Listed with other top experts in: 

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.

2011 to

(Undisclosed)

Intellectual Property

Special Counsel

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.

2008 to 2010

Hogan Lovells LLP

IPMT

Partner

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.

2000 to 2008

Johnson & Johnson/Centocor

Patent Law Department

Assistant Patent Counsel

Sole responsibility for REMICADE™ , J&J's Largest Product (>$4Billion annual sales). 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.

1998 to 1999

Eli Lilly and Company

Patent Department

Senior Patent Counsel

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.

1994 to 1998

Sterne, Kessler, Goldstein and Fox, LLP

Senior Associate

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

1992 to 1994

Browdy & Neimark

Patent Agent

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.

1990 to 1992

Sughrue, Mion, Zinn, Macpeak & Seas, LLP

Intellectual Property

Patent Agent

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.

1983 to 1988

National Institutes of Health

Molecular and Cellular Carcinogenesis

Molecular Biologist, GS-9

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.

• Expert has provided 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.
• Expert has developed, managed and implemented US, EU and Japanese patent pre-infringement, non-litigation or litigation strategies against competitors to support infringement, invalidity and potential cross-licensing of patent families, involving competing products in development, including interferences, reexams, and litigation preparation, such as invalidity, unenforceability and infringement analysis and strategy, technical analysis supporting invalidity, unenforceability and/or infringement case, and development of expert testing of asserted infringing product, witnesses, and testimony.
• Expert has managed US, EU and Japanese arbitrations and patent litigation defense preparation for a hundreds of millions to multibillion dollar products for large global companies, including litigation analyses, patent invalidity and non-infringement analysis and strategies, technical analysis supporting non-infringement case, litigation management, and development of expert testing, witnesses, and testimony, often resulting in settlement and significant reduction in, or avoidance of, royalties to at least less than potential litigation costs
• As an important example, Expert solely drafted, directly managed prosecution and initially managed the setting up of litigation of US patent 7.070,775, asserted by Centocor against Abbott that resulted in a record US$1.67 billion infringement verdict against Abbott in the Eastern District of Texas (07-cv-00139, E.D. Texas (Marshall)).
• 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 for consulting on licencing agreement.
• IP Licensing biopharma expert for consulting on Webinar/Blog Participation.

• Endocrine expert in diabetes for consulting on the physical effects of diabetes on a person.
• Expert in biotech patent malpractice litigation.
• Trademark survey expert for consulting on medical data integration.

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.

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.

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 1000 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, patent 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.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.