America Invents Act – stay up to date *

USA - May 9 2012
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.

Co-authors: Irene E. Hudson, Gauri M. Dhavan , Joseph J. Koipally Ph.D. .

Patent eligibility of method claims under section 101: the standard under Mayo v. Prometheus *

USA - May 9 2012
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.

Co-authors: Irene E. Hudson, Gauri M. Dhavan , Joseph J. Koipally Ph.D. .

The FDA’s recent guidance on biosimilars *

USA - May 9 2012
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.

Co-authors: Irene E. Hudson, Gauri M. Dhavan , Joseph J. Koipally Ph.D. .

Life sciences update - spring 2012 *

USA - April 9 2012
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.

Co-authors: Irene E. Hudson, Gauri M. Dhavan , Joseph J. Koipally Ph.D. .