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.

[email protected]

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


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)


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


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


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


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?


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.


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.


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.


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.


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.


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


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


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


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


What is patentable after Myriad?

• cDNA

• Probes/primers spanning exons

EXON 1 EXON 2

EXON 1 EXON 2


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


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


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


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


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


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

Date post:	26-May-2015
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Obtaining patentable claims after Prometheus and Myriad

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