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.
Read the Fine Print: Federal Circuit Vacates Dismissal of Patent Infringement Claims Based on an Express License, Where Some Transactions Could Fall Within the Scope of the Claims Yet Remain Unlicensed
ALEXSAM, INC. v. ATENA, INC.
Before Stark, Lourie, and Bryson. Appeal from the United States District Court for the District of Connecticut.
Summary: A narrowly defined patent license may result in some activity falling within the scope of the patent claims, but outside the scope of the license. Additionally, a trial court’s determination that an allegation in a complaint is merely conclusory and need not be taken as true when evaluating a motion to dismiss is reviewed de novo.
Women’s Health Medical Device Company Caldera Medical Acquires UVision 360
Caldera Medical, Inc. on October 8th, 2024, announced the acquisition of UVision 360, Inc. Caldera Medical develops medical devices for women’s health, including surgical products for the treatment of stress urinary incontinence, pelvic floor disorders, pelvic organ prolapse, and hysteroscopic removal of intrauterine tissue. UVision 360 is a developer of in-office hysteroscopy systems for evaluating and treating uterine conditions.
Vertos Medical Latest Acquistion in Stryker’s M&A Streak
Medical technologies giant Stryker announced on Tuesday, October 1st, that it completed the acquisition of Vertos Medical for an undisclosed amount. Vertos Medical is a privately held company specializing in interventional pain management solutions for chronic back pain caused by lumbar spinal stenosis.
Falsely Claiming Patent Protection May Violate the Lanham Act
CROCS, INC. v. EFFERVESCENT, INC.
Before Reyna, Cunningham and Albright. Appeal from the United States District Court for the District of Colorado.
Summary: A claim that an unpatented product feature is “patented,” “proprietary,” or “exclusive” may violate Section 43(a)(1)(B) of the Lanham Act.
Cook Medical Sells Lead Management Portfolio to Merit Medical
Cook Medical recently announced it is selling its lead management portfolio to Merit Medical. Cook Medical is a medical device manufacturer with a portfolio of products used in lead management procedures, including for patients who need a pacemaker or an implantable cardioverter-defibrillator lead removed or replaced. Merit Medical is a manufacturer of disposable medical devices and has products used in interventional, diagnostic, and therapeutic procedures, including in the fields of cardiology, critical care, endoscopy, oncology, and radiology.
Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
Getinge Acquires Paragonix Technologies
Getinge, a Swedish public limited company, announced on September 11, 2024 that it completed acquisition of Paragonix Technologies, Inc., a U.S. company specializing in organ transport products and services. According to Getinge’s press release, the total purchase price was $477 million.
FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease (Cgvhd)
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 Syndax Pharmaceuticals), for treatment of chronic graft-versus-host disease (cGvHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Tying Claimed Technological Advancements to Specific Technological Methods Is a Winning POV on Patent Eligibility
CONTOUR IP HOLDING LLC v. GOPRO, INC.
Before Reyna, Prost, and Schall. Appeal from the United States District Court for the Northern District of California.
Summary: Claims are patent-eligible under 35 U.S.C. § 101 where the written description discloses improving technology through specific technological means and the claims reflect that improvement.
Combining Abstract Ideas Does Not Make Them Less Abstract
BROADBAND ITV, INC. v. AMAZON.COM, INC.
Before Dyk, Reyna, and Stark. Appeal from the United States District Court for the Western District of Texas.
Summary: When assessing patent eligibility under 35 U.S.C. § 101, combining two abstract ideas does not make either less abstract, and conventionality can be analyzed at both steps of the Alice test.