With clarity concerning the Biologics Price Competition & Innovation Act and significant patent expirations on the horizon, the U.S. biologics market remains a highly prized landscape for industry players. Ms. Rathinam will lecture on strategic navigation of the BPCIA litigation framework and review 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. She will discuss how these two pieces of legislation together present unique considerations for collaboration and litigation strategies. This lecture will also include a current update on pertinent U.S. case law and legislative and FDA related developments, including the FDA's recent issuance of the Purple Book and the introduction of the FAST Generics Act.
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