Pete is a registered patent attorney* with more than 30 years of IP and patent prosecution experience involving complex technologies, particularly in the life sciences. He serves as intellectual property counsel to a number of leading US pharmaceutical companies, and leverages significant legal and technical insight to develop strategies that maximize the patent protection, market exclusivity, and longevity and value of branded drugs.
Pete has developed and prosecuted patent portfolios for several pharmaceutical products that have gone through and are now in clinical use. He has worked with technologies including small molecule pharmaceuticals and pharmacokinetic properties and profiles; biotechnology inventions, such as cloning systems and recombinant proteins; transgenics, stem cells, cell lines, various assays, vaccines, probes, and monoclonal and polyclonal antibodies; and medical devices.
Pete's focus includes complex legal intellectual property issues that concern all four phases of the drug development process: research, pre-clinical, clinical, and post-launch. Over the years, Pete has counseled life sciences clients on Hatch-Waxman and regulatory schemes and exclusivities, FDA Orange Book practice inclusive of patent listing and use code strategies; patent term exclusivity (PTE) and patent term adjustment (PTA) practice and strategies; US and foreign patent practice and strategies; first and multi-generation lifecycle management (LCM) practice and strategies, including protection for compounds, compositions of matter, processes, methods, syntheses, scale-ups, indications, formulations, metabolites, intermediates, polymorphs, pharmacokinetic characteristics, stabilization techniques and characteristics, mono and combination Rx and OTC therapies, delivery systems, dosage forms, e.g., enterals (tablets, capsules, capsules, lozenges, troches, sublingual, orally disintegrating, buccal, chewable, fast acting, slow release, controlled release, enteric coated, film coated, powders, and liquids), parenterals (intravenous, subcutaneous, intramuscular, intraocular), topicals (cream, ointment, gel, foam, liquid, and cryotherapy), transdermals, nasals (sprays and gels), inhalants (liquid and powder), ophthalmics, otics and rectals, dosage strengths, treatment regimens, implants, packaging and distribution systems and methods; FDA monograph patent practice and strategies, including USP and other national pharmacopeia considerations; regulatory patent practice and strategies, including 505(b)(1), 505(b)(2), ANDA, 510K, clinical, safety warning, toxicity, and labeling patent practice and strategies; citizens petitions patent practice and strategies; clinical trial patent practice; patent misuse and antitrust practice and strategies; licensing practice and strategies; IP due diligence practice and strategies; and merger, acquisition, and divestment patent practice and strategies.
In addition to patenting a very wide variety of biotechnology and pharmaceutical products, including everything from HIV antibodies to home pregnancy and HCV tests and other diagnostics, Pete has prosecuted domestic and foreign patent applications in other technology areas, including specialty chemicals, foods, flavors, and a variety of mechanical and cellular inventions, such as hands-free cellular smartphone and tablet devices.
Pete also has extensive experience in evaluation, licensing, acquisition, and enforcement of all types of intellectual property rights. He regularly conducts IP due diligence, including infringement and validity studies of patents; infringement and validity studies concerning public offerings and SEC filings; and infringement, availability, and enforceability studies concerning trademarks, service marks, and trade dress. He is also involved in drafting and negotiating a wide variety of agreements, including licensing, acquisition, asset purchase, confidentiality disclosure, technology and material transfer, research, employment, noncompete, assignment, and joint venture agreements.
Pete also has a significant amount of litigation experience, including patent infringement litigations in which the patents on which suits were brought were found to be valid, enforceable, and infringed.
He was invited to sit on three panels at a Bugs-to-Drugs program sponsored by the US Department of Defense and organized by the Sarnoff Corporation. The program addressed the need to shift to a national defense paradigm with a more biological orientation; develop and deploy technologies for disease surveillance, electronic medical records, and field-ready DNA fingerprinting technologies; and accelerate the development, manufacture, and distribution of novel and effective biological and/or chemical countermeasures - namely drugs, vaccines, and biologics - in the event of biological attack or pandemic.
Prior to embarking on his career as an IP attorney, Pete was a hospital and retail pharmacist at the University of Maryland shock trauma unit.
* Admitted in Ohio only. Practicing under the supervision and guidance of Members of the Boston office. (Also at West Palm Beach Office)