Obtaining patentable claims after Prometheus and Myriad
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Transcript of Obtaining patentable claims after Prometheus and Myriad
What are patentable claims after Myriad and Prometheus?
October 2013
Mary SmithSwanson & Bratschun, L.L.CDenver, Colorado, U.S.A.
U.S. Patent Law-General
• Patents provided for under the U.S. Constitution• Article 1, Section 8• A type of property right
• A patent gives a right to prohibit others from:• Making, using, offering to sell, or selling a patented
invention in jurisdictions where patent is held• Includes direct infringement, inducement of
infringement and and contributory infringement
• A patent is not• An assurance of freedom to operate• An indicator of commercial success
U.S. Patent Law – Requirements
• Patentable Subject Matter• Many recent decisions by Supreme
Court• Business methods• Diagnostics claims
Prometheus decision• DNA
Myriad Genetics decision
• Novelty• Nonobviousness• Utility
Patent Requirements:
Patentable Subject Matter
• 35 U.S.C. 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”
• i.e., “Anything under the sun invented by man”
• Not patentable subject matter:1. Laws of nature2. Natural phenomenon (products of nature)3. Abstract ideas (performed by a mental process)
Patentable Subject Matter-Law of Nature
• Broadly interpreted (1980s-2005) • Business methods/diagnostics methods
• State Street Bank v. Signature Financial Group (1998) Held: business method patents are not excluded subject matter
• Diagnostics methods patents were never challenged in litigation on grounds of lack of patentable subject matter
• Diagnostics patents routinely granted by USPTO
Patentable Subject Matter-
Law of Nature
• Since 2005, significant narrowing of patentable subject matter• U.S. Supreme Court got involved• “Law of nature” not patentable
• Prometheus Supreme Court case, 2012• Correlations between biomarker and efficacy are
natural law and not patentable
• Products of nature not patentable• Myriad Genetics, Supreme Court, 2013• Genomic DNA is a product of nature, not
patentable
Patentable Subject Matter-
Law of Nature
• Occurs without human intervention• Examples
Principle of gravityDisinfecting property of sunlightCorrelation of blood glucose level to diabetes
• Diamond v. Diehr, 450 U.S. 175 (1981)Claim to testing temperature of rubber in a mold and
automatically opening the mold at rubber-setting temperature
Held: relationship of temperature to setting was a natural principle, but the step of opening the mold when the setting temperature reached transformed the process into an inventive application of the natural principle
Thus, a law of nature may be patentable when practically applied (used for a particular process)
Patentable Subject Matter-
Law of Nature
• Diagnostics claims• “Detection of biomarker X (gene, protein, SNP, oncogene, etc.)
to diagnose disease Y”• “Detection of biomarker X to determine if patient can be
treated with Drug Z”
• Personalized medicine – of increasing importance• Identify subpopulations of patients that differ in their
susceptibility to a particular disease or response to a specific treatment
• 119 (March 2013) drugs approved by the U.S. FDA require determination of pharmacogenomics markers in their labels
Patentable Subject Matter-
Law of Nature
• Mayo Collaborative Services v. Prometheus
Laboratories, Inc. 132 S. Ct. 1289 (2012) “Prometheus”
• Method of optimizing thiopurine dosage by determining
level of metabolite in blood and adjusting dosage
accordingly is not patentable• Correlation of thiopurine metabolite and dose is a “law of
nature”• Adjusting dosage in accordance is a “well understood,
conventional” step
• Need more cases to be decided to completely understand
the scope of this ruling
Patentable Subject Matter-Law of Nature
Related Cases for Prometheus
• Perkin Elmer v. Intema (2012)• Claim invalid• Correlation between markers and disease is a “natural
law”• Comparison and diagnostic step a “mental step” and
measurement is a “routine and conventional activity”
• Classen v. Biogen Idec (2011) (not overruled by
Prometheus)• Claim valid• Correlation was “natural principle”, i.e., “natural law”• But, the active immunization step according to the
information from screening step was a non-conventional practical step
Patentable Subject Matter-
Law of Nature
• Cases say that• Diagnosing is a “mental step” • Correlations are a “natural law”• Detection of known biomarker is
“conventional”
• How to patent diagnostics claims?
Patentable Subject Matter-
Law of Nature
1. Detect a novel molecule• A method for diagnosing disease A by detecting
a new SNP or oncogene• Detecting novel molecule is not a well-
understood conventional step, therefore this confers patentability
• US patent No. 8,431,345 (April, 2013)A method for determining risk of glaucoma
progression comprising detecting a G nucleotide instead of an A nucleotide at position 31 of SEQ ID NO:X.
Patentable Subject Matter-
Law of Nature
2. Use a novel detection reagent• A method for analyzing for marker A where marker
A is detected by novel antibody B.• Use of novel detection reagent is not a well-
understood conventional step, therefore this confers patentability
• US patent No. 8,540,995 (September 2013)A method for detecting influenza A by contacting
the specimen with an monoclonal antibody 1C9 which is deposited with the American Type Culture Collection with Accession Number PTA-8759 and detecting the binding of said antibody.
Patentable Subject Matter-Law of Nature
3. Detection of combinations of markers• A novel combination of markers is unconventional • US Patent No. 8,465,923 (June, 2013)
A method to assess response to antibiotic treatment, comprising [measuring 6 markers] prior to antibiotic treatment and measuring the same markers after antibiotic treatment, comparing the levels of the markers, and predicting a response if there is a difference in the mRNA expression levels.
Patentable Subject Matter-Law of Nature
4. Add a treatment step • Add step to treating patient with nonspecific
drug class based on biomarker• If correlation new, then unconventional• Treatment claim can be generic (i.e., not tied to
specific drug)
• US patent No. 8,492,096 (July 2013)A method for treating cancer in a patient by
measuring for presence of reduced level of TGFBR1 compared to normal and then treating said patient with chemotherapy and/or radiation.
Patentable Subject Matter-Law of Nature
4. Add a treatment step (con’t)• Add step to treating with particular drug• If correlation new, then unconventional• Most useful for innovator pharmaceutical
companyCan license the diagnostic test to laboratories
• US patent No. 8,445,535 (May 2013)A method for treating Alzheimer’s disease in a
patient by measuring for presence of ApoE4 allele then treating said patient with medium chain triglycerides.
Patentable Subject Matter-Law of Nature
4. Add a treatment step (con’t)• Infringement liability
• Steps performed by testing laboratory and physician• These parties are not under each other's control
• Induced infringement liability 35 U.S.C. § 271(b): • Prior to 2012, there had to be one party who
performed all steps of the method • 2012, new decisions changed the law so now induced
infringement can be found where one party (e.g., testing laboratory) knowingly induced others (e.g., doctors) to commit the acts necessary to infringe the plaintiff’s patent
• Favorable for diagnostics laboratories
Concluding Thoughts on Prometheus
• Reduced scope for “diagnostics” claims• Full scope of rule not yet well understood• Current strategies to obtain claims
• Detect new marker or SNP• Use new detection reagent• Detect new combination of markers• Add a treatment step dependent on the
outcome of the correlationTreatment of disease by generic drug classUse of a particular drug
Patentable Subject Matter-Products of Nature
Natural phenomenon (products of nature)• Isolated genomic DNA previously was considered
patentable• USPTO Utility Guidelines, 2001:
“an inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules associated with it.”
• Myriad Genetics, Supreme Court, 2013• Compositions of matter comprising isolated, naturally
occurring genomic DNA is a product of nature, not patentable
• Includes naturally occurring SNPs, naturally occurring short (primer) sequences
Patentable Subject Matter-Products of Nature
Association for Molecular Pathology et al. v Myriad Genetics Inc, et al., 569 US (2013)
Challenged claims1. Genomic DNA
includes introns
2. cDNAExcludes introns
3. Fragments of Genomic DNA ≥ 15 nt
4. Fragments of cDNA ≥ 15 nt
Patentable Subject Matter-Products of Nature
A major change in the law• U.S. now inconsistent with other major jurisdictions;
Europe, Australia, South Korea, Canada, China, etc. all consider isolated genomic DNA patentable
What prompted this decision?• Concern regarding removal of basic tools of science
and research necessary for research• Concern regarding patients’ paying too much for
genetic testing• Widespread misperception that “gene patent” covers
natural human persons
Patentable Subject Matter-Products of Nature
Impacts?• Invalidates an estimated 8,703 genomic patents that are
still in force• Declining number of patents to genomic DNA
Annual number peaked in 1999 Since 2005, average number of gene patents about 600 per
year• Likely limited to genomic DNA
“We merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.”
Factor in decision was that relevance of genomic DNA in claim was of “information content” only
Patentable Subject Matter-Products of Nature
What is patentable after Myriad?
• cDNA
• Probes/primers spanning exons
EXON 1 EXON 2
EXON 1 EXON 2
Patentable Subject Matter-Products of Nature
Likely:• Genomic DNA, when:
• Non-naturally occurring• Degenerate • Codon-optimized• Mutagenized
• Linked to heterologous DNA• Vectors, other constructs• Transgenic cells, transgenic organisms
• Composition comprising genomic DNA and a carrier
INTRON EXON INTRON EXON
VECTOR INTRON EXON
Patentable Subject Matter-Products of Nature
Likely:• Probes/primers
• Exon-spanning
• Occurring in genomic DNA• Degenerate • Codon-optimized• Mutagenized
• Conjugated to a detectable label• Vectors, other constructs
• Composition comprising primer and a carrier
EXON
Patentable Subject Matter-Products of Nature
Likely:• RNA molecules
• Antisense, microRNA, siRNA• Have both an information component and
function component (can act as a drug)• Suggest reciting “synthetic”, not “isolated”
RNA, in claim• Chemically modified
Phosphorothioate backbones2’ hydroxy-modified sugars
Patentable Subject Matter-Products of Nature
Likely:• Recombinant native proteins
• Identical to sequence of native protein • Best practice: recite “recombinant” or “synthetic”
protein, not “isolated” protein• Recombinant proteins almost always differ in
glycosylation pattern from native protein
Patentable Subject Matter-Products of Nature
Likely:• Cultured cells
• Claim a composition comprising the isolated cells and a carrier
• Methods claims using genomic DNA• If genomic DNA is novel, then no Prometheus
problems
Patentable Subject Matter-Products of Nature
Concluding thoughts on Myriad• Definitively rules out composition of matter patents to genomic
DNA• Full scope of rule not yet well understood, but likely limited to
genomic DNA• Remaining patentable
• cDNA• Codon-optimized/degenerate genomic DNA• Primers/probes that span exons or contain detectable label• Synthetic RNA with functional aspect• Recombinant protein• Cultured cells (in a composition)• Methods directed to use of naturally occurring genomic DNA