In late December the FDA issued a new guidance, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The purpose of the guidance is to “describe best practices and procedures for timely, transparent, and
Latest from BioLoquitur - Page 3
Federal Circuit Opens Door for PTAB Institution Decision Appeals
The Federal Circuit on Wednesday reversed Court precedent and long held belief that inter partes review (“IPR”) institution decisions were categorically non-reviewable. The Court, sitting en banc, held that the issue of whether a petitioner is time-barred from filing an
2017 Patent Litigation: A Statistical Overview
It was a busy year for patent litigation across the broad, including the U.S. Patent and Trademark Office Patent Trial and Appeals Board (PTAB), U.S. District Courts (USDC), Court of Appeals for the Federal Circuit (CAFC), and the Supreme Court
FDA Announces New Digital Health Policy Documents to Encourage Efficient Development of Digital Health Tools
On December 7, 2017, the FDA announced three new policy documents geared toward advancing and properly overseeing innovative new digital health tools. The documents mark an acute recognition by the FDA that as consumers and health care providers increasingly use
No Longer the Stuff of Science Fiction: The FDA’s New Policy Approach to Regenerative Medicine Products
The ability to facilitate the regeneration of parts of the human body is “no longer the stuff of science fiction” according to FDA Commissioner Scott Gottlieb.[i] According to Commissioner Gottlieb, the cell based therapies and their use in regenerative
FDA Releases Draft Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application
This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug and Cosmetic Act (FD&C Act) is appropriate for the
Amicus Briefs at the PTAB Permitted For Question on Termination of Allergan IPR Case Based on Tribal Sovereign
In an unprecedented move by the U.S. Patent and Trademark Office (USPTO), the Patent Trials and Appeals Board (PTAB) has permitted the filing of amicus briefs on whether the Saint Regis Mohawk Tribe (“Tribe”) should be permitted to terminate the
“Tax Cut and Jobs Act” H.R. 1 Passes House Of Representatives: Provisions To Watch
When Are Swashbuckling Experts Seemingly ‘Flooding’ a Court with Large Number of References?
The Federal Circuit’s Review of Bayer’s Erectile Dysfunction Treatment Suggests Tolerance for a Wide Girth When Aiming for a Narrow Point
In Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. November 1, 2017), the Federal Circuit overturned the District
Is Medical Marijuana Really Medicinal?
This is a cross-posted blog from The Blunt Truth.
Despite the dearth of approved marijuana products, the term “medical marijuana” has become commonplace, and the term’s prevalence continues to increase as more states legalize the use of the marijuana