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Chapter 16: Biotechnology

Chapter 16: Biotechnology. Patent Issues and Other Controversies David Bankston. Intro to Biotech. What is Biotech?. What does a Biotech company do?. The Use of Biological Processes and Materials… . To Help Solve Problems and Satisfy Needs. Human Genome Project.

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Chapter 16: Biotechnology

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  1. Chapter 16: Biotechnology Patent Issues and Other Controversies David Bankston

  2. Intro to Biotech What is Biotech? What does a Biotech company do? The Use of Biological Processes and Materials… To Help Solve Problems and Satisfy Needs

  3. Human Genome Project • Started 1990 (DOE & NIH) • “Map Out” Reference Sequence of DNA • 3 Billion+ Base Pairs (BP) • 3,000 BP / 1 Gene • Largest Gene 2.4 Million BP • 1 of ~25,000 Genes • 99.9% of BP same in EVERYONE!

  4. Biotech Patent • March 31, 1981 AnandaChakrabarty patented a new single cell life form • A live, human-made micro-organism is patentable subject matter under U.S.C.S. ß101 • *FIRACT CASE* (Ass'nfor Molecular Pathology v. United States PTO, 2011) • Even with the patent, No commercial success – Public Opinion (Fear) Bioengineered Plants, Animals, & Humans How far up the ladder of life should proprietary rights through patents be allowed?

  5. Biotech Patent News

  6. Biological Safety Concerns • (rBGH) recombinant Bovine Growth Hormone Milk threatens health • Ecological Fears • Large Fish for consumption good, but bad on environment • Herbicide-resistant cross-pollinization • International Concerns? • Cartagena Protocol on Biosafety • Acknowledges a country's right to regulate bio-engineered organisms, subject to existing international obligations • Does not require product labeling

  7. USA Labeling Agencies

  8. Bioengineered Food/Fuel

  9. Cloning Concerns

  10. Genetic Testing

  11. FIRACT Ass'nfor Molecular Pathology v. United States PTO Background: On March 31, 1981, AnandaChakrabarty patented an isolated DNA sequences. Myriad Genetics patented isolated DNA sequences BRCA1 and BRCA2 Genes & Method for screening potential cancer therapeutics

  12. FIRACT • Ass'nfor Molecular Pathology v. United States PTO • Decided: July 29, 2011 • I. Declaratory Judgment Jurisdiction • Do the Plaintiffs have standing to exercise declaratory judgment jurisdiction over this case? • II. Patentable Subject Matter- Composition Claims: Isolated DNA Molecules • Does Myriad's composition claims to isolated DNAs provide eligibility for patentability? • III. Method Claims • A. Methods of "Comparing" or "Analyzing" Sequences • Does Myriad's method claims to comparing or analyzing gene sequences provide eligibility for patentability? • B. Method of Screening Potential Cancer Therapeutics • Does Myriad's method claim to screening potential cancer therapeutics via changes in cell growth rates provide eligibility for patentability?

  13. FIRACT • Ass'nfor Molecular Pathology v. United States PTO • Take-Home Message • Federal Court Upheld U.S.C.S. 101 Isolated DNA is patent-eligible subject matter • Diagnostic Methods Functional & Palpable Applications

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