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Dates Attended Name and Location Name of Program Dates Attended Name and Location Name of Program Document Transcript

  • CURRICULUM VITAE BIOGRAPHICAL Name: C. Allen Black, Jr. Home Address: 1579 Montgomery Rd. Birth Place: High Point, NC Allison Park, PA 15101 Home Phone: (412) 908-3268 Email: allen@patentlawyersite.com _______________________________________________________________________ _ SUMMARY OF QUALIFICATIONS Adjunct Professor of Law, Biotechnology Law, University of Pittsburgh Assistant Professor, Immunology, University of Pittsburgh Pro bono representation of Fabry disease victims in Bayh-Dole march-in petition Registered patent attorney J.D. cum laude, University of Pittsburgh Ph.D. Immunology, University of Newcastle, Australia B.A. summa cum laude, English, University of Alabama at Birmingham _______________________________________________________________________ _ EDUCATION GRADUATE: Dates Attended Name and Location Degree Received Major Advisor of Institution and Year and Discipline 2000-2003 University of Pittsburgh, J.D. cum laude School of Law 2003 Pittsburgh, PA 1994-1997 University of Newcastle Ph.D., 1997 Kenneth Beagley, Ph.D. Newcastle, NSW, Australia Immunology 1991-1994 University of Alabama Ph.D., Candidate Kenneth Beagley, Ph.D. at Birmingham Transferred 1994 Immunology Birmingham, Alabama POSTDOCTORAL: Dates Attended Name and Location Name of Program of Institution Director and Discipline 1997-1999 Magee-Womens Research Inst. Robert P. Edwards, M.D. Pittsburgh, PA Obstetrics, Gynecology & Reproductive Sciences
  • UNDERGRADUATE: Dates Attended Name and Location Degree Received Major/Minor of Institution and Year Subject 1985-1988 University of Alabama B.A., 1988 English/Chemistry at Birmingham summa cum laude Birmingham, Alabama _______________________________________________________________________ _ TEACHING EXPERIENCE Biotechnology Law, University of Pittsburgh, 2006-present The class provides an introduction to the major legal issues in the field of biotechnology including acquisition and management of intellectual property, administrative regulation of biotechnology, as well as transactional issues such as venture capital financing, industry collaborations, and intellectual property licensing. A substantial portion of this class is dedicated to biotechnology and pharmaceutical patent protection of genes, life forms, and biologicals in the U.S. and internationally under the Patent Cooperation Treaty. Other topics include: Bayh-Dole inventions, FDA regulation of biopharmaceuticals, USDA regulation of genetically engineered crops, Patriot Act laws regarding bioterrorism, and laws regulating vaccines. The course also covers practical issue in biotechnology such as technology transfer, industry collaborations, intellectual property licensing, and material transfer agreements. In addition, the course reviews laws regulating biotechnology research and ethics. Mucosal Vaccines: STDs and Gut Infections, University of Pittsburgh, 2000 The course is taught as part of the mucosal immunology section for Ph.D. students in molecular biology. As an assistant instructor, I taught the biology of infectious diseases of the gut, liver, and reproductive tract. My section covered the molecular biology, pathogenesis, and vaccination for such diseases as hepatitis, rotavirus infection, AIDS, and other infections. Undergraduate Thesis Advisor, Chatham College, Pittsburgh 1999 S. D. Geletei, The immunoglobulin G response to the immunodominant proteins of Lactobacillus crispatus. Review of Immunological Concepts, Magee-Womens Hospital, Pittsburgh, 1998 The course is taught to medical residents covering the history and development of immunology and specific treatment options for immunological diseases. _______________________________________________________________________ _ HONORS Curriculum Vitae C. Allen Black, J.D., Ph.D. page 2 Revised August 2010
  • Organization Year Winner, Faculty Award for Excellence in Legal Scholarship 2003 Univ. of Pittsburgh, School of Law Winner, Samuelson-Glushko Fellowship in Intellectual Property 2002 Univ. of Pittsburgh, School of Law CALI Award for Outstanding Scholarship in Intellectual Property 2002 Univ. of Pittsburgh, School of Law Managing Editor, Journal of Law and Commerce (invitation based on grades) 2001 Fall and Spring Semester Honors, Univ. of Pittsburgh, School of Law All semesters Dean’s Scholarship, Univ. of Pittsburgh, School of Law All semesters Infectious Diseases Society for OB/GYN Young Investigator Award 1998-1999 Australian Commonwealth Scholarship to Overseas Students 1994-1997 University of Newcastle Scholarship to Postgraduate Students 1994-1997 NIH National Research Award for Pre-Doctoral Fellows 1992 Undergraduate Presidential Honors All semesters Phi Kappa Phi, Senior Honor Society (top 5% of graduating class) 1988 University of Alabama at Birmingham, Birmingham, Alabama National Dean's List 1988 University of Alabama at Birmingham, Birmingham, Alabama Omicron Delta Kappa Leadership Honorary, 1987 University of Alabama at Birmingham, Birmingham, Alabama Sigma Delta Tau Department Honorary, 1986 University of Alabama at Birmingham, Birmingham, Alabama Alpha Lambda Delta Freshman Academic Honorary 1985 University of Alabama at Birmingham, Birmingham, Alabama Curriculum Vitae C. Allen Black, J.D., Ph.D. page 3 Revised August 2010
  • _______________________________________________________________________ _ EMPLOYMENT April ‘10- Present : Law Office of C. Allen Black Principal Current matters include: In re Fabrazyme: pro bono representation of Fabry disease patients in a request for Bayh-Dole march-in rights to allow other manufacturers to license the patents needed to end Genzyme's manufacturing shortage of the drug Fabrazyme, which was developed using public money. (Filed August 2, 2010). JP Morgan Chase Antitrust litigation: Co-counsel representation of the class of consumer credit recipients that paid excessive interest as a result of collusively sharing competitively sensitive data among banking and credit reporting agencies. (Filed June 25, 2010). Patent prosecution: representation of individual researchers seeking patent protection for inventions. Reporting and commentary on the In re Fabrazyme March-In Request • August 2, 2010, Andrew Pollack, Patients Want Patent Broken on Genzyme Drug, New York Times • August 3, 2010, Gareth Macdonald, "US patients call for Fabrazyme patent break" in- pharmatechnologist.com. • August 3, 2010, Ed Silverman, "Patients Seek To Break Patent On Genzyme Drug," Pharmalot.com • Mike Masnick, August 3, 2010, "Patents Getting In The Way Of Saving Lives; Fabry Disease Sufferers Petition US Gov't To Step In." TechDirt.Com • August 4, 2010, Richard Knox, "Fabry Patients Want Drug's Patent Eased," National Public Radio (NPR) radio interview. • August 4, 2010, Bruce Lehr, "Should HHS Override Genzyme Fabrazyme Patents?" The Big Red Biotech Blog. • August 4, 2010, George Miller, "Genzyme manufacturing woes yield patent threat," FiercePharma Manufacturing • August 4, 2010, Julie M. Donnelly, "Genzyme patients want patent lifted," Boston Business Journal. • August 4, 2010, "Pharmakonzern schließt Werk - Patente verhindern Medikamentenproduktion" • August 4, 2010, Patients Urge HHS to Widen Use of Fabry Drug Patent, BioWorld Today • August 5, 2010, Victoria Slind-Flor, "Patients Ask to Open Genzyme’s Fabrazyme Patents," Bloomberg. • August 6, 2010, Patients Petition HHS to Break Exclusive Patent on Rare Disease Drug, AAU Weekly Wrap-up. • August 9, 2010, Patients Petition HHS to Issue Open License for Fabrazyme, Washington Drug Letter, Vol. 42 No. 31 Nov. ’09- April ’10: University of Pittsburgh Associate Director of (Six month Office of the Research Compliance Curriculum Vitae C. Allen Black, J.D., Ph.D. page 4 Revised August 2010
  • temporary Senior Vice Chancellor position) Reviewed sponsored research agreements, material transfer agreements, data use agreements, et alia, with regard to institutional and federal compliance issues. Assisted individual researchers in navigating compliance mandates. Position closed at six months and now handled through committee. July. ’09-Nov. ‘09 Contract attorney (RNA Research Foundation) Pittsburgh, PA Prepared license agreements for foundation IP, prosecuted foundation patents, negotiated partnering agreement with outside counsel. Prepared business plan and negotiated with funding entities including private equity firms. Designed and implemented websites for client matters. See, www.rnaresearchfoundation.com. Dec. ’08-July ’09 Hirshman Law, L.L.C. Associate Pittsburgh, PA Practice Focus: Preparation and prosecution of US and overseas patents in technology areas including molecular biology, small organic molecules, immunology, diagnostics, and pharmaceuticals. Additional prosecution experience includes industrial chemical processing, therapeutic patents and medical device implants. Preparation of formal “Freedom to Operate” and patent validity opinions. Additional experience includes reviewing patent “landscapes” in various market spaces in order to identify potential licensing and partnering opportunities for clients. March ‘08-Dec.‘08 Pepper Hamilton, L.L.P. Associate Biotechnology Patent Group Pittsburgh, PA Practice Focus: Preparation and prosecution of US and overseas patents in numerous areas including molecular biology, nanoparticles, carbon nanotubes, immunology, RNAi, diagnostics, and pharmaceuticals. Additional prosecution experience includes industrial chemical processing and polymers. Preparation of formal “Freedom to Operate” and patent validity opinions. FDA regulatory compliance including “orange book” exclusivity analysis, and ANDA filing requirements. Trained junior attorneys and reviewed their work. 2005-2008 Kirkpatrick & Lockhart, L.L.P. Associate Patent Practice Group Pittsburgh, PA Practice Focus: Preparation and prosecution of US and overseas patents in technology areas including molecular biology (e.g., PCR, fluorescent tags, phage display, etc.), immunology (e.g., mAbs, flow cytometry, etc.), stem cells, diagnostics, and pharmaceuticals. Additional prosecution experience includes industrial chemical processing, fermentation products, polymers, medical devices, metal alloys, and food chemistry. Preparation of formal “Freedom to Operate” and patent validity opinions. Reviewing patent portfolios and conducting due diligence for Fortune 100 companies’ business acquisitions and mergers. Preparation of SEC reporting compliance documents. Litigation support related to state law IP ownership claims and settlement agreements, as well as formal inventorship analyses. Patent litigation support including prior art review and analysis. Managed junior attorneys and prosecution teams. Curriculum Vitae C. Allen Black, J.D., Ph.D. page 5 Revised August 2010
  • 2003-2005 Alston & Bird, L.L.P. Associate Biotechnology Law Practice Group Raleigh, NC Practice Focus: Preparation and prosecution of US and overseas patents in numerous technology areas including molecular biology (e.g., genetically modified crops, plasmids, expression systems and agricultural biochemisty), immunology (e.g., dendritic cells, chimeric Abs, cancer immunotherapy, etc.), stem cells, RNAi, diagnostics (e.g., biomarkers, assay systems etc), and small molecule pharmaceuticals. Additional prosecution experience includes excipient formulation and therapeutic methods. Preparation of formal “Freedom to Operate” and patent validity opinions. Due diligence for business acquisitions, as well as intellectual property escrow agreements. Summer 2002 Alston & Bird, L.L.P. Summer Associate Biotechnology Law Practice Group Raleigh, NC Summer 2001 McKenna & Cuneo, L.L.P. Summer Associate Biotechnology Law Department Washington, DC Mar 2000-Aug 2000 Magee-Womens Research Inst. Assistant Professor, Pittsburgh, PA Dept. of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine May 1999-Feb. 2000 Magee-Womens Research Inst. Research Asst. Professor Pittsburgh, PA Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine Curriculum Vitae C. Allen Black, J.D., Ph.D. page 6 Revised August 2010
  • _______________________________________________________________________ _ PUBLICATIONS In preparation 1. Black, C.A., The Safety Net has Broken: Legal and Policy Approaches to Bayh-Dole Inventions and Drug Shortages. Currently, there are 24 FDA approved drugs that are in shortage due to manufacturing delays. Many of these drugs were developed through tax-payer’s support. While the policy of promoting invention and manufacturing through patent exclusivity has succeeded, the threat of drug rationing of Bayh-Dole inventions has become a reality. The result of rationing Bayh-Dole drugs produces not only the expected monopolistic pricing damage, but physical damages including sickness, increased morbidity, and even death. This paper presents specific case studies of manufacturing shortages and why such shortages are occurring. The paper proposes legal approaches to remedying the shortages, including exercising March-in rights, filing FDA citizen petitions, as well as instigating tort and patent litigation. 2. Black, C.A., Sharing Customer Data and Consumer Lending: Competition and Antitrust Effects. One of the strangest behaviors of the lending industry is sharing customer data among competitors. Normally in most industries, customer data is a closely held trade secret and sharing competitively sensitive data on customers is a clear antitrust violation. However, courts have stated that in certain situations for lenders, sharing specific customer data is considered pro- competitive. Nevertheless, the real-time coordination of information sharing among competitors during ongoing transactions has never been examined by the courts, including the relatively recent market solutions that lenders have developed to reduce or eliminate lending risk such as credit default swaps and credit default insurance. This paper reviews how consumer lending products are priced and how sharing data allows lenders to coordinate actions and prices. 3. Black, C.A., Biotechnology Law. Case Book. The current choice for texts on Biotechnology Law is severely limited. I have spoken with editors at Westlaw and they are interested in entering the market and will review a sample chapter for a possible contract to publish a case book in the field. I am currently preparing a sample first chapter covering patents in biotechnology. If accepted, I have developed course material for a casebook as part of the Biotechnology Law curriculum that I have taught for the last four years. Refereed articles 4. Black, C.A., The Cure for Deadly Patent Practices: Preventing Technology Suppression and Patent Shelving in the Life Sciences. Albany Law Journal of Science and Technology, 2004, 14:397-450. 5. Black, C.A., Switching On Gene Therapy: Using Gene Profiles to Design Drugs, Pharmagenomics, 2003, 10:48-53. 6. Black, C.A., Rohan, L.C., Cost, M. Watkins, S.W. and Edwards, R.P., Vaginal mucosa serves as an inductive site for tolerance. J. Immunol. 2000, 165:5077-5083. Curriculum Vitae C. Allen Black, J.D., Ph.D. page 7 Revised August 2010
  • 7. Black, C.A., Eyers, F.M, Clancy, R.L., Russell, A., Dunkley, M.L., and Beagley, K.W. Major histocompatibility haplotype does not impact on the course of experimentally induced murine vaginal candidiasis. Lab Animal Sci. 1999, 49(6): 668-672. 8. Black, C.A., Clancy, R.L., Russell, A., Dunkley, M.L., Eyers, F.M., and Beagley, K.W. Increased severity of candida vaginitis in BALB/c nu/nu mice versus the parent strain is not abrogated by adoptive transfer of T cell enriched lymphocytes. J. Rep. Immunol. 1999, 45(1): 1-18. 9. Black, C.A Delayed Type Hypersensitivity: Current theories with an historic perspective. Dermatol. Online J. 1999, 5(1):7 (http://matrix.ucdavis.edu/DOJvol5num1/reviews/black.html). (Ranked No. 1 for most-relevent Google searches of “Delayed Type Hypersensitivity”) 10. Black, C.A., Eyers, F.M., Russell, A., Dunkley, M.L., Clancy, R.L., and Beagley, K.W. Acute neutropenia decreases inflammation associated with murine vaginal candidiasis but has no effect on the course of infection. Infect. Immun. 1998, 66:1273-1275. 11. Black, C.A. A brief history of the discovery and naming of the human immunoglobulins. Immunol. Cell Biol. 1997, 75:65-69. 12. Elson, C.O., Beagley, K.W., Sharmanov, A.T., Fujihashi, K., Kiyono, H. Tenneson, G.S., Cong, Y., Black, C.A., Ridwan, B.W., and McGhee, J.R. Hapten-induced model of murine inflammatory bowel disease, mucosal immune responses and protection by tolerance. J. Immunol. 1996, 157:2174-2185. 13. Beagley, K.W., Fujihashi, K., Lagoo, A.S., Lagoo-Deenadaylan, S., Black, C.A., Murray, A.M., Sharmanov, A.T.,Yamamoto, M., Elson, C.O., McGhee, J.R., and Kiyono, H. Differences in intraepithelial (IEL) T cell subsets isolated from murine small versus large intestine. J. Immunol. 1995, 154:5611-5619. 14. Lagoo, A.S., Eldridge, J.H., Lagoo-Deenadaylan, S., Barber, W.H., Black, C.A., Hardy, K.H., McGhee, J.R., and Beagley, K.W. Peyer's patch CD8 positive memory T cells secrete IL-5 and provide help for immunoglobulin secretion. Eur. J. Immunol. 1994, 24:3087-3092. 15. Beagley, K.W., Fujihashi, K., Black, C.A., Lagoo, A.S., Yamamoto, M., Kiyono, H., and McGhee, J.R. The M. tuberculosis 71 kD heat shock protein induces proliferation and cytokine secretion by murine intraepithelial lymphocytes. Eur. J. Immunol. 1993, 23:2049-2052. Practice Notes 16. Black, C.A., The National Institutes of Health Revisits the Issue of March-In Rights and Drug Pricing: In the Case of Norvir®, Life Sciences Advisory, Alston and Bird, LLP; (September 2004) Books and Book Chapters Curriculum Vitae C. Allen Black, J.D., Ph.D. page 8 Revised August 2010
  • 17. Black, C.A. (Contributor) Gene Profiles in Drug Design, ed. B.A. Libury, CRC Press, New York (2008). 18. Black, C.A. and Murphey-Corb M. Dendritic cells in the reproductive tract and mucosal barriers, in Dendritic Cells, 2nd. Edition, eds. M. T. Lotze and A. Thompson, Academic Press, San Diego, CA (2001). 19. Beagley, K.W., Black, C.A., Dunkley, M.L., and McGhee, J.R., Regulation of Mucosal Immunity, in Cytokine Regulation and Humoral Immunity: Basic and Clinical Aspects. ed. C.M. Snapper, John Wiley and Sons, (1996). 20. Beagley, K.W., Black, A., DiFabio, S., McGhee, J.R., Kearney J. and Eldridge, J.H. Do CD5 B cells respond to oral antigens? In: Advances in Mucosal Immunology. S. Jackson, H. Kiyono, J.R.McGhee, J. Mestecky, S.M. Michalek, M.W. Russell, J. Sterzi and H.Tlaskalova (eds.), Plenum Publishing Corporation, New York, NY (1995). 21. Jackson, G.D.F., Beagley, K.W., Black, A., McGhee, J.R., Mestecky, J. and Dai, Y. 1992. Cytokines in bile--A marker of activity in the liver. In:Advances in Mucosal Immunology. S. Jackson, H. Kiyono, J.R. McGhee, J. Mestecky, S.M. Michalek, M.W. Russell, J. Sterzi and H. Tlaskalova (eds.), Plenum Publishing Corporation, New York, NY (1995). 22. K.W. Beagley, O.W. Cummings, C.A. Black and C.O. Elson. Experimentally induced colitis in mice. In Frontiers of Mucosal Immunology. Eds. M. Tsuchiya, H. Nagura, T. Hibi, I. Moro. Excerpta Medica, Elsevier Sciences Publishers, Amsterdam, New York, Oxford. Vol. 1, (1991). Conference Proceedings: 23. Black, C.A. and RP Edwards. Peritoneal dendritic cell precursors detected at high frequency in ovarian cancer patients on IL-2 therapy. Proceedings 89th Annual American Association for Cancer Research 1999, 39:152 A1037 24. Black, C.A. and RP Edwards. Dendritic cells from normal blood and ascites fluid from IL-2 therapy ovarian cancer patients form giant multinuclear cells when starved of IL-4 and GM-CSF. Proceedings 90th Annual American Association for Cancer Research 1999, 40:657 A4335 Published Abstracts: 25. Black, C.A., Rutherford, N., Clancy, R.L., and Beagley, K.W., Feeding of whole killed C. albicans protects mice against candida vaginitis. Clin. Immunol. Immunopathol. 1995, 76, pt. 2: O248, p. S42 (Oral, Society for Mucosal Immunology) 26. Black, C.A., Rohan LC, Cost MR, Herberman R, and RP Edwards. Ascites from ovarian cancer patients on IL-2 therapy contains dendritic cell precursors. J. Leu. Biol., 1998 Supp 2:J35 (Poster) Curriculum Vitae C. Allen Black, J.D., Ph.D. page 9 Revised August 2010
  • 27. Black, C.A., and RP Edwards. IgG transport through the vagina and ectocervix via exfoliative transcytosis. J. Soc. Gynecol. Invest., 1998 5:53A (Oral, Society for Gynecological Investigation) 28. Black, C.A., and RP Edwards. Dendritic cells from normal blood and ascites fluid from IL-2 therapy ovarian cancer patients form giant multinuclear cells when starved of IL-4 and GM-CSF. (Poster, American Association for Cancer Research) 29. Black, C.A., Geletei SD, Cost MR, Edwards RP and SL Hillier. Attenuated antigen-specific humoral immune responses to the vaginal commensal Lactobacillus crispatus. FASEB J. 1999, 13 pt.1: 481.3, pg. A6 (Oral, American Association of Immunology) 30. Black, C.A., Rohan LC, Cost MR, and RP Edwards. Induction of mucosal tolerance by vaginal inoculation of antigen in a mouse model, Immunol. Letters, 1999 69:18.4 (Oral, Society for Mucosal Immunology) Other publications: 31. Black, C.A., Mucosal Vaccination and Immune Responses in Experimental Candida Vaginitis. Doctoral Thesis. University of Newcastle, Newcastle, Australia. 1997 Research Funding: 1. Grant Number Role in project Years Source (Funded) Grant Title & percent effort Inclusive $ Amount Infectious The role of PI, 50% effort 1998-1999 $25,000 Diseases Society allergy in of Obstetrics vaginal candidiasis MWH-99-06 _______________________________________________________________________ _ PATENTS US Patent 6,323,003 granted November 27, 2001 Compositions and Methods for Activating Genes of Interest to Charles Allen Black, Jr. Gene based drug for conditional expression of toxin or therapeutic genes in cancerous and virally infected cells. U.S. Patent 7,052,903 granted May 30, 2006 Compositions and Methods for Activating Genes of Interest to Charles Allen Black, Jr. Curriculum Vitae C. Allen Black, J.D., Ph.D. page 10 Revised August 2010
  • Gene based drug for conditional expression of toxin or therapeutic genes in cancerous and virally infected cells. _______________________________________________________________________ _ MEMBERSHIPS in PROFESSIONAL and SCIENTIFIC SOCIETIES Organization Year American Intellectual Property Law Association 2001 American Association for Cancer Research 1998 Society for Mucosal Immunology 1997 American Association of Immunology 1992 _______________________________________________________________________ _ PROFESSIONAL LICENSES License Year Pennsylvania Bar 2006 U.S. Court of Appeals for the Federal Circuit 2004 North Carolina Bar (inactive status) 2003 U.S. Patent Attorney 53,835 2003 Curriculum Vitae C. Allen Black, J.D., Ph.D. page 11 Revised August 2010