Expert Details
Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
ID: 727557
Colorado, USA
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.
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 |
|---|---|---|---|
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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. |
|||
Career Accomplishments
| Associations / Societies |
|---|
| Patent Office Society |
| Licenses / Certifications |
|---|
| PA Bar; Colorado Bar |
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