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FDA’s draft guidance on scientific considerations in demonstrating biosimilarity

USA - February 10 2012 Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act

Co-authors: Paul T. Kim, James M. Flaherty, Jr., Barbara A. Fiacco.


Government strategies alert: FDA releases long-awaited draft guidances on biosimilar product development

USA - February 9 2012 Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars.

Co-authors: Paul T. Kim, James M. Flaherty, Jr., Barbara A. Fiacco.


Supreme Court holds that facts underlying patent challenge must be proved by clear and convincing evidence

USA - June 13 2011 In Microsoft Corp. v. i4i Limited Partnership, a unanimous Supreme Court held last week that an accused infringer must prove the facts underlying any challenge to the validity of a United States patent by clear and convincing evidence.

Co-authors: Barbara A. Fiacco.


Federal Circuit finds method of treatment claims patentable

USA - January 5 2011 In the first case to consider the patentability of a life sciences invention since the U.S. Supreme Court decided Bilski v. Kappos, the Federal Circuit held that medical treatment claims asserted by Prometheus Laboratories were eligible for patent protection.

Co-authors: Jeremy A. Younkin, Barbara A. Fiacco.


Supreme Court clarifies scope of patentable inventions

USA - June 28 2010 The Supreme Court today affirmed the Federal Circuit’s holding that Bilski’s business method was unpatentable subject matter because it sought to claim patent protection on an abstract idea.

Co-authors: Philip C. Swain.

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