Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
In re Roslin Institute (Edinburgh) - Addressing patent eligible subject matter under 35 U.S.C. § 101, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office...more
At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more
The Supreme Court decision last year on June 13, 2013 in Association of Molecular Pathology v. Myriad Genetics may have been a watershed moment for the biotechnology industry. So far the effects have been hard to detect, but...more
Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more
MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more
Last week, in In re Roslin Institute (Edinburgh), the Federal Circuit affirmed the rejection by the United States Patent and Trademark Office (USPTO) of product claims covering cloned mammals. This case relates to Dolly,...more
Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research...more
A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more
Last month, Consumer Watchdog filed its opening brief in an appeal of a Board decision affirming the patentability of U.S. Patent No. 7,029,913, arguing that the claims of the '913 patent are invalid because they cover...more