Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
The use of artificial intelligence (AI) to advance stem cell therapy has produced exciting results, with a key role in driving recent growth and innovation. Separated into three parts, this article provides an overview the...more
China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...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
Last Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human...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
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
In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more
Generally, the European Patent Office does not allow claims to methods involving the use of human embryos for industrial or commercial purposes. It was therefore perhaps not surprising that the Examiner objected to the...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
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
Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog...more