Transcript Uwe Szipl - Recent Cases Myriad - American Intellectual Property

American Intellectual Property Law Association
Recent cases citing Myriad and their influence on
practice
Joerg-Uwe Szipl
Griffin and Szipl, P.C.
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AIPLA IP Practice in Japan Committee
FirmMeeting
Logo with the Intellectual Property High Court
Tokyo, Japan, April 9, 2014
AIPLA1
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Association For Molecular Pathology v.
Myriad Genetics, Inc., 133 S.Ct. 2107 (2013)
• Federal Circuit (689 F.3d 1303 (Fed. Cir. 2012) ruled on three types
of claims
– Isolated DNA coding for BRCA polypeptides (gene claims)
(valid)
– Isolated DNA having a specific sequence (cDNA claims)(valid)
– Isolated DNA having at least 15 nucleotides of (cDNA) sequence
(probe claims) (valid)
– Method of screening tumor samples requiring comparing BRCA
gene from tumor sample with BRCA gene from non-tumor
sample (invalid).
– Method of screening potential cancer therapeutics using
transformed eukaryotic host cells (valid)
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Myriad Genetics, Inc.
• Supreme Court granted review on the issue of whether
the isolated DNA claims were patentable subject matter
under 35 U.S.C. §101.
• Court held: “Genes and the information they encode are
not patent eligible under §101 simple because they have
been isolated from the surrounding genetic material”.
• 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 this situation, a short strand of cDNA
may be indistinguishable from natural DNA.
• What was not decided:
– Patent eligibility of method claims
– Patent eligibility of probes and primers
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In re BRCA1-and BRCA2-based Hereditary
Cancer Test Patent Litigation, 2014 WL
931057 (D. Utah 2014)
• Decision of the District Court denying plaintiff’s motion
for preliminary injunction.
• Myriad, after the Supreme Court decision, sued
defendants including Ambry Genetics and sought
preliminary injunction to stop them from selling tests to
screen BRCA1 and BRCA2 genes
• Plaintiff seeking preliminary injunction must show
– Likelihood of success on the merits
– Likelihood of irreparable harm
– Balance of equities in movant’s favor
– Injunction is in the public interest
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In re BRCA1
• Plaintiffs are likely to suffer irreparable harm
– Price erosion and market share.
– Loss of remainder of patent term.
– Defendants unlikely to pay significant damages.
• Harm to Defendants (going out of business) outweighs
harm harm Plaintiffs are likely to suffer without an
injunction.
• Public interest does not clearly favor an injunction.
• Plaintiffs are not likely to succeed on the merits.
– Defendants have raised substantial questions
concerning whether Plaintiffs’ patents claim patent
eligible subject matter.
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In re BRCA1
• Patent’s primer claims are drawn to ineligible subject
matter
– Isolated DNA is patent ineligible insofar as the
location and order of the nucleotides existed in
nature.
– That is true whether that DNA is cleaved, genomic
DNA, or synthetic primers and probes with the same
encoded information.
– Probes and primers, although synthetically designed,
are not markedly different from naturally occurring
DNA.
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In re BRCA1
• Plaintiff’s method claims are drawn to patent ineligible
subject matter
– Ruling consistent with the holding of the Federal
Circuit that was not considered by the Supreme Court
– Plaintiff argued that claims apply the BRCA1 and
BRCA2 genes to apply physical steps that were not
well-understood, routine or conventional at the time
the time the patents were filed.
– Court held that added steps were conventional.
– Court held that the claims preempt all practical
application of the discovery of the BRCA1 and
BRCA2 genes, because they employ PCR, the most
widely used method of gene amplification, to the
scientific principle that certain gene mutations make
cancer more likely.
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Aria Diagnostics, Inc. v. Sequenom,
Inc., 726 F.3d 1296 (Fed. Cir. 2013)
• Court reviewed District Court denial of a preliminary
injunction
• Patent related to test for certain genetic mutations (e.g.,
Downs Syndrome) by isolating fetal paternal DNA
(cffDNA) from maternal blood serum
• Claims included steps of amplifying “paternally inherited
nucleic acid” and detecting the presence of such DNA
• Court remanded issue of infringement in view of
improper claim interpretation.
• Price erosion as irreparable harm was discounted by
District Court.
• The fact that Defendant would be put out of business
from injunction does not control decision.
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Aria Diagnostics, Inc. v. Sequenom, Inc.,
2013 WL 5863022 (N.D. Cal. 2013)
• District Court considered cross motions for summary
judgment.
• Court grants summary judgment on invalidity of the
claims
– The claims apply only conventional techniques to the
discovery of paternally inherited cffDNA.
– Even though there may be alternative ways of
detecting cffDNA, these alternatives are not practical
or commercially viable.
– Claims covering the only commercially viable way of
detecting the cffDNA carry a substantial risk of
preempting all practical uses of it
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Genetic Technologies Ltd. V. Agilent
Technologies, Inc., 2014 WL 941354
(N.D.Cal. 2014)
• Defendant seeks to dismiss complaint under Rule
12(b)(6) for failing to state a claim upon which relief
could be granted.
• Lack of claim was based on the assertion that the claims
were not directed to patent eligible subject matter.
• Patentee made discovery that non coding regions of
DNA were correlated to mutations in the coding regions
of DNA, admittedly a non patentable scientific principle
• Parties dispute whether the remaining steps, i.e., using a
primer pair to amplify a non-coding intron sequence
amount to well-understood, routine, or conventional
techniques at the time the patent was filed.
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Genetic Technologies Ltd.
• Federal Circuit test of whether a claim is meaningfully
limited:
– Preempts all applications of the natural law.
– Contains only insignificant post solution activity.
– Provides no real direction.
– Requires a particular machine or implements a
transformation of matter.
• Defendant has not shown by clear and convincing
evidence that the claims are directed to non-patentable
subject matter.
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Thank you
Joerg-Uwe Szipl
Griffin and Szipl, P.C.
Arlington, VA, USA
[email protected]
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