FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product...
Stryker Acquires Inari Medical for $4.9 Billion
Stryker Corporation (“Stryker”) recently announced that it has entered into a definitive agreement to acquire Inari Medical, Inc. (“Inari”) for approximately $4.9 billion. Inari develops technologies and products for treating pulmonary embolism, deep vein thrombosis, in-stent...
A Published Patent Application Is IPR Prior Art as of Its Filing Date
LYNK LABS, INC. v. SAMSUNG ELECTRONICS CO., LTD. Before Lourie, Prost, and Stark Summary: In an IPR, a patent application is considered a “printed publication” as of the application’s filing...
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...