Transcript What is a Patent?

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
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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
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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
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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
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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
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Parts of a Patent
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Abstract
Figures
Background of invention
Summary of invention
Detailed description of invention
Examples
CLAIMS
 Define scope of right to exclude
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© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.
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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
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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?
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How to Search for Patents and Applications
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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)
 Internet
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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
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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
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Isolation methods
Generation methods
Detection methods
Therapeutic methods
Prophylactic methods
Screening methods
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Stem Cell Patenting
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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
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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
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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
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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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