Playing with Fire? Patenting Diagnostic Methods After Mayo v. Prometheus. Christopher D. Gram, J.D., M.S.

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1 Playing with Fire? Patenting Diagnostic Methods After Mayo v. Prometheus Christopher D. Gram, J.D., M.S.

2 March 2011

3 I am REALLY glad to be here March 2011 April 4, 2014

4 Patent Eligibility 35 U.S.C. 101 Inventions patentable. 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.

5 Patentability 35 U.S.C. 102: Novelty 35 U.S.C. 103: Nonobvious 35 U.S.C. 112 Is the invention enabled? Does the application describe the full scope of what is claimed? Are the claims clear to a person of ordinary skill in the art?

6 Back to 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

7 Back to 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 Congress intended statutory subject matter to include anything under the sun that is made by man. Diamond v. Chakrabarty, 447 U.S. 303 (1980)

8 Exceptions to 35 U.S.C. 101 Judge-made exceptions to patentable subject matter Natural Products Natural Laws/Natural Phenomena Abstract Ideas/Mental Processes/Algorithms

9 Exceptions to 35 U.S.C. 101 Judge made exceptions to patentable subject matter Natural Products Natural Laws/Natural Phenomena Abstract Ideas/Mental Processes/Algorithms They are part of the storehouse of knowledge free to all men and reserved exclusively to none. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)

10 Patent Eligibility vs. Patentability Traditionally, patent-eligibility has been a low standard Almost any human involvement is sufficient Patentability a more demanding standard 102, 103, and 112

11 Prometheus the discovery Thiopurine drugs for treatment of autoimmune diseases 6-thioguanine prodrug Metabolized to 6-thioguanine (6-TG) Further 6-TG metabolites known to correlate with: Efficacy Toxicity Precise metabolite levels previously unknown

12 U.S. Patent No. 6,355,623 6-TG nucleotides Toxicity at >400 pmoles/8x10 8 cells Low efficacy at <230 pmoles/8x10 8 cells 6-methyl-mercaptopurine (6-MMP) Toxicity at >7000 pmoles/8x10 8 cells

13 U.S. Patent No. 6,355, 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 8x10 8 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 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

14 U.S. Supreme Court analysis 1. A method comprising: (a) administering a drug; and (b) determining the level of 6-thioguanine in the patient; (c) results indicate a need to change dosing Correlation is a law of nature namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.

15 U.S. Supreme Court analysis 1. A method comprising: (a) administering a drug; and (b) determining the level of 6-thioguanine in the patient; (c) results indicate a need to change dosing Claim is, essentially, apply the correlation No affirmative change in treatment required No limits on the determining step Conventional methods S.Ct. says the claim preempts all use of the correlation

16 What s happened since? S.Ct. Mayo v. Prometheus decision came out in October 2011 No case has made it to the Federal Circuit What is the USPTO doing? Issued Examiner Guidelines for Patent Eligibility Analysis

17 What s happened since? S.Ct. Mayo v. Prometheus decision came out in October 2011 No case has made it to the Federal Circuit What is the USPTO doing? Issued Examiner Guidelines for Patent Eligibility Analysis March 4, 2014

18 USPTO Guidelines Three questions 1. Is the claim directed to a statutory category process, machine, manufacture, composition? 2. Does the claim fall within a judicial exception? 3. Does the claim recite something significantly different than the judicial exception?

19 What is significantly different? Includes elements or steps in addition to the natural law/phenomenon that practically apply the natural law/phenomenon in a significant way Includes features or steps that demonstrate the claimed subject matter is markedly different from what exists in nature

20 Examples U.S. Pat. 6,033,857 A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence. This claim was held ineligible by the Federal Circuit in AMP v. Myriad.

21 Examples U.S. Pat. 5,710, A method for screening a tumor sample from a human subject for the presence of a somatic alteration in a BRCA1 gene, wherein said comparing is performed by (i) detecting either a full length polypeptide or a truncated polypeptide in each sample or (ii) contacting an antibody which specifically binds to either an epitope of an altered BRCA1 polypeptide or an epitope of a wild-type BRCA1 polypeptide to the BRCA1 polypeptide from each sample and detecting antibody binding, wherein a difference between the BRCA1 polypeptide from said tumor sample from the BRCA1 polypeptide from said nontumor sample indicates the presence of a somatic alteration in the BRCA1 gene in said tumor sample.

22 Examples U.S. Pat. 8,642, A method of treating breast cancer in a subject having a triple negative (TN) breast cancer, the method consisting of the steps: (a) quantifying mrna expression level of biomarkers STK3 and KLF6, and at least one biomarker selected from CD24 and KRAS in a test sample from a subject using a biological assay; (b) comparing said mrna expression level of said biomarkers selected from STK3, KLF6, and at least one of CD24 and KRAS quantified in step (a) to the expression level of said biomarkers quantified using the biological assay in a standard sample indicative of a recurrent TN breast cancer; and (c) administering an aggressive cancer treatment regimen to the subject based on an increase in the expression level of the biomarkers between the standard sample and the test sample.

23 Examples U.S. Pat. 8,568, A method for treating high risk B-precursor acute lymphoblastic leukemia (B-ALL) in a patient in need comprising: A) determining whether said patient is a candidate for traditional therapy for B-ALL comprising i) obtaining a biological sample from said patient; ii) analyzing said sample to determine the expression level of the gene products MUC4 (Mucin 4) and IGJ (immunoglobulin J) in said sample; and iii) comparing the observed gene expression levels for each of said gene products to a control gene expression level ; wherein an observed expression level that is higher than the control gene expression for both of said gene products is indicative of therapeutic failure with traditional leukemia therapy; and

24 Examples U.S. Pat. 8,568, (cont.) B). treating B-ALL in said patient with non-traditional leukemia therapy if the observed expression level is higher than control level.

25 Examples U.S. Pat. 8,568,974 Filed before Prometheus v. Mayo Claim 1, cast as a diagnostic method, was rejected under 35 U.S.C. 101 Claim 1 amended to recite the treatment step Application allowed

26 Examples USPTO Guidelines A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in the blood sample, wherein said determining is performed by contacting the blood sample with antibody XYZ and using flow cytometry ; and diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.

27 Strategies Specify a particular manner of detection Avoids preempting the entire scope of the correlation Recast as a method of treatment and/or specify a treatment regimen aggressive treatment or palliative treatment may be enough specificity Induced infringement

28 Conclusions In many cases, diagnostic methods remain patent-eligible Inventors can assist STC and patent attorney be thinking about limitations that, as a practical matter, don t narrow the scope of the methods

29 Questions?