1 myriad, metabolite, bilski, and prometheus: the four horsemen of the biotech apocalypse? kevin e....
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Myriad, Metabolite, Bilski, andPrometheus:The Four Horsemen of the Biotech Apocalypse?
Kevin E. Noonan, Ph.D.McDonnell Boehnen Hulbert & Berghoff
LLP
Professor Christopher Holman
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Outline of the Talk Introduction
How did we get here?
AMP v. Myriad Genetics Parties and interests The claims: DNA and methods The arguments The court’s decision Constitutional issues?
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Outline of the Talk Labcorp v. Metabolite
The claims The Supreme Court argument The dissent from dismissal of cert
In re Bilski The Claims and Federal Circuit decision How does this relate to biotech?
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Outline of the Talk Prometheus v. Mayo Labs
Claims and issue The Federal Circuit decision: Diagnostic
method claims can be patent-eligible Relevance to Myriad decision
Recommendations To patent or not to patent
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Introduction
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How did we get here? Tremendous success of a technological age Biotechnology the beneficiary of strong
patent protection Biotechnology developed in university
setting – 1980 Bayh-Dole Act promotes patenting
But success breeds criticism – from variety of sources
These include political criticism from those opposed to university patenting
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Where is here?
Politically-motivated groups in the arena: ACLU and PubPat
PubPat challenges variety of patents (not just biotech); notable the WARF human ESC patents
General attitude that patents have become too powerful and retard innovation (little empirical support)
Time ripe for Myriad challenge: in addition, the “right” defendant, due to aggressive patent enforcement tactics
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AMP v. Myriad
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Myriad: The parties
Suit brought in May 2009, SDNY (Judge Sweet) Plaintiffs: several breast cancer victims,
variety of physicians’ groups, certain researchers who claimed research impeded by BRCA patents
Defendants: University of Utah (patent assignee), Myriad Genetics, U.S. PTO
Supporters: ACLU, PubPat, academics Seven patents/ 15 claims at issue Invalid under patent statute and Constitution
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Patent eligibility versus patentability
Patent-ineligible means that the subject matter is not eligible for a patent for public policy reasons notwithstanding the fact that it may be patentable (i.e., useful, novel, and not obvious).
Patentable subject matter means the invention as claimed is useful, novel, and not obvious.
Myriad: The issue
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Myriad: The claims
Two broad types of claims at issue: claims to isolated DNA molecules, and diagnostic method claims
DNA claims recite “isolated” DNA encoding specific amino acid sequences (cDNA)
Also claims to oligonucleotide probes Method claims: methods of detecting mutation
or providing a diagnosis/risk assessment Method claims involve “comparing” mutant
sequence to normal sequence
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Myriad: The claims
Composition of matter claims covering “isolated DNA” covering the BRCA 1 and BRCA 2 genes. Claim 1 of US Patent 5,747,282 is representative of this class of claims:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
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Myriad: The claims
Composition of matter claims covering “isolated DNA” covering the mutations of BRCA 1 and BRCA 2 genes. Claim 1 of US Patent 5,693,473 is representative of this class of claims:
An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.
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Myriad: The claims
Methods of detecting mutations in the BRCA genes. Claim 1 of US Patent 5,709,999 is the only claim in this class:
A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1
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Myriad: The claims
Methods that “compare” and “correlate” mutations in the BRCA genes with an increased risk of breast or ovarian cancer. Claim 2 of US Patent 6,033,857 is representative of this class of claims:
A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
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Myriad: The arguments
Regarding the DNA claims, plaintiffs argue that they are “products of nature” and hence not “inventions”
No Supreme Court case that DNA patent-eligible
Precedent (19th century, subject to interpretation) that “supports” their view
Method claim arguments based on Bilski Constitutional argument: violation of 1st
Amendment right to biological information and 14th Amendment due process
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Myriad: The decision
Judge Sweet agrees that DNA an unpatentable “product of nature”
DNA is “the physical embodiment of genetic information”
Distinguishes other types of “natural products” (antibiotics, vitamins) on this basis
Method claim invalid on Bilski Constitutional arguments avoided, Patent
Office dismissed from the lawsuit
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Myriad: The Constitution
Although the judge avoided, still important Quickest way to get the Supreme Court’s
attention Depends on a failure to appreciate that the
information isn’t what is patented in claims to isolated DNA
However, information is implicated in method claims, because that is what a diagnostic method claim produces – diagnostic information
Should it matter?
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Myriad: Remaining claims A vector comprising isolated DNA operative in a
host cell. A host cell containing isolated DNA and control
sequences Methods for producing BRCA1 polypeptide
comprising culturing cells and harvesting the BRCA1 polypeptide
A kit for detecting mutations in the BRCA1 gene A nucleic acid probe specifically hybridizable to
BRCA1 DNA The method that amplifies all or part of a BRCA1
gene and sequences the amplified BRCA1 nucleic acids.
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Patentability of Diagnostic Methods
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Labcorp v. Metabolite
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Claim 13. 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; [a “detecting” step] and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate [an “inferring” step].
Labcorp Claim
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General problem of “determine and infer” claims (Prof. Kevin Emerson Collins):
Characterized by one or more “determining” steps that involve assays, etc. = transformative
Include “mental step” of reaching a conclusion or arriving at an inference based on outcome of determining steps
Claim preamble directs method to activity (e.g., diagnosing) based on inference
Labcorp dissent - context
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Supreme Court argument
Defendant argued that the claim was not patent-eligible, because it was merely mental activity directed at making a diagnosis
Raised the issue of patents interfering with medicine (surgical techniques earlier lost patent infringement liability)
Methods that occur wholly in the mind, by “correlating” or “comparing” should not be patented
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Supreme Court argument
Justices heard the arguments, then decided (for procedural reasons) that the Court should not have heard the case
Justices Breyer, Souter and Stevens dissented from this decision
Justice Breyer’s dissent based on his acceptance and agreement with defendants’ argument that the claims not eligible for patenting
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“As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors' efforts to use that correlation to diagnose vitamin deficiencies in a patient. Does the law permit such protection or does claim 13, in the circumstances, amount to an invalid effort to patent a ‘phenomenon of nature’"?
“At most, respondents have simply described the natural law at issue in the abstract patent language of a ‘process.’ But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.”
“[H]ere, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable ‘natural phenomenon,’ and I can find nothing in claim 13 that adds anything more of significance.
Labcorp dissent
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Justice Breyer misses a few points of well-established patent law:
Whether a claim recites patent-eligible subject matter does not depend on whether the claim is itself patentable
Applications of “phenomena of nature” are patentable; the phenomenon itself is not
Patent eligibility of a claim must be determined from the claim “as a whole”
Labcorp dissent
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In re Bilski
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In re Bilski: The claims
Claims directed to a method for hedging risk in commodities trading
Rejected by the patent examiner, affirmed by the patent board of appeals
Federal Circuit (appellate court that hears these appeals) agrees, announcing a new test
A method to be patentable has to either Be tied to a particular machine orTransform a particular article into a
differentstate or thing
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Supreme Court weighs in
Does not reject Federal Circuit test, but says it is not the only test
Goes back to first principles, relating to whether what is claimed is an abstract idea that pre-empts every use thereof
Benson/Flook/Diehr precedent, wherein applications of abstract ideas are patent-eligible but not if the idea is completely pre-empted
But MOT test “should be satisfied” is most cases
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How does Bilski apply to biotech?
MOT test not limited to “business methods” Test required for any method, including
diagnostic methods Typical diagnostic method is not tied to a
particular machine Many diagnostic methods (like in
Metabolite) involve using data to make a diagnosis, so don’t “transform”
Also based on medical knowledge – is this an “abstract idea”?
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Prometheus Labs v. Mayo
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Consequences of Bilski Decision
Prometheus Labs v. Mayo (decided September 16, 2009) Claims a method for optimizing treatment of an immune-
mediated gastrointestinal disorder with 6-thioguanine
Recited steps of administering the drug to a patient and detecting 6-thioguanine or 6-methyl-mercaptopurine (metabolite) in blood
Recites inferring step of therapeutic efficacy when 6-thioguanine levels in red blood cells are between 230 pmol-400 pmol per 8 x 108 red blood cells
Levels outside these ranges “indicates a need” to adjust administration amounts accordingly – but does not recite affirmative steps of adjusting
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Prometheus Labs v. Mayo Steps for administering a drug and determining
metabolites can be transformative and satisfy Bilski
Such steps can be “method of treatment” steps that are “always transformative”
Involving “natural processes” not determinative, since “every transformation of physical matter . . . occurs as the result of natural processes”
A process for chemical or physical transformation of a physical object or substance are “virtually self-evidently” patent-eligible subject matter
Inclusion of a mental step does not negate patent-eligibility
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Prometheus Labs v. Mayo
In the wake of Bilski, the Supreme Court granted cert, vacated the Federal Circuit decision and remanded
Mayo has asked the court for en banc review
No matter what the Federal Circuit decides, expect appeal to Supreme Court
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Consequences and the Future
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Recommendations: Isolated DNA claims
If “isolated” is insufficient, many DNA claims invalid
Consequences depend on what the claims are protecting For making therapeutic proteins,
recombinant cell claims should survive Vector claims should also be patentable
(man-made) Kit claims should also be patentable, as
manufactures
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Recommendations: Diagnostic Method claims
Fate of diagnostic method claims may be language-dependent
Insofar as claim can be cast as “merely mental step” then at greater risk
“Correlating”/“comparing” language problematical
Claims containing more active steps (like “sequencing”) may be at lower risk
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Recommendations: Diagnostic Method claims
Bigger problem for these claims (even if they survive Bilski /Prometheus decisions)
Potential for a patent “thicket”
Some efforts around this (patent pooling, SNP consortium, Navigenics “ASCAP” solution)
Will get worse before it gets better, particularly regarding personalized medicine
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Recommendations: Ways forward
• Patented technology
• Licensing
• Litigation
• New technology
• To patent or not to patent
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Recommendations: Patented technology
“Narrowing” reissue a possibility
For DNA claims, can limit to “manufactured” DNA – claim scope expressly outside chromosomal DNA by structure
Can also narrow vector claims to these embodiments
Diagnostic method claims to include “active” steps like sequencing
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Recommendations: Patented technology
In litigation, DNA claims not usefully asserted
But then, what damage (usually) from DNA claim alone?
Recombinant cells should survive Myriad even at Supreme Court
Pharmaceutical infringement should involve at least use of recombinant cells
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Recommendations: New technology
Patenting may not be an option (or at least be unattractive)
For industry, when you cannot patent, trade secret becomes attractive
Not easy, but attractive
But may be worth the risk and investment
Broad (and negative) implications for academic research
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“Old” technology
BRCA1 and BRCA2 the anomalous – many common diseases (diabetes, most cancers, cardiovascular disease) multigenic
Requires detection of more than one dominant mutant gene
Not difficult to identify “disease” genes
But may be difficult to obtain sufficient correlations between several genes to be useful
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Recommendations: New technology
Academia versus industry: what industry does better
Focused investigation to determine which genes in combination are diagnostic
Wealth of genetic data (thanks, Human Genome Project) + large reservoirs of frozen tumor and other tissue
Capacity to use both for to develop assays for making diagnostic decisions
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Recommendations: Diagnostic methods/ trade secrets
With existing technology, can analyze tens of thousands of frozen normal and disease-specific tissue samples
Identify the differences between normal and disease that are common in disease
Perform prospective study on normal/ diseased cohorts to show predictive power
Assemble roster of disease-specific genes for a particular disease
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Recommendations: Diagnostic methods/ trade secrets
Diagnostic test is “gene chip” containing >10,000 sequences
Some of these are specific for the disease (multiple sequences from different genes)
Some are positive controls
Some are negative controls
All are assembled on the chip “randomly” – positions encrypted for each chip
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Recommendations: Diagnostic methods/ trade secrets
Encryption informs reader which sequences are determinative for disease
Billions of permutations, (almost) impossible to decipher/reverse engineer
Showing of reliability may be required, but identity of genes should not be
FDA issues regarding extent of disclosure required, but alternative may be no test at all
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Recommendations: Diagnostic methods/ trade secrets
Consequences: Academia/industry collaborations over Research-intensive efforts preclude global
approaches Pace of genetic research on diseases
slows Disclosure disappears No disclosure = no need to reduce prices
ever Fundamentally shifts progress
(negatively) and incentives to innovate
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Recommendations: Possible alternative
Industry abandons the space entirely Diagnostic genetic testing done in
university or hospital settings exclusively
Concentrated in large medical centers, with advantages and disadvantages: Test consistency and reliability concerns Relationship to university mission Best use of resources Availability/cost of genetic counseling
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Recommendations: Diagnostic methods/ trade secrets
Exchange of powerful incentives Today, early-stage, research-
intensive, high-risk research
Tomorrow, focused, disease-specific research by industry to develop diagnostic products
Provides rationale/explanation to counter “free is good” arguments
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Conclusions
Situation very unsettled No clear and unambiguous path forward Myriad appeal on track, appellant briefs
due in October Prometheus will most likely be the next
opportunity for a Supreme Court decision Possible that the Court will let the Federal
Circuit flesh things out in a few cases before granting cert
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Thank you!
Kevin E. Noonan, [email protected]
www.patentdocs.org
MBHB300 South Wacker DriveChicago, Illinois 60606-6709312 913 0001 phone312 913 0002 faxwww.mbhb.com