On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more
The June 2024 issue of Vanity Fair included the provocative headline: “Why Counterfeit Ozempic Is a Global-Growth Industry." Novo Nordisk’s patented drug Ozempic® (semaglutide injection) was first approved by the FDA in 2017...more
On June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder (PTSD) voted 9-2 that MDMA in combination with talk...more
The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more
On June 6, 2023, the Senate Judiciary Committee's Subcommittee on Intellectual Property introduced a Bill entitled “Patent Eligibility Restoration Act of 2023” (PERA) aiming to amend the law relating to patent subject matter...more
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in...more
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more
As predictions of an economic recession in the United States loom, 2023 has started with extensive layoffs throughout the tech industry. Though not to an equal degree, the biotechnology, pharmaceutical, and life science...more
The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any related patent and...more
On May 12, 2020, the United States Patent and Trademark Office issued over 700 new design patents. Fashion-related designs figured prominently among the new patent grants including accessories like eyeglasses (see U.S. Design...more
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a memorandum of understanding (MOU), to jointly regulate the...more
3/21/2019
/ Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Meat Inspection Act (FMIA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Memorandum of Understanding ,
Poultry Products Inspection Act (PPIA). ,
Regulatory Oversight ,
USDA
It was recently reported that China had successfully cloned a 12-year old schnauzer — the most recent of over 20 dog breeds successfully cloned by the nation so far. "Doudou" the schnauzer was cloned through somatic cell...more
11/9/2018
/ Bioengineering ,
Biotechnology ,
China ,
Clones ,
DNA ,
Dogs ,
Ethical Standards ,
Genetic Materials ,
Innovative Technology ,
Life Sciences ,
Patent-Eligible Subject Matter ,
Patents ,
Regulatory Oversight ,
USPTO
Fashion Week San Diego is this weekend—one of the few fashion shows open to the fashion industry and the general public! Fashion shows are exhilarating. As an intellectual property (“IP”) attorney, however, fashion shows...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
On July 2, 2018, the Federal Circuit Court of Appeals affirmed the decision of the Patent Trial and Appeal Board holding that some of the claims relating to artificial glands and various methods of creating them were not...more
Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more
Until the cloning of Dolly the sheep in 1996 by scientists at the Roslin Institute, the idea of cloning a mammal, let alone a human being, was an idea relegated to science fiction. Dolly was created using a technique known as...more
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells from a donor (such as skin cells), and differentiating the...more
5/25/2018
/ America Invents Act ,
Foreign Patent Applications ,
Human Genes ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Method Claims ,
Patent Cooperation Treaty ,
Patent-Eligible Subject Matter ,
Patents ,
Product of Nature Doctrine
A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro...more
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more
On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more
Edited by Catherine Holland What is a Utility Patent? Utility patents cover a new and useful process, machine, manufacture, or composition of matter. Design patents are much more common in the fashion industry since design...more
On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment of moderate-to-severe plaque psoriasis patients who are candidates for...more
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016...more
Does the use of Google AdWords amount to the advertising, promoting, marketing, or offering for sale of goods covered by a registered trademark? Tipsy Elves, LLC. vs. Ugly Christmas Sweater, Inc. is the latest in a string of...more
6/8/2017
/ AdWords ,
Consumer Confusion ,
Deceptive Intent ,
False Advertising ,
Fashion Industry ,
Google ,
Keyword Advertising ,
Lanham Act ,
Trademark Infringement ,
Trademarks ,
Young Lawyers