Patenting Personalized Medicine in the Wake of Mayo v. Prometheus. Antoinette F. Konski August 24 th, 2012

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1 1 Patenting Personalized Medicine in the Wake of Mayo v. Prometheus Antoinette F. Konski August 24 th, 2012

2 2 Roadmap Supreme Court invalidates diagnostic method claims in Mayo v. Prometheus, 132 S. Ct (2012) Federal Circuits Assn. for Molecular Pathology v. Myriad Genetics (gene patenting case) USPTOs Interim Guidelines applying Mayo Strategic considerations and practice points

3 3 Prometheus Representative Claim (U.S. Patent 6,355,623) 1. 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 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 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

4 4 Case History U.S. patents issued, patent-eligibility ( 101) rejection not raised by PTO S. District of California held claims invalid because directed to a natural phenomenon and therefore ineligible Federal Circuit (I) reversed applied machine-or-transformation test of Bilski administering and determining steps were transformative

5 5 Case History Mayo petitioned Supreme Court, which issued a GVR in view of Bilski Federal Circuit (II) applied Bilski again, and held that claims satisfied patenteligibility statute ( 101) Mayo appealed to Supreme Court

6 6 Question Presented And Holding Question: Whether a diagnostic method claim based on the bodys natural metabolic processes recites a natural phenomena such that it is ineligible for patent protection Holding: The diagnostic method claim is ineligible for patent protection because it recites nothing more than a natural phenomena

7 7 Supreme Courts Reasoning Within the exceptions to patenteligibility: laws of nature, natural phenomena and abstract ideas, are not patentable Prometheus claims recite a law of nature Only applications of a law of nature are eligible for patenting

8 8 Prometheus Representative Claim (U.S. Patent 6,355,623) 1. 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 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 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

9 9 Wherein Clause The Court stated that the wherein clause simply tells a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions. Additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim. The wherein clause tells the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decision making.

10 What Makes a Law of Nature Patent Eligible? 10 The question (posted by Justice Breyer) is do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws? New analysis framed by the Court: a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to an inventive concept, sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. New methods of using compositions still patent eligible as well as methods for treating patients

11 11 USPTO Applies Mayo On July 3, 2012, USPTO issued 2012 Interim Procedures for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (2012 Interim Procedures for Laws of Nature) For use by USPTO personnel (and applicants!) to evaluate process claims in which a law of nature, natural phenomenon or natural principle might be claimed

12 12 3-STEP INQUIRY 1. Is a Process Claimed? Is the claim a process or method? If yes, go to Inquiry #2.

13 13 3-STEP INQUIRY 2. Does the Claim Focus on a Law of Nature, a Natural Phenomenon, or Naturally Occurring Relation or Correlation? If yes, go to Inquiry # 3 The process or method claim is then examined to determine if it uses a natural principle, a natural phenomenon, or naturally occurring relation or correlation in a manner that is a limiting feature of the claim. A natural principle is defined as the handiwork of nature and occurs without the hand of man. For example: The disinfecting property of sunlight is a natural principle. A correlation that occurs naturally when a man-made product such as a drug, interacts with a naturally occurring substance, such as blood, is a natural principle. A claim that recites a correlation used to make a diagnosis is a natural principle.

14 14 3-STEP INQUIRY 3. Practical Application and Preemption A process or method claim (Inquiry # 1) that focuses on a natural principle, law of nature or naturally occurring relation or correlation (Inquiry # 2) will be patent-eligible if the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention. The claim has to amount to significantly more than the natural principle itself. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on claim scope. A bare statement of a naturally occurring correlation would fail this inquiry (the wherein clause) It is not necessary that every element or step integrate or relate to the natural principle as long as it is applied in some practical manner.

15 15 USPTO GUIDELINES Patent-eligible claims A claim that does not include a natural principle as a limitation does not raise an issue under the law of natural exception. A claim that recites the administration of a manmade drug that does not recite other steps or elements directed to the use of a natural principle, such as a naturally occurring correlation. A claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle.

16 16 USPTO GUIDELINES 1. A method of determining the increased likelihood of having or developing rheumatoid arthritis in a patient, comprising the steps of: obtaining a serum sample from a patient; contacting the serum sample with an anti-igm antibody; and determining that the patient has rheumatoid arthritis or an increased likelihood of developing rheumatoid arthritis based upon the increased binding of the anti-igm antibody to IgM rheumatoid factor in the serum sample.

17 17 USPTO GUIDELINES 2. The method of claim 1, further comprising: providing a positive control sample; and contacting the positive control sample with an anti-igm antibody, wherein the step of developing that the patient has rheumatoid arthritis comprises a step of comparing the anti-igm antibody in the serum sample to the positive control sample. 3. The method of claim 1 or 2, wherein the anti-igm antibody is antibody XYZ. 4. The method of claim 2, wherein the step of comparing anti-igm antibody to the positive control sample includes performing assay M and then performing assay N.

18 Assn for Molecular Pathology v. Myriad Genetics Supreme Court, GVR to the Federal Circuit in light of Mayo Federal Circuit issued its decision on August 16, 2012 Interpreted Mayo to apply to process claims only Claims to isolated DNA, cdna and DNA fragments held patent-eligible as well as certain method claims 18

19 Assn for Molecular Pathology v. Myriad Genetics 19 Patent-eligible: 20.A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

20 Assn for Molecular Pathology v. Myriad Genetics 20 Patent-ineligible: 1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor sample which comprises comparing a first sequence selected from the group consisting of a BRCA1 gene with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cdna from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said subject.

21 Strategic Considerations and Practice Points 21 What is patent eligible? Compositions and new uses of compositions Methods applying novel technology, such as new detection methods or laboratory assays Methods reciting unconventional steps Methods that recite the use of otherwise patentable composition

22 22 THANK YOU Questions? Follow the issue on Foleys Blogs Personalized Medicine Bulletin PharmaPatents