Patenting Human DNA, Embryos andOrgans: Recent Case Law Developments          in the United States             CASRIP 2012...
Topics Covered• Why is Strong Patent Protection Essential  to the Biotechnology Industry?• Historical Context for Broad Pa...
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   ...
Role of Patents• PRO  – Patents provide a limited monopoly     • Competitors are excluded from the market for a       limi...
35 U.S.C. 101    Patentable EligibilityWhoever invents or discovers any new and useful process, machine, manufacture, or c...
Patentable Subject Matter:     Fundamental Principles• Funk Bros. v. Kalo (S.Ct. 1948)   – Mixed culture of root-nodule ba...
Patentable Subject Matter:     Fundamental Principles• Funk Bros. v. Kalo (S.Ct. 1948)   – “Manifestations of nature are f...
Patentable Subject Matter:           Fundamental Principles• Diamond v. Chakrabarty (S.Ct.  1980)   – Dr. Chakrabarty     ...
Patentable Subject Matter:     Fundamental Principles• Diamond v. Chakrabarty (S.Ct. 1980), cont.   – USPTO      • Rejecte...
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...
Myriad v. ACLU (NY FDC 2010) • In May 2009, the ACLU filed a lawsuit against   the USPTO, Myriad Genetics, and the   Unive...
Myriad v. ACLU (NY FDC 2010) • March 29, 2010, Judge Sweet granted   Summary Judgment in favor of the ACLU   – Human genet...
Myriad v. ACLU• Decision appealed to the Federal Circuit   – Myriad Amicus Brief      • Composition of matter claims direc...
Myriad v. ACLU• Department of Justice Amicus Brief   – Genomic DNA that has merely been isolated from     the human body, ...
Myriad v. ACLU (CAFC 2011)• July 29, 2011, Federal Circuit   – Reverses NY District Court       • Composition claims to “i...
Myriad v. ACLU (CAFC 2011)•   CAFC Distinguishes “Isolated” and “Purified”    – Isolated = Patent Eligible?        • The c...
Myriad v. ACLU (S.Ct.)• December 7, 2011: Petition for writ of  certiorari filed with U.S. Supreme Court• March 26, 2012: ...
Practice Tips• Product Claims   – Draft claims to “isolated” rather than “purified” products      • Describe in specificat...
Ethical Issues
Sherley v. Sebelius, (CA Dist. Col.) • Lawsuit, filed in 2009, challenges the   legality of the funding by the National   ...
Patenting of Embryonic Stem Cells • 1998: James Thompson at University of   Wisconsin developed technique to   isolate and...
America Invents Act  (September 16, 2011)– Weldon Amendment  • “*N+o patent may issue on a claim directed to or    encompa...
AIA Legislative History• Representative Lamar Smith (157 Cong. Rec. E1182-85, June 23, 2011)   – Nothing in this section s...
USPTO• September 20, 2011, Robert Bahr, Senior Patent  Counsel• Claims Directed to or Encompassing a Human  Organism   – S...
Induced Pluripotent Stem Cells
Patenting of Induced   Pluripotent Stem Cells• March 23, 2010: Jaenish (Fate  Therapeutics) awarded US patent no.  7,682,8...
Stay Tuned …       Thank You!   Gary M. Myles, Ph.D.gmyles@merchantgould.com      (206) 342-6226
CASRIP 2012 -- Patenting of Human DNA and Embryos
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CASRIP 2012 -- Patenting of Human DNA and Embryos

  1. 1. 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
  2. 2. 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
  3. 3. Many Compounds Tested for Every Product on the Market
  4. 4. 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)
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. 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.”
  10. 10. 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”
  11. 11. Myriad v. ACLU
  12. 12. Central Dogma of Molecular Biology
  13. 13. Gene Cloning
  14. 14. 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
  15. 15. 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.
  16. 16. 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
  17. 17. 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
  18. 18. 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.
  19. 19. 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
  20. 20. 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”
  21. 21. 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
  22. 22. 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
  23. 23. Ethical Issues
  24. 24. 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
  25. 25. 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”
  26. 26. 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
  27. 27. 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
  28. 28. 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”
  29. 29. Induced Pluripotent Stem Cells
  30. 30. Patenting of Induced Pluripotent Stem Cells• March 23, 2010: Jaenish (Fate Therapeutics) awarded US patent no. 7,682,828 on induced pluripotent stem cells
  31. 31. Stay Tuned … Thank You! Gary M. Myles, Ph.D.gmyles@merchantgould.com (206) 342-6226

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