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The Labor Law Insider: NLRB Does a U-Turn on Make-Whole Settlement Remedies, Part II
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The LathamTECH Podcast — Where Digital Assets Slot Into a Shifting Fintech Regulatory Landscape: Insights From the US, UK, and EU
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Wiley's 2025 Key Trade Developments Series: CFIUS Review and Outbound Investments
Wiley's 2025 Key Trade Developments Series: U.S.-Mexico-Canada Agreement (USMCA)
The Presumption of Innocence Podcast: Episode 60 - Enforcement Priorities of the Second Trump Administration: Employee Retention Tax Credit
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Non-Competes Eased, Anti-DEI Rule Blocked, Contractor Rule in Limbo - Employment Law This Week® - #WorkforceWednesday®
Business Better Podcast Episode - Manufacturing Moment: How State Associations Navigate the Policy Landscape
CHPS Podcast Episode 3: Unlocking America's Mineral Potential
Clocking in with PilieroMazza: Latest Developments on DEI Executive Order and Action Items before April 21 Deadline
Sunday Book Review: April 13, 2025, The Books on Trade and Tariffs Edition
Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast
State AG Pulse | With the Reshaping of Government, More Power To State AGs
Consumer Finance Monitor Podcast Episode: A Deep Dive Into Judge Jackson’s Preliminary Injunction Order Against CFPB Acting Director Vought
AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more
The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more
On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more
The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices. See Targeting...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more
The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...more
On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy." The Executive Order (in Section...more
Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
On June 8, 2022, a bipartisan group of U.S. Senators sent a letter to Kathi Vidal, Director of the U.S. Patent & Trademark Office, requesting that the PTO take action on patent thickets. According to the Senators, “large...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more
On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more