Patenting Products of Nature: Assoc. Molecular Pathol. v. U.S. PTO
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Transcript of Patenting Products of Nature: Assoc. Molecular Pathol. v. U.S. PTO
Patenting Products of Nature:Assoc. Molecular Pathol. v. U.S. PTO
Technology Transfer TacticsWebinar
August 31, 2011
Kevin E. Noonan, Ph.D.
Outline of the Talk
Introduction How did we get here? Gene patenting myths
Patenting “products of nature” 19th Century Supreme Court cases Brogdex, Funk Bros. Bergy and Chakrabarty
Outline of the Talk AMP v. US PTO (“the Myriad case”)
Parties and interests The claims: DNA and methods The arguments The court’s decision CAFC opinion
Consequences and Recommendations Alternatives to patent Effects of non-disclosure Policy and societal concerns
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
Gene Patenting Myths
The Ownership Myth Michael Crichton, ACLU
and “Who Owns You”
The Information Myth “Physical Embodiment of Genetic Information” Information not what’s patented; “DNA is a
chemical compound, albeit a complex one”
Gene Patenting Myths The “Natural Product” Myth
Isolated DNA not found in nature cDNA not found in nature Natural products not patent-ineligible
per se
The “Inhibits Research” Myth The Anti-commons are not tragic Progress promoted by disclosure No evidence of research inhibition
Patenting “Products of Nature”
Is it possible? Widespread belief
that “products of nature” cannot be patented
Little support in binding precedent
Some sporadic support for both sides of the argument in lower court cases
No binding precedent 19th Century cases
Wood Paper Patent Cases (1874) Cochrane v. Badische Anilin Soda Fabrik,
(1874)
20th century cases American Fruit Growers v. Brogdex (1931) Funk Bros. Seed Co. v. Kalo Inoculant Co. (1948) In re Bergy (1979) Diamond v. Chakrabarty (1980) Bilski v. Kappos (2010)
What does the law say?20th century casesFunk Bros. Seed Co. v. Kalo Inoculant Co. (1948):
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either . . . is no more than the discovery of some of the handiwork of nature and hence is not patentable . . . The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility . . . does not improve in any way their natural functioning.
What does the law say?20th century casesDiamond v. Chakrabarty (1980):
The laws of nature, physical phenomena, and abstract ideas have been held not patentable . . . Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of . . . nature, free to all men and reserved exclusively to none."
What does the law say? Diamond v. Chakrabarty (1980)
[R]espondent's micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter - a product of human ingenuity "having a distinctive name, character [and] use."
Better way to state the proposition: mere products of nature, unmodified by man, are not patent-eligible (predominantly because they are not novel)
What does the law say?20th century casesIn re Bergy (1979):
Therefore, in case there is doubt as to whether the examiner's product-of-nature rejection is still an issue in this case, in the interest of judicial economy we rule on it now . . . We hold that Bergy's claim 5 clearly does not define a product of nature.
We were thinking of something preexisting and merely plucked from the earth and claimed as such, a far cry from a biologically pure culture produced by great labor in a laboratory and so claimed.
AMP v. USPTO (“Myriad”)
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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 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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District Court Decision Judge Sweet agrees that DNA an
unpatentable “product of nature” DNA is “the physical embodiment of genetic
information” Distinguishes other types of “natural product
s” (antibiotics, vitamins) on this basis Method claim invalid under Bilski
Federal Circuit Decision Oral argument April 4th; decision July
29th Three separate opinions, Judge Lourie
wrote the majority opinion Judge Moore concurred and Judge
Bryson concurred in part and dissented in part
Overall consensus on outcome for most issues
Important differences in approach
Federal Circuit Decision Consensus on:
Standing (but for just one plaintiff) Patent-ineligibility of diagnostic method
claims Patent-eligibility of screening method
claims Patent-eligibility of composition of matter
claims to cDNA
Federal Circuit Decision Disagreement over patent-eligibility of
“isolated DNA” claims encompassing genomic DNA and primers
Also fundamental differences in approach in “majority” opinion, but agreement on decision in this case
Judge Bryson dissenting indicates a different approach
Federal Circuit: Majority Judge Lourie: “isolated DNA” patent-eligible
because it satisfies the Supreme Court “test” from Funk Brothers and Chakrabarty that a natural product can be patented provided that there is “a change in the claimed composition's identity compared with what exists in nature” and “that human intervention has given ‘markedly different,’ or ‘distinctive, characteristics.
Chemical changes in isolated DNA enough
Isolated DNA claims “Isolated DNA”
comes in two forms: genomic DNA and cDNA
Significant differences in structure and how isolated/ prepared
Is DNA a “product of nature”?
Genomic DNA may be But chemically
modified from native state
cDNA certainly is not Claims limited to
specific sequence that does not exist prior to human intervention
Federal Circuit: Majority 19th Century cases dismissed as being
based on novelty issues Many lower court decisions directed to
“products of nature” also dismissed as precedent as not addressing fundamental issue before court
Funk Bros. and Chakrabarty primary precedent
In re Bergy also dismissed as being non-precedential
Federal Circuit: Concurrence Judge Moore: DNA a polymer, like
nylon Isolated DNA not just purified from
nature Also reads precedent as requiring
alteration of natural product This rationale convincing for cDNA and
oligonucleotide fragments because do not occur in nature – made by man
Federal Circuit: Concurrence “Isolated DNA” claims are a “closer case
” Not entirely convinced that isolation
effects sufficient change to satisfy precedent
But, not “drawing on a blank canvas” - cannot ignore 30 years of PTO practice and CAFC precedent (Amgen v. Chugai etc.)
Change in the law up to Congress
“Isolation” vs. “Purification” Both the majority opinion and Judge
Moore’s concurring opinion set up a dichotomy
“Isolated” DNA as claimed patent-eligible because it has been chemically transformed
Thus, DNA has not “merely” been isolated
Implications for other biological molecule-based inventions
Federal Circuit: Dissent Judge Bryson: “common sense”
conclusion that human DNA not patent-eligible (including oligonucleotide primers)
Applies the same Supreme Court precedent, comes to the opposite conclusion
Concern seems to be negative effects on whole genome sequencing
Discounts PTO practice and deference to Congress, citing DOJ position
DOJ amicus brief On the one hand, the brief argues that
manipulated DNA (cDNA, vectors, oligonucleotides, etc.) are patent-eligible because they show “the hand of man”
On the other, isolated genomic DNA not patent-eligible because it is not sufficiently changed
Tries to “split the baby” by arguing on both sides of the issue
Genetic diagnostic methods also patent-ineligible, since merely a “natural phenomena”
Not from the Department of Commerce or the PTO and seemingly with little or no PTO input
Federal Circuit Decision
Method claims: claims reciting merely “analyzing” or “comparing” fail the “machine-or-transformation” test
Claims to screening methods do not, since cell growth in presence of putative BRCA inhibitor is transformative
Method claims Methods that “compare” and “correlate”
mutations in the BRCA genes with an increased risk of breast or ovarian cancer.
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.
Claim 2 of US Patent 6,033,857
Federal Circuit Decision
Standing: rejects standing for most plaintiffs – no immediacy and reality
One plaintiff (Dr. Ostrer) on record that he will “immediately” provide testing
This is sufficient for standing Recent controversy on whether the
predicate condition – Dr. Ostrer’s capacity to begin immediate testing - still met
Federal Circuit Decision Status: a few possibilities
Petition for panel rehearing Petition for rehearing en banc Petition for writ of certiorari
Both parties have grounds for filing Plaintiffs filed petition for rehearing on
August 25th Parties have 90 days to petition for
certiorari
Consequences and Recommendations
Consequences of CAFC decision
For now, “gene patents” claim patent-eligible subject matter
Practically, consensus decision on gene patent-eligibility for cDNA covers most patents on genes
Isolated genomic DNA claims less certain, but less valuable
Oligonucleotide claims more certain as man-made manufactures
Consequences of PON ban
Not a good thing for DNA patents, but not the end of the world
BUT, the philosophy not limited to DNA claims
The best biologic drugs will be as close as possible to how they exist “in nature” – in the body
The better the drug, the less patent-eligible it will be
Can’t be the correct result
Proposition Bad analogies make bad law Isolated DNA is not a leaf (Judge Dyk),
or a mineral (DOJ brief) or information (Judge Sweet) or an arm (Morley Safer)
Consider these examples: Isolated chemical compound from crude oil
useful as a lubricant Isolated chemical compound from a plant
useful as a drug Isolated protein from an animal useful to
cure/ameliorate human disease
Consequences of CAFC decision
Diagnostic method claims less certain Claims at issue flawed by claim language Interpreted to broadly encompass mere
comparison of germline and patient BRCA gene sequences by inspection
Claims do not recite affirmative steps for obtaining sequence
Myriad has many other claims that do recite such steps
Consequences of CAFC decision
Diagnostic method claims generally less certain
Supreme Court will consider question this term in Mayo Labs v. Prometheus
Slightly different question, since the Prometheus case involves determination of effective dose of administered drug
Basis for Federal Circuit to find a “transformation”
Also implicates “practice of medicine”
Why should these claims be patent-eligible?
Only way to protect “correlation” discoveries – basis for molecular diagnostics
Promotes disclosure from academic/medical scientists, and translation of information into patentable technologies = innovation
Alternatives – such as trade secret – greater negative effects Risk of upsetting balanced approach to innovation
(academics do basic research, industry develops commercial embodiments)
Possible Solutions
• Machine or transformation test remains viable
• De-emphasize purely informational aspects of claims; recite claims containing more active steps (like “sequencing”)
• Recite method of treatment step relating to diagnosis
But this raises MuniAuction issues
• Will depend on Supreme Court decision in Prometheus
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Additional considerations
Potential for a patent “thicket”
Involves reagents for performing the assays – need to license dozens/thousands of genes correlated with disease
Some efforts around this (patent pooling, standard setting SNP consortium, Navigenics “ASCAP” solution)
Will get worse before it gets better, particularly regarding personalized medicine
Unintended (?) Consequences
No remedy for women Myriad patents expire in ~4-6 years Test availability depends on insurance
companies, not patents
Financial impact on biotech industry Burrill Report
http://www.patentdocs.org/2011/01/steve-burrill-makes-predictions-for-the-biotech-industry-in-25th-annual-report.html
Unintended (?) Consequences
Patent ineligibility promotes non-disclosure
Non-disclosure contrary to academic mission
Academia (U.S. taxpayer) as uncompensated corporate R&D department (foreign and domestic)
Unintended (?) Consequences
The future will be different from the past – much more complicated
Trade secret protection perpetual (and biotech hard to reverse engineer)
“Natural product” patent ineligibility extends to all medicinal chemistry and biologic drugs
Thank you!
Kevin E. Noonan, Ph.D.
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