Stem Cells and Intellectual Property

Stem Cells and Intellectual Property May 13, 2009 presented by: Maryanne Trevisan Daniel Young O. Tobias Brambrink Wolf, Greenfield & Sacks, P.C. | 6...
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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

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Agenda ƒ ƒ ƒ ƒ

Intellectual Property/Patent Introduction Medical Librarian Interface with Patents Stem Cell Patenting Introduction Particular Stem Cell Patenting Developments

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Intellectual Property Protection ƒ Patents ƒ Right to exclude; quid pro quo

ƒ Trademarks ƒ Indicator of source and quality

ƒ Copyrights ƒ Prevent unauthorized copying

ƒ Trade secrets ƒ “Secret” providing economic advantage © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Why Patent? ƒ Competitive advantage ƒ Exclude others from practicing invention ƒ Build fences around your invention

ƒ Secure investment ƒ Licensing revenue ƒ Allow others to practice invention for $$

ƒ Mark of innovation, cutting edge research ƒ Annual reports ƒ Hiring © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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What is a Patent? ƒ Intangible property right that gives owner right to exclude others from making, using, selling, offering to sell, or importing invention ƒ Look to claims for limits of exclusionary rights

ƒ Not necessarily right to practice invention yourself ƒ Must check others’ patent rights before commercializing

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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What Can You Patent? ƒ Processes ƒ Diagnostic, prophylactic, therapeutic methods ƒ “Machine-or-Transformation” test

ƒ Machines ƒ CT scanner, cell sorters, engines

ƒ Compositions ƒ Drugs, cells, non-human organisms

ƒ Manufactures ƒ New forms for raw materials

ƒ Not laws of nature, physical phenomena, or abstract ideas

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Standards of Patentability ƒ Useful ƒ Specific, substantial and credible utility (landfill or paperweight utility not enough)

ƒ Novel ƒ Not publicly known, not offered for sale, not in use publicly ƒ Prior art: literature references, patents, patent applications, talks, abstracts, conference proceedings, information on internet, etc.

ƒ Non-obvious ƒ 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) ƒ Written description ƒ What is invention?

ƒ Enablement ƒ How to make and use invention?

ƒ Best mode ƒ Best way known to practice invention – subjective test

ƒ No morality requirement in US (but see EP) ƒ Quid pro quo system ƒ 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 ƒ ƒ ƒ ƒ ƒ ƒ ƒ

Abstract Figures Background of invention Summary of invention Detailed description of invention Examples CLAIMS ƒ Define scope of right to exclude

© 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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© 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 © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Patents v. Patent Applications ƒ U.S. patents published upon grant ƒ Rights granted by USPTO

ƒ Some but not all U.S. patent applications are published ƒ Rights being pursued by patent applicant ƒ Monitor progress made by patent applicant ƒ WWW.uspto.gov → Patents → Public PAIR

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Post Grant Issues ƒ Re-issue ƒ Re-examination ƒ Substantially new question of patentability

ƒ Enforcement ƒ Invalidity challenges: invalid claims ƒ Inequitable conduct: unenforceable patent

ƒ Opposition ƒ EP, not US (but see proposed Patent Reform)

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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U.S. versus Foreign Patent Rights ƒ U.S. patent only grants exclusionary rights in the U.S. ƒ For foreign rights ƒ “International” applications (PCT) ƒ Regional applications (EP) ƒ National applications (TW)

ƒ Know jurisdictional patent law differences ƒ What can you patent? ƒ Method of treatment (EP)? ƒ Only novel compositions (IN)?

ƒ Absolute novelty required? ƒ Deposit of biological required? © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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How to Search for Patents and Applications ƒ ƒ ƒ ƒ ƒ ƒ ƒ

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 $$ Chinese Abstracts $$

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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How to Search for Prior Art ƒ Patent/patent applications searching ƒ See websites (previous page)

ƒ Literature reference searching ƒ PubMed (www.ncbi.nlm.nih.gov/sites/entrez)

ƒ Chemical structure searching ƒ CAS/STN searches (www.cas.org/) $$

ƒ Nucleic acid/Amino acid sequence searching ƒ PubMed (blast.ncbi.nlm.nih.gov → nucleotide or amino acid sequence)

ƒ Internet © 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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What to Look for? ƒ Invention ƒ Claims versus specification ƒ Know equivalent terminology: ƒ Stem cells ƒ Precursors ƒ Progenitors

ƒ Inventor ƒ Assignee/Owner ƒ Company, Institute

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Stem Cell Patenting

Markers Stem Cells

Assays

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

Reagents

Therapeutic Applications

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Stem Cell Patenting ƒ Compositions ƒ ƒ ƒ ƒ

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

ƒ Processes ƒ ƒ ƒ ƒ ƒ ƒ

Isolation methods Generation methods Detection methods Therapeutic methods Prophylactic methods Screening methods

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Stem Cell Patenting Totipotent versus pluripotent Deposit requirements for lines, antibodies Commercialization potential Range of sources: adult, cord blood, embryonic ƒ 878 granted patents with “stem cell” in claims ƒ 3178 patent applications with “stem cell” in claims ƒ ƒ ƒ ƒ

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Embryonic Stem Cell Patents ƒ ƒ ƒ ƒ ƒ

James Thomson/WARF US 5843780 (primate ES cells) US 6200806 (human ES cells) US 7029913 (human ES cell cultures) others

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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WARF’s “Power-Play” ƒ Patents ƒ Required licenses from academic and commercial researchers

ƒ Federal funding restrictions ƒ ES cell lines were on short list ƒ Guaranteed customers

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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WARF US Patents Challenged ƒ Re-examinations brought by Public Patent Foundation on behalf of the Foundation for Taxpayer and Consumer Rights ƒ Asserted claims were not novel and/or obvious in view of prior art relating to ES cell generation from other non-human species ƒ WARF amended claims to recite “preimplantation embryo” as source (effect on iPS) ƒ 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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© 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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WARF’s EP Patent Application Denied ƒ Contravened morality requirement ƒ 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.”

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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WARF’s EP Patent Application Denied (cont) ƒ Issue was whether specification described practice of invention without requirement of embryo destruction ƒ Applies to any composition, method, use requiring destruction of embryo to practice invention ƒ Suggestion: Describe another way of getting to invention for EP protection

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Looking Forward ƒ iPS cells ƒ Shouldn’t be hampered by re-examined WARF patents ƒ No morality issues in EP (do not use/destroy embryos) ƒ See Izumi PCT applications ƒ WO2009/007852 ƒ WO2009/006997 ƒ WO2009/006930 ƒ ƒ

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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.

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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Questions??

© 2009 Wolf, Greenfield & Sacks, P.C. All rights reserved.

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