Transcript Meyer Prometheus Presentation - American Intellectual Property

American Intellectual Property Law Association
Politics, Health Care, Subject Matter
Eligibility, & Patent Preemption
Mercedes K. Meyer, Ph.D.
April 2013
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These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law and practice.
These materials reflect only the personal views of the speaker and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will
vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, Drinker Biddle & Reath LLP and the speaker cannot be bound either philosophically or as representatives of
their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with Drinker Biddle
& Reath LLP and the speaker. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
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Where do we stand?
• Method claims – Lab
Corp., Classen,
Prometheus & Myriad
– Personalized medicine
• Have Akamai and
McKesson helped?
• Composition claims Gene claims under fire
– Gene Claims – Myth v.
Fact
• Politics
Health Care
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in the U.S.
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35 USC 101
• § 101:
– 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.
• The Exceptions to Eligibility:
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Law of nature (naturally occurring correlates) MPEP §2106.01
Algorithm
Abstract idea
AIA § 33 (a). Notwithstanding any other provision or law, no patent
may issue on a claim directed to or encompassing a human
organism
• See also MPEP § 2105 and 1077 Off. Gaz. Pat. Off 24 (1987) – multicellular
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organisms
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American Intellectual Property Law Association
Treatment Method Claims
Status Check
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We saw it coming - Lab Corp.
Lab Corp.. v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006)
• Certiorari was dismissed
as improvidently granted.
• Claim 13 (still valid):
– A method for detecting a
deficiency of cobalamin or
folate in warm-blooded animals
comprising the steps of:
• assaying a body fluid for an
elevated level of total
homocysteine; and
• correlating an elevated level
of total homocysteine in said
body
fluid with a deficiency of
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cobalamin or folate.
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Personalized Medicine
•
Obtain biological sample.
•
Measure biomarker with diagnostic.
– Metabolites, single & multiple biomarkers,
genes, alleles, polymorphisms
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Correlate biomarker with therapy.
THE DIVIDING LINE
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Administer therapy.
– TheFirm
problem
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administered in the Prometheus claims.
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Prometheus – Claim 1
USPN 6,355,623
• 1. A method of optimizing therapeutic efficacy for treatment
of an immune-mediated gastrointestinal disorder,
comprising:
– (a) administering a drug providing 6-thioguanine to a subject having
said immune-mediated gastrointestinal disorder; and
– (b) determining the level of 6-thioguanine in said subject having
said immune-mediated gastrointestinal disorder,
– wherein the level of 6-thioguanine less than about 230 pmol per
8x108 red blood cells indicates a need to increase the amount of said
drug subsequently administered to said subject and
– wherein the level of 6-thioguanine greater than about 400 pmol per
8x108 red blood cells indicates a need to decrease the amount of
said drug subsequently ad ministered to said subject.
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• INELIGIBLE SUBJECT MATTER
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USPN 6,638,739 – Classen
Immunization Schedule = Patent Eligible
• 1. A method of immunizing a mammalian subject which comprises:
– (I) screening a plurality of immunization schedules, by
• (a) identifying a first group of mammals and at least a second
group of mammals, said mammals being of the same species,
the first group of mammals having been immunized with one or
more doses of one or more infectious disease-causing
organism-associated immunogens according to a first screened
immunization schedule, and the second group of mammals
having been immunized with one or more doses of one or more
infectious disease-causing organism-associated immunogens
according to a second screened immunization schedule, each
group of mammals having been immunized according to a
different immunization schedule, and
• (b) comparing the effectiveness of said first and second
screened immunization schedules….,
– (II) immunizing said subject according to a subject immunization
schedule, ….
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And finally, Myriad
• All of the method claims except for claim 20 of the
USPN ‘282 were patent ineligible.
– 20. A method for screening potential cancer therapeutics
which comprises: growing a transformed eukaryotic host cell
containing an altered BRCA1 gene causing cancer in the
presence of a compound suspected of being a cancer
therapeutic, growing said transformed eukaryotic host cell in
the absence of said compound, determining the rate of growth
of said host cell in the presence of said compound and the
rate of growth of said host cell in the absence of said
compound and comparing the growth rate of said host cells,
wherein a slower rate of growth of said host cell in the
presence of said compound is indicative of a cancer
therapeutic.
– “…at the heart of claim 20 is a transformed cell, which is
made
man, in contrast to a natural material.”
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American Intellectual Property Law Association
Akamai & McKesson
Game Changers?
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The Tension
• How do you write a method claim
that is patentable and
enforceable?
– The origin of the claims in
Prometheus and Lab Corp. was to
claim the essential components of the
invention that generally only require
one actor in order to practice the
process.
• 35 USC § 271 (b) for induced infringement
is difficult to prove.
• Direct infringement under § 271 (a) is
easier to prove.
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– Claims were written for proving
direct infringement.
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American Intellectual Property Law Association
Myriad – DNA Claims
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Myriad
• The Question: “Are human
genes patentable?”
• April 15, 2013 S. Ct. hearing
• Claim construction is not an
inviolable prerequisite to a
eligibility determination under
§ 101
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Myriad: USPN 5,747,282
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1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide
having the amino acid sequence set forth in SEQ ID NO:2.
Gene?
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide
sequence set forth in SEQ ID NO:1.
cDNA?
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
Fragment of a gene?
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
Fragment of a cDNA?
7. An isolated DNA selected from the group consisting of:
– (a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1
having T at nucleotide position 4056;
– (b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1
having an extra C at nucleotide position 5385;
– (c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1
having G at nucleotide position 5443; and, (d) a DNA having the
nucleotide
sequence set forth in SEQ ID NO:1 having 11 base pairs at
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nucleotide positions 189-199 deleted.
cDNA variants?
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Politics: Sec. 27 of AIA
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SEC. 27. STUDY ON GENETIC TESTING.
(a) IN GENERAL.--The Director shall conduct a study on effective ways to
provide independent, confirming genetic diagnostic test activity where gene
patents and exclusive licensing for primary genetic diagnostic tests exist.
(b) ITEMS INCLUDED IN STUDY.--The study shall include an examination of
at least the following:
– (1) The impact that the current lack of independent second opinion testing has had
on the ability to provide the highest level of medical care to patients and recipients of
genetic diagnostic testing, and on inhibiting innovation to existing testing and
diagnoses.
– (2) The effect that providing independent second opinion genetic
diagnostic testing would have on the existing patent and license
holders of an exclusive genetic test.
– (3) The impact that current exclusive licensing and patents on
genetic testing activity has on the practice of medicine, including
but not limited to: the interpretation of testing results and
performance of testing procedures.
– (4) The role that cost and insurance coverage have on access
to and provision of genetic diagnostic tests.
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ResultsFirm
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No study results
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Thanks for your attention! Questions?
Mercedes K. Meyer, Ph.D., J.D.
Drinker Biddle & Reath LLP
1500 K Street, NW
Suite 1100
Washington, DC 20005
+1-202-842-8821
[email protected]
www.drinkerbiddle.com
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Prometheus – Claim 1
USPN 6,680,302
• 1. A method of optimizing therapeutic efficacy for treatment
of an immune-mediated gastrointestinal disorder,
comprising:
– (a) administering a drug providing 6-thioguanine to a subject having
said immune-mediated gastrointestinal disorder; and
– (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine
in said subject having said immune-mediated gastrointestinal
disorder,
– wherein a level of 6-thioguanine less than about 230 pmol per 8x108
red blood cells indicates a need to increase the amount of said drug
subsequently administered to said subject and wherein a level of 6thioguanine greater than about 400 pmol per 8x108 red blood cells or
a level of 6-methyl-mercaptopurine greater than about 7000 pmol per
8x108 red blood cells indicates a need to decrease the amount of
said drug subsequently administered to said subject.
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• INELIGIBLE SUBJECT MATTER
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Rewriting Claim 1 from the ‘623 Patent
• Perhaps a patentable alternative?
– A method of administering 6-thiopurine to a patient in
need thereof for treating an immune-mediated
gastrointestinal disorder, comprising the step of
administering a therapeutically effective amount of the
drug that produces a level of 6-thiopurine
no less than 230 pmol and no more than 400 pmol per
8x108 red blood cells in blood from the patient.
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USPN 5,783,283 – Classen
Patent Ineligible
• 1. A method of determining whether an immunization
schedule affects the incidence or severity of a chronic
immune-mediated disorder in a treatment group of
mammals, relative to a control group of mammals, which
comprises immunizing mammals in the treatment group of
mammals with one or more doses of one or more
immunogens, according to said immunization schedule,
and comparing the incidence, prevalence, frequency or
severity of said chronic immune-mediated disorder or the
level of a marker of such a disorder, in the treatment group,
with that in the control group.
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Resources
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Akamai Technologies Inc. v. Limelight Networks Inc. (Fed. Cir. 2012); McKesson Technologies
Inc. v. Epic Systems Corp., 692 F.3d 1301 (Fed. Cir. 2012)
Ass’n for Mol. Path. et al. v. Myriad Genetics, Inc., 689 F.3d 1303 (Fed. Cir. 2012)
Bancorp Services, L.L.C. v. Sun Life Assur. Co. of Canada, 687 F.3d 1266 (Fed. Cir. 2012)
Coliainni et al., “Impact of gene patents and licensing practices on access to genetic testing
and carrier screening for Tay-Sachs and Canavan disease.” Genet. Med. 12(4 Suppl): S5-S14
(2010) available at: http://www.ncbi.nlm.nih.gov/pubmed/20393311.
HHS Draft Report on Gene Patents:
http://oba.od.nih.gov/oba/SACGHS/SACGHS%20Patents%20Consultation%20Draft%203%209%202
009.pdf
HHS Report on Access to Medical Testing:
http://oba.od.nih.gov/oba/sacghs/reports/SACGHS_patents_report_2010.pdf
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Laboratory Corp. of America Holdings v. Metabolite Laboratories Inc. , 548 U.S. 124 (2006)
Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011)
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)
MPEP: http://www.uspto.gov/web/offices/pac/mpep/index.html
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Public Consultation Draft Report on Gene Patents and Licensing Practices and Their
Impact on Patient Access to Genetic Tests.” 74 F.R. 11730
Recent Examiner Training and Developments Under 35 USC §101 (Sep. 5, 2012):
http://www.cabic.com/bcp/090512/BIO_9_2012_101_Train_Update(HANDOUT)_TC1600
.pdf
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Smartgene
Inc.
v. Advanced Biological Lab., SA (D.D.C. Mar. 30, 2012) Case 1:08-cv00642-BAH – claims found ineligible in view of Prometheus.
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