A Patent Must Describe What Is Claimed, Not What Infringes
NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC. Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack...
No Patent-Like Claims Under State Law
BearBox, LLC, Austin Storms, v. Lancium LLC, Michael T. McNamara, Raymond E. Cline, Jr. Before Chen, Bryson, and Stoll. Appeal from United States District Court for the District of Delaware....
Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
Unsupported Expert Testimony Cannot Create a Genuine Issue of Material Fact
MIRROR WORLDS TECHS., LLC v. META PLATFORMS, INC. Before Prost, Taranto, and Stark. Appeal from the United States District Court for the Southern District of New York. Summary: Expert testimony...
Bound to Happen: Inherent Property Leaves No Question of Reasonable Expectation of Success
CYTIVA BIOPROCESS R&D AB V. JSR CORP. Before Prost, Taranto, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: A claim limitation merely reciting an inherent property or...
“Quotation” Letter Found to Constitute Offer Invalidating Patents
CROWN PACKAGING TECHNOLOGY, INC. v. BELVAC PRODUCTION MACHINERY, INC. Before Dyk, Hughes, and Cunningham. Appeal from the United States District Court for the Western District of Virginia. Summary: An offer for...
An Award of Attorneys’ Fees and Costs Under 35 U.S.C. §285 Does Not Preclude Sanctions Pursuant to the Court’s Inherent Authority
PS PRODUCTS INC. V. PANTHER TRADING CO. INC. Before Moore, Stoll, and Cunningham. Appeal from the Eastern District of Arkansas. Summary: Section 285 does not prohibit an award of deterrence...
Deleted Definition “Highly Significant” for Claim Construction
DDR HOLDINGS, LLC V. PRICELINE.COM LLC, BOOKING.COM B.V. Before Chen, Mayer, and Cunningham. Appeal from the United States District Court for the Northern District of Delaware. Summary: Deleting a definition...
End of an Era: The After Final Consideration Pilot Program 2.0 Concludes
The sun is officially setting on the United States Patent and Trademark Office’s (USPTO) After Final Consideration Pilot Program 2.0 (AFCP 2.0)[1]. This program, which has been instrumental in facilitating...
Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in...
Building Bridges: How Patent Pathways is Shaping a Diverse IP Future
In this episode of the Knobbe IP+ podcast, Knobbe Martens Chief Diversity & Talent Development Officer Terra Davis speaks with guest Elaine Spector, Harrity & Harrity partner and Advisory Board...
CDRH Announces Pilot Program to Improve Recall Communication
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for...
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial intelligence...
Medical Device Deal Activity Shows Signs of Life for Q3 2024
Market reports indicate the global medical device industry for Q3 2024 saw an increase in merger and acquisition (M&A) activity in terms of value year-over-year. Although deal value decreased compared to...
Teva v. Amneal Oral Arguments and Claim Construction Order: Recent Developments in the Ongoing Debate Over the Orange Book Listing of Device Patents
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8,...
Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson[1], the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal...
The Intersection of FRAND Obligations and Anti-Suit Injunctions
TELEFONAKTIEBOLAGET LM ERICSSON v. LENOVO (UNITED STATES), INC. Before Lourie, Prost, and Reyna. Appeal from the Eastern District of North Carolina. Summary: The threshold requirement for anti-suit injunctions, that the...
Resolving Claim Construction Dispute at 12(b)(6) Stage May Be Error if Specification Indicates Claim Term Does Not Have its Plain Meaning
UTTO INC. v. METROTECH CORP. Before Prost, Taranto, and Hughes. Appeal from the United States District Court for the Northern District of California. Summary: The district court erred in construing...
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected.
Nobel Prize in Medicine Awarded to American Scientists for Discovery of microRNA
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of microRNA, a new class of small noncoding RNA molecules, and the role microRNAs play in turning genes on and off, known as gene regulation.