).
• Fourth exception for “products of nature” having
“markedly different characteristics from any found in
nature and one having the potential for significant
utility” (Chakrabarty)?
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“Products of nature”
• Chakrabarty sets forth two verbal formulations for
patent-eligibility:
• “a nonnaturally occurring manufacture or composition of
matter—a product of human ingenuity ‘having a
distinctive name, character and use.’” (447 U.S. at 30910, quoting Hartranft v. Wiegmann, 121 U.S. 609, 615
(1887))
• “Here, by contrast, the patentee has produced a new
bacterium with markedly different characteristics from
any found in nature and one having the potential for
significant utility.” (447 U.S. at 310)
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The panel’s areas of agreement
• Of 20 plaintiffs, only Dr. Ostrer had standing
• Composition claims: cDNA claims are patent-eligible
• Method claims:
• Claims where the “comparing” can be done by
“mere inspection alone” not patent-eligible, but
directed to “the abstract mental process of
comparing two nucleotide sequences”
• Claim to method of screning potential cancer
therapeutics was patent-eligible; involved a
transformation and was not abstract
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The panel’s area of disagreement
• Composition-of-matter claims drawn to “isolated” DNA
molecules
• Judge Lourie: Chemical approach to
distinctiveness from a pure product of nature—
broken covalent bonds make a new composition
• Judge Moore: Functional (utility) approach—
isolated molecules can be used as primers and
probes; native DNA cannot
• Judge Bryson: Focus on similarity in structure
and similarity in utility
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Judge Lourie: Chemical distinction
• “[T]he challenged claims are drawn to patentable subject matter
because the claims cover molecules that are markedly different—
have a distinctive chemical identity and nature—from molecules
that exist in nature. [¶] It is undisputed that Myriad’s claimed
isolated DNAs exist in a distinctive chemical form—as distinctive
chemical molecules—from DNAs in the human body, i.e., native
DNA.”
• “[I]solating genes to provide useful diagnostic tools and
medicines is surely what the patent laws are intended to
encourage and protect.”
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Judge Moore: Utility distinction
• “I analyze the isolated DNA claims below, to determine whether
they have markedly different characteristics with the potential for
significant utility, e.g., an ‘enlargement of the range of . . . utility’
as compared to nature.” (Quoting Funk Bros., 333 U.S. at 131.)
• “[T]he claimed isolated DNA molecules, which are truncations
(with different ends) of the naturally occurring DNA found as part
of the chromosome in nature, are not naturally produced without
the intervention of man. [¶] Given the differences, we should, as
precedent instructs, consider whether these differences impart a
new utility which makes the molecules markedly different from
nature.”
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Judge Bryson: Distinct structure
and utility required
• “[T]he test employed by the Supreme Court in Chakrabarty
requires us to focus on two things: (1) the similarity in structure
between what is claimed and what is found in nature and (2) the
similarity in utility between what is claimed and what is found in
nature. What is claimed in the BRCA genes is the genetic coding
material, and that material is the same, structurally and
functionally, in both the native gene and the isolated form of the
gene.”
• Concludes that isolating DNA molecules is “akin to snapping a
leaf from a tree.”
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The “Magic Microscope” Test
• “According to the government’s test, if an imaginary
microscope could focus in on the claimed DNA
molecule as it exists in the human body, the claim
covers unpatentable subject matter. The government
thus argues that because such a microscope could
focus in on the claimed isolated BRCA1 or BRCA2
sequences as they exist in the human body, the
claims covering those sequences are not patent
eligible.”
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The “Magic Microscope” Test
• Judge Lourie: “It misunderstands the difference between
science and invention and fails to take into account the existence
of molecules as separate chemical entities. * * * * It is the
difference between knowledge of nature and reducing a portion
of nature to concrete form, the latter activity being what the
patent laws seek to encourage and protect.”
• Judge Moore: “[F]undamentally changes more than a century of
precedent and Patent Office practice in the pharmaceutical and
biotechnology arena. The proposed test is a purely mechanical
inquiry that fails to account for the possibility that chemical
changes to the isolated DNA sequences at issue, as compared to
their natural state, could result in markedly different uses.”
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Settled expectations
• “[T]he PTO has issued patents directed to DNA molecules for almost
thirty years. In the early 1980s, the Office granted the first human gene
patents. It is estimated that the PTO has issued 2,645 patents claiming
“isolated DNA” over the past twenty-nine years, and that by 2005, had
granted 40,000 DNA-related patents covering, in non-native form, twenty
percent of the genes in the human genome. In 2001, the PTO issued
Utility Examination Guidelines, which reaffirmed the agency’s position
that isolated DNA molecules are patent eligible, 66 Fed. Reg. 1092-94
(Jan. 5, 2001), and Congress has not indicated that the PTO’s position is
inconsistent with § 101. If the law is to be changed, and DNA inventions
excluded from the broad scope of § 101 contrary to the settled
expectation of the inventing community, the decision must come not
from the courts, but from Congress.”
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More § 101
• CyberSource Corp. v. Retail Decisions, Inc., No. 2009-1358 (Fed. Cir. Aug. 16, 2011)
(Bryson, Dyk, Prost) (method for verifying credit-card transactions over the Internet and
“Beauregard” claim to computer-readable medium not patent-eligible) (unanimous)
• Classen Immunotherapies, Inc. v. Biogen IDEC, No. 2006-1634 (Fed. Cir. Aug. 31,
2011) (Rader, Newman, Moore) (method of lowering risk of chronic immune-mediated
disorder, including physical step of immunization, patent-eligible; claims directed
toward abstract principle that variation in immunization schedules may have
consequences for certain diseases were not) (Rader additional views; Moore
dissenting)
• Ultramercial, LLC v. Hulu, LLC, No. 2010–1544 (Fed. Cir. Sept. 15, 2011) (Rader,
Lourie, O’Malley) (unanimous) (method for distributing copyrighted products like songs,
movies, or books over the Internet, where consumer receives copyrighted product for
free in exchange for viewing an advertisement, and the advertiser pays for the
copyrighted content, was patent-eligible) (“Unlike the claims in CyberSource, the
claims here require, among other things, controlled interaction with a consumer via an
Internet website, something far removed from purely mental steps.”)
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In summary . . .
• Major §101 battleground is method claims
(Prometheus), not compositions
• Panel decision on compositions consistent with
statutory language, with Chakrabarty, and with 2001
PTO Utility Guidelines
• “The hand of man” created these compositions
(“Whoever invents or discovers” in §101)
• Policy concerns (“should we have these kinds of
patents”?) properly taken to Congress, not courts
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