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From Banks to FinTech: The Evolution of Small Business Lending — Payments Pros – The Payments Law Podcast
Podcast - Navigating the Updated SF-328 Form
Five Tips for a New Public Company Director
Doc Fees Decoded: The Price of Paperwork in Auto Sales — Moving the Metal: The Auto Finance Podcast
PODCAST: Williams Mullen's Benefits Companion - Gag Clause Prohibitions
Episode 371 -- DOJ's New Corporate Enforcement Program
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(Podcast) The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
The Briefing: Influencer Fail – ALO Yoga & Influencers Named in $150M Class Action Lawsuit for FTC Violations
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
LEGAL ALERT | NAD Finds Kevin Hart’s Social Media Disclosures Insufficient in Monitoring Decisions
Choosing Your LDA Reporting Path for 2025
Bar Exam Toolbox Podcast Episode 305: Spotlight on Civil Procedure (Part 2 – Discovery)
Compliance Tip of the Day: Clarifying Compliance Mandates
Consumer Finance Monitor Podcast Episode: How to Use the Restatement of Consumer Contracts - A Guide for Judges
Compliance Tip of the Day: Corporate Leaks and Compliance
On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
It is well established that an enantiomerically pure compound exhibiting advantageous properties not present in its isomer or its corresponding racemic mixture, can be patented even if its corresponding racemic mixtures are...more
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more
Federal Circuit Holds That the Preamble of Jepson-Style Claims Must Be Supported by an Adequate Written Description - U.S. patent claims have a preamble, and, in most cases, the preamble is not limiting. Jepson-style...more
Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more
On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more
Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more
IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more
On June 25, 2018, the United States Supreme Court agreed to review the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals, No. 17-1229. In Helsinn, the Federal Circuit considered whether the America...more
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more
The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...more
The 2014 BIO International Convention begins next week in San Diego. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore,...more