FDA Issues Order Noting Resolution of Tirzepatide Shortage: Update for Compounding Pharmacies On December 19th, the FDA issued a FDA declaratory order noting the resolution of the shortage for tirzepatide injection products, including Mounjaro and Zepbound. The tirzepatide shortage, which began in December 2022, was driven by overwhelming demand for these breakthrough medications used in managing type 2 diabetes and obesity. The FDA’s most recent decision, effective […] Read Post →
Small business owner? Prepare for compliance with new “wise but unconstitutional” Corporate Transparency Act Attention Small Business Owners: The enactment of the Corporate Transparency Act (CTA) marks a significant shift in the regulatory landscape for businesses across the United States. This pivotal piece of legislation, primarily aimed at combating financial deception such as money laundering and tax evasion, requires a clear disclosure of beneficial ownership information to the Financial […] Read Post →
Unraveling EPA’s New Gene Edited Plant Rules – Effective July 31, 2023 Today, the EPA’s new gene editing rules go into effect, with noteworthy implications for the use of biotechnology in agriculture. This finalizes draft rulemaking that was proposed back in 2020, and these new rules clarify the broad scope of the agency’s jurisdiction over gene-edited crops, specifically those defined as plant-incorporated protectants (PIPs) under 40 CFR […] Read Post →
Luddites, Lawyers, Illustrators: Embrace AI as a Tool The Unhappy Painter, by Theodor Hosemann, 1843, illustrating a painter as a victim of technology, made obsolete by photography. Artificial intelligence (AI) is disruptive and will change the way we create and innovate – similar to disruption from the printing press, the camera, Photoshop, and gene editing. Use of any tool does not remove the […] Read Post →
FDA’s New Pathway for CBD Products: What Businesses Need to Know The CBD industry is buzzing with today’s news that the U.S. Food and Drug Administration (FDA) is working with Congress to develop a new regulatory framework for cannabidiol (CBD) products. This is great news for businesses developing CBD products, as it means that there will be a clear path forward for the lawful marketing of […] Read Post →
AI in Healthcare: What You Need to Know About the FDA’s Regulatory Role Artificial intelligence (AI) technology is increasingly being used in the healthcare field, and the US Food and Drug Administration (FDA) plays a crucial role in regulating these applications. Below, we examine the different ways that the FDA regulates AI technology in healthcare and look at some of the challenges and opportunities presented by this rapidly […] Read Post →
Patent Fees for Small and Micro Entities Reduced Small and micro businesses can now take advantage of lower patent fees thanks to the Consolidated Appropriations Act, 2023 and the Unleashing American Innovators Act of 2022. These new laws were recently signed into law by President Biden and aim to support small and micro entities by increasing small entity discounts from 50% to 60% […] Read Post →
Who is monetizing your online presence? Commercial surveillance and the FTC’s new rules The Federal Trade Commission just posted notice of its intent to increase federal regulations regarding commercial surveillance, data security and privacy. The FTC defines commercial surveillance as “the business of collecting, analyzing, and profiting from information about people.” Currently, the FTC’s ability to deter unlawful conduct is limited because the agency generally lacks authority to seek financial […] Read Post →
In a diminishing talent pool, should you hire an independent contractor? Remember the ABCs. It is increasingly hard to find top talent to fill roles. As a result, organizations are adopting flexible models to allow remote/hybrid work to help fill needs, in addition to paying increased wages compared to pre-pandemic levels. For those asking if they should hire an independent contractor instead of an employee, the waters are increasingly […] Read Post →
Engagement announcement: USPTO and Regulatory Agencies Tie the Knot After many years of casual data sharing between agencies, the USPTO has formally announced its intentions to marry the duty of disclosure for patent prosecution with the regulatory process. Today’s notice clarifies the scope of duties of inquiry and disclosure to the Patent Office, including for statements made to the FDA and other regulatory agencies […] Read Post →
When your own patent application counts as prior art: Beware the Continuation-In-Part Often during patent prosecution new technologies, concepts and data grow out of an original filing. How can you protect those new innovations? The natural reaction is to file a child application off of the parent filing, in order to preserve the earlier priority date through a continuation or continuation-in-part (CIP) application. A continuation is limited […] Read Post →
The Great Dichotomy: Patent Protection vs. Regulatory Approval As a scientist in discovery mode, the primary focus is often on points of novelty and seeking patent protection for the invention. The supporting data in the patent application serves as proof that this is a unique innovation, has never been seen before, and overcomes key challenges. However, when the product is regulated, converse arguments […] Read Post →
A Blizzard and a Regulatory Freeze For those in the Midwest today, I hope you are staying warm & are ready for the predicted snowfall and wind gusts currently in progress. There’s been a lot of news in recent months about agricultural biotechnology regulatory changes underway at various stages of public comment and implementation (7 CFR part 340, proposed EPA rules […] Read Post →
EPA Provides Draft Guidance for Regulation of Gene Edited Plants Background Although the USDA gets the most attention related to the regulation of gene edited plants, in the United States products of biotechnology are regulated by the USDA, FDA and EPA under the Coordinated Framework for the Regulation of Biotechnology, updated most recently in 2017. Under this framework, the USDA, FDA and EPA each regulate in […] Read Post →
USDA’s new Part 340 and impact on gene edited plants The USDA published a new version of agricultural biotechnology regulations (7 CFR Part 340, aka “Part 340”) which is the culmination of several years of revision and public review. In this revised rule, which will begin implementation 90 days from May 18th, developers now have more definitive guidelines on where plants will be exempt from […] Read Post →
Farm Bill Amendments to Enable CBD Oil and Hemp Industry On June 27th, the Senate published the latest version of amendments to the Farm Bill which contain updates to the regulatory framework for hemp and derived products including CBD (cannabidiol) oil. Cannabidiol oil has documented health benefits such as effectiveness in treating certain types of seizures, and the U.S. Department of Health and Human Services […] Read Post →
National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing National Bioengineered Food Disclosure Standard rules publish May 4: Ties to patent protection and gene editing In 2016 Congress passed an amendment to the Agricultural Marketing Act of 1946 to establish a national bioengineered food disclosure standard. This law was an important milestone in establishing transparency for consumers, ensuring labeling certainty for innovators developing […] Read Post →
Patent Covering Methods of Advanced Genomic Selection from Guinea Pigs to Corn Survives Opposition in EU Effectively protecting improved genetics requires a multi-pillared strategy considering the biological organisms themselves, methods of use, methods of breeding, and any regulatory data protection. The EPO recently upheld a patent (EP 2813141, granted August 5, 2015) drawn to methods of breeding using genome-wide estimated breeding values (EBVs) to identify combinations of individuals in a population […] Read Post →