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Patentable Subject Matter in Biotechnology
 

Patentable Subject Matter in Biotechnology

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Knobbe attorneys presented "Patentable Subject Matter in Biotechnology" at a recent seminar held in Japan.

Knobbe attorneys presented "Patentable Subject Matter in Biotechnology" at a recent seminar held in Japan.

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    Patentable Subject Matter in Biotechnology Patentable Subject Matter in Biotechnology Presentation Transcript

    • Patentable Subject Matter in Biotechnology Kerry Taylor October 19, 2012 TokyoThe recipient may only view this work. No other right or license is granted. ©2012 Knobbe, Martens, Olson & all rights reserved. ©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 1
    • Prometheus Labs., Inc. v. Mayo Collaborative Servs. Background: • 6-MP (6-mercaptopurine) drugs were previously known, were known to treat the claimed disease, and were known to metabolize to 6-thioguanine (6-TG). • 6-MP drugs are metabolized to 6-TG by individuals at different rates, and different metabolic rates led to efficacy and toxicity concerns. • Prior art suggested that an individual patient’s concentration of metabolites could predict clinical efficacy and toxicity in that individual. • Inventors discovered the level at which concentration of the metabolite correlated with efficacy and toxicity© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2
    • Prometheus – Representative Claim 1. A method of optimizing therapeutic efficacy for treatment of [a specific] disorder, comprising: (a) administering a drug providing 6-TG to a subject having said … disorder; and (b) determining the level of 6-TG in said subject having said … disorder, wherein the level of 6-TG less than about 230 [units] indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-TG greater than about 400 [units] indicates a need to decrease the amount of said drug subsequently administered to said subject.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3
    • Prometheus – Analyzing the Claims • Administering step – Limits claim scope to a particular environment or audience • Determining step – Not specific; tells doctors to determine the level of metabolites using any (current or future) process – Routine and conventional activity • Wherein clause – Recitation of the natural law / natural phenomenon© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4
    • Prometheus Opinion – Holding • Claims are not patent eligible under 35 U.S.C. § 101 • The administering and detecting steps are not sufficient to transform correlations into specific patentable applications • “Transformation” alone is not sufficient – In “stating that the ‘machine-or-transformation’ test is an ‘important and useful clue’ …, we have neither said nor implied that the test trumps the ‘law of nature’ exclusion.” • Limiting claims to a particular technological field is not the same as reciting a specific application and is insufficient© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
    • Prometheus Opinion – Application of Precedent • Compare: – “It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. … The “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.” (Diehr) – “[Diehr] nowhere suggested that all these steps…were in context obvious, already in use, or purely conventional. …--they transformed the process into an inventive application of the formula.” (Prometheus)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6
    • Association for Molecular Pathology v USPTO (“Myriad”) Isolated DNA Claims • An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. Method Claims • A method for detecting a germline alteration in a BRCA1 gene . . . 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 . . .© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
    • Association for Molecular Pathology v USPTO (“Myriad”)Method Claims• A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises . . . comparing a first sequence . . . made from mRNA from said tumor sample with a second sequence . . . .• A method for screening potential cancer therapeutics which comprises: growing a trans-formed eukaryotic host cell containing an altered BRCA1 gene . . . , growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth . . . , wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8
    • Myriad – Panel Decision • Fractured Three Judge Panel • One Judge Concurring-in-Part, One Judge Dissenting-In-Part • “[T]he [isolated DNA] claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from those found in nature.” • The method claims that recite only “‘comparing’ or ‘analyzing’ two gene sequences fall outside the scope of §101 because they claim only abstract mental processes.” • The method claims for screening potential cancer therapeutics satisfies§101 because the “growing” step is transformative and does more than simply apply a law of nature.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9
    • Myriad – What’s Next? This case is still going through the courts, but the Supreme Court is likely to take it up for consideration© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 10
    • Strategies for Chemical and Biotechnology Inventions©2012 Knobbe, Martens, Olson & all rights reserved.©2012 Knobbe Martens, Olson & Bear, LLPBear, LLP all rights reserved. 11
    • Claim Drafting Strategies • Will modifying the claim to satisfy§101 raise other issues? – Is the claim still useful against your competitor(s)? – Will the claim raise issues of “divided infringement”? – Will the claim embrace the prior art? – Will the claim permit an Examiner to shift the burden in prosecution? • Who is your audience? – USPTO, Federal Circuit and Supreme Court may apply different standards. – How likely are you to enforce your rights in court?© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 12
    • Would This Claim Satisfy§101? 1. A method of optimizing therapeutic efficacy for treatment of [a specific] disorder, comprising: (a) administering a drug providing 6-TG to a subject having said … disorder; (b) determining the level of 6-TG in said subject having said … disorder, wherein the level of 6-TG less than about 230 [units] indicates a need to increase the amount of said drug subsequently administered to said subject, and wherein the level of 6-TG greater than about 400 [units] indicates a need to decrease the amount of said drug subsequently administered to said subject; and (c) administering an increased or decreased amount of said drug as indicated by said level of 6-TG.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 13
    • Would This Claim Satisfy§101? 1. A method of optimizing therapeutic efficacy for treatment of [a specific] disorder, comprising: administering a first amount of a drug providing 6-TG to a patient in need thereof, administering an increased amount of said drug to the patient when an amount of 6-TG in the patient’s blood is less than 230 [units], and administering a decreased amount of said drug to the patient when an amount of 6-TG in the patient’s blood is greater than 400 [units].© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 14
    • Would This Claim Satisfy§101? 1. A method of detecting cancer X comprising: obtaining a tissue sample from a patient at risk of cancer X; and measuring/detecting the level of marker Y in said sample, wherein the presence of marker Y indicates the presence of cancer X.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 15
    • Would This Claim Satisfy§101? 1. A method of treating cancer X, comprising: obtaining a tissue sample from a patient at risk of cancer X; measuring/detecting the level of marker Y in said sample; and administering treatment Z to said patient when marker Y is present in said sample.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 16
    • Hypothetical – Effect on Biotechnology • Compound X is naturally present in dandelion wine, and acts as anti-cancer agent • Researchers have successfully isolated compound X from the dandelion wine© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 17
    • Would These Claims Satisfy § 101? 1. Isolated, purified compound X. 2. An orally-administered capsule comprising: isolated, purified compound X, and a pharmaceutically acceptable carrier. 3. A method of treating cancer comprising: administering the compound X to a patient in need thereof.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 18
    • 12790 El Camino Real Kerry Taylor San Diego, California 92130 Kerry.Taylor@knobbe.com© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 19