While most brand owners understand the importance and value of registered trademarks in safeguarding the goodwill between themselves and consumers, not all might be fully aware of the comprehensive protection offered by another intellectual property right: design patents. Trademarks, in their own right, play a crucial role in curtailing consumer confusion regarding the source of…
In a significant development in pharmaceutical patent litigation, the case of Astellas Pharma Inc. v. Sandoz Inc., Civ. No. 20-1589, has been making waves across the legal landscape. The argument revolves around the drug Myrbetriq® (mirabegron) and U.S. Patent No. 10,842,780 (the ’780 patent). The proceedings were held in the Delaware District Court, on June…
Notable recent events in the U.K. legal sector cover an array of issues, brought into focus by corporations from varied industries. Tech giants Lenovo and Motorola took their patent disagreement with InterDigital to the U.K., related to wireless tech. The case captures the perpetual challenge of patent delineation in the ever-evolving tech industry. Additionally, litigation…
In a recent development, Nexus Pharmaceuticals, LLC has confirmed its procurement of approval from the U.S. Food and Drug Administration (FDA) for their Fluorescein Injection, USP. The announcement was made on September 26, 2023, further establishing the company’s reputation as a producer of generic drugs. Knobbe Martens reports the essential details. Fluorescein is a synthetic…
In what appears to be a trend, the 5th Circuit Court has once again placed a law into immediate effect despite it having already been ruled unconstitutional by a district court. This move came without any explanation as to why the appeals court would disregard the detailed reasoning provided by the district court judges arguing…
In an increasingly competitive market, corporations and law firms must consistently distinguish their products and services from those of their competitors. One often underutilized tool for achieving this distinction is Trade Dress Protection. This legal framework protects the visual appearance of a product or its packaging that signifies the source of the product to consumers….
Welcome to the September 2023 issue of MarkIt to Market®. This month’s edition brings attention to two prime areas of legal development: revisions to the Federal Trade Commission’s guidelines for endorsements and the merit of design patent protection harmonizing with trademark protection. The Federal Trade Commission (FTC) is redrawing the landscape of influencer marketing with…
In the case of In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.), the drug product and patent(s)-in-suit include Bridion® (sugammadex sodium) and U.S. Patent No. RE44,733 (the ‘733 patent). The detailed report of this case can be found here. Sugammadex (marketed as Bridion) is an important innovation in…
In a significant recent decision, the US Court of Appeals for the Federal Circuit addressed a question of first impression regarding the realm of prior art relevant to design patent infringement analysis. The court concluded that to be considered suitable as comparison prior art, an existing design must be applied to the article of manufacture…
The US Patent and Trademark Office (PTO) published a freshly updated Oral Hearing Guide on August 31, 2023, with the aim of assisting parties through oral arguments before the Patent Trial and Appeal Board. This latest publication is a revision of the 2019 Oral Hearing Guide, which was published on August 30, 2019. Designed to…
The looming threat of a U.S. federal government shutdown on October 1, 2023 is throwing both patent and trademark holders into uncertainty. This is due in part to ongoing debates in Congress over funding for Federal Fiscal Year 2024 (FFY24). JD Supra has reported on the issue, significantly drawing attention to how the situation could…
The intricate landscape surrounding the protection of artificial intelligence (AI) inventions continues to evolve, meriting robust discussion among legal professionals. A case that neatly illustrates this topic is IBM v. Zillow, where IBM accused Zillow of infringing on seven of its artificial intelligence patents, specifically designed for assessing property values. The focus of our analysis…
A California federal judge has granted summary judgment to Qualcomm Inc. in the antitrust multidistrict litigation concerning the chip manufacturer’s “no license, no chips” policy. This case has attracted significant attention due to Qualcomm’s status as both a manufacturer of cellphone chips and a licenser of essential patents within the industry. The plaintiffs in the…
September 21, 2023, commemorated the sixth year since substantial alterations were made to the Patented Medicines (Notice of Compliance) Regulations in Canada. The regulations play a critical role in Canada’s pharmaceutical industry, providing balance between encouraging innovative drug development and safeguarding the accessibility of cost-efficient generic alternatives. The sixth anniversary also serves as a juncture…
In a significant development in biotechnology patent law, biotech genus claims defined solely by function are proving exceedingly difficult to enable. This has been evidenced time and again in recent court verdicts, continuing a trend set forth in the aftermath of Amgen v. Sanofi.Baxalta Incorporated v. Genentech Inc. is the latest in a series of…
As the legal world turns its gaze towards the ongoing litigation between REGENXBIO Inc. and Sarepta Therapeutics, the latest developments come in the form of a scheduling order issued by the courts. This order comes after a claim, filed in Delaware in June 2023, by both REGENXBIO Inc. and the Trustees of the University of…
Law professionals are often called upon to navigate the intricacies of intellectual property (IP) licensing. It is a domain that requires a comprehensive understanding of various legal elements and practical considerations. It is with this need for expertise in view that an upcoming event has garnered significant attention among legal circles. The Hybrid Event: Understanding…
In a recent patent case twist, Judge Failla of the Southern District of New York rejected Amtrak’s motion to dismiss in a case involving claims directed at train-traffic-control systems. Amid allegations from Amtrak that Railware, Inc.’s patent claims were directed to an abstract idea, Judge Failla stood firm in denying the motion. This case, entitled…
The ongoing case of Sanofi-Aventis U.S. LLC v. Sandoz, Inc. still prompts various legal discussions among experts. The backdrop of the case revolves around the drug Jevtana® (cabazitaxel), and specifically the U.S. Patent No. 10,716,777, simplified as the ‘777 patent. Case details reveal that the lawsuit was filed as Sanofi-Adventis U.S. LLC against Sandoz, Inc.,…
On May 18, 2023, a groundbreaking verdict was reached in the Supreme Court case Amgen Inc. v. Sanofi. The court unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of antibodies with unknown amino acid sequences. This marks a significant milestone…
In a notable development in the legal regulation governing intellectual property, the Federal Circuit has reconsidered its standard for the enablement of antibody claims. At the center of the case, Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit upheld the district court’s decision, confirming Genentech’s motion for summary judgment, which determined that claims 1-4,…
In the latest legal update, we direct your attention towards the recent Federal Court cases of September 2023. An appeal that stands out among these is “Baxalta Inc. v. Genentech, Inc.”, referenced as Appeal No. 22-1461. The case unfolded on September 20th, 2023. The primary point of interest revolves around the ‘enablement’ requirement, marking its…
The FDA’s Center for Biologics Evaluation and Research (CBER), a unit responsible for regulating cell and gene therapies in the ever-evolving biotech sector, is currently on the brink of significant transformation. This change is anticipated across several fronts – leadership, significant growth, and new measures to tackle complex scientific and regulatory issues. CBER maintains a…
In a recent Federal Circuit ruling, Baxalta Inc. v. Genentech, Inc., ongoing debates about patent rights and the ways U.S. patent law applies continue to evolve. This application is centered on preventing innovators from acquiring patent rights that extend beyond the bare minimum they may be entitled to. Let’s explore this further. The specifics of…
In the recent ruling of Baxalta Inc. v. Genentech, Inc, the Federal Circuit affirmed the District of Delaware’s grant of summary judgment regarding the lack of enablement for broad antibody claims. This judgement upheld the Supreme Court’s precedent set in Amgen Inc. v. Sanofi, maintaining that antibody claims that specify functionality rather than structure lack…