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CASRIP 2012 -- Patenting of Human DNA and Embryos
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CASRIP 2012 -- Patenting of Human DNA and Embryos






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    CASRIP 2012 -- Patenting of Human DNA and Embryos CASRIP 2012 -- Patenting of Human DNA and Embryos Presentation Transcript

    • Patenting Human DNA, Embryos andOrgans: Recent Case Law Developments in the United States CASRIP 2012 High Technology Protection Summit Gary M. Myles, Ph.D. July 28, 2012
    • Topics Covered• Why is Strong Patent Protection Essential to the Biotechnology Industry?• Historical Context for Broad Patent Eligibility for Biotechnology Inventions under 35 U.S.C. § 101• Patent Eligibility of DNA• Patent Eligibility of Embryos and Stem Cells
    • Many Compounds Tested for Every Product on the Market
    • Very Expensive and Time Consuming to Get a Biotech Product on the Market • Average Cost to Develop a New Biotechnology Product is $1.2 Billion, According to the Tufts Center for the Study of Drug Development (November 09, 2006)
    • Role of Patents• PRO – Patents provide a limited monopoly • Competitors are excluded from the market for a limited period of time • Provides the incentive for companies to invest in product R&D• CON – Too much protection can stifle innovation and inhibit patient access to needed therapeutics and diagnostics
    • 35 U.S.C. 101 Patentable EligibilityWhoever 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
    • Patentable Subject Matter: Fundamental Principles• Funk Bros. v. Kalo (S.Ct. 1948) – Mixed culture of root-nodule bacteria for inoculating seeds of leguminous plants • No patentable subject matter – Each species infects same group of plants – No species acquires a different use – No change in the individual bacteria – No change in their individual utilities – Use in combination does not improve natural functioning
    • Patentable Subject Matter: Fundamental Principles• Funk Bros. v. Kalo (S.Ct. 1948) – “Manifestations of nature are free to all men and reserved exclusively to none” • Laws of nature – E = mc2 – Law of gravity • Physical phenomena • Principles • Abstract ideas • Products of nature
    • Patentable Subject Matter: Fundamental Principles• Diamond v. Chakrabarty (S.Ct. 1980) – Dr. Chakrabarty • Created oil-eating bacterium • Claimed “a bacterium from the genus Pseudomonas containing therein at least two stable energy- generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.”
    • Patentable Subject Matter: Fundamental Principles• Diamond v. Chakrabarty (S.Ct. 1980), cont. – USPTO • Rejected claim because a bacterium is – A “product of nature” – A living thing – Supreme Court • Upholds validity of Chakrabarty’s claim – “Anything under the sun that is made by man”
    • Myriad v. ACLU
    • Central Dogma of Molecular Biology
    • Gene Cloning
    • Patentability of DNA• Federal Circuit – Amgen v. Chugai (CAFC 1991) • Court upholds validity of claims directed to “*a+ purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin.” – In re Kubin (CAFC 2009) • “The isolation and sequencing of a human gene that encodes a particular domain of a protein” is “a classic biotechnology invention”• USPTO – Utility Examination Guidelines, 66 Fed. Reg. 1092 (2001) • “A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature.” – Issued >2,000 patents to isolated and purified DNA
    • Myriad v. ACLU (NY FDC 2010) • In May 2009, the ACLU filed a lawsuit against the USPTO, Myriad Genetics, and the University of Utah Research Foundation • Challenged patents claiming, inter alia: • An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.
    • Myriad v. ACLU (NY FDC 2010) • March 29, 2010, Judge Sweet granted Summary Judgment in favor of the ACLU – Human genetic sequences are not patentable • constitutes a natural phenomena, a law of nature, and abstract ideas
    • Myriad v. ACLU• Decision appealed to the Federal Circuit – Myriad Amicus Brief • Composition of matter claims directed towards isolated DNA molecules are patent eligible, in part, because they have “markedly different characteristics” than their naturally occurring counterparts
    • Myriad v. ACLU• Department of Justice Amicus Brief – Genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. – The unique chain of chemical base pairs that induces a human cell to express a cancer protein is not a human-made invention.
    • Myriad v. ACLU (CAFC 2011)• July 29, 2011, Federal Circuit – Reverses NY District Court • Composition claims to “isolated” DNA are patent eligible since the molecules as claimed do not exist in nature
    • Myriad v. ACLU (CAFC 2011)• CAFC Distinguishes “Isolated” and “Purified” – Isolated = Patent Eligible? • The claimed “isolated” molecule has “a markedly different chemical structure” or “a distinctive chemical identity and nature” from a molecule that exists in nature • “Isolated” molecules are “manipulated chemically” … “chemically cleaved from their chemical combination with other *+ materials” as exists in nature … differences “are directly related to the change in chemical bonds.” – Purified = Patent Ineligible? • “Purification makes pure what was the same material, but was previously impure” • “Mere purification of a naturally occurring element is typically insufficient to make it patentable subject matter”
    • Myriad v. ACLU (S.Ct.)• December 7, 2011: Petition for writ of certiorari filed with U.S. Supreme Court• March 26, 2012: Petition granted, judgment vacated, case remanded to CAFC for decision in light of Mayo v. Prometheus• July 20, 2012: CAFC heard oral arguments
    • Practice Tips• Product Claims – Draft claims to “isolated” rather than “purified” products • Describe in specification how “isolated” product is structurally and chemically distinct from what is found in nature • Describe in specification new uses or functions for the claimed product as compared to a natural product in its natural environment. – Draft claims to commercial embodiments • Compositions and /or kits comprising “isolated” or “purified” products • Hybrid and fusion molecules • Vectors • Recombinant cells
    • Ethical Issues
    • Sherley v. Sebelius, (CA Dist. Col.) • Lawsuit, filed in 2009, challenges the legality of the funding by the National Institutes of Health of hESC research • 1996 Dickey-Wicker amendment bars US from supporting research in which a human embryo is “destroyed, discarded, or knowingly subjected to risk of injury or death.” • Oral arguments heard April 23, 2012
    • Patenting of Embryonic Stem Cells • 1998: James Thompson at University of Wisconsin developed technique to isolate and grow human embryonic stem cells in culture • USPTO Issued the following patents, assigned to WARF: – US 5,843,780 “Primate Embryonic Stem Cells” – US 6,200,806 “Primate Embryonic Stem Cells” – US 7,029,913 “Primate Embryonic Stem Cells”
    • America Invents Act (September 16, 2011)– Weldon Amendment • “*N+o patent may issue on a claim directed to or encompassing a human organism” Pub.L. 112- 29, H.R. 1249, Section 33(a) • Controversy over whether “directed to” a human organism may be construed to exclude patents for DNA, stem cells, or other technologies
    • AIA Legislative History• Representative Lamar Smith (157 Cong. Rec. E1182-85, June 23, 2011) – Nothing in this section should be construed to limit the ability of the USPTO to issue a patent containing claims directed to: • Chemical compounds whether obtained from animal/human or produced synthetically … including nucleic acids, polypeptides, proteins, antibodies and hormones • Cells, tissue, organs or other bodily components produced through human intervention … including stem cells, stem cell derived tissues … synthetic organs • Methods for creating, modifying, or treating human organisms including … methods for creating embryos … • Nonhuman organism incorporating genes from human
    • USPTO• September 20, 2011, Robert Bahr, Senior Patent Counsel• Claims Directed to or Encompassing a Human Organism – Section 33(a) of the AIA “does not change existing law or longstanding USPTO policy that a claim encompassing a human being is not patentable”
    • Induced Pluripotent Stem Cells
    • Patenting of Induced Pluripotent Stem Cells• March 23, 2010: Jaenish (Fate Therapeutics) awarded US patent no. 7,682,828 on induced pluripotent stem cells
    • Stay Tuned … Thank You! Gary M. Myles, Ph.D.gmyles@merchantgould.com (206) 342-6226