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Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
Biotechnology Patent Eligibility
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Biotechnology Patent Eligibility

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This presentation discusses the historical context for the recent court decisions that affect the patent eligibility of biotechnology inventions, including those directed to genes, cDNAs, proteins, …

This presentation discusses the historical context for the recent court decisions that affect the patent eligibility of biotechnology inventions, including those directed to genes, cDNAs, proteins, antibodies, and diagnostic methods. Discussed are the early Funk Brothers and Chakrabarty decisions as well as the Lab Corp, Bilski, Prometheus, Classen, and Myriad court opinions. The impact of the court holdings on the future development of biotechnology inventions, in particular personalized medicine inventions, is analyzed as is the erosion of the requisite incentives of innovative companies to invent and commercialize in areas where patent protection is less certain.

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  • 1. Biotechnology:Technology, Role of Patents, and Patent Eligibility under 35 U.S.C. § 101 University of Washington School of Law Advanced Patent Law P545 Gary M. Myles, Ph.D. February 1, 2012
  • 2. Topics Covered• A Biotechnology Primer• Why is Strong Patent Protection Essential to the Biotechnology Industry?• Biotechnology Patent Claims• Recent Cases Affecting Patent Eligibility under 35 U.S.C. § 101
  • 3. A Biotechnology Primer
  • 4. The Eukaryotic Cell
  • 5. DNA
  • 6. The Central Dogma of Molecular Biology
  • 7. RNA Splicing in Eukaryotic Cells
  • 8. The Genetic Code
  • 9. Amino Acids are the Building Blocks of Proteins
  • 10. Proteins are Linear Polymers of Amino Acids
  • 11. Proteins adopt Three-dimensional Structures
  • 12. Therapeutic Biotech Products• Nucleic Acid-based Therapeutics – DNA-based Cancer Vaccines – RNAi and antisense – Viral Vectors for Gene Therapy• Protein-based Therapeutics – Cytokines and Soluble Receptors – Vaccines against Infectious Disease – Antibodies and other Immunotherapeutics
  • 13. Why is Strong Patent Protection Essential to the Biotechnology Industry?
  • 14. Biotech Drug Discovery Process Timeline
  • 15. Many Compounds Tested for Every Product on the Market
  • 16. 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)
  • 17. Role of Patents• Patents provide a limited monopoly such that competitors are excluded from the market for a limited period of time• The limited monopoly afforded by patent protection provides the incentive for companies to invest in product R&D
  • 18. Biotechnology Patent Claims
  • 19. Biotechnology Patent Claims• Product Claims – A DNA (RNA, polynucleotide) comprising the nucleotide sequence of SEQ ID NO: 1. – A protein (peptide, polypeptide) comprising the amino acid sequence of SEQ ID NO: 2.
  • 20. Biotechnology Patent Claims• Therapeutic Method Claims – A method for the treatment of a disease, said method comprising the step of administering to a patient a composition comprising a DNA (RNA, polynucleotide, protein, peptide, poly peptide) comprising the nucleotide (amino acid) sequence of SEQ ID NO: 1.
  • 21. Biotechnology Patent Claims• Diagnostic Method Claims – A method for the detection of a disease, said method comprising the steps of: • isolating from a patient sample a DNA that is homologous to SEQ ID NO: 1, • comparing the nucleotide sequence of said DNA to the nucleotide sequence of SEQ ID NO: 1, • determining whether said DNA comprises one or more nucleotide substitutions as compared to SEQ ID NO: 1, wherein the presence of a nucleotide substitution is predictive of said disease.
  • 22. 35 U.S.C. 101Patentable Eligibility
  • 23. 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
  • 24. 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
  • 25. 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
  • 26. 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.”
  • 27. 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”
  • 28. Are These Inventions Patentable?• “Biologically pure” bacterial culture – Yes per CCPA in In re Bergy (1977) – The culture is not a “product of nature” because the culture did not exist in nature in its pure form• “Purified and isolated” DNA sequences – Yes per Fed. Cir. In Amgen v. Chugai (1991)• “Purified and isolated” stem cells – Yes per USPTO (Q. Todd Dickinson)• Hydrostatically altered Pacific polyploid oysters, – Yes per Ex parte Allen (BPAI 1987)• A transgenic non-human mammal – Yes per Phil Leder, US Patent No. 4,736,866; “The Harvard Mouse”
  • 29. LabCorp v. Metabolite (S.Ct. 2006) • Claim at issue 13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: • assaying a body fluid for an elevated level of total homocysteine; and • correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate
  • 30. LabCorp v. Metabolite (S.Ct. 2006) • Lower Courts – Upheld the patent claim’s validity and found that LabCorp infringed the claim • Supreme Court – Granted cert to determine whether claim is invalid because it seeks to “claim a monopoly over a basic scientific relationship” • Correlation between in vivo cobalamin/folate levels and in vivo homocysteine levels – Dismissed writ of certiorari as improvidently granted
  • 31. LabCorp v. Metabolite (S.Ct. 2006) • Justice Breyer dissent – Laws of nature are unpatentable because “sometimes too much patent protection can impede rather than ‘promote the Progress of Science and useful Arts.’ ” U.S. Const., Art 1, 8 • “the enormous potential for rent seeking that would be created if property rights could be obtained in [those basic principles]” and • “the enormous transaction costs that would be imposed on would-be users”
  • 32. LabCorp v. Metabolite (S.Ct. 2006) • Justice Breyer, cont. – “There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomenon’ ” – “*t+he process described in claim 13 is not a process for transforming blood or any other matter. – Claim 13’s process instructs the user to • (1) obtain test results and • (2) think about them”
  • 33. So, what makes a process patentable?
  • 34. In re Bilski (Fed. Cir. 2008)Claim 1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of: (a) initiating a series of transactions … ; (b) identifying market participants … ; and (c) initiating a series of transactions … .
  • 35. In re Bilski (Fed. Cir. 2008)• The § 101 inquiry – If a claim preempts substantially all uses of a fundamental principle, it is unpatentable subject matter – If a claim preempts only a particular application of a fundamental principle, it is patentable subject matter
  • 36. In re Bilski (Fed. Cir. 2008)• Federal Circuit applies a machine-or- transformation test to determine preemption of a fundamental principle – A claimed process is directed to patentable subject matter under § 101 if it: (1) is tied to a particular machine or apparatus; or (2) transforms a particular article into a different state or thing
  • 37. Diagnostic Tools and Personalized Medicine: The Future of Biotechnology? Health Care in the 21st Century P4 Medicine: • Predictive • Preventive • Personalized • ParticipatoryLee Hood, M.D., Ph.D.PresidentInstitute for Systems Biology
  • 38. Diagnostic Tools and PersonalizedMedicine: The Future of Biotechnology? • Genomic Personalized Medicine – Information about a patients genotype or gene expression profile used to tailor medical care • Provide a specific therapy for an individuals disease • Initiate a preventative measure suited to an individual • “Rational drug design" based on knowledge of disease pathophysiology
  • 39. Vioxx May Increase the Risk of Heart Attacksand Strokes -- Arthritis Drug Vioxx Taken Off the Market as Unsafe • WASHINGTON, D.C. — October 4, 2004 — A major drug manufacturer, Merck, has withdrawn its painkiller Vioxx (rofecoxib) from the market because it may increase the risk of heart attacks and strokes (FDA News, September 30, 2004). Vioxx is a nonsteroidal anti–inflammatory drug (NSAID) that blocks the enzyme COX–2. The Food and Drug Administration (FDA) approved the drug in 1999 to relieve arthritis symptoms, severe pain in adults, and painful menstrual cycles. • Merck’s decision to halt Vioxx sales is based on data from a long–term clinical trial to see if Vioxx could be effective in preventing new polyps from forming in colon cancer patients. The researchers stopped the study when they discovered that patients who took Vioxx had a greater risk of heart attacks and strokes than those who took a placebo (a sugar pill). The increased risk was particularly great in patients who had been taking Vioxx for more than 18 months.
  • 40. Diagnostic Tools and PersonalizedMedicine: The Future of Biotechnology? • A method for detecting in a patient a Vioxx- associated risk of heart attack, said method comprising the step of: - identifying in said patient a mutation in a “Vioxx risk gene,” wherein the presence of said “Vioxx risk gene” indicates an increased probability in said patient of heart attack following the administration of Vioxx
  • 41. Classen v. Biogen (DC MD 2006)• Classen ‘283 Patent claims: – A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune- mediated disorder…, comprising • immunizing …; and • comparing the incidence of chronic immune mediated disorders … relative to a control group
  • 42. Classen v. Biogen (DC MD 2006)• DC MD – “The * + patent does not claim a specific technique or technical process of testing [ ] safety – Instead, the [ ] patent describes only a general inquiry of whether the proposed correlation between an immunization schedule and the incidence of chronic disorders exists – As such, the process is indistinguishable from the idea itself – Accordingly, the [ ] patent seeks to patent an unpatentable natural phenomenon”
  • 43. Classen v. Biogen (CAFC 2008) • Federal Circuit – “In light of our decision in In re Bilski … we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. 101 – Dr. Classen’s claim is neither ‘tied to a particular machine or apparatus’ nor does it ‘transform a particular article into a different state or thing’ ” • Classen files a petition for writ certiorari to the U.S. Supreme Court
  • 44. Prometheus v. Mayo (SD CA 2008) • Prometheus Claim 1 – A method of optimizing therapeutic efficacy…, comprising: • administering a drug providing 6-thioguanine to a subject…; and • determining the level of 6-thioguanine in said subject … wherein – 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug – 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug
  • 45. Prometheus v. Mayo (SD CA 2008) • District Court – Claimed correlations between certain thiopurine drug metabolite levels and therapeutic efficacy and toxicity are natural phenomena • Result from innate metabolic activity in human body • Inventors did not “create” the correlation; the correlation results from a natural body process • Claims wholly preempt use of the correlations – The only practical use of the correlation is in drug treatment for autoimmune diseases
  • 46. Prometheus v. Mayo (Fed. Cir. 2009) • September 2009, Federal Circuit reverses district court upholding patentability of methods for calibrating a drug dosage under 35 USC § 101
  • 47. Prometheus v. Mayo (Fed. Cir. 2009) • Federal Circuit, cont. – Applying the Bilski Machine or Transformation test, the required administration of a drug “transforms an article into a different state or thing.” – Distinguish diagnosis claims that merely require data gathering and correlation rather than injection of drugs
  • 48. Prometheus v. Mayo• October 2009, Mayo files a petition for writ of certiorari to the U.S. Supreme Court• Question Presented “Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations”
  • 49. Bilski v. Kappos (S.Ct. 2010)• June 28, 2010, Supreme Court affirms CAFC Bilski decision – The machine or transformation test is not the exclusive test for patent eligibility, but in most instances the existence of a machine or transformation is highly relevant to the question of patent eligibility – Grants certiorari, Vacates the Federal Circuit’s Classen and Prometheus decisions and Remands to the Federal Circuit in view of its Bilski decision
  • 50. Classen v. Biogen (CAFC 2011) • August 31, 2011, on remand from S.Ct., CAFC affirms prior decision – “Methods that simply collect and compare data, without applying the data in a step of the overall method, fail to traverse the § 101 filter.” – Considered the “immunizing” step as the gathering of published data – Moore (dissent) • Criticized majority for mischaracterizing the “immunizing mammals” step as “reviewing the effects of known immunization schedules.” • Nonetheless, distinguishes Prometheus’ claims, which are directed to administration of a specific compound for a specific disease • Petition for writ certiorari to the U.S. Supreme Court due November 29, 2011
  • 51. Prometheus v. Mayo (CAFC 2010) • December 17 2010, on remand from S.Ct., CAFC upholds claim validity – Bilski provides broad – although not unlimited – scope for patent protection, and “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” – Patent eligibility rests on the specific treatment steps recited by the claims: the “administering” step and the “determining” step.
  • 52. Prometheus v. Mayo (CAFC 2010) • December 17 2010, on remand from S.Ct., CAFC upholds claim validity – “The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment.”
  • 53. Prometheus v. Mayo (CAFC 2010) • December 17 2010, on remand from S.Ct., CAFC upholds claim validity – The asserted claims are “claims to methods of treatment, which are always transformative, when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” – The “determining” step is transformative because it involves “some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims … ” – The presence of “mental steps” does not “negate the transformative nature of prior steps.”
  • 54. Prometheus v. Mayo• June 20, 2011, Supreme Court grants certiorari• Question Presented: – Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.• Oral arguments heard on December 7, 2011
  • 55. Prometheus v. Mayo• Mayo’s Amicus Brief – Prometheuss patent claims "preemp[t] all practical use of an abstract idea, natural phenomenon, or mathematical formula." – “Recite a natural phenomenon—the biological correlation between metabolite levels and health—without describing what is to be done with that phenomenon beyond considering whether a dosage adjustment may be necessary." – The claims drug-administration and metabolite- measurement steps are merely "token and conventional data-gathering steps" that cannot establish subject-matter eligibility. – Patent protection is unnecessary to promote the development of diagnostic methods like those claimed and will in fact interfere with both their development and actual medical practice.
  • 56. Prometheus v. Mayo• United States Solicitor General – The claimed methods recite "patent-eligible subject matter," and petitioners objections to patentability are properly understood as challenges to the claimed methods novelty and nonobviousness.
  • 57. Prometheus v. Mayo• Roche & Abbott – Patents are crucial for innovation in personalized medicine and … development diagnostic tests that can enable such medicines practice. – Arguments "that patents on diagnostic tests stifle innovation and basic scientific research" are "largely based on speculation, rather than sound evidence.“ – “Market-driven business practices and self- enforcing market norms correct for any perceived limitations on the accessibility of patented diagnostic technologies.”
  • 58. 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 the human BRCA1/BRCA2 DNA and methods employing the detection of the BRCA1/BRCA2 gene/mRNA for the diagnosis of breast and ovarian cancer
  • 59. Myriad v. ACLU (NY FDC 2010) • Claims at Issue – An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.
  • 60. Myriad v. ACLU (NY FDC 2010) • Claims at Issue – A method for diagnosing a predisposition for breast cancer in a human subject which comprises • comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
  • 61. Myriad v. ACLU (NY FDC 2010) • ACLU argued: – “Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article 1, section 8, clause 8 of the United States Constitution and 35 U.S.C. § 101.” – Art. 1, Sect. 8, Clause 8 “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”
  • 62. Myriad v. ACLU (NYFDC 2010)• March 29, 2010, Judge Sweet granted Summary Judgment in favor of the ACLU – Human genetic sequences and the scientific inquiry of looking at a gene or comparing two genes are not patentable • constitutes a natural phenomena, a law of nature, and abstract ideas
  • 63. 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 – “Products of nature” are patentable and have been held to be for nearly 100 years – Such a “sweeping exception” would bar the patenting of pharmaceuticals derived from natural sources (e.g., Taxol)
  • 64. Myriad v. ACLU• Decision appealed to the Federal Circuit – Myriad Amicus Brief • Methods of diagnosis claims are patent eligible, in part, because they all require physical transformation of a DNA sample (i.e., isolation, processing, and analysis) that satisfies the Bilski machine or transformation test – NOTE: Compare Prometheus » Methods that involve the processing of a biological sample “necessarily involve a transformation” and, thus, meet the Bilski machine or transformation test
  • 65. 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. – Nor is the fact that particular natural mutations in that unique chain increase a womans chance of contracting breast or ovarian cancer."
  • 66. Myriad v. ACLU (CAFC 2011)• July 29, 2011, Federal Circuit – Affirms NY District Court • Method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible because they do not include a transformative step and cover only abstract, mental steps – Reverses NY District Court • Composition claims to “isolated” DNA are patent eligible since the molecules as claimed do not exist in nature
  • 67. 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 = 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”
  • 68. Myriad v. ACLU (S.Ct.)• October 12, 2011, ACLU announces decision to petition U.S. Supreme Court for writ of certiorari• Petition filed on December 7, 2011
  • 69. Post Myriad Point- Counterpoint• Patents give a monopoly to one company, which makes the costs of products and diagnostic tests prohibitively expensive for those without insurance vs.• Without patents, companies have a greatly reduced incentive to take risk and, as a consequence, are less likely to invest in the development of products and diagnostic tests
  • 70. 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
  • 71. Practice Tips• Method Claims – Draft method claims that recite a transformative step • Administering a compound • Isolating or purifying a sample • Determining a sequence (avoid a solely mental step) • Detecting a molecule – Draft method claims that recite the use of a machine in a method step • Apparatus used to sequence a nucleic acid or protein • Device to measure a particular parameter. – Draft method claims that include an end result step that follows an analysis or comparison • Adjusting a dosage • Performing a treatment protocol
  • 72. Stay Tuned … Thank You! Gary M. Myles, Ph.D.gmyles@merchantgould.com (206) 342-6226
  • 73. Market Capitalization
  • 74. US National Biotech Clusters
  • 75. Top US Companiesby Market Capitalization (Oct 2007)• Exxon Mobil $511B• General Electric $414B• Microsoft $328B
  • 76. • Therapeutic Proteins are expressed through Recombinant DNA Technology Recombinant Protein
  • 77. Seattle Biotechnology Products Approved for Marketing by the FDAEnbrel Immunex/Amgen Rheumatoid Arthritis Nov 1998Cialis ICOS/Eli Lilly Erectile Dysfunction Nov 2003Recothrom ZymoGenetics Surgical Bleeding May 2008BEXXAR Corixa/GlaxoSmithKline CD20-positive May 2008 Non-Hodgkins LymphomaProvenge Dendreon Prostate Cancer Apr 2010
  • 78. Recombinant Proteins as Therapeutics• Rheumatoid Arthritis
  • 79. Recombinant Proteins as Therapeutics • Cytokines, such as tumor necrosis factor, promote an inflammatory response • Causes the clinical problems associated with autoimmune disorders such as rheumatoid arthritis
  • 80. Enbrel – Soluble TNF-R
  • 81. Recombinant Proteins as Therapeutics • Enbrel (Immunex/Amgen) – Recombinant soluble TNFα-R – Binds soluble, extracellular TNFα thereby preventing its binding to cellular TNF α-R – Therapeutic efficacy for the auto-immune disease rheumatoid arthritis (RA)
  • 82. ImmunexU.S. Patent Nos. 5,712,155 and 5,945,397An isolated DNA sequence selected from the group consisting of: (a) a DNA sequence that encodes a polypeptide having the amino acid sequence selected from the group consisting of amino acids 1 to X of FIG. 2A and amino acids 1 to 233 of FIG. 3A, wherein X is an amino acid from 163 to 235; and (b) a DNA sequence capable of hybridization to the complement of the DNA sequence of (a) under moderately stringent conditions (50oC., 2x SSC) and which encodes a polypeptide that is capable of binding to TNF and which is at least 88% identical to a polypeptide encoded by the DNA of (a).A composition consisting essentially of a protein comprising a sequence of amino acids selected from the group consisting of amino acids 1-163 of SEQ ID NO:2 and amino acids 1-233 of SEQ ID NO:4, wherein said protein is capable of binding TNF.
  • 83. Antibodies
  • 84. Antibody TherapeuticsTarget Mouse Ab (IgG) Chimeric Ab Ag (Variable region is exchanged) Humanized Ab CH1 CH1 CH1 CH1 1st Generation CL CL CL CL (CDRs exchanged) CH2 CH2 CH2 CH2 1975 1983 CH3 CH3 CH3 CH3 CH1 CH1 CL CL CH2 CH2 1986 CH3 CH3 CH1 CH1 CL CL CH1 CH1 CL CL Fully human CH2 CH2 Ab CH2 CH2 1988 1990s CH3 CH3 Humanized Ab – 2nd Generation CH3 CH3 (CDRs / FW residues exchanged)
  • 85. Anti-CD20 Antibodies• Non-Hodgkin’s Lymphoma – B-cells expressing CD20, a phosphoprotein found on the surface of >90% of B cells from peripheral blood or lymphoid organs
  • 86. Rituxan
  • 87. Bexxar(Corixa/GlaxoSmithKilne)
  • 88. Corixa U.S. Patent No. 6,015,542A composition comprising:(1) a radioactively labelled monoclonal antibody or radioactively labelled monoclonal antibody fragment in an amount providing 1 to 200 mCi of radioactivity and providing irradiation in a dose range of 10 to 200 cGy [Rads] to the whole body of a human patient, said amount being effective for achieving remission of B- cell lymphoma in the patient, wherein said antibody or said antibody fragment binds to CD20 antigen present on the surface of cells of B-cell lymphoma and wherein the amount of radioactivity that labels the antibody or antibody fragment is less than the amount which causes myelosuppression severe enough to require the reintroduction of hematopoietic stem cells into said patient in order for the patient to recover hematopoietic function, and(2) a pharmaceutically acceptable carrier.
  • 89. Biotechnology vs. Pharmaceutical• Biotechnology: The use of biomolecules to treat disease• Pharmaceutical: The use of small molecules to treat disease
  • 90. What are Biomolecules?• Genetic Material – DNA – RNA• Proteins – Receptors and Ligands – Enzymes – Antibodies• Lipids• Carbohydrates

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