Sughrue Mion, PLLC, USA
Ms. Rathinam is a partner in the Washington D.C. office. She has served as litigation counsel in matters involving the chemical, pharmaceutical and mechanical arts, and has significant experience in all pre-trial, trial, and post-trial aspects of patent litigation. Central to Ms. Rathinam's practice is Hatch-Waxman Act analysis, and as such she has represented a number of pharmaceutical companies in ANDA/NDA related actions. She also engages in pharmaceutical/biotechnology patent infringement and validity opinion practice and counseling particularly in connection with preparation of Paragraph IV Notifications under section 505(j), as well as freedom-to-operate, due diligence and product clearance work, licensing and contract matters, including joint ventures. Ms. Rathinam's practice additionally includes analysis of the Biologics Price Competition and Innovation Act (BPCIA) and counseling with respect to developments pertaining to implementation of the U.S. abbreviated approval pathway as well as litigation strategies particular to interchangeable, biosimilar, and biobetter products and platform technologies.
With clarity concerning the Biologics Price Competition & Innovation Act (BPCIA) of 2010 and imminent significant patent expirations on the horizon, the U.S. biologics market remains an increasingly prized landscape for industry players. We will revisit the BPCIA litigation framework and also examine critical paradigm shifts in U.S. patent law via the America Invents Act of 2011 that cannot be overlooked by biosimilar applicants or reference product sponsors. We will examine how these two pieces of legislation together present unique considerations for prosecution, collaboration and litigation strategies that should be implemented now. Proposed roadmap for presentation: *Brief review of BPCIA patent information exchange and litigation framework - updates on applicable U.S. case law (e.g. Sandoz Inc. v. Amgen Inc. appeal) *Brief review of key modifications under the America Invents Act *Practical steps and immediate considerations for prosecution, collaboration/partnering and litigation strategies