Expert Details

Expert in Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development

Expert ID: 727557 Colorado, USA

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Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution,
opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than 10 years of in house and 12 years of law firm experience, Expert has supported the transactional, licensing, regulatory, and related legal business needs of small, medium and global high technology companies in the United States, Europe and Asia.

Expert has also conducted more than 100 major product ad company transactional and technology due diligences, negotiations and agreements, as well as more than 5000 agreement negotiations and drafting, including academic, non-profit, government, feasibility, research, service, investigator initiated clinical studies, clinical studies and master agreements, manufacturing, product and technology licensing, know how and patent licenses, acquisitions, and product & technology out-licensing.

In the European Union, Expert has directly managed prosecution of more than 150 EPO patent applications in more than 20 EU countries and has managed more than 15 patent oppositions & appeals. In Japan, he has directly managed the prosecution of more than 100 patent applications & 10 appeals.

Expert has presented, managed & developed more than 100 in house & public presentations relating to various aspects of international patent, regulatory, dispute resolution, & related IP & transactional issues.

Expert has worked on international pharmaceutical & biotechnology dispute resolution & patent litigation, including patent arbitrations & litigation in the US, EU, & Japan. Expert has also worked for more than 10 years as in house patent & business development counsel at Johnson & Johnson & Eli Lilly. Expert began his legal career with several large law firms representing various pharmaceutical, medical device, biotech, chemical, plant & other life sciences companies.

Before attending law school, Expert worked as a molecular biologist at the NIH studying DNA repair & cytochrome p450 expression, characterization, enzymology & monoclonal antibody inhibition in recombinant vaccinia, retrovirus & baculovirus expression systems, including analysis using spectroscopy, protein expression and purification, enzyme kinetics, and nucleic acid analysis.

Expert has provided transactional/ acquisition/licensing/ counseling/ management of global biotech, plant, and pharmaceutical legal issues, analysis & strategic planning for products and technologies in all stages of development, relating to discovery, technology development, product development, formulation, administration, manufacturing, clinical development & marketing; licensing in & out (due diligence, negotiations & agreement drafting), 50 major products in development and commerciallized, technologies, M&A, regulatory issues, counseling; members of management committee relating to regulatory, manufacturing, discovery, clinical, licensing & marketing; foreign filing portfolios, & strategic licensing; including EU, worldwide, & Japanese patent prosecution, oppositions, appeals, litigation preparation, & arbitration. Expert has managed US, EU and Japanese arbitrations and litigation defense preparation for a hundreds of millions to multibillion dollar products for large global companies, including litigation analyses and strategies, technical analysis supporting prelitigation and litigation, litigation management, and development of expert testing, witnesses, and testimony, often resulting in settlement.Specific examples of technologies that Expert has supported include research, diagnostic, and therapeutic technology, methods and apparatus relating to software, business methods, devices, and apparatus for diagnostic and therapeutic applications of small molecules, antibodies and antibody fusions, proteins, RNA and DNA; spectroscopy apparatus, mass spectroscopy, semiconductor laser diodes, LEDs, & flow cytometers; engine transmissions; chemical compounds, formulations and methods; DNA/RNA/protein conjugates, RNA and DNA amplification, sequencing and analysis, alternative expression systems including phage, bacteria, yeast, and mammalian cells; Phage display and transgenic animal DNA/RNA/protein and antibody library design, transformation, generation, screening, production and optimization. DNA, RNA and protein screening, analysis and engineering, Southern, Northern, Western blots, cloning, screening, selection, analysis, mass spectroscopy, kinetics, affinity off and on rates, crystallography and molecular modeling; DNA, RNA, and protein solubility and activity screening, selection and optimization, formulations, dosing, administration, devices.

Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Aurora, Colorado - Fort Collins, Colorado - Arvada, Colorado - Pueblo, Colorado - Westminster, Colorado - Boulder, Colorado - Greeley, Colorado - Longmont, Colorado

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Education

Year Degree Subject Institution
Year: 1993 Degree: J.D. Subject: Intellectual Property and Licensing Law Institution: George Mason School of Law
Year: 1983 Degree: M.S. Subject: Zoology (Biochemistry, Molecular Genetics and Endocrinology) Institution: University of Maryland
Year: 1980 Degree: B.S. Subject: Zoology Institution: Duke University

Work History

Years Employer Title Department Responsibilities
Years: 2009 to Present Employer: Undisclosed Title: Principal Department: IP Agreements, Licensing and Business Development Responsibilities: Business development, licensing, acquisition, transactional, due diligence, & regulatory counseling, and dispute resolution, for the development, manufacturing & commercialization of high and clean technology, health care, medical devices, plant, pharmaceutical, chemical, and biotechnology, diagnostic devices, mechanical, and computer related products & technologies. Disclaimer: as also working as a US Patent Examiner, I cannot work on or aid in the prosecution of pending patent or TM applications with the USPTO or violate any code of ethics or create any conflict of interest.
Years: 2008 to 2009 Employer: Hogan Lovells LLP Title: Partner Department: IPMT Responsibilities: Business development, licensing, acquisition, transactional, due diligence, Intellectual property, & regulatory counseling, dispute resolution, opinions, & appeals for the development, manufacturing & commercialization of high and clean technology, health care, medical devices, plant, pharmaceutical, chemical, and biotechnology, diagnostic devices, mechanical, and computer related products & technologies. Management of attorneys, patent agents, paralegals and administrative staff.
Years: 2000 to 2008 Employer: Johnson & Johnson/Centocor Title: Assistant Patent Counsel Department: Patent Law Department Responsibilities: Legal and IP management for REMICADE™ J&J’s Largest Product (>$4Billion annual sales), Simponi(TM); and Stelara(TM). Transactional/ acquisition/licensing/ counseling/management of global biotech, plant, and pharmaceutical IP issues, analysis & strategic planning for products and technologies in all stages of development, relating to discovery, technology development, product development, formulation, administration, manufacturing, clinical development & marketing; licensing in & out (due diligence, negotiations & agreement drafting) of patents, 10-12 products, technologies, M&A, regulatory issues, litigation counseling; opinions; managing in house & outside patent counsel & litigation counsel, attorneys, patent agents, paralegals and administrative staff; members of management committee relating to patent, regulatory, manufacturing, discovery, clinical, licensing & marketing; managing invention disclosures, patent applications, patent portfolios, foreign filing portfolios, & strategic licensing; personal drafting of 15-25 patent applications/year, managing worldwide patent portfolios for products on market & in development, including US, EU & Japanese patent prosecution, oppositions, appeals, litigation preparation, & arbitration. Health care, plant, pharmaceutical, chemical, and biotechnology, medical and diagnostic device, chemical, mechanical, and computer related products & technologies. Subject matter including medical device related work included diagnostic assays and kits, intra-articular, IV, intramuscular, subcutaneous, transdermal, inhalation, intranasal, and oral administration devices, formulations, combinations, and dosing for chemical and biotech drugs, antibodies, proteins, vaccines, chemicals, devices, business methods, software. Management of attorneys, patent agents, paralegals and administrative staff.
Years: 1998 to 1999 Employer: Eli Lilly and Company Title: Senior Patent Counsel Department: Patent Department Responsibilities: Counseling/management/acquisition/transactions relating to global biotech, plant, chemical, and pharmaceutical IP issues, analysis & strategic planning for 5-10 products in all stages of development, securing freedom to operate from 3rd party patents relating to discovery, technology development, product development, formulation, administration, manufacturing, clinical development & marketing; representation of company on priority IP issues & projects as part of products teams, cross functional teams, & R&D, preclinical, manufacturing, clinical development, managing in house & outside patent counsel & litigation counsel, attorneys, patent agents, paralegals and administrative staff; members of management committee relating to patent, regulatory, manufacturing, discovery, clinical, licensing & marketing; managing of invention disclosures, patent applications, patent portfolios, foreign filing portfolios, & strategic licensing; drafing & personal drafting of 50-60 patent applications/year. Subject matter including medical device related work included diagnostic assays and kits, intra-articular, IV, intramuscular, subcutaneous, transdermal, inhalation, intranasal, and oral administration devices, formulations, combinations, and dosing for chemical and biotech drugs, antibodies, proteins, vaccines, chemicals, devices, business methods, software. Management of attorneys, patent agents, paralegals and administrative staff.
Years: 1994 to 1998 Employer: Sterne, Kessler, Goldstein and Fox, LLP Title: Senior Associate Department: Responsibilities: Biotech, Chemical, Device & Software IP counseling, licensing, product clearances, infringement & invalidity opinions, patent drafting, prosecution & appeals & interferences, chemical, biotech & pharma companies, academic & non-profit institutions, including NIH/government licensing. Trademark matters, including drafting, prosecution and clearances. Personal drafting of 30-40 patent applications/year. Subject matter including medical device related work included diagnostic assays and kits, intra-articular, IV, intramuscular, subcutaneous, transdermal, inhalation, intranasal, and oral administration devices, formulations, combinations, and dosing for chemical and biotech drugs, antibodies, proteins, vaccines, chemicals, devices, business methods, software. Management of attorneys, patent agents, paralegals and administrative staff
Years: 1992 to 1994 Employer: Browdy & Neimark Title: Patent Agent Department: Responsibilities: Chemical, biotech & mechanical patent licensing, product clearances, infringement & invalidity opinions, patent drafting, prosecution & appeals & interferences, for chemical, biotech & pharma companies, & for academic & non-profit institutions. Trademark matters, including drafting, prosecution and clearances. Personal drafting of 40-50 patent applications/year. Subject matter including medical device related work included diagnostic assays and kits, intra-articular, IV, intramuscular, subcutaneous, transdermal, inhalation, intranasal, and oral administration devices, formulations, combinations, and dosing for chemical and biotech drugs, antibodies, proteins, vaccines, chemicals, devices, business methods, software. Management of patent agents, paralegals and administrative staff.
Years: 1990 to 1992 Employer: Sughrue, Mion, Zinn, Macpeak & Seas, LLP Title: Patent Agent Department: Intellectual Property Responsibilities: Chemical, biotech & mechanical patent infringement & invalidity opinions, patent drafting, prosecution & appeals & interferences, for chemical, biotech & pharma companies, academic & non-profit institutions. Personal drafting of 40-50 patent applications/year. Trademark matters, including drafting, prosecution and clearances. Subject matter including medical device related work included diagnostic assays and kits, intra-articular, IV, intramuscular, subcutaneous, transdermal, inhalation, intranasal, and oral administration devices, formulations, combinations, and dosing for chemical and biotech drugs, antibodies, proteins, vaccines, chemicals, devices, business methods, software. Management of patent agents, paralegals and administrative staff.
Years: 1983 to 1988 Employer: National Institutes of Health Title: Molecular Biologist, GS-9 Department: Molecular and Cellular Carcinogenesis Responsibilities: Chemical & biological analysis of : (a) DNA repair in xeroderma pigmentosum patients & cloning & expression of cytochrome p-450s in vaccinia, retrovirus & baculovirus expression systems, characterization, antibodies & enzyme assay development & kinetics, including protein, DNA and RNA analysis, enzyme and protein spectroscopy and mass spectroscopy, and gene expression analysis.

International Experience

Years Country / Region Summary
Years: 1994 to 2009 Country / Region: European Union Summary: In the European Patent Office, Expert has managed more than 15 patent oppositions & appeals, & managed prosecution of more than 150 EPO patent applications.

Expert has also managed setting up and supporting EU arbitrations and patent litigation relating to multibillion dollar biotechnology products for a large global pharmaceutical company, including litigation analyses, patent invalidity and non-infringement analysis and strategies, technical analysis supporting non-infringement case, and development of expert testing, witnesses, and testimony, resulting in arbitration settlement before litigation initiated with significant reduction in royalties to an amount significantly less than expected litigation costs.

Expert has worked on more than 25 major due diligences, negotiations, and agreement drafting for multimillion to multibillion collaboration and licensing agreements with EU companies. Expert has also worked on more than 100 IP related agreements with EU companies.
Years: 1990 to 2008 Country / Region: Japan Summary: In the Japan patent office, Expert has managed the prosecution of more than 100 patent applications & 10 appeals, including in person interviews.

Expert has also worked on international pharmaceutical & biotechnology dispute resolution & patent litigation, including patent arbitrations & litigation in Japan.

Expert has worked on more than 10 major due diligences, negotiations, and agreement drafting for multimillion to multibillion collaboration and licensing agreements with Japanese companies. Expert has also worked on more than 50 IP related agreements with Japanese companies.
Years: 1994 to 2008 Country / Region: Worldwide Summary: In addition to managing more than 50 patent & regulatory product portfolios worldwide, Expert has drafted more than 500 international patent applications, prosecuted more than 1000 patent applications & managed worldwide patent prosecution for more than 500 patent families.
Expert has conducted more than 100 major worldwide product & company transactional & IP due diligences, negotiations & agreements, as well as more than 1000 agreement negotiations & drafting, including worldwide academic, non-profit, government, feasibility, research, service, investigator initiated clinical studies, clinical studies & master agreements, manufacturing, product & technology licensing, know how & patent licenses, acquisitions, & product & technology out-licensing.
Expert has worked on international pharmaceutical & biotechnology dispute resolution & patent litigation, including patent arbitrations & litigation in the US, EU, & Japan, and other countries.

Career Accomplishments

Associations / Societies
Patent Office Society
Licenses / Certifications
PA Bar; Colorado Bar

Additional Experience

Marketing Experience
Expert has more than 25 years experience as in house and outside counsel involving all types of US and worldwide business development, acquisition, co-development, marketing, manufacturing and IP and know how licensing for discovery, therapeutic, diagnostic, and manufacturing biotechnology, pharmaceuticals, medical devices, and related technologies.

Expert has worked on more than 100 major, worldwide product and company acquisition and license agreements, including transactional, IP and regulatory due diligence, negotiations and agreement drafting. Expert has also worked on more than 5000 agreements, including due diligence, negotiations and drafting, including multi-product licensing, therapeutic area and technology licensing, co-promotion, co-development, multi-tiered and multi-party option agreements, medical and administration device feasibility, IP licensing, co-development and co-manufacturing, technology feasibility and option agreements, research, service, investigator initiated clinical study, clinical study and master agreements, manufacturing, product and technology licensing, know-how and patent licenses, and product and technology out-licensing.
Other Relevant Experience
Biopharma and Pharma Business Development,
Licensing and cross-licensing IP and Know How,
Due diligence,
Licensing,
Acquisition, and
Technology and Business Development Agreements and Consulting services

Language Skills

Language Proficiency
English Expert in English
Spanish Basic and limited ability to read, write and understanding, long experience reading and understanding Spanish patents and applications.
French Basic and limited ability to read, write and understanding, long experience reading and understanding French patents and applications.

Fields of Expertise

international licensing, bioinformatics, bioprocessing, biotechnology, business development, drug, drug delivery, drug development, drug discovery, drug screening, drug validation, Food and Drug Administration regulation, intellectual property licensing, international technology transfer, pharmaceutical drug, pharmaceutical manufacturing, pharmaceutical product development, pharmaceutical product formulation, pharmaceutical research, pharmaceutical research and development, pharmacogenomics, proteomics, technology licensing, Hatch Waxman Act, product licensing, commercial licensing, business licensing, mergers and acquisitions, structural bioinformatics, dispute, biodiesel startup, abbreviated new drug application, canons of claim construction, business valuation, antitrust, conventional licensing, DNA microarray, agricultural biotechnology, merger, globalization, international patent law, competitive benchmarking, royalty rate, industrial biotechnology, amino acid sequence, hip replacement, generic drug manufacturing, bioanalytical chemistry, technology acquisition, endotoxin contamination, food biotechnology, competitive intelligence, pharmacogenetics, computer software licensing, General Agreement on Tariffs and Trade, agreement, generic drug, joint venture, biological cell adhesion, hollow fiber bioreactor, biomedical application, action, startup, trade secret law, trade secret, biomechanical engineering, biofuel, European patent, licensable technology, transdermal patch, Food and Drug Administration CFR-21 part 175, chemical research and development, corporate strategic planning, foreign patent, pharmaceutical engineering, government-industry-education interaction, clinical engineering, document, reverse engineering, application, technology transfer, analysis, new product development, computer-aided drug design, bioreactor design, international manufacturing, licensing, genetic probe, electromechanical device, genetically engineered material, biomedical device, biochemical engineering, microorganism, biological process, bioengineering, chart, peptide, amino acid, organic compound, pharmaceutical chemistry, gene expression, fluorescence, computer software, bioreactor, biomedical engineering, biology, biocompatible polymer, industrial biochemical process, alternative fuel

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