Stem Cells and Intellectual Property May 13, 2009
presented by: Maryanne Trevisan Daniel Young O. Tobias Brambrink Wolf, Greenfield & Sacks, P.C. | 600 Atlantic Avenue | Boston, Massachusetts 02210 | 617.646.8000 | 617.646.8646 fax | wolfgreenfield.com
Presentation Team Maryanne Trevisan
Daniel W. Young
Shareholder, Biotechnology Group
Patent Agent, Biotechnology Group
B.S. Molecular Genetics and Biology Specialist, University of Toronto Ph.D., Medical Biophysics, University of Toronto J.D., Suffolk University Law School
B.S., Marine Engineering, Mass. Maritime Academy M.E., Biomedical Engineering, Worcester Polytechnic Institute Ph.D., Biomedical Science, University of Massachusetts Medical School J.D., 2012 Candidate, Suffolk University Law School
O. Tobias Brambrink Technology Specialist, Biotechnology Group B.S., Biology, University of Wuerzburg M.S., Biology, University of Wuerzburg Ph.D., Biology, University of Wuerzburg
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Agenda
Intellectual Property/Patent Introduction Medical Librarian Interface with Patents Stem Cell Patenting Introduction Particular Stem Cell Patenting Developments
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Intellectual Property Protection Patents Right to exclude; quid pro quo
Trademarks Indicator of source and quality
Copyrights Prevent unauthorized copying
Trade secrets “Secret” providing economic advantage © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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Why Patent? Competitive advantage Exclude others from practicing invention Build fences around your invention
Secure investment Licensing revenue Allow others to practice invention for $$
Mark of innovation, cutting edge research Annual reports Hiring © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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What is a Patent? Intangible property right that gives owner right to exclude others from making, using, selling, offering to sell, or importing invention Look to claims for limits of exclusionary rights
Not necessarily right to practice invention yourself Must check others’ patent rights before commercializing
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What Can You Patent? Processes Diagnostic, prophylactic, therapeutic methods “Machine-or-Transformation” test
Machines CT scanner, cell sorters, engines
Compositions Drugs, cells, non-human organisms
Manufactures New forms for raw materials
Not laws of nature, physical phenomena, or abstract ideas
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Standards of Patentability Useful Specific, substantial and credible utility (landfill or paperweight utility not enough)
Novel Not publicly known, not offered for sale, not in use publicly Prior art: literature references, patents, patent applications, talks, abstracts, conference proceedings, information on internet, etc.
Non-obvious Difference between what is claimed and what is known in art is obvious to person of ordinary skill in art © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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Standards for Patentability (cont) Written description What is invention?
Enablement How to make and use invention?
Best mode Best way known to practice invention – subjective test
No morality requirement in US (but see EP) Quid pro quo system Limited exclusionary rights followed by dedication of invention to public © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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Parts of a Patent
Abstract Figures Background of invention Summary of invention Detailed description of invention Examples CLAIMS Define scope of right to exclude
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Patent Process 0 YEARS
EXAMINATION
ALLOWANCE
PATENT ISSUES
RESPONSE(S)
PUBLICATION
REGULAR APPLICATION
CONCEPTION
WITHIN 1 YEAR TERM: 20 YEARS FROM EARLIEST FILING DATE © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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Patents v. Patent Applications U.S. patents published upon grant Rights granted by USPTO
Some but not all U.S. patent applications are published Rights being pursued by patent applicant Monitor progress made by patent applicant WWW.uspto.gov → Patents → Public PAIR
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Post Grant Issues Re-issue Re-examination Substantially new question of patentability
Enforcement Invalidity challenges: invalid claims Inequitable conduct: unenforceable patent
Opposition EP, not US (but see proposed Patent Reform)
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U.S. versus Foreign Patent Rights U.S. patent only grants exclusionary rights in the U.S. For foreign rights “International” applications (PCT) Regional applications (EP) National applications (TW)
Know jurisdictional patent law differences What can you patent? Method of treatment (EP)? Only novel compositions (IN)?
Absolute novelty required? Deposit of biological required? © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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How to Search for Patents and Applications
www.uspto.gov → Patents, Search Patents www.wipo.int/pctdb/en/ www.espacenet.com → Advanced Search www.epoline.org → Register Plus www.pat2pdf.org JAPIO $$ Chinese Abstracts $$
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How to Search for Prior Art Patent/patent applications searching See websites (previous page)
Literature reference searching PubMed (www.ncbi.nlm.nih.gov/sites/entrez)
Chemical structure searching CAS/STN searches (www.cas.org/) $$
Nucleic acid/Amino acid sequence searching PubMed (blast.ncbi.nlm.nih.gov → nucleotide or amino acid sequence)
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What to Look for? Invention Claims versus specification Know equivalent terminology: Stem cells Precursors Progenitors
Inventor Assignee/Owner Company, Institute
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Stem Cell Patenting
Markers Stem Cells
Assays
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Reagents
Therapeutic Applications
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Stem Cell Patenting Compositions
Isolated stem cells (derived from natural sources) De novo generated stem cells (iPS cells) Probes (e.g., antibodies) specific for stem cells Molecules that drive self-renewal, differentiation, dedifferentiation
Processes
Isolation methods Generation methods Detection methods Therapeutic methods Prophylactic methods Screening methods
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Stem Cell Patenting Totipotent versus pluripotent Deposit requirements for lines, antibodies Commercialization potential Range of sources: adult, cord blood, embryonic 878 granted patents with “stem cell” in claims 3178 patent applications with “stem cell” in claims
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Embryonic Stem Cell Patents
James Thomson/WARF US 5843780 (primate ES cells) US 6200806 (human ES cells) US 7029913 (human ES cell cultures) others
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WARF’s “Power-Play” Patents Required licenses from academic and commercial researchers
Federal funding restrictions ES cell lines were on short list Guaranteed customers
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WARF US Patents Challenged Re-examinations brought by Public Patent Foundation on behalf of the Foundation for Taxpayer and Consumer Rights Asserted claims were not novel and/or obvious in view of prior art relating to ES cell generation from other non-human species WARF amended claims to recite “preimplantation embryo” as source (effect on iPS) USPTO concluded that WARF claims are valid: novel and non-obvious in view of cited art © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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WARF’s EP Patent Application Denied Contravened morality requirement Claims to ES cell cultures contravened EP patent law provision which states: “European Patents shall not be granted in respect of biotechnology inventions which …concern…..(c) uses of human embryos for industrial or commercial purposes.”
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WARF’s EP Patent Application Denied (cont) Issue was whether specification described practice of invention without requirement of embryo destruction Applies to any composition, method, use requiring destruction of embryo to practice invention Suggestion: Describe another way of getting to invention for EP protection
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Looking Forward iPS cells Shouldn’t be hampered by re-examined WARF patents No morality issues in EP (do not use/destroy embryos) See Izumi PCT applications WO2009/007852 WO2009/006997 WO2009/006930
1. A human stem cell that is pluripotent, somatic, non-embryonic, and having the property of long-term self renewal. 2. A human stem cell that is somatic, non-embryonic, alkaline phosphatase positive, and expresses two or more genes selected from the group consisting of TDGFl , Dnmt3b, FoxD3, GDF3, Cyp26al , TERT, zfp42, Sox2, Oct3/4, and Nanog. 3. A human stem cell generated by a method comprising forcing the expression of an Oct3/4 polypeptide, a Sox2 polypeptide, and a Klf4 polypeptide in human postnatal cells to obtain one or more colonies of cells that have a high nucleus to cytoplasm ratio and are smaller in size than cells surrounding the one or more colonies, and isolating at least one of the one or more colonies.
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Questions??
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