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FDA Releases New Guidance for Biosimilar Applications

Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical...more

5/14/2014 - Biosimilars BPCIA FDA Guidance Update

USPTO Issues New Subject Matter Eligibility Examination Guidelines for Claims Involving Laws of Nature, Natural Principles,...

On March 4, 2014, the USPTO issued a Guidance memorandum for examination of subject matter eligibility under 35 U.S.C. ยง 101 in view of AMP v. Myriad (2013) and Mayo v. Prometheus (2012). Under the new guidelines, the...more

3/18/2014 - AMP v Myriad Mayo v. Prometheus Patent-Eligible Subject Matter Patents USPTO

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