- Expert in planning and executing pharmaceutical and biotechnology research and development strategies.
- Experienced Hatch-Waxman litigator from a corporate point of view.
- Prepared witnesses and attended depositions for corporate personnel.
- Conducted due diligence for possible in-licensing candidates.
- Negotiated and drafted licensing agreements.
- Familiar with FDA regulations as they pertain to NDA's and sNDA's.
- Patent strategy, patent portfolio management and patent assessments.
- Skilled at Paragraph Four Patent litigations.
- Drafted patent term extension applications.
- Reviewed patents for suitability for listings in the Orange Book.
- World wide business development in negotiating and drafting license agreements.
- Understands the relationships between patent law and FDA requirements.
Undisclosed Pharmaceutical Firm, Vice-President, Corporate Intellectual Property Department, 1991 - 2009
- Supervised a group of 6 attorneys with world-wide responsibility for Oncology and Anti-Infective research.
- Participated in two major Paragraph Four Litigations.
- Prepared witnesses, attended depositions and helped plan overall strategy with major issues involving double patenting, inequitable conduct and 103 art.
- Led various due diligence teams in evaluating in-licensing and acquisition opportunities.
- Advised management as to the strengths and weaknesses of patent portfolios.
- Worked with world-wide business development in negotiating and drafting license agreements.
- Familiar with the relationship between patent law and FDA requirements.
- Worked with the intricacies of the Hatch-Waxman Act.
- Decided on Orange Book listings for newly launched products.
- Produced Freedom to Operate opinions for research and development management.
- Worked with R&D Management in planning and executing patent strategy.
Bristol-Myers Squibb, Princeton, New Jersey, Staff Attorney, 1980 - 1990
- Prepared and prosecuted patient applications in the pharmaceutical area.
- Developed expertise in foreign filing patent matters.
- Performed client counseling for the Consumer Division.
Wyeth Laboratories, New York, NY, 1972 - 1980
- Drafted and prosecuted patent applications for various divisions of the company which included pharmaceuticals, household products and automobile touch-accessories.
Mobile Oil Corporation, New York, NY, 1969 - 1972
- Worked as staff attorney dealing with new catalytic compositions.
Honors & Publications
- Registered in the United States Patent Office
- Member of the New York Bar
Academic and Professional Affiliations
- American Bar Association
- American Patent Law Association
- Written patent numbers can be supplied upon request
- M.S. Chemistry, St. John's University, Graduate School, New York, NY
- B.S. Chemistry, City College of New York, NY
- LLB School of Law Fordham University, New York, NY