Podcast - The FTC Takes Action Against Old Southern Brass for False "Made in the USA" Claims
Podcast - FTC's Approach to Made in the USA Claims
Proposition 65 – Changes That Will Impact the Cannabis Sector
PODCAST: Williams Mullen's Trending Now: An IP Podcast - False and Misleading Advertising, Label Review
Cannabis Counsel Cast: What Cannabis Companies Need to Know About California’s Prop. 65 (Even if They Aren’t in California)
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely
Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
If you are a patent holder and are selling a product covered by your patent, please remember to mark your products. The purpose of patent marking is to give notice to the public that the product being sold is patented. If...more
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
As we continue to assess the ripple effects from the Supreme Court's denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of...more
In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...more
On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
Generic pharma and companies interested in new uses for old drugs alike include skinny labels – labels which do not recite uses for the drug that remain covered by a competitor’s patent – as part of their intellectual...more
Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more
On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021,...more
A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23. Back in...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more
Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals. In so doing, the label would closely reflect limitations in the asserted patent claims...more
THE DISTRICT COURT’S FINDINGS REGARDING INDEFINITENESS, NON-INFRINGEMENT, AND NON-OBVIOUSNESS WERE AFFIRMED BY THE APPELLATE COURT. Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153,...more
HZNP Medicines LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc. Before Prost, Newman, and Reyna. Appeal from the District Court for the District of New Jersey. Summary: Claims using “consisting...more
In a Hatch-Waxman case involving patents directed to a polymorphic compound for a treatment for polyneuropathic pain, the US Court of Appeals for the Federal Circuit affirmed a district court finding that a patent was not...more
As 2019 is underway and the government is back up and running (at least for now), we have summarized for you key developments from 2018 and projections for 2019 on issues that we have been monitoring closely in the cosmetics...more
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more
Federal Circuit Summaries - Before PROST, WALLACH, and TARANTO. Appeal from the District of Delaware Summary: (1) A party may not avoid inducement based on “substantial non-infringing uses,” and (2) prosecution history...more
FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more
Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more
Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more
In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more
“Common Sense” Alone Is Not a Sufficient Motivation to Combine References - In In Re: Van Os, Appeal No. 2015-1975, the Federal Circuit held that the Patent Trial and Appeal Board’s reliance on intuition or common sense...more