Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
As noted in the first article in our Medtech Coming to America series, “US Emerging as Top Global Medtech Destination,” perceived regulatory advantages are prompting European medtechs to enter the US market earlier in their...more
The doctrine of equivalents (DOE), a creation of the Supreme Court in Graver Tank & Mfg. v. Linde Air Products (1950), is balanced by the concept of prosecution history estoppel (PHE), the contours of which were delineated...more
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more
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
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
Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...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
For sale, or not for sale- That is the question in Larry G. Junker v. Medical Components Inc. et al., case that started in the U.S. District Court for the Eastern District of Pennsylvania and which has now been appealed to...more
A recent Federal Circuit decision, Junker v. Med. Components, Inc., No. 2021-1649 (Feb. 10, 2022), serves as a warning to prospective filers that making pre-filing offers for sale, or engaging in discussions for future sales,...more
Publication of an algorithm prevents the algorithm from being a trade secret, right? Not necessarily. The Federal Circuit just reminded us that under certain circumstances that may not be the case. ...more
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the...more
The U.S. Patent and Trademark Office (USPTO) allows a patent applicant to pay reduced fees if it qualifies as a “small entity.” Many types of filing fees are reduced by 50%. These savings can be important for companies on a...more
On May 6, 2021, the Brazilian Supreme Court determined that the minimum ten-year patent term set forth in Article 40 of the Brazilian Intellectual Property Statute (Law No. 9,279) was unconstitutional (ADI 5529), and, on May...more
The importance of medical diagnostic technologies has been brought to the fore with the COVID-19 pandemic. Rarely does a day pass when the media does not report on matters of approval and availability of tests, testing...more
Partner Hussein Akhavannik breaks down specific patent protection and clearance strategies for each stage of medical device development, from concept and design to the manufacturing and sale....more
The Canadian Intellectual Property Office (CIPO) has launched a pilot program to provide accelerated examination of Canadian patent applications concerning medical technology related to COVID-19 and for which Health Canada...more
Traditionally, it has been fairly uncommon to see new legislation in intellectual property (IP) law, compared to other areas of law. Instead, courts have generally been the avenue through which changes in IP law have been...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
Patent activity provides an important signal that is helpful in identifying and forecasting industry trends including the development of new products and services. It can predict the future focus of individual competitors...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
Addressing pre-America Invents Act (AIA) 35 USC § 102(b), the US Court of Appeals for the Federal Circuit held that the public-use and on-sale bars did not apply to the claimed surgical method because pre-critical-date...more
At the recent ACC-Socal Double Header Event, Knobbe Martens presented, "CardiAQ - An IP Success Story." ...more
Most people are familiar with blockchain technology because of its use in cryptocurrency, but its use is going to be far more widespread than just as a ledger for digital currency. As explained in a previous blog post,...more
Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D information, technical know-how, and intellectual property....more
Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more