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The U.S. Patent and Trademark Office (“USPTO”) Acting Director’s recent decision to deny institution of inter partes review (“IPR”) in iRhythm Technologies Inc. v. Welch Allyn Inc. offers valuable lessons for both patent...more
In a recent decision with important implications for artificial intelligence (AI) driven innovation, the Patent Trial and Appeal Board (PTAB) denied a patent for an AI-based medical tool. The refusal was not because the...more
The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more
After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more
On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more
As predictions of an economic recession in the United States loom, 2023 has started with extensive layoffs throughout the tech industry. Though not to an equal degree, the biotechnology, pharmaceutical, and life science...more
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent...more
Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more
Newly released statistics (2015-06-30 PTAB Statistics) from the USPTO reveal that the number of bio/pharma IPR challenges almost doubled in 2015, even though fiscal year 2015 still has three months to go. Last year, there...more
Case Name: Novartis Pharms. Corp. v. Watson Labs., Inc., Fed. Cir. Nos. 2014-1799, -1800, 2015-1061, -1062, -1120, -1121, -1141, 2015 U.S. App. LEXIS 8374 (Fed. Cir. May 21, 2015) (Circuit Judges Lourie, Taranto, and Hughes...more
In a landmark judgment delivered on April 1, 2013, the Supreme Court of India dismissed an appeal by Novartis AG, a Swiss pharmaceutical giant, to win patent protection in India for its cancer drug Glivec. The polarizing...more