Steven J. Birkos is an associate at Rakoczy Molino Mazzochi Siwik LLP.
Opinion Work and Patent Counseling
Mr. Birkos is active in the firm's patent counseling practice group. In this context, Mr. Birkos has prepared opinions of counsel for clients on a variety of intellectual property issues and with respect to a wide range of pharmaceutical technologies, including small molecule chemistry, pharmaceutical compounds and formulations, polymorphic forms of active pharmaceutical ingredients, immediate and extended release dosage forms, injectable dosage forms, inhalation dosage forms, topical dosage forms, and pharmaceutical dosing methods.
Mr. Birkos has also prepared a number of detailed statements in support of a variety of different regulatory filings including Abbreviated New Drug Applications, 505(b)(2) New Drug Applications, and abbreviated Biologics License Applications.
Mr. Birkos has also prepared a number of freedom to operate opinions and has assisted clients with their due diligence efforts.
Mr. Birkos is also active in the firm's patent litigation practice, with an emphasis on pre-suit investigation work and expert discovery.
Practice Before the U.S. Patent and Trademark Office
Mr. Birkos is registered to practice before the United States Patent and Trademark Office and also has significant experience with inter partes review proceedings, including preparation of IPR petitions and expert declarations.
Prior to attending law school, Mr. Birkos had an extensive scientific career. While employed at the drug discovery companies Nanosyn and Amphora Discovery, he developed an industrial high-throughput screening operation, supervised a team of scientists that generated chemical genomic data for the identification of active compounds, and performed early-stage chemistry analyses on those compounds. Mr. Birkos also worked as a research specialist for the Department of Immunology at the Hospital of the University of Pennsylvania, where he conducted molecular-based histocompatibility testing on patient and potential donor samples.