Expert Details
Intellectual Property Law, Patent Law; Industries: Biotech, Pharmaceutical, Life Sciences
ID: 723216
Florida, USA
He completed postdoctoral research fellowships at Harvard Medical School / NIH (Alzheimer’s disease, tau gene, genomic cloning), Johnson & Johnson (skin diseases, homeobox transcription factors), and Memorial Sloan-Kettering Cancer Center (immunology, MHC class I genes, NF-kappa-B). He has publications in all these areas.
He completed a B.Sc. at the University of Southampton, England, with first class honors (summa cum laude) in biochemistry with chemistry.
Expert has broad experience in modern molecular biology techniques and has publications illustrating cDNA and genomic cloning.
Expert has a published undergraduate textbook on transcription (see publications list).
Expert is a registered US Patent Attorney with broad pharmaceutical and biotechnology experience. He has worked in-house at drug companies and for law firms serving such companies.
Expert is a registered US Patent Attorney and has been involved in a series of biotech- and pharma-related patent litigations.
Served as a consultant to Fahnestock & Co, Inc. in a private placement for Qualigen, Inc., a diagnostics company (2003). Scientific and patent review and evaluation of the company, its technology and the prior art and competitors.Served as a consultant to Kleinwort Benson in connection with the acquisition of Divysio, a Canadian cardiovascular stent company by BioCompatibles, a British biotech company (1996-1997), a business unit since acquired by Abbott Laboratories.Served as a consultant to Fahnestock & Co, Inc. in a private placement for DepoMed, Inc., a drug delivery technology company (2001). Scientific and patent review and evaluation of the company, its technology and the prior art in the area, reviewed contracts with their collaborators.Served as a consultant to Fahnestock & Co, Inc. in a private placement for Senesco Technologies, Inc., an agbiotech company (2000). Scientific and patent review and evaluation of the company, its technology and the prior art in the area.Serve as a patent consultant to a Wall Street research firm and newsletter publisher (2002-present).
Serve as a patent consultant to an equity research firm (2004-present).
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1998 | Degree: J.D. | Subject: Law | Institution: New York, Law School, NY |
| Year: 1997 | Degree: M.B.A. | Subject: Management | Institution: Fairleigh Dickinson University, NJ |
| Year: 1991 | Degree: Ph.D. | Subject: Molecular Biology / Biochemistry | Institution: University of Southampton, England |
| Year: 1988 | Degree: B.Sc. | Subject: Biochemistry / Chemistry | Institution: University of Southampton, England |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2005 to Present | Employer: Undisclosed | Title: Consultant, Director of Intellectual Property | Department: Legal |
Responsibilities:Responsible for Intellectual Property (IP) strategy, management of outside counsel, patent drafting, website content. |
|||
| Years | Employer | Title | Department |
| Years: 2004 to Present | Employer: Undisclosed | Title: Consultant, Director of Corporate Development | Department: Business Development |
Responsibilities:Responsible for patent, contract, and scientific due diligence, FDA law issues, deal prospecting, freedom-to-operate analyses, management of outside counsel, and litigation management. Paragraph IV ANDA strategy. |
|||
| Years | Employer | Title | Department |
| Years: 2005 to Present | Employer: Undisclosed | Title: Advisor | Department: |
Responsibilities:Responsible for Intellectual Property (IP) due diligence. |
|||
| Years | Employer | Title | Department |
| Years: 2004 to Present | Employer: Undisclosed | Title: Consultant | Department: |
Responsibilities:Responsible for patent strategy, business plan analysis, scientific writing and editing, deal prospecting, freedom-to-operate analyses, litigation management. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2003 | Employer: Pharmasset, Inc. | Title: Senior Director, Legal Affairs | Department: Legal |
Responsibilities:Responsible for all legal issues, especially management of patent portfolio, patent licensing (in & out), clinical trial contracts, general contract review and negotiation, liability and insurance issues, confidentiality and materials transfer agreements, research and manufacturing / supply agreements employment agreements, trademark filings. Prepared documents for proposed funding round. Supervised outside counsel. |
|||
| Years | Employer | Title | Department |
| Years: 2000 to 2002 | Employer: Restoragen (formerly BioNebraska) | Title: Vice President, General Counsel | Department: |
Responsibilities:Responsible for all legal issues and competitive intelligence efforts. Managed patent portfolio, trademark filings, freedom-to-operate opinions. Domain name, web site management. Employment agreements, clinical trial contracts, general contract review and negotiation, insurance issues, collaborator & consultant agreements, materials transfer & confidentiality agreements. Participated in preparation of a private placement memorandum and documents for a proposed funding round. Supervised outside counsel. |
|||
| Years | Employer | Title | Department |
| Years: 1999 to 2000 | Employer: Taro Pharmaceuticals, Inc. | Title: Patent Counsel | Department: Legal |
Responsibilities:Analyzed patents and prepared internal opinions on patents that might be susceptible to paragraph IV ANDA challenge. Member of the R&D and New Product committees. Managed patent portfolio, trademark filings. Supervised outside counsel. Domain name management. |
|||
| Years | Employer | Title | Department |
| Years: 1997 to 1999 | Employer: Kaye Scholer, llp | Title: Associate | Department: |
Responsibilities:Represented major pharmaceutical companies in Hatch-Waxman paragraph IV lawsuits against generic drug companies. Represented major pharmaceutical company in biotech patent infringement lawsuit. Expert witness and consultant work. Document production, review, and analysis. |
|||
Career Accomplishments
| Associations / Societies |
|---|
| Fellow of the Royal Society of Chemistry (C.CHEM., F.R.S.C.) (2001) and the Institute of Biology (C.BIOL., F.I.BIOL.) (2001). Member of the New York Academy of Sciences (1994). |
| Licenses / Certifications |
|---|
| Attorney, admitted to the bars of New Jersey (1998), New York (1999), Washington, D.C. (2002), Nebraska (2002; inactive), U.S. Supreme Court (2002), U.S. Courts of Appeals for the 3rd (2002), 8th (2002) 11th (2002) D.C. (2002), and Federal Circuits (1999), U.S. District Courts for the District of New Jersey (1998), Southern District of New York (1999), District of Nebraska (2002), District of Columbia (2002), U.S. Court of Federal Claims (2002), U.S. Tax Court (2002). Registered to practice before the U.S. Patent & Trademark Office (Reg. No. 43,518) (1999). Regulatory Affairs Certified (R.A.C.) (1998). Chartered Scientist (C.SCI.) (2004). European Chemist (EURCHEM.) (1994). European Professional Biologist (EURPROBIOL.) (1995). |
| Professional Appointments |
|---|
| Articles Editor, New York Law School Law Review (1997-1998). Author of a monthly feature on new drug patents for Current Opinion in Investigational Drugs (2000-2001). Writer and Editor for Institute for the Study of Aging meetings on barriers to drug discovery and development in Alzheimer’s disease (2000), age-associated memory impairment (2001), and tau-based Alzheimer therapies (2002). Peer reviewer for the AAPS journal, Pharmaceutical Sciences (1999-present) Author of occasional reviews of drugs in development for the Current Drugs database and publications (including iDrugs) (1997-present). Member of the Editorial Advisory Board of Recent Patents on Cardiovascular Drug Discovery (2005-present). Member of the International Reviewers’ Panel of Medical Science Monitor (2004-present). |
| Awards / Recognition |
|---|
| Otto L. Walter Distinguished Legal Writing Award (1998), New York Law School Law Review Member (1995-1996), Articles Editor (1996-1997), and Certificate of Merit recipient (1998), Irving Mariash Scholar, New York Law School (1994-1998), Woodrow Wilson Award for Constitutional Law (1998), NIH Visiting Research Fellow (1991-1992), G.A. Kerkut Prize for Biochemistry (1988), Wellcome Trust Research Scholarship (1987), British Association for the Advancement of Science Award (1987). |
| Medical / Professional |
|---|
| Postdoctoral Research Fellow, Immunogenetics Laboratory, MEMORIAL SLOAN-KETTERING CANCER CENTER, NY. Studied transcriptional control of HLA / MHC class I genes; promoter analysis, cloning, sequencing (1993-1994). Postdoctoral Fellow, Skin Biology Research Center, JOHNSON & JOHNSON, NJ. Analyzed role of homeobox gene products in skin & skin diseases. cDNA, genomic cloning (1992-1993). Research Fellow in Neurology, HARVARD MEDICAL SCHOOL; Postdoctoral Fellow, BRIGHAM & WOMEN’S HOSPITAL’S CENTER FOR NEUROLOGIC DISEASES, Boston; NIH Visiting Fellow, NIH GERONTOLOGY RESEARCH CENTER, Baltimore. Genomic cloning, mapping, sequencing of the human tau gene, implicated in Alzheimer’s disease (1991-1992). |
| Publications and Patents Summary |
|---|
| Author of more than 75 scientific and legal publications, including books on Alzheimer's disease, plasma proteins, and DNA transcription. |
Fields of Expertise
biochemical research, molecular biology, biotechnology, biochemistry, cloning technique, gene expression regulation, intellectual property, patent, patent law, patentability evaluation, United States patent, patent claim construction brief, claim (patent), patent infringement, Markman hearing, patent specification, canons of claim construction, Doctrine of Equivalents, literal infringement, direct infringement, contributory infringement, induced infringement, patent claim chart, patent claim construction, patent searching, life science research, legal practice, legal writing, legal counsel, court transcription, transcription, insurance law, molecular diversity, international patent law, industrial biotechnology, generic drug manufacturing, drug product approval, peptide mimetic, Cooperative Research and Development Agreement, trade secret law, trade secret, medicinal chemistry, biotechnology assessment, applied biotechnology, device patent, lipid biochemistry, European patent, licensable technology, Northern blotting, copyright, protein biochemistry, nutritional biochemistry, molecular medicine, molecular oncology, molecular immunology, molecular immunogenetics, molecular endocrinology, molecular cytogenetics, molecular cardiology, molecular biochemistry, eukaryotic molecular biology, DNA technology, analytical biochemistry, applied molecular biology, free radical biochemistry, computer-aided design patent figure, patent cost reduction, drug development, biomedical product development, foreign patent, biotin-avidin technology, reverse engineering, technology transfer, legal liability, technology management, Food and Drug Administration, immunochemistry, birth control device, molecular genetics, international licensing, legal patenting, Food and Drug Administration regulation, drug regulation, drug, monoclonal antibody, molecular biophysics, animal molecular biology, metabolism, genetics, genetic probe technology, genetic manipulation, genetic engineering, enzymology, bioreactor, biology