Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
When most people think of cattle, they think of Ferdinand the Bull and their favorite steakhouse. The reality of beef production is far from most consumers’ radar. However, as of 2016, less than 2% of the U.S. population...more
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more
Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for...more
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
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
As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more