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The America Invents Act (AIA), enacted on September 16, 2011, changes the landscape for those seeking to challenge the validity of an issued patent outside of litigation
On March 20, 2012, the US Supreme Court issued an opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (No. 10-1150) regarding the patent eligibility of method claims, finding the particular claims in Prometheus’ patents, relating to methods of treatment, patent-ineligible under 35 U.S.C. 101
On February 9, 2012, the US Food and Drug Administration (FDA) published the longawaited guidance documents on the criteria for development of biosimilars, for which an abbreviated approval pathway is envisioned under the Biologics Price Competition and Innovation Act of 2009
On March 20, 2012, the US Supreme Court issued an opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (No. 10-1150) regarding the patent eligibility of method claims, finding the particular claims in Prometheus’ patents, relating to methods of treatment, patent-ineligible under 35 U.S.C. 101
