Pharmaceutical & Life Sciences
[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column width="2/3"][vc_column_text]Fay Sharpe members have worked closely with pharmaceutical clients in a variety of areas within in the pharmaceutical industry including: Hatch-Waxman patent and regulatory exclusivity strategy; pharmaceutical patent litigation; freedom to operate and patentability opinion work; patent and trademark preparation and prosecution; pharmaceutical lifecycle management; Paragraph IV Abbreviated New Drug Application (ANDA) and 505b2 New Drug Application (505b2 NDA) filing and launch strategies, FDA Orange Book exclusivity and forfeiture analysis, FDA Citizen Petition counsel, biosimilar and over-the-counter product filing and launch strategy, State Boards of Pharmacy and Medicine licensing, and FDA/DEA compliance consultation. Firm members also have IP and regulatory experience in the dynamic and ever-changing Medical Marijuana/Cannabis Industry space. Pharmaceutical Patent Opinions, Counseling and Hatch-Waxman Litigation Fay Sharpe works closely with clients to determine offensive and defensive patent strategies. Issues we routinely addresses include: freedom to operate, invalidity, patent infringement, unenforceability, licensing, and...
